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Innovation Inventors Patent Law Uncategorized

Artur Fischer's Life Illustrates the Power of Invention

Whether taking a photograph, hanging a picture, or doing some work around the house, it’s easy to take for granted all the inventions that make our lives better on a daily basis. But the devices, tools and machines we use every day are all the products of creative genius, hard work and constant innovation. Look around you and you’ll see countless devices that were once the brainchild of a visionary who was able to put his or her idea into practice, secure a patent, and improve the world. One of these visionaries just passed away, and it’s important to recognize him and the patent system that facilitated his extraordinary life in creation.

Artur Fischer is considered one of the greatest inventors of all time, with over 1,100 registered patents. The New York Times recently ran an obituary detailing his life and highlighting many of the inventions that would become regarded as some of the most resourceful of the 20th century and would earn him comparisons to Thomas Edison.

The obituary notes that while Artur Fischer was a locksmith by training, he was a compulsive tinkerer and patented his first invention when he created a synchronized mechanism that triggered a camera flash when the shutter was released. Although Fischer may not have considered himself an inventor at the time, he was looking for a better way to photograph his infant daughter and decided to take matters into his own hands. It wasn’t long before a large camera company bought his device and Fischer was able to dedicate his life and career to coming up with hundreds of solutions to nagging technical problems.

Fischer’s path from mundane job to innovating genius is one that has been repeated by the world’s most respected thinkers and inventors (think Albert Einstein at the Swiss patent office), and one that would not be possible without a strong patent system and assurances in intellectual property rights. Had Fischer not been able to secure a patent in his synchronized flash photography trigger, and subsequently profit from the sale to a large company, he may have just returned to his job as a locksmith and not pursued a passion that led to so many beneficial creations.

Fischer kept tinkering and inventing well into his 80s, telling a German magazine in 2007, “I am interested in any problem to which I can provide a solution.” In 2014, the European Patent Office presented him with a lifetime achievement award recognizing a creative mind and imaginative spirit that only comes along once in a generation. Artur Fischer’s life is a testament that when a great innovator is supported by a patent system that respects and encourages his work, the sky is the limit.

 

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Administrative Agency Innovation Inventors Patent Law Patent Litigation Uncategorized

#AliceStorm: When It Rains, It Pours…

The following guest post from Robert R. Sachs, Partner at Fenwick & West LLP, first appeared on the Bilski Blog, and it is reposted here with permission.

By Robert R. Sachs

Last year I christened the post-Alice impact on patents #Alicestorm, riffing on the hashtag #hellastorm used to refer to the Pineapple Express storms the drenched the Bay Area in December 2014. This year we have El Niño bringing day after day of rain, and so too we have Alice decisions coming down in sheets. Here is a comparison of number of decisions per month since Alice.

Table 1 Quarterly Numbers

On average, we’re seeing about eleven Section 101 decisions per month in the federal courts. The overall success rate has been holding in the low 70% range, currently 72.1% (down from 73% in October). Similarly, motions on the pleadings continue with an equally strong success rate of 71.7% (down from 71.9%):

Table 2 Summary

The number of patents invalidated has increased dramatically from 354 as of October 2015 to over 400, while the number of invalidated claims is now over 12,000. The courts routinely invalidate all of the claims of a patent based on a single “representative” claim, including all dependent claims regardless of their level of specificity. This seems entirely contrary to the notion that dependent claims necessarily narrow the broad and presumably abstract independent claims, and likely provide at least some features that are “significantly more” then than the abstract idea, as well as recitations that are non-generic technology that provides some “improvement” over the art. Is it really possible that so many thousands of dependent claims had no merit? If dependent claims are hedges against invalidity under Section 103, why do they have so little bearing under Section 101?

PTAB continues to be the points leader on the board, with the institution rate on Section 101 based Covered Business Method petitions climbing to 84.8% (up from 83.7%) and an unbroken string of 38 final decisions on Section 101 finding the challenged patent ineligible.

The motion analysis remains consistent with what we’ve seen before:

Motions

The most active courts and judges, by number of Section 101 decisions, are in Delaware with 35 decisions (Andrews, Robinson, Stark, Sleet, Burke) and Texas with 29 (Gilstrap, Payne, Mitchell, Schroeder).

Judges

The number of new patent cases filed climbed in 2015, including a large filing spike at the end of November, 2015 due to the elimination of Form 18, which required only the basic allegation that the plaintiff owned the patent and that the defendant infringed, without any substantive allegations. As a result, we expect to see the continued stream of Section 101 motions and ineligibility outcomes.

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Innovation Inventors Patent Law Uncategorized

Jennifer Lawrence Movie “Joy” Highlights the Need for Patent Protection

The following guest post comes from Rebecca Cusey, a second year law student at George Mason University School of Law and a movie critic at The Federalist.

By Rebecca Cusey

Rebecca_Cusey_Headshot

There are two patents in the movie “Joy”: the one the titular character failed to get and the one for which she is willing to fight tooth and nail.

The first, for an idea she had in high school to improve dog collars, fills her with regret as she sees a similar product successfully sold in shops. As a single mother working to care for not only her children, but her extended family, Joy instinctively knows that owning that idea and marketing the product would have put her life on a different track.

When she has an idea to vastly improve the household mop, she sets out to found a new business empire on ownership of her idea. Joy has a million ideas and the passion to see them through. What she does not have is experience with patents. Her main investor, who happens to also be her father’s girlfriend, gets some bad advice from a lawyer with no patent expertise. His cursory patent search turns up an owner of a similar idea in Hong Kong and his legal advice is to pay advance royalties to this owner.

The owner’s United States representative is only too happy to take her money and, furthermore, he has connections with a factory that can make the parts for her product. A match made in heaven!

However, Joy increasingly loses confidence in the manufacturer. When she flies out to investigate, she discovers the representative is taking steps to fully patent her idea himself and freeze her out. She learns that paying him royalties may have weakened her legal claim to the patent.

That’s when Jennifer Lawrence goes all black leather and aviator sunglasses. She becomes a bad-to-the-bone (but still legal) heroine, an infringer avenger, and a crusader for intellectual property rights. Joy is going to fight to own her idea for a better mop.

The movie does an excellent job of showing why it matters. The mop is more than a mop. It is literally the roof over her kids’ heads. She has taken financial risks, put all her assets into her invention. That alone is enough, but there is more to it than that. Her lifelong dream has been to invent ways to make the world better. An innovator is who she is, down in her core. If some fly-by-night outfit can just take her idea, they take something from her that is the essence of who she is.

Sadly, perhaps, for patent lawyers, and probably only for patent lawyers, the final battle of the film does not happen in a courtroom. Joy finds, shall we say, alternate means of protecting her property. The point stands, however, in a surprisingly ringing endorsement of intellectual property rights. The idea for the mop belongs to Joy and no one has the right to take it from her.

In fact, the movie notes that, in the years after winning her first battle, Joy Mangano secured over a hundred patents. One became the highest selling product ever on the Home Shopping Network. Not bad for a girl who started with just with an idea and a dream.

Written and directed by David Russell and starring Jennifer Lawrence, Bradley Cooper, and Robert Di Nero, Joy is currently playing in theaters.

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Economic Study Innovation Inventors Legislation Patent Law Uncategorized

How Patents Help Startups Grow, Innovate, and Succeed

Many academic studies of the patent system focus on the negative, extrapolating from anecdotes about a few bad actors to make the case that our patent system is broken and to bolster cries for legislation weakening patent rights. Precious few studies focus on the countless honest and hardworking patent owners whose inventive labors benefit us all. But understanding how patents support inventive enterprises is a crucial part of the equation, especially at a time when Congress is considering legislation that would make it extremely difficult for startups and individual inventors to enforce their patent rights.

In a newly-published working paper, The Bright Side of Patents, CPIP Edison Fellow Deepak Hegde, along with co-authors Joan Farre-Mensa and Alexander Ljungqvist, take a look how patents help startups grow. They show that, contrary to the claims made by several academics and activists, startups are not victims of the patent system. On the contrary, patents help startups become more successful and innovative.

The study finds that “patent approvals help startups create jobs, grow their sales, innovate, and eventually succeed.” When a startup’s first patent application is approved, its employment growth increases by 36% and its sales growth increases by 51% on average over the next five years. First-patent approval also has a strong causal effect on a startup’s continued ability to innovate, increasing the number of subsequent patent grants by 49% and increasing the quality of those patents by 27%. In fact, a startup with first-patent approval is twice as likely to end up listed on a stock exchange—a common indication of success for a startup.

Negatively affecting startups are delays in the patent application process and ultimate application rejections. For every year an ultimately-approved patent application is delayed, the startup’s employment growth decreases by 21% and its sales growth decreases by 28% on average over the following five years. Furthermore, each year a patent application is delayed, the average number of subsequent patents granted decreases by 14% while the quality of those patents decreases by 7%. And for each year of delay, the probability that a startup will go public is cut in half.

One big reason why patents help startups is that they make it easier to access capital from external investors. The authors find that patents serve to mitigate frictions in information between potential investors and startups. Patents play an important role by alleviating startups’ concerns about having their inventions misappropriated by investors and by alleviating investors’ concerns about the credibility, quality, and monetary future of the startups. Having access to capital in turn sets startups on a path of growth where they can turn ideas into products and services, generate jobs, increase revenue, and undertake further innovation.

What makes this study unique is its unprecedented access to the USPTO’s internal databases, which allowed the authors to evaluate detailed review histories of both approved and rejected patent applications. Prior studies only focused on approved applications, thus making it impossible to accurately separate out the economic and innovative effects. The authors here are able to demonstrate the direct benefits of patent protection with causal evidence from a large-sized sample—45,819 first-time patent applications filed by startups.

There is a surprising amount of criticism of the patent system today. Some claim that patents are a waste of time and resources for startups, useful only for defensive purposes. Others claim that patents actually harm startups. The authors here show that startups that secure patent protection are in fact more likely to succeed. As Congress considers yet another round of large-scale patent legislation, lawmakers need to understand the role that enforceable patent rights play in enabling startups to grow and succeed. This study is a great step in adding some much needed clarity to the ongoing patent policy debates.

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Administrative Agency Innovation Inventors Patent Law Patent Litigation Uncategorized

#AliceStorm for Halloween: Was it a Trick or a Treat?

The following guest post from Robert R. Sachs, Partner at Fenwick & West LLP, first appeared on the Bilski Blog, and it is reposted here with permission.

By Robert R. Sachs

Alice has been busy the last two months, continuing to haunt the federal courts and the Knox and Randolph buildings at the USPTO. Here are the latest #AliceStorm numbers through the end of October 2015:

There have been 34 district court decisions in the past two months, but the percentage of invalidity decision is holding constant at 70.5%. The number of patent claims invalidated is now over 11,000, but also holding steady at around 71%.

There have been no new Federal Circuit Section 101 decisions, but we’re going to see a flurry of activity in the next couple of months, as the court has recently heard oral argument in a number of patent eligibility cases, and more are on calendar for November.

Motions on the pleadings have soared, with 23 in the past two months alone, and the success rate is up a tick from 70.1% to 71.4%.

PTAB is a bit mixed: the CBM institution rate is down from 86.2% 83.7%, but the final decision rate is still 100%, with 6 decisions in the past two months invalidating the patents in suit.

Turning to the motion analysis, the motions on the pleadings are the second scariest thing to a patent holder after the specter of attorney fees under Octane Fitness:

The Delaware district court continues as the graveyard of business methods and software patents, with 31 eligibility decisions, up from 19 just two months ago, and their invalidity rate is up from 86.4% to 90.3%.

Jumping into second place is the Eastern District of Texas, with 23 decisions total (up from 16). Contrary to the rest of the rest of the bench, their invalidity rate is 34.8%. The Northern District of California edged up from 75% to 78.9% invalidity, and C.D. Cal is up almost 2%.

And finally, here is the run down on the all district court judges with two or more Section 101 decisions.

With today’s blog, I’m introducing some entirely new types of data, looking at the characteristics of the patents that have been subject to Section 101 motions.

As expected, business method patents are the most heavily litigated and invalidated (click to see full size):

The distribution of patents in terms of earlier priority dates shows a very large fraction of the invalidated patents were first filed in 2000:

Now compare that to the distribution of patent classes with respect to priority year as well:

Here too we see a very large number of the business method patents filed in 2000. I’ve coded all of the software related technologies as blue to group them visually.

Why the cluster around 2000? State Street Bank, which held that there was no rule against business method patents, was decided in mid-1998. As those of us who were practicing them remember, it took about two years before the impact of the decision was widespread. This was also the time of the Dotcom bubble when it seemed that just about everyone was starting up a business on Internet. Those two factors resulted in a surge of patent filings.

Of all the patents that have been thus challenged under Alice, only two have post-Bilski priority dates:

  • 8447263, Emergency call analysis system, filed in 2011, and litigated in Boar’s Head Corp. v. DirectApps, Inc., 2015 U.S. Dist. LEXIS 98502 (E.D. Cal., 7/28/2015). The court granted DirectApps motion to dismiss, finding the patent invalid.
  • 8938510, On-demand mailbox synchronization and migration system, filed in 2010, and litigated in BitTitan, Inc. v. SkyKick, Inc., 2015 U.S. Dist. LEXIS 114082 (W.D. Wash, 8/27/2015). BitTran’s motion for preliminary injunction was denied in part because of SkyKick successfully argued that BitTrans was not likely to succeed on the merits due to Alice problems.
  • 8,604,943; 9,070,295; 9,082,097; 9,082,098 and 9,087,313, all of which claim priority to March, 2012, and were invalidated just last week in MacroPoint LLC v. FourKites Inc., Case. No. 1:15-cv-01002 (N.D. Ohio, Nov. 5, 2015). The court invalided all 94 claims in these patents, as being directed to the abstract idea of “tracking freight.” While the last four patents were issued in June and July, 2015, none of them overcome an Alice rejection, and the court noted that “Nothing in the Reasons for Allowance dictate a finding that these concepts are inventive on the issue of patent-eligible subject matter.”

Over time we’ll see more post-Bilski patents being litigated, and then eventually a true test: a business method patent granted after Alice that overcame an Alice rejection. By my count, there are about 80 such patents thus far, and about another 90 that have been allowed. It will not be too long then before one of these patents is challenged under Section 101.

In my next column, I’ll review some very disturbing decisions by coming out of the Delaware district courts.

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Administrative Agency Innovation Inventors Patent Law Patent Litigation Uncategorized

Overview of Comments on the USPTO's July 2015 Update to the Interim Examination Guidance

The following guest post from Robert R. Sachs, Partner at Fenwick & West LLP, first appeared on the Bilski Blog, and it is reposted here with permission.

By Robert R. Sachs

In late July, the USPTO issued its July 2015 Update to the 2014 Interim Section 101 Patent Eligibility Guidance (IEG). The July 2015 Update addresses a number of the issues and concerns raised in the public comments to the IEG and is supposed to assist examiners in applying the 2014 IEG during the patent examination process. The July 2015 Update also includes a new set of examples of claims involving abstract ideas and sample analysis under the Mayo framework. The USPTO is seeking public comments on the July 2015 Update, and comments are due on October 28, 2015, via email at 2014_interim_guidance@uspto.gov.

Here is an overview of what I think are the key issues and concerns with the July 2015 Update. Feel free to use any of my analysis in your comments to the USPTO.

1. Requirements of Prima Facie Case and the Role of Evidence

A significant number of the public comments on the 2014 IEG noted that examiners have the burden to make the prima facie case that a patent claim is ineligible, and that the Administrative Procedures Act (APA) and Federal Circuit case law requires that this determination be made based on “substantial evidence,” and not examiner opinion. In particular, all of the public comments that addressed this issue stated that examiners should have to provide documentary evidence to support a conclusion that a claim is directed to a judicial exception or that claim limitations are well understood, routine, and conventional.

In the July 2015 Update, the USPTO responded by stating that whether a claim is ineligible is a question of law and courts do not rely on evidence to establish that a claim is directed to a judicial exception, and therefore examiners likewise do not need to rely on any evidence that a particular concept is abstract, or a fundamental economic concept, or even a law of nature. The USPTO’s reliance on the judicial model is legally incorrect. First, examiners are bound by the APA and judges are not. Second, that eligibility is a question of law does not mean that there are not factual issues, as well—it merely determines whether the court or a jury is to make the finding. Obviousness is likewise a question of law, but there are clearly factual issues involved. Third, when judges take judicial notice, they are making a finding of fact, and they must do so under the requirements of Federal Rules of Evidence, Rule 201, which states that “The court may judicially notice a fact that is not subject to reasonable dispute because it: … can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” This requirement is similar to the requirements of Official Notice set forth in MPEP 2144.03: “Official notice unsupported by documentary evidence should only be taken by the examiner where the facts asserted to be well-known, or to be common knowledge in the art are capable of instant and unquestionable demonstration as being well-known.” Thus, by its own logic, examiners should comply with the requirements of MPEP 2144.03.

As to the role of evidence, again the public comments that discussed this issue all took the position that examiners must cite authoritative documentary evidence, such as textbooks or similar publications to support a conclusion that a claim recites a judicial exception or that certain practices are well known, conventional or routine. The public comments on this issue all made the same argument: that the Supreme Court in Bilski and Alice cited references in support of their conclusions that the claims were ineligible.

In response to this uniform opinion, the USPTO maintained its position that citations of references was not necessary because the references in Bilski and Alice were technically not “evidence” since the Court is an appellate court, and further that the references were not necessarily prior art. This argument misses the point. Regardless of whether the references were evidence under the Federal Rules of Evidence, the Court felt it necessary and proper to cite them. Further, the Court did not cite references as prior art or suggest that they need to be prior art—rather, the Court cited the references as an authoritative basis to show that the claims were directed to longstanding, well-known concepts. That the Court did this not once, but twice, is strong guidance that the USPTO should follow suit.

Similarly, examiners should be instructed to accept and give substantial weight to documentary evidence submitted by applicants rebutting the examiner’s conclusions under either Step 2A or 2B of the Mayo framework. This includes declarations from the inventor or others showing that particular limitations are not considered judicial exceptions by a person of ordinary skill in the relevant technical or scientific community, or that claims limitations would be considered “significantly more” by such person, or that the claim limitations provide improvements to the art.

2. The Role of Preemption in the Mayo Framework

The majority of public comments stated that preemption is the core concern underlying the judicial exceptions to Section 101, and that the examiner should be required to establish that a claim preempts a judicial exception in order to find the claim ineligible. The USPTO again took an opposing view to this consensus interpretation, asserting that questions of preemption are inherently addressed in the two-part Mayo test. The USPTO also stated that “while a preemptive claim may be ineligible, the absence of complete preemption does not guarantee that a claim is eligible.” This has effectively eliminated arguments made by applicants that their claims were patent eligible because they did not preempt other practical applications of the judicial exception. Neither the Supreme Court nor the Federal Circuit has endorsed the concept that preemption does not matter given the Mayo framework. Instead, the courts continue to evaluate patent claims with respect to preemption even after the Mayo framework has been applied.

More significantly, the USPTO’s argument fails to address the more likely situation: that a claim blocks (preempts) only a narrow range of applications or implementations of the identified judicial exception. This is not merely a case of an absence of complete preemption; it is the absence of any significant degree of preemption at all. The Supreme Court recognized that preemption is a matter of degree and held that a claim is ineligible where there is a disproportionate risk that the judicial exception is fully preempted. In Alice, the Court stated:

The former [claims on fundamental building blocks] “would risk disproportionately tying up the use of the underlying” ideas, and are therefore ineligible for patent protection. The latter [claims with limitations that provide practical applications] pose no comparable risk of pre-emption, and therefore remain eligible for the monopoly granted under our patent laws.” 134 S.Ct. at 2354 (emphasis added).

Since by definition a claim must preempt something, it is only where the scope of the claim covers the full scope of the judicial exception that the claim is rendered ineligible. Judge Lourie, whose explanation of the Mayo framework in CLS v. Alice was directly adopted by the Supreme Court, put it this way:

Rather, the animating concern is that claims should not be coextensive with a natural law, natural phenomenon, or abstract idea; a patent-eligible claim must include one or more substantive limitations that, in the words of the Supreme Court, add “significantly more” to the basic principle, with the result that the claim covers significantly less. See Mayo 132 S. Ct. at 1294. Thus, broad claims do not necessarily raise § 101 preemption concerns, and seemingly narrower claims are not necessarily exempt. What matters is whether a claim threatens to subsume the full scope of a fundamental concept, and when those concerns arise, we must look for meaningful limitations that prevent the claim as a whole from covering the concept’s every practical application.

Thus, both the Supreme Court and the Federal Circuit use preemption as the mechanism to evaluate whether a claim is eligible or not by applying it on both sides of the question: ineligible if preemptive, eligible if not preemptive. In addition, over 100 district court decisions since Alice have expressly considered whether the claims preempt, even after applying the Mayo framework. If the Mayo framework inherently addressed the preemption issue as the USPTO asserts, there would be no reason for the courts to address it. Finally, by removing preemption from the Mayo framework, the USPTO has turned the framework into the sole test for patent eligibility—directly contrary to the Supreme Court’s holding in Bilski that there is no one sole test for eligibility.

Lourie’s statement that a claim is patent eligible when it includes “substantive limitations…with the result that the claim covers significantly less” than the judicial exception provides a simple and expedient basis for using preemption as part of the streamlined analysis–something the USPTO has resisted in the July 2015 Update. Examiners are well trained to evaluate the scope of a claim based on its express limitations. Accordingly, they can typically determine for the majority of claims that, whatever the claim covers, it has limitations that prevent it from covering the full scope of some judicial exception. If the point of the streamlined analysis is to avoid the unnecessary burden of the Mayo framework, then a preemption analysis provides the best way to achieve that goal.

Finally, to suggest that the Mayo framework is precise enough to be a definitive test is to ignore the obvious: both steps of the framework are undefined. See McRO, Inc. v. Sega of America,, Inc., No. 2:12-cv-10327, 2014 WL 4749601,at *5 (C.D. Cal. Sept. 22, 2014) (Wu, J.) (“[T]he two-step test may be more like a one step test evocative of Justice Stewart’s most famous phrase [‘I know it when I see it’].”). The Court refused to define the scope of abstract ideas in Alice (Step 2A), and Step 2B entails evaluating the subjective requirement of “significantly more” or “enough.” What is left, then, is analysis by analogy and example—and both common sense and life experience tell us that these approaches very often lead to mistakes. Analogies can be good or bad, and most examples can be argued either way. Preemption serves as a way of evaluating whether the outcome from such analysis is consistent with the underlying rationale for the judicial exceptions in the first place.

3. Abstract Ideas Must be Prevalent and Longstanding in the Relevant Community

The majority of public comments on the IEG argued that to establish that an idea is abstract, an examiner must show that the idea is “fundamental” in the sense of being “long-standing” and “prevalent,” following the statements of the Supreme Court. Various commentators suggested specific rules for examiners, such as evidence that the idea has been known and used in practice for a period of 25 or more years. Even those who supported a restrictive view of patent eligibility suggested that examiner should look to “basic textbooks” to identify abstract ideas.

The USPTO responded in the July 2015 Update by asserting that abstract ideas need not be prevalent and longstanding to be fundamental, arguing that even novel abstract ideas are ineligible: “examiners should keep in mind that judicial exceptions need not be old or long‐prevalent, and that even newly discovered judicial exceptions are still exceptions.” The USPTO stated that ”The term ’fundamental‘ is used in the sense of being foundational or basic.” This analysis begs the question. An idea is foundational or basic because it is widely accepted and adopted in the relevant community—it is fundamental to the practices of the community. Indeed, any textbook on the “foundations” of a particular scientific field would explain the principles and concepts that are long-standing and widely-accepted by scientists in that field. It would not be a significant burden on the examiner to cite to such publications to support a finding under Step 2A. Indeed, the inability of an examiner to do so would be strong evidence that a claim is not directed to a foundational or basic practice.

4. USPTO Reliance on Non-Precedential Federal Circuit Decisions

Public comments noted that the 2014 IEG included citations and discussions of non-precedential Federal Circuit cases, such as Planet Bingo, LLC v VKGS LLC, and SmartGene, Inc. v Advanced Biological Labs, and indicated that because the cases are non-precedential, they should not be cited and relied upon by the USPTO as the basis of its guidance to examiners. Further, it was pointed out that the 2014 IEG mischaracterizes the abstract ideas at issue in these cases.

For example, the USPTO characterizes SmartGene as holding that “comparing new and stored information and using rules to identify options” is an abstract idea. The Federal Circuit’s actual holding was much more specific: that “the claim at issue here involves a mental process excluded from section 101: the mental steps of comparing new and stored information and using rules to identify medical options.” The court itself unambiguously limited the scope of its decision: “[o]ur ruling is limited to the circumstances presented here, in which every step is a familiar part of the conscious process that doctors can and do perform in their heads.” Thus, the USPTO’s characterization removed key aspects of the court’s expressly-limited holding: that the comparing steps were inherently mental steps (not computer steps) performed by a doctor considering medical rules (not any type of rules) to evaluate medical options (not other types of options). The court’s ruling cannot be generalized to all types of comparisons on all types of information using all types of rules. The improper generalization of the court’s holding has resulting in examiners applying SmartGene to find many claims for computer-implemented inventions ineligible. This is because many, if not most, computer processes can be characterized as comparing stored and new information and applying a decision rule to produce a useful result. For example, most automobiles use computers and embedded software to monitor vehicle sensors and take actions. A typical fuel management computer compares a current measure of fuel (new value) with a predefined minimum amount of fuel (stored information) and determines whether to turn on a low fuel light (using rules to identify option). Under the USPTO’s characterization of SmartGene, a claim to such a process would be deemed an abstract idea, an obviously incorrect outcome.

The USPTO did not address any of the problems identified by the public comments regarding non-precedential cases. Instead, the July 2015 Update simply states that the “2014 IEG instructs examiners to refer to the body of case law precedent in order to identify abstract ideas by way of comparison to concepts already found to be abstract,” and makes multiple other references to precedent. Even so, the July 2015 Update relies repeatedly on non-precedential Federal Circuit decisions, such as Dietgoal Innovations LLC v. Bravo Media LLC, Fuzzysharp Technologies Inc. v. Intel Corporation, Federal Home Loan Mortgage Corp. aka Freddie Mac v. Graff/Ross Holdings LLP, Gametek LLC v. Zynga, Inc., Perkinelmer, Inc. v. Intema Limited, and Cyberfone Systems, LLC v. CNN Interactive Group, Inc.

The USPTO should eliminate any discussion of or reliance upon non-precedential decisions. In the alternative, the USPTO should at minimum explain to examiners that such decisions are limited to their specific facts and are not to be generalized into controlling examples or rules.

5. There is No Separate Category for Methods of Organizing Human Activity

Public comments to the 2014 IEG pointed out various issues with the category of “methods of organizing human activities” as a basis of abstract ideas, and in particular requested clarification as to which types of method would fall within the category. Here too there was a broad agreement among the commentators that the proper interpretation of Bilski and Alice: The Court found that the claims in Alice and Bilski were abstract ideas because they were directed to a fundamental economic practice, not because the claims were methods of organizing human activity. The Court noted that Bilski’s claims were methods of organizing human activity only to rebut Alice’s arguments that abstract idea must always be “fundamental truths.” The Court’s analysis does not logically imply that methods of organizing human activity are inherently abstract ideas.

The USPTO responded by broadly interpreting the scope of the category, stating that many different kinds methods of organizing human activity can also be abstract ideas, but providing no explanation (other than examples) to determine when this is the case and when is it not. The USPTO then mapped various Federal Circuit case into this category, even where the court itself did not expressly rely upon such categorization. For example, the USPTO listed buySAFE, DealerTrack, Bancorp, PlanetBingo, Gametex, and Accenture as examples of cases dealing with methods of organizing human activity. However, none of these cases actually held that the methods in suit were methods of organizing human activity. Instead, every single one of these cases held that the claims were abstract as either mental steps or fundamental economic practices. Attempting to map Federal Circuit cases into this category is both confusing to examiners and the public and unnecessary.

The USPTO should remove this category from the Guidance until such time as the Federal Circuit or the Supreme Court provides a clear definition of its bounds.

6. There is No Separate Category for “An Idea of Itself”

Public comments noted that this is catch-all category that the courts have mentioned in passing but have never provided any definition of its contours, and further suggested that the USPTO clarify that this is not a distinct category of abstract ideas.

In response, once again the USPTO broadly described the category and linked various Federal Circuit cases to it as examples, where the court itself never so characterized the invention. The USPTO lists in this category cases the court held to be ineligible in other categories, such as mental steps (Cybersource, Smartgene*, Classen*, Perkinelmer*, Ambry, Myriad CAFC*, Content Extraction); mathematical algorithms (In re Grams, Digitech); and economic activities (Ultramercial) (*indicates non-precedential decision). In fact, there is no precedential Federal Circuit or Supreme Court case that has defined “an idea of itself” as a distinct category. It is only mentioned in dicta, never in a holding.

The result of the USPTO’s categorization of cases into multiple, different undefined categories is to make it more difficult, not less, for examiners to properly determine which types of claims are within which category. Further, where an examiner asserts that a claim falls into multiple categories (which is a simple assertion to make, since most inventions deal with multiple different concepts), the applicant is forced to rebut each categorization.

7. “Mathematical Algorithms” Are Limited to Solutions to Problem in Pure Mathematics

This category, more than any other, reflects the USPTO’s failure to substantively and meaningfully analyze the issues and provide clear guidance. Public comments to the 2014 IEG provided extensive analysis of the case law and the problems arising from mathematical algorithms being considered abstract ideas. The USPTO did not respond to the substantive analysis at all. Instead, the July 2015 Update merely lists cases that have held claims invalid as mathematical algorithms, without explanation. This is inadequate for several reasons.

First, the USPTO must clarify that the presence of a mathematical algorithm in the specification or claims is not a per se indication that the claims are directed to an abstract idea. In Alice, the Court expressly stated that “[o]ne of the claims in Bilski reduced hedging to a mathematical formula, but the Court did not assign any special significance to that fact, much less the sort of talismanic significance petitioner claims.” Equally so, examiners must not assign any special significance to the presence of a mathematical formula either in the disclosure or in the claim. What matters is the underlying concept, not how it is expressed (e.g. “no special significance”), whether in words or mathematical symbols.

Second, the presence of a mathematical formula or equation does not make an invention abstract for a very simple reason: mathematics is a language that allows for the very precise and formal description of certain types of ideas. All modern engineering, including, civil, mechanical, electrical, chemical, computer, etc., as well as all of the physical sciences, relies on mathematical analysis for design and formulation. Using a mathematical equation is simply one—albeit highly precise—way of expressing concepts, which may be either patent-eligible or not. Thus, the presence of a mathematical equation does not by itself imply or suggest anything about the underlying concept, and should not be relied upon by examiners as an automatic evidence of an ineligible abstract idea. While mathematics may be used to describe abstract ideas like the laws of mathematics, it can equally be used to describe entirely mundane and non-abstract ideas like fuel-efficient aircraft approach procedures (U.S. Patent No. 8,442,707), compressing video for transmission on cell phones (U.S. Patent No 8,494,051), efficiently allocating farming resources (U.S. Patent No. 6,990,459), or calculating golf handicaps and the difficulty of golf courses (U.S. Patent No. 8,282,455).

The correct interpretation of “mathematical algorithms” as used by the Supreme Court are algorithms that are solutions to inherently mathematical problems. This was the specific definition used by the Supreme Court in Benson, and confirmed in Diehr. In Benson, the Court stated:

A procedure for solving a given type of mathematical problem is known as an “algorithm.” The procedures set forth in the present claims are of that kind; that is to say, they are a generalized formulation for programs to solve mathematical problems of converting one form of numerical representation to another.

Later, in Diehr, the Court stated that in Benson “we defined ‘algorithm’ as a ‘procedure for solving a given type of mathematical problem,” noting that “our previous decisions regarding the patentability of ’algorithms‘ are necessarily limited to the more narrow definition employed by the Court.” The Court expressly rejected a broader definition that covered any “sequence of formulas and/or algebraic/logical steps to calculate or determine a given task; processing rules.”

The USPTO should clarify that this more limited definition of mathematical algorithms is to be used. This approach beneficially distinguishes between inventions in pure mathematics—which as the Court stated are precisely those that have the disproportionate risk of preemption because they can be used in an unlimited number of different fields—from inventions in applied mathematics, the mathematics used in the engineering and physical sciences. Examiners are well-accustomed by their formal scientific and technical training to distinguish between claims to these two types of inventions making use of mathematical formulas and equations.

8. Identifying Whether a Claim Limitation Recites a Conventional, Routine, and Well-Understood Function of a Computer

The public comments to the 2014 IEG discussed the problems resulting from considering the normal operations of a computer to be merely “generic” functions that are conventional, well-understood, and routine, and therefore by definition insufficient to support eligibility of a patent claim.

In response, the USPTO again ignored the substantive arguments, instead simply stating that examiners may rely on what the courts have recognized as “well understood, routine, and conventional functions” of computers, including “performing repetitive calculations,” “receiving, processing, and storing data,” “receiving or transmitting data over a network”. The July 2015 Update goes on to state that “This listing is not meant to imply that all computer functions are well‐understood, routine and conventional.”

This caveat is hardly sufficient, since the list essentially wipes out all computing operations as they are typically claimed. Just as claims for mechanical processes use verbs and gerunds that describe well-known mechanical operations, so too do claims for computer-based inventions necessarily describe the operations of a computer: receive, transmit, store, retrieve, determine, compare, process, and so forth. There is no other way to claim the operations of a computer except to use such terminology.

Accordingly, since the Supreme Court did not hold that all software and computer-implemented inventions are per se ineligible, the proper interpretation of the Court’s discussion of the generic functions of a computer is more narrowly-focused. Specifically, it is necessary to consider the entirety of each claim limitation, not merely the gerund or verb that introduces a method step. The claim limitation as a whole must recite nothing more than generic functions. When considering computer processing steps on computer data, limitations as to the source of data, the types of data, the operations performed on the data, how the outputs is generated, where the data is stored or transmitted, must all be considered. This is because it is these limitations that distinguish between the merely generic operations (“receiving a data input and determining an output”) and the particular applications.

Categories
Antitrust Commercialization DOJ High Tech Industry Innovation Inventors Patent Law Patent Licensing Uncategorized

Busting Smartphone Patent Licensing Myths

closeup of a circuit boardCPIP has released a new policy brief, Busting Smartphone Patent Licensing Myths, by Keith Mallinson, Founder of WiseHarbor. Mr. Mallinson is an expert with 25 years of experience in the wired and wireless telecommunications, media, and entertainment markets.

Mr. Mallinson discusses several common myths concerning smartphone patent licensing and argues that antitrust interventions and SSO policy changes based on these myths may have the unintended consequence of pushing patent owners away from open and collaborative patent licensing. He concludes that depriving patentees of licensing income based on these myths will remove incentives to invest and take risks in developing new technologies.

We’ve included the Executive Summary below. To read the full policy brief, please click here.

Busting Smartphone Patent Licensing Myths

By Keith Mallinson

Executive Summary

Smartphones are an outstanding success for hundreds of handset manufacturers and mobile operators, with rapid and broad adoption by billions of consumers worldwide. Major innovations for these—including standard-essential technologies developed at great expense and risk primarily by a small number of companies—have been shared openly and extensively through standard-setting organizations and commitments to license essential patents on “fair, reasonable, and non-discriminatory terms.”

Despite this success, manufacturers seeking to severely reduce what they must pay for the technologies that make their products possible have widely promoted several falsehoods about licensing in the cellular industry. Unsubstantiated by facts, these myths are being used to justify interventions in intellectual property (IP) markets by antitrust authorities, as well as changes to patent policies in standard-setting organizations. This paper identifies and dispels some of the most egregious and widespread myths about smartphone patent licensing:

Myth 1: Licensing royalties should be based on the smallest saleable patent practicing unit (SSPPU) implementing the patented technology, and not on the handset. The SSPPU concept is completely inapplicable in the real world of licensing negotiations involving portfolios that may have thousands of patents reading on various components, combinations of components, entire devices, and networks. In the cellular industry, negotiated license agreements almost invariably calculate royalties as a percentage of handset sales prices. The SSPPU concept is inapplicable because it would not only be impractical given the size and scope of those portfolios, but it would not reflect properly the utility and value that high-speed cellular connectivity brings to bear on all features in cellular handsets.

Myth 2: Licensing fees are an unfair tax on the wireless industry. License fees relate to the creation—not arbitrary subtraction—of value in the cellular industry. They are payments for use of essential patented technologies, developed at significant cost by others, when an implementer chooses to produce products made possible by those technologies. The revenue generated by those license fees encourages innovation, and is directly related to the use of the patented technologies.

Myth 3: Licensing fees and cross-licensing diminish licensee profits and impede them from investing in their own research and development (R&D). Profits among manufacturers are determined by competition among them, including differences in pricing power and costs. Core-technology royalty fees, which are charged on a non-discriminatory basis and are payable by all implementers, are not the cause of low profitability by some manufacturers while others are very profitable. Cross-licensing is widespread: It provides in-kind consideration, which reduces patent-licensing costs and incentivizes R&D.

Myth 4: Fixed royalty rates ignore the decreasing value of portfolio licenses as patents expire. Portfolio licensing is the norm because it is convenient and cost efficient for licensor and licensee alike. All parties know the composition of the portfolio will change as some patents expire and new patents are added. Indeed, this myth is particularly fanciful given that the number of new patents issued greatly exceeds the number that expires for the major patentees. In fact, each succeeding generation of cellular technology has represented and will continue to represent a far greater investment in the development of IP than the prior generation.

Myth 5: Royalty charges should be capped so they do not exceed figures such as 10% of the handset price or even well under $1 per device. There is no basis for arbitrary royalty caps. It is not unusual for the value of IP to predominate as a proportion of total selling prices, in books, CDs, DVDs, or computer programs. Market forces—not arbitrary benchmarks wished for or demanded by vested interests and which do not reflect costs, business risks, or values involved—should also be left to determine how costs and financial rewards are allocated in the cellular industry with smartphones.

Categories
Patent Law Uncategorized

#AliceStorm: July is Smoking Hot, Hot, Hot…and Versata is Not, Not, Not

The following guest post from Robert R. Sachs, Partner at Fenwick & West LLP, first appeared on the Bilski Blog, and it is reposted here with permission.

By Robert R. Sachs

July invokes images of hot days, cool nights, and fireworks. When it comes to #Alicestorm, the fireworks are happening in the courts, with the Federal Circuit lighting up the sky.

Table1

In just the first ten days of July, there have been twelve decisions on patent eligibility—more decisions in the first ten days of any month since the dawn of time. At this pace, we could see some twenty to thirty decisions this month. #AliceStorm is accelerating.

Here are the numbers by motion type:

Motions

Here are the numbers for all the courts, by tribunal:

Courts

Finally, here’s a summary of the number of Section 101 decisions by the various judges on the Federal Circuit since Alice:

Fed cir

I leave the interpretation of this graph as an exercise for the reader.

Versata: The Federal Circuit is Large and In Charge

While the indices are steady, the recent decisions are very interesting. Most importantly, there have been two Federal Circuit decisions in July, Versata Development Group v. SAP Am., Inc. and Intellectual Ventures I LLC v. Capital One Bank (USA), both of which found the patents in suit ineligible. Today, I’ll focus on Versata.

Versata was a closely watched appeal since it was the first appeal to the Federal Circuit of a Covered Business Methods review. The Court covered a lot of ground including 1) whether it could review PTAB’s determination that Versata’s patent was eligible for CBM review, 2) what is the meaning of “covered business method patent,” including whether USPTO’s definitions of a “financial product or service” and “technological invention” were correct, 3) what is the appropriate standard for claim construction, broadest reasonable interpretation or one correct construction, and 4) an evaluation of the merits. Briefly, the court decided:

  • The Court can review PTAB final decisions, even when they touch upon the same legal issues that lead to the institution decision (which the Federal Circuit does not have authority to review), including whether a patent qualifies as a covered business method patent;
  • The USPTO’s definitions of covered business method patent (which simply copies the statutory language without any definition at all) are just fine.
  • PTAB can use broadest reasonable construction; and
  • Versata’s patent is for a financial service, not a technological invention and is an ineligible abstract idea.

I’m not going to do an extensive analysis of the Federal Circuit’s handling of all these issues. Essentially, the Federal Circuit is saying: PTAB, keep up the good work of invalidating patents, but just remember, we’re still in charge. Instead, I’m going just to highlight some of the issues in the Court’s reasoning regarding the definitions of a covered business method patent.

As background, Versata’s patent is a way of determining prices where you have a very complex collection of products types and business groups, all overlapping and intersecting. Consider a company like General Motors with dozens of divisions and subsidiaries, hundreds of cars, and millions of parts. The problem is that conventional systems use multiple database tables to track and compute prices, requiring significant storage and reducing run-time performance. In a nutshell, Versata used hierarchical data structures representing product and business organizational hierarchies to store and compute product prices. By using hierarchical data structures, Versata’s invention saved memory and resulted in faster run-time performance than existing approaches.

What Is a Financial Product or Service?

Section 18(d)(1) of the statute that authorizes the CBM review states that a covered business method patent is:

a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions

The question is what is a financial product or service. The Court adopted the USPTO’s parsing of the phrase into financial and product or service. In doing so, the Court adopted PTAB’s incorrect grammatical parsing of the statute, which looked at the definition of financial apart from products and services. According to PTAB, “The term financial is an adjective that simply means relating to monetary matters.”

Running with this analysis the court concludes:

We agree with the USPTO that, as a matter of statutory construction, the definition of “covered business method patent” is not limited to products and services of only the financial industry, or to patents owned by or directly affecting the activities of financial institutions such as banks and brokerage houses. The plain text of the statutory definition contained in § 18(d)(1)— “performing . . . operations used in the practice, administration, or management of a financial product or service”— on its face covers a wide range of finance-related activities. The statutory definition makes no reference to financial institutions as such, and does not limit itself only to those institutions.

To limit the definition as Versata argues would require reading limitations into the statute that are not there.

This analysis is incorrect. The phrase financial product or service is not just the adjective financial modifying the nouns products and services—it’s not like sweet pastries and pies or funny songs and videos or complex issues and problems. Rather, financial product and financial service are open compound nouns, like high school, cell phone, and half sister. The meaning of these nouns is not determined by looking at the meaning of the individual words; the entire noun has its own meaning. When you attended high school, you did not go to a school that was “of great vertical extent”; when you speak on your cell phone you’re not talking on a telephone made of “the smallest structural and functional unit of an organism.” And when you offer to introduce me to your half sister, I don’t ask “Left or right?”

The term financial product means something specific and different from the simple combination of financial and product. It’s important to remember that the Covered Business Method program was pushed by three of the largest financial lobbying groups: the Financial Services Roundtable, the Independent Community of Banks of America, and the Securities Industry and Financial Markets Association. In the financial industry, financial products and services has a specific meaning.

Consider the following definitions of financial product:

a product that is connected with the way in which you manage and use your money, such as a bank account, a credit card, insurance, etc.
Cambridge Dictionary of Business English

Financial products refer to instruments that help you save, invest, get insurance or get a mortgage. These are issued by various banks, financial institutions, stock brokerages, insurance providers, credit card agencies and government sponsored entities. Financial products are categorised in terms of their type or underlying asset class, volatility, risk and return.
EconomyWatch

Better yet, look at the U.S. Treasury’s definition:

The overarching definition of financial product will focus on the key attributes of, and functions performed by, financial products. A financial product will be defined as:

A facility or arrangement through which a person does one or more of the following:

— Makes a financial investment;
— Manages a financial risk;
— Obtains credit; or
— Obtains or receives a means of payment.

The facility or arrangement may be provided by means of a contract or agreement or a number of contracts or agreements.

The term financial services is equally specific

Financial services are the economic services provided by the finance industry, which encompasses a broad range of businesses that manage money, including credit unions, banks, credit card companies, insurance companies, accountancy companies, consumer finance companies, stock brokerages, investment funds, real estate funds and some government sponsored enterprises.
Wikipedia, “Financial services”

Financial Services is a term used to refer to the services provided by the finance market. Financial Services is also the term used to describe organizations that deal with the management of money. Examples are the Banks, investment banks, insurance companies, credit card companies and stock brokerages.
Streetdictionary.com, “What exactly does financial services mean?”

The USPTO and the Federal Circuit ignored these definitions of financial products and services as used by the very industries that sought protection from abusive business methods patents. The Court even notes that “It is often said, whether accurate or not, that Congress is presumed to know the background against which it is legislating.” Indeed, it did here, but the Court simply chooses to discount both that background and correct English language usage.

The Court further argues that the statutory definition makes no reference to financial institutions as such, implying that Congress did not intend to limit financial products and services to the financial services industries. To riff off the logical fallacy—evidence of an absence is not the absence of evidence. There was no need to mention explicitly the financial industry in the statute because the industry context is built into the terms themselves. Contrary to the Court’s final statement, the limitations are already in “the plain text of the statute.”

In short, looking up the Random House definition of the adjective financial apart from financial products and services is like extracting greasy from spoon and concluding that a greasy spoon is an oily small, shallow oval or round bowl on a long handle.

Spoons

Whether you are talking business or busing tables, you must interpret words according to the relevant context, the relevant grammar, and the relevant dictionary.

Deference to the USPTO’s Expertise: Only Sometimes

In concluding its analysis of the meaning of a covered business method patent, the Court relies on a deference argument. In its final paragraph regarding the propriety of USPTO’s definition of financial product and services, the Court says:

Furthermore, the expertise of the USPTO entitles the agency to substantial deference in how it defines its mission.

The overall mission of the USPTO is to issue patents for inventions. The Ninth Circuit made a similar observation about the Copyright Office. In Garcia v. Google, the Copyright Office refused to register Garcia’s five-second appearance in a film. The Ninth Circuit noted “We credit this expert opinion of the Copyright Office—the office charged with administration and enforcement of the copyright laws and registration.” And thus the Ninth Circuit found it appropriate to defer to the office’s expertise in deciding copyrightable subject matter. The parallel could not be more perfect: the USPTO is the office charged with the administration and enforcement of the patent laws and registration. Likewise, the courts should defer to its expertise as well.

Here, when the USPTO comes up with a definition of technology in its interpretation of Section 18(d)(1) of the patent statute–a very small part of its mission–the Federal Circuit says that the Office is due substantial deference. Yet, when the Office comes up with a definition of Section 101–the section of the statute most fundamental to its mission–and when an examiner implements that definition and determines that a particular claim satisfies Section 101, that definition and that decision is given no deference at all.

Thus, I find it rather inconsistent of the Court to be deferential the USPTO’s definition of technology in a very narrow context, but entirely dismissive of the USPTO’s historical expertise in identifying patent eligible subject matter. When it comes to patents, the USPTO is like Rodney Dangerfield: it gets no respect.

Categories
Innovation Legislation Patent Law Uncategorized

Will Increasing the Term of Data Exclusivity for Biologic Drugs in the TPP Reduce Access to Medicines?

The following guest post comes from Philip Stevens, Director of the Geneva Network, a research and advocacy organization working on international health, trade, and intellectual property issues. The original research note can be found here.

By Philip Stevens

scientist looking through a microscopeIn the Trans-Pacific Partnership (TPP) negotiations, the U.S. and Japan have proposed that TPP partners increase their period of regulatory data protection (RDP) for biologic medicines to align with practice in other countries. These proposals have been strongly opposed by a number of academics, who claim that such a move would significantly increase public spending on medicines, thereby potentially limiting access.[1], [2]

Past experiences in Canada and Japan, which lengthened their respective terms of RDP some years ago, however, indicate that these fears of budget increases are unlikely to materialise.

Canada and Japan increased RDP[i] substantially but did not experience increases in expenditures for medicines

Like several TPP countries, the governments of Canada and Japan have national health insurance systems, and cover most health care costs, including medicines. Unlike other TPP countries, Canada and Japan have in the past decade adopted substantially longer terms of RDP. Their experiences, captured in the data provided below, show that expenditures on medicines did not change appreciably from previous trends.

In 2006 Canada changed its regulations in a way that effectively increased their RDP term from 0 years to 8 years.[ii] As shown in Figure 1 (based on 2014 OECD data[iii]), pharmaceutical spending as a percentage of total health spending has actually decreased since then.

Figure 1: Pharmaceutical expenditure as a percentage of Canada’s healthcare expenditure (2005-2011)

Canada - OECD Health Data 2014. Pharma spend as % of total health spend. 2005: 17.2. 2006: 17.4 (Note: RDP Increased). 2007: 17.2. 2008: 17.0. 2009: 17.0. 2010. 16.6. 2011: 17.1.

As indicated in Figure 2 below, over the same period (2005-2011) pharmaceutical expenditure as a percentage of GDP (blue bars) remained relatively stable after RDP was increased in Canada in 2006, whereas overall health spending as a percentage of GDP in Canada has gradually increased (red bars).

Figure 2: Health and pharmaceutical expenditure as a percentage of Canada’s GDP (2005-2011)

Canada - OECD Health Data 2013. Red=Health spend as % of GDP. Blue=Pharma spend as % of GDP. 2005: Red, 9.8; Blue, 1.69. 2006: Red: 10.1; Blue 1.73. 2007: Red: 10.0; Blue: 1.73. 2008: Red: 10.3; Blue: 1.74. 2009: Red: 11.4; Blue: 1.93. 2010: Red: 11.4; Blue: 1.89. 2011: Red, 11.2; Blue: 1.86.

Similarly, Japan increased data protection in 2007 from 6 to 8 years (effectively 9 years).[iv] As indicated by Figure 3, fluctuations in expenditures after that time have been in line with growth in health care spending as a percentage of GDP. In fact, in 2010 pharmaceutical spending decreased in a year where health care spending increased.

Figure 3: Pharmaceutical expenditure as a percentage of Japan’s health care expenditure (2005-2010)

Japan - OECD Health Data 2014. Pharma spend as % of total health spend. 2005: 19.7. 2006: 19.5. 2007: 19.9 (Note: RDP Increased). 2008: 19.7. 2009: 20.7. 2010. 20.3.6. 2011: 20.8.

Figure 4 shows that the gradual increases in pharmaceutical expenditure as a percentage of GDP in Japan between 2005 and 2010 (blue bars) was in line with the overall increase in health spending as a percentage of GDP in Japan over the same period (red bars).

Figure 4: Health and pharmaceutical expenditure as a percentage of Japan’s GDP (2005-2010)

Japan - OECD Health Data 2013. Red=Health spend as % of GDP. Blue=Pharma spend as % of GDP. 2005: Red, 8.2; Blue, 1.62. 2006: Red: 8.2; Blue 1.60. 2007: Red: 8.2 (Note: RDP increased); Blue: 1.63. 2008: Red: 8.6; Blue: 1.70. 2009: Red: 9.5; Blue: 1.97. 2010: Red: 11.4; Blue: 1.89. 2011: Red, 9.6; Blue: 1.94.

Conclusion

The past experiences of Canada and Japan described above indicate that increases in RDP terms do not result in meaningful increases in health care expenditures or expenditures on medicines relative to overall health care spending. There could be many explanations for this result, ranging from changes in procurement policies, to increases in the number of medicines whose patent terms have expired. The evidence presented above, however, suggests that those concerned about access to medicines and the financial sustainability of public healthcare systems should focus their attention on policies other than Regulatory Data Protection for medicines.


[1] Moir et al, (2014) “Proposals for extending data protection for biologics in the TPPA: Potential consequences for Australia”, Submission to the Department of Foreign Affairs and Trade, available at http://dfat.gov.au/trade/agreements/tpp/submissions/Documents/tpp_sub_gleeson_lopert_moir.pdf

[2] Gleeson, D, Lopert, R, and Reid, P, (2013), “How the Trans Pacific Partnership Agreement could undermine PHARMAC and threaten access to affordable medicines and health equity in New Zealand”, Health Policy, 116:2-3

[i] Japan has a “post marketing surveillance system” which we consider a surrogate for RDP and use the term RDP in this paper to include Japan’s approach.

[ii] Canada’s 5-year data protection term was made ineffective by a 1998 Federal Court interpretation of regulations. Bayer Inc. v. Canada (Attorney General), 84 C.P.R. (3d) 129, aff’d 87 C.P.R. (3d) 293, leave to appeal to SCC refused, [1999] S.C.C.A. No. 386. The Federal Court held that RDP protection in Canada was not triggered if a generic applicant could demonstrate bioequivalence without requiring the Health Minister to consult the data submitted by the innovative company. Because that was a common occurrence, RDP rarely applied under the pre-2006 regulations.

[iii] 2013/14 OECD data on Canada and Japan is found at: http://www.oecd-ilibrary.org/social-issues-migration-health/health-key-tables-from-oecd_20758480;jsessionid=k26q30wbgljb.x-oecd-live-02.

[iv] Japan’s system prevents filing applications for follow-on approval for eight years after the innovator’s approval. An additional year after that is required for the regulatory approval process to conclude.

Categories
Administrative Agency Copyright High Tech Industry Innovation International Law Internet Inventors ITC Patent Law Remedies Software Patent Trademarks Uncategorized

Digital Goods and the ITC: The Most Important Case That Nobody is Talking About

circuit boardBy Devlin Hartline & Matthew Barblan

In its ClearCorrect opinion from early 2014, the International Trade Commission (ITC) issued cease and desist orders preventing the importation of infringing digital goods into the United States. The ITC’s 5-1 opinion has since been appealed to the Federal Circuit, with oral argument scheduled for the morning of August 11th, and the case has drawn a number of amicus briefs on both sides. Despite receiving little attention in media or policy circles, the positive consequences of the ITC’s decision are significant.

This case is important because the problem of the importation of infringing digital goods continues to grow. The ITC’s authority over digital goods can be a powerful tool for creators and innovators against a threat that has only gotten worse, and it would permit the ITC to go about doing what it’s always done in the intellectual property space—protecting our borders from the threat of foreign infringing goods. Interestingly, a look at the proceedings in the ITC and the briefs now before the Federal Circuit reveals how some parties now opposing the ITC’s authority over digital goods had argued for the opposite just a few years back.

The ITC Proceedings

This case began in March of 2012, when Align Technology Inc. filed a complaint with the ITC alleging that its only competitor, ClearCorrect Operating LLC, violated Section 337 of the Tariff Act of 1930 by importing digital goods that infringed several of its orthodontic patents. Section 337, codified at 19 U.S.C. § 1337, makes unlawful the “importation . . . of articles” that infringe “valid and enforceable” patents, copyrights, or trademarks, and it declares that the ITC “shall investigate any alleged violation of this section on complaint under oath or upon its initiative.”

There are two statutory remedies available to a complainant in an ITC proceeding. The first is an exclusion order, which dictates that “the articles concerned . . . be excluded from entry into the United States.” Exclusion orders are issued by the ITC and enforced by the U.S. Customs and Border Protection. The second remedy is a cease and desist order, which directs any person violating Section 337 “to cease and desist from engaging in the unfair methods or acts involved.” The ITC enforces its own cease and desist orders through the imposition of civil penalties, recoverable in the federal district courts.

Align’s complaint with the ITC involved its patented Invisalign System, a “proprietary method for treating crooked and misaligned teeth” using modern plastic aligners instead of old-fashioned metal braces. Align alleged that ClearCorrect violated Section 337 by importing “digital models, digital data and treatment plans that . . . infringe or induce infringement of” its patents, and it asked the ITC to “issue permanent cease and desist orders” prohibiting ClearCorrect from importing the digital files. In response, ClearCorrect argued that “no articles” had been imported since the digital data associated with the teeth aligners were not themselves “articles.”

This was the primary bone of contention: The ITC only has statutory authority over the “importation . . . of articles,” and if digital goods are not “articles,” then the ITC has no jurisdiction. After an administrative law judge (ALJ) determined that the digital files at issue were indeed “articles” within the meaning of Section 337, ClearCorrect petitioned the ITC to review that determination. The ITC took the case and solicited comments from the public as to whether electronic transmissions are “articles” under Section 337.

The ITC ultimately sided 5-to-1 with Align. On the threshold issue of whether electronic transmissions constitute “articles” under Section 337, the ITC affirmed the ALJ’s conclusion that they do: “[T]he statutory construction of ‘articles’ that hews most closely to the language of the statute and implements the avowed Congressional purpose for Section 337 encompasses within its scope the electronic transmission of the digital data sets at issue in this investigation.” This was consistent, said the ITC, with the “legislative purpose . . . to prevent every type of unfair act in connection with imported articles . . . and to strengthen protection of intellectual property rights.”

Appeal to the Federal Circuit

Having lost at the ITC, ClearCorrect appealed to the Federal Circuit. There, it focused its arguments on the statutory question of whether digital goods constitute “articles” under Section 337.

Public Knowledge and the Electronic Frontier Foundation (EFF) filed an amicus brief calling the ITC’s decision “sweeping and unprecedented,” and they urged the Federal Circuit to reject the ITC’s “overzealous construction” of the term “articles.” Aside from the statutory issue, the digital rights groups suggested that there were “important reasons” why Section 337 “ought not cover telecommunications.” They stressed the “real and unanswered questions about the enforcement role” ISPs would play, and they noted how ISPs “could be required to actively block transmission of certain content.”

It’s worth noting that no ISPs were involved in the ClearCorrect litigation—only ClearCorrect itself was subject to a cease and desist order. But this ISP question seems to be the reason why the case drew their attention: The real concern wasn’t whether ClearCorrect had infringed Align’s patents; it was whether the ITC had the authority to issue cease and desist orders to ISPs. This sentiment was echoed in an amicus brief by the Internet Association, which includes Google, arguing that the internet “should not be restricted to national borders” because of “the unforeseeable but far-reaching results that would follow.”

The policy arguments made by Public Knowledge, the EFF, Google, and others were essentially circular: The internet should be “open” so we shouldn’t let the ITC “close” it. But that begs the question of what the ideal “open” internet looks like, and what illegal activities should or should not be tolerated in the digital space. We shut our borders to infringing physical goods. What makes infringing digital goods so special? A right is only as good as the remedies available to enforce it, so why should we give short shrift to the property rights of artists, creators, and innovators?

Align’s intervenor brief took the groups to task: “The amici briefs supporting ClearCorrect brim with hyperbole.” Align noted that the ITC “only asserts jurisdiction over the ‘articles” that are electronically transmitted, not over all acts of transmission.” It pointed out that it is the “owner, importer, or consignee” of the “articles” that violates Section 337, not the carrier, and it said that the claim that the ITC could issue cease and desist orders against ISPs for “data transmission activities” is “baseless.”

Supporting the ITC’s understanding of “articles,” an amicus brief filed by the Association of American Publishers explained that the ITC’s “authority over electronically transmitted copyrighted works is critical because . . . there has been rapid growth in digital publications.” It pointed to the rise in digital piracy “at the expense of U.S. creators and innovators.” It urged that affirming the ITC’s decision was “crucial” since it “will help ensure that unfair trade practices abroad do not harm the livelihoods” of those that “rely on copyright protection.”

An amicus brief filed by Nokia supporting the ITC also noted the importance of protecting intellectual property: “Stripping the Commission of its long-exercised authority over electronic transmissions could gravely damage the protection of valid patent rights through Section 337 investigations.” It pointed out that holding otherwise would lead to “absurd results” since the ITC would have jurisdiction over software “imported on a USB stick or CD-ROM” but not software disseminated by “electronic transmission.” Such a result would be “wholly contrary to the remedial purpose of Section 337.” Nokia concluded that the ITC’s “authority should not wax and wane as technology develops new methods of dissemination.”

The MPAA and the RIAA likewise submitted an amicus brief supporting the ITC. The industry groups pointed out that “illegal downloads and illegal streaming” account for most of the infringement losses they suffer, and they argued that “copyright protection is essential to the health” of their industries. They urged the Federal Circuit to affirm the ITC because “Section 337 is a powerful mechanism for stopping illegal electronic imports,” and doing so “would give effect to the intent of Congress that Section 337 protect U.S. industries from all manner of unfair acts in international trade.”

Who has the better argument here? Obviously, both sides argued that the text of Section 337 favored their positions. ClearCorrect and its supporters claimed that “articles” should be interpreted narrowly to include only tangible goods, while the ITC and its supporters wanted a read of the statute that allows the ITC to continue to fulfill its mission even as new technology and methods of trade become more common. What may come as a surprise, however, is that many of the groups now seeking to limit the ITC’s jurisdiction were arguing just the opposite a few years ago.

Remember the OPEN Act?

It may seem like ages ago, but it’s been less than four years since Congress debated the Stop Online Piracy Act (SOPA) and the PROTECT IP Act. Those two bills would have explicitly afforded artists and creators robust tools to use in the federal district courts against foreign rogue sites that aim their infringements at the United States. Many vocal opponents of the bills supported an alternative approach: the OPEN Act. Under the OPEN Act, the ITC would have been given explicit authority to investigate complaints against foreign rogue sites that import infringing digital goods into the United States.

The OPEN Act’s sponsors set up a website at keepthewebopen.com where members of the public could see the text of the bill and suggest changes to it. The website included an FAQ to familiarize supporters with the thinking behind the OPEN Act. As to why online infringement was an issue of international trade, the FAQ pointed out that “there is little difference between downloading a movie from a foreign website and importing a product from a foreign company.”

When advocating for the OPEN Act as a good alternative to SOPA and the PROTECT IP Act, the bill’s sponsors touted the ITC as being a great venue for tackling the problems of foreign rogue sites. Among the claimed virtues were its vast experience, transparency, due process protection, consistency, and independence:

For well over 80 years, the independent International Trade Commission (ITC) has been the venue by which U.S. rightsholders have obtained relief from unfair imports, such as those that violate intellectual property rights. Under Section 337 of the Tariff Act of 1930 – which governs how the ITC investigates rightsholders’ request for relief – the agency already employs a transparent process that gives parties to the investigation, and third party interests, a chance to be heard. The ITC’s process and work is highly regarded as independent and free from political influence and the department already has a well recognized expertise in intellectual property and trade law that could be expanded to the import of digital goods.

The Commission already employs important safeguards to ensure that rightsholders do not abuse their right to request a Commission investigation and the Commission may self-initiate investigations. Keeping them in charge of determining whether unfair imports – like those that violate intellectual property rights – [sic] would ensure consistent enforcement of Intellectual Property rights and trade law.

Some of the groups now arguing that the ITC shouldn’t have jurisdiction over digital goods openly supported the OPEN Act. Back in late 2011, the EFF stated that it was “glad to learn that a bipartisan group of congressional representatives has come together to formulate a real alternative, called the OPEN Act.” The EFF liked the bill because the “ITC’s process . . . is transparent, quick, and effective” and “both parties would have the opportunity to participate and the record would be public.” It emphasized how the “process would include many important due process protections, such as effective notice to the site of the complaint and ensuing investigation.”

Google likewise thought that giving the ITC jurisdiction over digital goods was a great idea. In a letter posted to its blog in early 2012, Google claimed that “there are better ways to address piracy than to ask U.S. companies to censor the Internet,” and it explicitly stated that it “supports alternative approaches like the OPEN Act.” Google also signed onto a letter promoting the virtues of the ITC: “This approach targets foreign rogue sites without inflicting collateral damage on legitimate, law-abiding U.S. Internet companies by bringing well-established International trade remedies to bear on this problem.”

Conclusion

The ITC has been protecting our borders against the importation of infringing goods for nearly a century now. As technology and trade evolves, it makes perfect sense to let the ITC continue to do its job by protecting our borders against the importation of infringing digital goods. This is an important tool for our innovators and creators in combating the ever-growing flood of foreign infringing goods.

The fact that many of those who supported the OPEN Act are now supporting ClearCorrect suggests that for them this appeal isn’t really about whether digital goods are “articles” under Section 337. The ITC is an appropriate venue for all of the reasons the supporters of the OPEN Act publicized just over three years ago: The process is transparent, there’s ample due process protections, the commissioners are experienced and independent, and their decisions are consistent.

As the 5-1 opinion suggests, affirming the ITC’s decision should be an easy choice for the Federal Circuit. Let’s hope the Federal Circuit does the right thing for our artists and innovators.