Tag: Section 101

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Patent Law Patent Theory

Rethinking § 101: Professor Talha Syed Takes a Different Look at Subject Matter Eligibility

The following post comes from Colin Kreutzer, a 2E at Scalia Law and a Research Assistant at CPIP.

shelves full of booksBy Colin Kreutzer

When most people think of patentability requirements, they think of whether an invention has been “done before.” Novelty and non-obviousness under 35 U.S.C. §§ 102 and 103 are certainly key hurdles to obtaining a patent. But courts are often tied up over the more fundamental issues presented in § 101. That provision addresses patent eligibility itself—whether an idea, new or not, falls within some class of inventions that qualify for patent protection.

Section 101 of the Patent Act of 1952 says that a patent may be issued to “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter.” It seems fairly straightforward. But the common law decisions, both pre- and post-1952, are riddled with exceptions and questions that the statute hasn’t resolved on its own. How do we treat intangible notions, such as scientific principles or other abstract ideas? Is a business method a patentable process? What property rights can be granted to an inventor who discovers a fundamental law of nature? And should we treat the realm of pure mathematics as being fundamental to nature itself? As we move deeper into the information age, these questions aren’t getting any simpler.

In a new paper from CPIP’s Thomas Edison Innovation Fellowship program entitled Owning Knowledge: A Unified Theory of Patent Eligibility, Professor Talha Syed of Berkeley Law argues that the confusion surrounding this issue is two-fold. First, it results from our failure to develop a functionality doctrine that can clearly distinguish technological applications of knowledge from other forms of knowledge. Second, he offers a root cause of this failure. There is a distracting preoccupation in patent law with “physicalism,” that is, the notion that a patent is awarded for a thing (tangible or not) rather than for knowledge of that thing.

In order to move forward, Prof. Syed states that we must first unwind the physicalist assumptions that are tangled up in our § 101 analyses. Only then can we develop a functionality doctrine free of those encumbrances. As he puts it, “[r]econstructing eligibility doctrine requires, then, extricating incipient functionality concerns from the physicalist thicket, developing their independent basis, and properly following through on their doctrinal implications.”

On its face, when someone proposes that we fundamentally rethink a subject, it sounds as if they are calling for some kind of seismic shift. But Prof. Syed argues that his proposal merely provides a clearer perspective on a subject that has long needed clarity. Rather than requiring any major statutory reforms or total abandonment of our jurisprudence, he says that the “dephysicalization” of patent eligibility serves to better integrate our existing statutory and common law frameworks.

How We Got Here

The questions mentioned above are not new. To understand the current state of things, Prof. Syed first details some of the cases that led us here, beginning with Neilson v. Harford, Le Roy v. Tatham, Boulton & Watt v. Bull, among others.

Neilson is instructive. It was an 1841 English case that dealt with an improvement to an industrial process. The applicant’s invention involved pre-heating air before it was injected it into an iron furnace. The Court of Exchequer expressed some doubts as to whether this intangible aspect of an industrial process was truly patentable. In the end, it only granted a patent because the inventive principle—that the pre-heated air provides better ignition efficiency than cold air—was embodied in a physical machine designed for that purpose. The patentee “does not merely claim a principle, but a machine embodying a principle.”

Neilson and the others influenced a number of cases in the 20th century American courts. Prof. Syed points to three variants of the general rationale. While a principle on its own is not patent eligible, it becomes so: (1) in an embodied application of the principle, (2) if it is delimited to a specific zone of industry, or (3) in an “inventive” mode of application.

These variants illustrate a schism already appearing by the end of the 19th century as to why an “abstract” idea may be unpatentable. If “abstract” is taken in the dephysicalized sense, then the problem may only be cured by applying the idea in some physical form. Alternatively, it could be abstract in the sense that it is a pure unapplied principle. In this case, patent eligibility may not require a tangible form, but instead some delimitation to a specific industrial zone of applicability. Prof. Syed attributes what came next at least partly on a failure to recognize and fully develop these distinctions.

Principles, in the abstract, were but one concern. The eligibility problem was compounded by similar questions about patent rights over natural phenomena. In the 1948 case of Funk Brothers Seed Co. v. Kalo Inoculant Co., the Supreme Court considered whether a set of naturally occurring bacterial strains—unmodified except by their selective combination—was a patentable invention. They answered “no.” Citing Le Roy, the Funk Bros. Court ruled that “patents cannot issue for the discovery of the phenomena of nature. . . . The qualities of these bacteria, like the heat of the sun, . . . are part of the storehouse of knowledge of all men.” Therefore, an invention based on a natural phenomenon must do more than rely upon “the handiwork of nature” in order to become patentable.

Then the waters got even muddier. At the crossroads of abstract principles and natural phenomena lies the fundamental concept of mathematics itself. In Gottschalk v. Benson, the Court addressed an algorithm for converting signals from one numerical form into a computer-friendly binary form. In Parker v. Flook, it was an algorithm for updating threshold alarm limits while monitoring certain chemical processes. In both cases, the Court held that the claimed invention was not a patentable process, but merely a mathematical formula which belonged to the “basic tools of scientific and technological work.”

However, both cases offered a different manner of distinguishing these abstract concepts from patentable inventions. Benson mentioned, but did not require, that an eligible process should transform a particular article or require a particular machine (much later, the Federal Circuit imposed the “machine-or-transformation test” as the sole test for eligibility, only to have it demoted to “useful tool” by the Supreme Court). Flook, on the other hand, looked for some “inventive” aspect that went beyond the algorithm itself.

The whole story is too convoluted to do it justice here. The strength of these various eligibility bars has fluctuated over the years. But through these cases and more, we arrived at the modern two-part test under Mayo Collab. Svcs v. Prometheus Labs, Ass’n for Molecular Pathology, Inc. v. Myriad Genetics, and Alice Corp. v. CLS Bank.

Quoting Alice, Prof. Syed lays out the test as:

(1) Step 1: First, we ask “whether the claims at issue are directed to” a law of nature, natural phenomenon, or abstract idea.(2) Step 2: If so, “we then ask, ‘what else is there in the claims before us,’” considering “the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Step two of this analysis is “a search for an ‘inventive concept.’”

Critique of the Modern Test, and a New Proposal

Prof. Syed cites a fundamental disconnect in this test between its “why” and “how,” that is, why an invention is ineligible at all (claiming “basic building blocks” of scientific and technological work) and how it may become eligible (by containing an “inventive concept in application”). He asks, “[i]f the reason certain spaces of knowledge are ineligible is because they are ‘basic,’ then why doesn’t delimiting the claims to a zone of ‘application’ suffice for eligibility?”

Prof. Syed says that at each stage of our § 101 development, courts have touched on proper functionality issues only to leave them obscured by physicalist notions. He moves to recast the three exceptions as “laws of nature, products of nature, and abstract formulas.” More importantly, he insists that when discussing eligible categories or their exceptions, we preface them with the phrase “knowledge of.” So, knowledge of a law of nature can include discovered knowledge of some natural process. To analyze whether that knowledge should be patent-eligible, we should focus on the functional application of that knowledge. The inventor must go from “knowing that” to “knowing how.”

Prof. Syed uses Neilson as an example to distinguish between understanding (having basic knowledge) and intervening (having applied knowledge). A claim to “[k]nowledge of the principle that heated air promotes ignition better than cold” is not patent eligible. But why? Not because it is an abstract idea, but because it claims the sheer knowledge that some process exists rather than knowledge of how to do something with it. This may not seem like a huge difference from the analysis we have now in the Alice/Mayo test. It isn’t. But it might arguably be a clearer way of looking at things.

Prof. Syed’s version of the Alice framework would ask, at step one, whether the claim seeks to cover knowledge of a law of nature, product of nature, or abstract formula. If so, then step two asks whether the claim delimits the ambit of its coverage to a zone of practical application. Finally, he urges (as others have) that the § 101 analysis be kept separate from analyses of substantive issues under §§ 102 and 103: “claims should be truly evaluated ‘as a whole’ so that, for instance, a claim whose delimited application is obvious, but which also involves a nonobvious basic contribution, should pass matter under § 103 just as easily as one whose delimited application is itself nonobvious.”

Conclusion: Reconstructing § 101

Taking these considerations, Prof. Syed reconstructs § 101 into three patentability requirements for “inventions” or “discoveries” in the “useful arts”:

(1) Such “inventions” or “discoveries” must be conceived in a thoroughly dephysicalized way, as spaces of “knowledge of” a “process, machine, manufacture, or composition of matter.”(2) Such spaces of knowledge must be spaces of “useful”—i.e., applied or functional—knowledge.

(3) Finally, such candidate functional spaces of knowledge still need to satisfy the substantive requirements laid out in the rest of the statute to qualify for protection.

Prof. Syed further recasts the statutory categories of subject matter eligibility. Where the “process, machine, manufacture, or composition of matter” comprises one intangible process category and three tangible product categories, his version is the opposite. There are three distinct process categories and one category for knowledge of physical things:

(1) “Knowledge of” a way of doing something (so-called “functional” claims)(2) “Knowledge of” some thing, its structure, and at least one property (“product” claims)

(3) “Knowledge of” a way of making something (method-of-making process patents)

(4) “Knowledge of” a way of using something (method-of-use process patents)

This reconstruction reflects the two fundamental concepts of Prof. Syed’s paper—physicalism and functionality. In order to see the latter clearly, one must abandon the former. But Prof. Syed says that’s easier said than done: “What gives physicalism its lasting power in patents—what makes the spell linger—is, in fact, precisely functionality: it is precisely because patents properly obtain only in spaces of functional knowledge, or knowing how to do something, that it becomes easy to forget that they nevertheless still only obtain in spaces of functional knowledge, or knowing how to do something.” That could help explain why courts have long struggled with this deceptively complicated subject.

To read the paper, please click here.

Categories
CPIP Roundup

CPIP Roundup – August 31, 2020

Greetings from CPIP Executive Director Sean O’Connor

Sean O'Connor

August has seen the beginning of a highly unusual school year, but I hope everyone is continuing to stay safe. And, since even a pandemic can’t keep the world from having a busy back-to-school month, I’ll keep this month’s note short.

First, we’re gearing up for The Evolving Music Ecosystem conference on September 9-11, 2020. The conference will be held via Zoom and feature a keynote address by singer, songwriter, and author Rosanne Cash. Registration is still open, and we hope you’ll join us!

Second, I’d like to welcome University of Missouri-Kansas City School of Law Professor Chris Holman as CPIP’s new Senior Fellow for Life Sciences. He will be taking over the role from Professor Erika Lietzan of University of Missouri School of Law, who has been supporting CPIP in that capacity for the past year. (Clearly, we have an affinity for the Show-Me State!) We’re excited to have him join us, and by way of an introduction, we encourage you to check out his recent guest column for The Phoenix advocating for protection of new uses for old medicines.

Third, we are finalizing the schedule for our Eighth Annual Fall Conference, to be held via Zoom on October 7-8, 2020. This year’s theme is 5G at the Nexus of IP, Antitrust, and Technology Leadership.

In other news, CPIP Senior Fellow for Innovation Policy Jonathan Barnett is now blogging at Truth on the Market, a platform for academics and economists to discuss various aspects of business law. You can read his inaugural post here. CPIP Senior Scholar Erika Lietzan has been appointed a Public Member at the Administrative Conference of the United States (ACUS), which focuses on improving the administrative process. CPIP Director of Copyright Research and Policy Sandra Aistars spoke this past month on a copyright licensing panel hosted by Artomatic with the goal of informing visual artists about essential aspects of copyright law. It has also been a busy month for CPIP Senior Scholars Kristen Osenga and Mark Schultz—I encourage you to keep reading below to keep up with their recent news!

Registration Closing Soon for Evolving Music Ecosystem Conference with Rosanne Cash on September 9-11

Rosanne Cash

Please join us for The Evolving Music Ecosystem conference, which will be held online from Antonin Scalia Law School in Arlington, Virginia, on September 9-11, 2020. The event features three days of panel presentations by leading experts and a keynote address by Grammy-winning singer, songwriter, and author Rosanne Cash.

This unique conference continues a dialogue on the music ecosystem begun by CPIP Executive Director Sean O’Connor while at the University of Washington School of Law in Seattle. In its inaugural year in the D.C. area, the conference aims to bring together musicians, music fans, lawyers, artist advocates, business leaders, government policymakers, and anyone interested in supporting thriving music ecosystems in the U.S. and beyond.

For more information, and to register, please click here.

Spotlight on Scholarship

a pair of glasses, an apple, and a stack of books

Kristen Osenga, Patent-Eligible Subject Matter… Still Wielding the Wrong Weapon–12 Years Later, 60 IDEA: L. Rev. Franklin Pierce Center for Intell. Prop. 104 (2020)

CPIP Senior Scholar Kristen Osenga has published a new paper on patent-eligible subject matter at IDEA entitled Patent-Eligible Subject Matter… Still Wielding the Wrong Weapon–12 Years Later. The paper looks at changes to patent eligibility that have developed since Prof. Osenga published an article on the same subject in 2007. At the time, she concluded that the Patent Office was using the “elephant gun” of new guidelines on the “ants” of patent eligibility. In the new paper, Prof. Osenga traverses the Supreme Court’s subsequent Section 101 decisions that drove the courts and Patent Office to continue wielding an “outsized elephant gun” when it comes to patent eligibility. However, she does note that recent activities at the Patent Office and Congress offer some hope that things may be changing for the better.

Mark F. Schultz, The Importance of an Effective and Reliable Patent System to Investment in Critical Technologies (USIJ July 2020)

Venture capitalists pouring money into a small startup has become a sort of new American Dream for many innovators. The success stories of big American companies starting with nothing more than an idea have pervaded their way into pop culture, inspiring TV shows, movies, and the like. However, CPIP Senior Scholar Mark Schultz has released a new report for USIJ entitled The Importance of an Effective and Reliable Patent System to Investment in Critical Technologies showing that this dream may be harder to attain today due to recent shifts that have weakened the patent system and driven away venture capital investment. Our blog post summarizing the report is available here, and you can read the summary at IPWatchdog here.

Activities, News, & Events

a lit lightbulb hanging next to unlit bulbs

On August 5, 2020, CPIP Director of Copyright Research and Policy Sandra Aistars joined Jaylen Johnson, Attorney Advisor at the U.S. Copyright Office, and Kim Tignor, Executive Director at the Institute for Intellectual Property & Social Justice (IIPSJ), for a virtual panel presentation on copyright protection for visual artists that was hosted by Artomatic. The panel focused on explaining key concepts of copyright law pertinent to visual artists and sharing resources that they can use to learn more about the basics of copyright protection. It also touched on common pitfalls among visual artists when it comes to protecting their creative works, including those that befall joint authors, and common misconceptions about fair use. Our blog post summarizing the event is available here.

On August 25, 2020, CPIP Senior Fellow for Innovation Policy Jonathan Barnett published a new essay at Truth on the Market entitled Will Montesquieu Rescue Antitrust? In the post, Prof. Barnett examines recent pressure on state and federal regulators to use antitrust laws against firms that have established market dominance, and he praises the genius of the eighteenth-century philosopher Montesquieu for developing the theory of separation of powers that allows the judiciary to police overly zealous antitrust prosecutors today. Traversing recent—and failed—antitrust enforcement actions, including AT&T’s acquisition of Time-Warner, Sabre’s acquisition of Farelogix, and FTC v. Qualcomm, Prof. Barnett explains how the judicial branch has become an important counterbalance to prosecutorial antitrust overreach that betrays the fundamental objective of promoting the public interest in deterring anticompetitive business practices.

On August 25, 2020, CPIP Senior Scholar Kristen Osenga published an op-ed in the Washington Times entitled If We Want Innovation, Companies Must Be Able To Rely on Patent Law To Protect Their Investments. The op-ed explains the importance of effective patent protection for innovative companies to develop and commercialize their new technologies. In particular, Prof. Osenga praises the recent antitrust victory of Qualcomm over the FTC in the Ninth Circuit, noting that a “race that results in innovation that other companies, and the public, dearly desires is exactly the point of competition.” Prof. Osenga also authored a recent op-ed for the Richmond Times-Dispatch, With Biomedical Research, Taxpayers Are Getting a Great Deal, explaining how the critics are wrong to argue that the government should take control of important biomedical inventions like remdesivir. She was also quoted in a recent article at Bloomberg Law entitled Court Split Over Driveshaft Patent Muddies Eligibility Question about the Federal Circuit’s recent 6-6 split on whether to review an important patent-eligibility case en banc.

Categories
Biotech Patents Pharma

“No Combination Drug Patents Act” Stalls, but Threats to Innovation Remain

superimposed images from a chemistry labBy Kevin Madigan & Sean O’Connor

This week, the Senate Judiciary Committee was to mark up a bill limiting patent eligibility for combination drug patents—new forms, uses, and administrations of FDA approved medicines. While the impetus was to curb so-called “evergreening” of drug patents, the effect would have been to stifle life-saving therapeutic innovations. Though the “No Combination Drug Patents Act”—reportedly to be introduced by Senator Lindsey Graham (R-SC)—was wisely withdrawn at the last minute, it’s likely not the last time that such a misconceived legislative effort will be introduced.

An Exaggerated Response to a Disputed Theory

The bill would have established a presumption of obviousness for drug or biologic patent applications whose invention was a new: dosing regimen, method of delivery, method of treatment, or formulation. While there was a rebuttal provision where the claim covered a new treatment for a new indication or “increase[d] . . . efficacy,” the latter was almost certain to introduce years of uncertainty and litigation. Further, the bill would have covered a broader class than true combination drug patents, in which one active ingredient is combined with another or with a non-drug.

Like many recent legislative efforts, the amendment sought to address a perceived lack of affordability of prescription drugs. After praising the America Invents Act of 2011 and subsequent Supreme Court rulings for strengthening the US patent system, the bill claimed that rising drug prices have outpaced “spending on research and development with respect to those drugs.” In addition to applauding Supreme Court decisions that have injected unquestionable uncertainty into patentable subject matter standards, the amendment went on to blame high drug prices on continually overstated issues related to advanced drug patents.

According to critics, combination drug patents have granted drug makers unearned and extended protection over existing drugs or biological products. But, quite simply, when properly issued by the USPTO under existing patentability standards, these are new patents for new products or processes.

Combination patents have been maligned as anticompetitive, resulting in a “thicket” of patents that impedes innovation through transaction costs and other inefficiencies. Unfortunately, notwithstanding a lack of empirical evidence validating the harm of follow-on innovation patents, patent thicket rhetoric is now being echoed by the media, the academy, courts, and policy makers in a fraught attempt to fix drug pricing.

Reports (see here, here, here, and here) from leading antitrust experts and intellectual property scholars have detailed the value of incremental innovation and challenged the notion that patent thickets are a true threat to competition and innovation. These studies have exposed patent thicket claims—much like the “troll” narrative that for years infected patent law debates—as an empty strawman theory, the repetition of which has led to undue confidence in its accuracy. The reality is that what critics point to as problematic cases of combination patents are in fact infrequent outliers, strategically highlighted to discount evidence of the value of new and innovative drug uses and administrations.

A similar claim by those promoting the patent thicket narrative is that combination patents extend exclusivity on a drug for years beyond an initial patent term, thereby blocking generic entry in the market. But if an underlying drug has gone off patent, no follow-on or combination patent will prevent a generic drug company from producing the underlying formulation—it’s only the new formulation, use, or administration that is protected.

Vague, Yet Oddly Familiar Standards

The language of the Graham amendment asserted that because “numerous” combination patents “contain obvious product developments,” a restructuring of 35 USC 103 is necessary to combat patent thickets and achieve optimal drug pricing. Suggesting that 103 obvious standards for advanced drug development should include a presumption that the covered claimed invention and the prior art to which it relates would have been obvious, the legislation would have undermined a unitary system of patent law in favor of different standards for different fields of technology. It was a bold proposal, and it’s one that ignored the proven value of new drug formulations and methods of treatment.

While the amendment provided for a rebuttal to the presumption of obviousness, the language was ambiguous and likely to render the patent system even more unreliable than it already is. The proposed statute said that an applicant may rebut the presumption of obviousness if the covered claimed invention “results in a statistically significant increase in the efficacy of the drug or biological product that the covered claimed invention contains or uses.” It is unclear what would qualify as “statistically significant,” and proving this vague standard would be nearly impossible.

In order to show a “statistically significant increase in efficacy,” long and costly head-to-head clinical trials would be necessary. To be clear, this is not a standard required by the FDA for new drug approval, let alone patentability.

As if that wasn’t enough reason to reject the Graham amendment, the language was alarmingly similar to that of an Indian patent law statute that has been recognized by the US Trade Representative as a “major obstacle to innovators.” In 2005, in order to comply with the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, India adopted for the first time patent protection for pharmaceuticals. Despite its recognition of IP rights in pharmaceuticals, India’s Act contains a troubling ambiguity in its Section 3(d), which requires an “enhanced efficacy” for known drugs in addition to the standard novelty, inventive step, and industrial applicability requirements.

India’s Section 3(d) has been invoked to reject patent protection for life-saving drug innovations, including Novartis’ landmark leukemia drug, Gleevec. Drug companies, government agencies, and policy makers have all recognized the threat to innovation that India’s patent law poses. In 2013, not long after the Novartis ruling, a bipartisan group of 40 Senators signed a letter to then Secretary of State John Kerry urging the state department to take action against India’s “deteriorating IP environment,” citing its willingness to “break or revoke patents for nearly a dozen lifesaving medications.”

Despite the widespread condemnation of India’s Section 3(d), the Graham amendment proposed adopting similarly indefinable standards to US patent law. While the language differed slightly—replacing “enhanced efficacy” with “increase in the efficacy”—it was no clearer, and implementation of this type of standard would only cause more confusion.

Protecting and Incentivizing Medical Innovation

Like most forms of innovation, the development of medicines and therapeutics is a process by which one builds and improves upon previous discoveries and breakthroughs. Sometimes those improvements are major advancements, but often they are incremental steps forward. In the pharmaceutical field, incremental or follow-on innovation frequently results in new therapeutic uses for existing drugs, which address serious challenges related to adverse effects, delivery systems, and dosing schedules. While they might not sound like medical breakthroughs on par with the discovery of penicillin, these advancements in the administration and use of pharmaceuticals improve public health and save lives.

Additionally, follow-on innovations are—and should remain—subject to the same patentability standards as any other technologies. Patents reward advancements that are novel, useful, and nonobvious, and our patent system has long recognized that patent claims are to be presumed patentable and nonobvious. The Graham amendment would have turned this established standard on its head, creating a separate and ill-defined hurdle for certain advancements in medicine.

The benefits of incremental innovation to public health and patients cannot be overstated. New formulations of malaria drugs, dosing regimens and delivery systems for AIDS patients, more efficient administrations of insulin for the treatment of diabetes, and developments in the treatment of cognitive heart disease have all been possible because of incremental innovation.

Imposing unjustified restrictions on the patentability of advancements like these would be disastrous for drug development, as the incentives that come with patent protection would be all but eliminated. Without the assurance that their innovative labor would be supported by intellectual property protection, pioneering drug developers would shift resources away from improving drug formulations and uses. The development of more effective treatments of some of the most devastating diseases would stall, as innovators would be unable to commercialize their products, recoup losses, or fund future research and development.

As critics continue to target myopically the patent system for a broader issue of drug prices in the American health care system, it’s likely not the last time that language like this will be proposed. In order to avoid the implementation of such ill-conceived standards into our patent laws, understanding what’s at stake is critical. The future of medical innovation depends on it.

Categories
Legislation Patent Law Uncategorized

Rep. Massie Introduces New Legislation to Restore America’s Patent System

dictionary entry for the word "legislation"Yesterday, Representative Thomas Massie introduced the Restoring America’s Leadership in Innovation Act of 2018 (H.R. 6264). This legislation would reverse many of the harms that have been caused by recent changes to the patent laws from all three branches of government. Patents are an important part of our innovation economy, providing an incentive for inventors to invent and protecting those creations for commercialization and investment.

Unfortunately, the past decade has witnessed the gradual weakening of our patent system. The America Invents Act (AIA) created new post-issuance methods for reviewing patent validity on top of the review that already occurred in federal courts. The Supreme Court has handed down case after case weakening patents and excluding broad swaths of innovation from the patent system entirely. The USPTO, through the Patent Trial and Appeal Board (PTAB), has been systematically invalidating worthwhile patents based on flawed procedures that are easily abused. Together, these changes have done substantial damage to our innovation economy.,

This new bill will reverse many of these recent changes. Although some of the proposals are new, most are merely the codification of what had long been the law for the patent system. The following provides a breakdown of the most important sections of this legislation:

    • Section 3 (the first substantive section), returns the United States to a first to invent patent system. As noted by CPIP Founder Adam Mossoff, giving patents to the first inventor rewards the intellectual labor that results in the invention. This conception of patents as private property rights protecting the innovator’s creation is arguably required by the Patent Clause of the Constitution, and thus, this Act will bring patent laws back within constitutional limits. Conversely, a first to file system merely rewards those who can win a race to the Patent Office.
    • Section 4 abolishes Inter Partes Review (IPR) and Post-Grant Review (PGR). In addition to covered business method review, which was created with a sunset provision, these procedures allow the Patent Office to cancel at patent it has previously issued. Numerous scholars have identified the substantial harms caused by the PTAB. The problems have been so extensive that other legislation focused on trying to fix these procedures has been introduced. This bill goes the necessary next step. Because these procedures fundamentally undermine the status of patents as private property, the bill eliminates IPR and PGR entirely.
    • Section 5 abolishes the PTAB. The PTAB is a terrible example of regulatory overreach. In light of the elimination of IPR and PGR and the return to a first to file system, the creation of the PTAB by the AIA to administer these systems serves no purpose. The legislation instead recreates the Board of Patent Appeals and Interferences, which existed prior to the AIA and handled the administrative appeals and trials that occurred under the prior system. This change also overrules the holding of Oil States v. Greene’s Energy and accomplishes legislatively the outcome of a CPIP led amicus brief in that case.
    • Section 6 eliminates fee diversion and provides for full funding of the USPTO. Innovators and the public alike count on the USPTO to perform timely, quality examinations of patent applications in the first instance. Ensuring that adequate resources are available for this purpose is essential, particularly given that applicants pay fees to the USPTO for precisely this purpose.
    • Section 8 is mainly technical to assure that the restored § 102 retains the one-year grace period and that certain disclosures by the inventor do not become prior art.
    • Section 9 reestablishes the previously long-held status of patents as a property right. The Constitution secures a patent as a property right and many scholars have noted the important implications of treating patents as property. This section not only states that a patent is a property right, but confirms that a patent may only be revoked in a judicial proceeding, which has substantial benefits, unless the patent owner consents to another procedure. This reverses the broad reasoning in Oil States. The parts of this section returning to patent owners the right to control their property also largely overturn Impression Products v. Lexmark International, now allowing patent owners to exclude unlicensed users from their supply chains.
    • Section 10 ends the automatic publication of patent applications. This change will allow applicants to keep their inventions secret until they have the security that comes with an issued patent.
    • Section 11 codifies the details of the presumption of validity and available defenses to patent infringement. For the first time, this will enshrine in statute that the “clear and convincing standard” must be used to invalidate a patent. Additionally, this section provides for tolling of the patent term during litigation challenging the patent’s validity.
    • Section 12 confirms that injunctions are available to protect the patent property. Although not explicit, the new statutory presumption that infringement of patent causes irreparable harm largely abrogates the Supreme Court’s decision in eBay, which dramatically limited the availability of injunctions. Furthermore, having this rule placed into the statute will limit the inter-court variability that has led to inconsistent outcomes.
    • Section 13 restores the possibility of invalidating a patent for failure to comply with the best mode requirement.
Categories
Patent Law

The Value of Public Data: Update to “Turning Gold to Lead”

files labeled as "patents"By Kevin Madigan & Adam Mossoff

A key value in the empirical work done in the social sciences and in the STEM fields is that data is made public and available for review, testing, and confirmation. Humans are neither infallible nor omniscient, and thus this standard practice in empirical research has evolved as a way to ensure that mistakes are identified and corrected. All scholars should ensure that their data is accessible, their analysis is understandable, and the means by which they draw their conclusions in both content and method is independently verifiable. As scholars, we embrace these principles.

Thanks to our making the data publicly available, we recently discovered that we made a mistake in listing a patent application number in an essay we published on a dataset of patent applications. In Turning Gold to Lead: How Patent Eligibility Doctrine Is Undermining U.S. Leadership in Innovation, George Mason Law Review, vol. 24 (2017), pp. 939-960, we reported on a dataset compiled by David Kappos and Bob Sachs of 17,743 patent applications “that received a § 101 rejection in initial or final office actions and then were abandoned between August 1, 2014 and September 27, 2017” (p. 941, footnote 10). The Kappos-Sachs dataset, as we detail in our article, identifies 1,694 patent applications among these 17,743 applications that received initial or final rejections and were ultimately abandoned in the United States, but patents were granted on the same inventions by the European Patent Office, China, or both.

We used the Kappos-Sachs dataset in our essay to highlight a “disturbing trend” in the U.S. patent system today in comparison to other countries. Our essay does not draw statistical inferences about this dataset, but rather reports on it and contextualizes it within the changes in patent eligibility jurisprudence recently wrought by the U.S. Supreme Court. We compare the more restrictive approach in patent eligibility doctrine in the U.S. today with historically a more open and accessible patent system for cutting-edge innovation in the U.S. The earlier approach led commentators to refer to the U.S. patent system as the “gold standard” compared to the rest of the world. Thus the title of our essay, “Turning Gold to Lead.”

In our essay, we listed twelve patent applications that exemplified this new disturbing trend of the closing of the U.S. patent system to cutting-edge innovation, as compared to other countries (pp. 957-958). In accord with publicly accessible data standards, we identified these twelve applications in a table with their patent application numbers, the titles of the inventions in the applications, the publication dates of the applications, and the assignees of the now-abandoned U.S. applications.

We have since learned that we made a mistake in one of the patent application numbers listed in this table. The invention, “Method for Growing Plants,” is listed as application number US12/139,753. This was a “parent” application that was ultimately rejected on novelty (§ 102) and nonobviousness (§ 103) grounds, but it was not rejected for lack of § 101 patent eligibility. We should have instead listed patent application US12/968,726, which has the same title, “Method for Growing Plants,” and is the “child” application of the mistakenly listed “parent” application.

(For non-patent-law geeks, a “parent” is a patent application during which, while its examination is still pending, the applicant files another patent application on a related invention that is linked to the “parent” in order to receive the earlier invention/filing date of the parent. These patent applications are also linked in the database of applications in the USPTO. This related “child” application is a new application that may disclose new features of or adds new claims to the original “parent.” These additional, related applications are expressly permitted under § 120 and § 121 of the Patent Act.)

We would also like to make clear that our essay reports on the Kappos-Sachs dataset, which comprises patent applications that have been abandoned by the applicants after an initial or final rejection on § 101 patent eligibility grounds. A typo at the end of footnote 10 on p. 941 leaves out the “initial,” and this could be confusing given the earlier sentence in the footnote that refers to both “initial or final rejections.” An example of an initial rejection for lack of § 101 patent eligibility is a patent application in our table on pp. 957-958: patent application US13/746,180, titled “Methods For Diagnosing and Treating Prostate and Lung Cancer.” This patent application received an initial rejection based on § 101 for lack of patent eligibility, but the applicant continued to pursue the application at the USPTO, revising and resubmitting the application in the hope it would be granted. This patent application was ultimately abandoned, just like all the others in the dataset, and the very last rejection before this abandonment was one in which the examiner argued that it was not patentable given its obviousness (§ 103) and a lack of proper disclosure (§ 112).

Pursuant to the terms of the Kappos-Sachs dataset, there was an initial rejection under § 101 for patent application US13/746,180 and it was ultimately abandoned. In fact, given the extensive confusion now in the courts and at the USPTO between the legal standards of § 101 and § 103, as many scholars and others have widely recognized, it is completely unsurprising to find an initial rejection under § 101 morph into a rejection under § 103 after which the applicant then abandoned it (while the corresponding patent for the same invention was granted in other countries where it was not similarly rejected and abandoned).

We regret any confusion that may arise from the dynamic and evolving examination histories of the patent applications in the Kappos-Sachs dataset, and we especially regret listing the wrong “parent” application number instead of the “child” application number.

This is just the start of data collection on the nature and impact of the overly restrictive approach to patent eligibility in the U.S. in the past several years. We hope that scholars trained in rigorous statistical analysis will start to scrutinize the Kappos-Sachs dataset. As we state in the conclusion of our essay:

This Essay highlights empirical data about extensive invalidations of patents by the courts and by the PTO, and hundreds of patent applications rejected in the U.S. but granted for the same or similar inventions in Europe and China. This data reflects a very disturbing trend that portends darkly for the future of the U.S. innovation economy. The data deserves to be mined further with rigorous statistical analysis, investigating more closely issues like technology classes and other relevant variables, but this is beyond the scope of this conference Essay.

Our essay is short and so we invite any interested parties to consider it for themselves. Also, as we said, the dataset is on the Internet and available to all (unlike empirical claims made by others in the patent policy debates that are based in secret, proprietary data and infected with basic methodological problems in statistical analysis).

In conclusion, we wish to express (again) our profound appreciation to David Kappos and Bob Sachs for sharing their dataset with us. We were honored that they gave us permission to report on it. We apologize for any confusion caused by our “scrivener’s error” in listing the wrong patent application number and any confusion caused by an applicant’s ongoing attempts at trying to obtain a U.S. patent before abandoning it after receiving an initial § 101 patent eligibility rejection.

One final minor update is necessary. In our essay, we expressly state that if anyone has questions about the dataset, they should contact Robert Sachs, but the email address is at his old law firm and is now defunct. Bob can now be contacted at rsachs@patentevaluations.com.

Categories
Patents

CPIP Scholars To Federal Circuit: Protect Innovation in the Life Sciences

Microscopic image of cellsLast week, a group of CPIP scholars—Chris Holman, David Lund, Adam Mossoff, and Kristen Osenga—filed an amicus brief in Natural Alternatives International v. Creative Compounds, a case currently on appeal to the U.S. Court of Appeals for the Federal Circuit. The amici ask the appellate court to correct the district court’s misapplication of the patent-eligibility test under Section 101 of the Patent Act since it threatens innovation in the life sciences.

The plaintiff-patentee, Natural Alternatives International or NAI, provides nutritional products, including proprietary ingredients and customized nutritional supplements, to its clients. NAI owns several patents relating to beta-alanine, a non-essential amino acid that delays the onset of muscle fatigue. The district court held that the claims were ineligible subject matter under the two-step Alice-Mayo test: the claims were directed to a natural phenomenon and lacked an inventive concept containing more than conventional, routine activity.

The amici point out that the district court’s overly-restricted view of patent-eligibility doctrine will dissuade the research and development of natural products that are beneficial for mankind. They note that the district court glossed over several predicate factual questions and failed to properly consider the claims as a whole. They conclude that the continued misapplication of the Section 101 analysis has resulted in legal uncertainty, undermining the innovation industries that rely on stable and effective patent rights.

The Summary of Argument is copied below, and the amicus brief is available here.

***

SUMMARY OF ARGUMENT

The district court’s decision in Natural Alternatives International, Inc. v. Creative Compounds, LLC, No. 16-cv-02146-H-AGS, (S.D. Cal. Sept. 5, 2017) and Natural Alternatives International, Inc. v. Hi-Tech Pharmaceuticals, Inc., No. 16-cv- 02343-H-AGS, (S.D. Cal. Sept. 5, 2017), represent an improper application of 35 U.S.C. § 101. The parties in their briefs address the relevant innovation covered by Natural Alternatives’ patents, as well as the application of the Supreme Court’s and the Court of Appeals for the Federal Circuit’s § 101 jurisprudence. Here, amici offer additional insight concerning the legal and policy problems with the trial court’s decision. Specifically, amici contend that Natural Alternatives’ claims represent precisely how the patent system should reward discovery of a therapeutic use of a natural compound, and thus their invention should be eligible for patent protection. The Supreme Court has repeatedly emphasized that patents claiming new uses of known drugs or new applications of laws of nature are patent eligible, and these teachings properly applied provide patent eligibility for the kinds of claims at issue in this case. Assoc. for Molec. Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 594 (2013); Mayo Collaborative Servs v. Prometheus Labs., Inc., 566 U.S. 66, 87 (2012). The district court’s decision to the contrary conflicts with the Patent Act as an integrated statutory framework for promoting and securing innovation in the life sciences, as construed by this court as well as by the Supreme Court.

The Supreme Court has recognized that the plain meaning of the language of § 101 indicates that the scope of patentable subject matter is broad. See Diamond v. Chakrabarty, 447 U.S. 303, 315 (1980); Myriad at 577. This is why the Supreme Court consistently has held that “[t]he § 101 patent-eligibility inquiry is only a threshold test.” Bilski v. Kappos, 561 U.S. 593, 602 (2010). Accordingly, the “threshold test” of § 101 is necessarily followed by the more exacting statutory requirements of assessing a claim as a whole according to the standard of a person having skill in the art as to whether it is novel, nonobvious, and fully disclosed as required by the quid pro quo offered to inventors by the patent system. Id.

Unfortunately, courts have applied the two-step “Mayo/Alice test” from the Supreme Court’s recent § 101 cases in an unbalanced and legally improper manner. See Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014); Mayo, 566 U.S. at 66. These practices of the inferior courts include dissecting claims into particular elements and then construing these elements in highly generalized terms with no evidentiary support. Thus, as happened in this case, a district court all too often merely asserts a conclusory finding that the claim—actually, specific elements dissected out of the claim as a whole—covers ineligible laws of nature or natural products to conclude that a patented invention is ineligible.

The lower courts’ unduly stringent and restrictive patent eligibility test under the Mayo/Alice test produces results such as the district court’s decision in this case. This improper application of the Mayo/Alice test inevitably leads to § 101 rejections of patentable product and method inventions; here, the district court rejected an innovative invention in the biotechnology sector that the patent system is most certainly designed to promote. When a patent describes a discovery made by the inventor, even if that invention relates to a natural product or natural law, it should be possible to describe a particular application of that law or discovery that is patent eligible so as to reward the inventor for their efforts.

Furthermore, the improper treatment of the § 101 inquiry as primarily a question of law requiring no evidentiary findings whatsoever, especially when the parties expressly disagree as to what a person having skill in the art would consider routine or ordinary, allows courts to gloss over both what the claims are directed to and what importance limitations beyond the ineligible material may have. See Berkheimer v. HP Inc., 881 F.3d 1360, 1368-69 (Fed. Cir. 2018). This improper characterization of § 101 has sowed indeterminacy in patent eligibility doctrine, and has left inventors and companies in the innovation industries with little predictability concerning when or how courts will dissect claims and make conclusory assertions that they are patent ineligible under § 101.

The court in this case has an opportunity to more properly instruct the lower courts in the manner in which the § 101 analysis should be made, particularly with regard to the role of factual evidence in determining when a claimed application of a natural law or product is routine, well-understood, or conventional and when it is not and thus that the claimed invention is eligible for patenting.

To read the amicus brief, please click here.

Categories
Patents Supreme Court

CPIP Scholars Ask Federal Circuit to Fix Patent Eligibility Doctrine in Cleveland Clinic Appeal

files labeled as "patents"Last week, a group of CPIP scholars filed an amicus brief in Cleveland Clinic Foundation v. True Health Diagnostics, a case currently on appeal to the U.S. Court of Appeals for the Federal Circuit. The patents at issue cover diagnostic tests used to assess a person’s risk of developing cardiovascular disease. The U.S. Patent & Trademark Office initially found the claims to be unpatentable subject matter under Section 101; however, the claims were eventually allowed as new and unconventional applications of known laboratory techniques. Nevertheless, the district court held the claims unpatentable under Section 101, reasoning that they were ineligible under the Alice-Mayo test.

The amicus brief filed last week, written by CPIP’s David Lund and Adam Mossoff, points out that the diagnostic methods at issue are the very sort of innovations the patent system is meant to encourage. Moreover, given the factual conclusions that must be made in order to determine whether the claims are directed to a natural law or whether the laboratory techniques are routine and conventional, they argue that the procedural posture of the case—a motion to dismiss—precludes proper application of the Alice-Mayo test. They note that misapplication of the patent eligibility test continues to lead courts to reject patent protection for many meritorious inventions—as demonstrated in this very case. The amici urge the Federal Circuit to bring clarity and predictability to Section 101 doctrine by rejecting the district court’s conclusory assertions that were made without proper factual support.

The Summary of Argument from the amicus brief is copied below:

SUMMARY OF ARGUMENT

The district court’s decision in The Cleveland Clinic Foundation v. True Health Diagnostics, LLC, No. 17-cv-198, 2017 WL 3381976 (E.D. Va. Aug. 4, 2017), represents an improper application of 35 U.S.C. § 101. The parties address the relevant innovation covered by Cleveland Clinic’s patents, as well as the application of the Supreme Court’s and the Court of Appeals for the Federal Circuit’s § 101 jurisprudence; accordingly, amici offer additional insight concerning the legal and policy problems with the trial court’s decision: innovation in improving the assessment of a patient’s risk of developing cardiovascular disease is an invention that the patent system is designed to promote, and thus it should be eligible for patent protection. Barring a properly reasoned, factually-based determination that either a claimed method-of-treatment invention covers a law of nature or, under step two of the Alice-Mayo test, that it would be considered routine or ordinary by a person having skill in the art, a district court should not find claims to be ineligible subject matter under § 101 on a motion to dismiss. See Berkheimer v. HP Inc., __ F.3d at ___, No. 2017-1437 (Fed. Cir. 2018). The district court’s decision in this case conflicts with the Patent Act as an integrated statutory framework for promoting and securing innovation in the life sciences, as construed by both the Supreme Court and this court.

The Supreme Court has recognized that the plain meaning of the language of § 101 indicates that the scope of patentable subject matter is broad. See Diamond v. Chakrabarty, 447 U.S. 303, 315 (1980). This is why the Supreme Court consistently has held that “[t]he § 101 patent-eligibility inquiry is only a threshold test.” Bilski v. Kappos, 561 U.S. 593, 602 (2010). Accordingly, this “threshold test” is necessarily followed by the more exacting statutory requirements of assessing a claim as a whole according to the standard of a person having skill in the art as to whether it is novel, nonobvious, and fully disclosed as required by the quid pro quo offered to inventors by the patent system. Id.

Unfortunately, courts have been focusing on out-of-context statements in the Supreme Court’s recent § 101 cases that have led those courts to inexorably apply the two-step “Alice-Mayo test” in an unbalanced and legally improper manner. See Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014); Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). Courts are dissecting claims into particular elements and then construing these elements in highly generalized terms with no evidentiary support. Thus, as happened in this case, a district court all too often merely asserts a conclusory finding that the claim— actually, specific elements dissected out of the claim as a whole—covers ineligible laws of nature or abstract ideas.

This has led lower courts to create an unduly stringent and restrictive patent eligibility test under the Alice-Mayo test, as evidenced by the district court’s decision in this case. This contradicts the Supreme Court’s decisions in Chakrabarty and Bilski that § 101 is only a threshold inquiry identifying broad statutory categories of patent-eligible inventions. This improper application of the Alice-Mayo test inevitably leads to § 101 rejections of patentable method inventions, as the district court in this case rejected an innovative invention in the bio-pharmaceutical sector that the patent system is designed to promote.

Furthermore, the improper treatment of the § 101 inquiry as a pure question of law requiring no evidentiary findings whatsoever, especially when the parties expressly dispute as to what a person having skill in the art would consider routine or ordinary, conflicts with the Supreme Court’s and this Court’s decisions that the application of the patentability requirements in the Patent Act present questions of law with underlying questions of fact. See Teva Pharm. USA Inc. v. Sandoz, Inc., 135 S.Ct. 831, 838 (2015) (claim construction); KSR v. Teleflex, 550 U.S. 398 (2007) (nonobviousness under § 103); Berkheimer, __ F.3d at ___, No. 2017-1437 (Fed. Cir. 2018) (patentable subject matter under § 101); Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d 1334, 1343 (Fed. Cir. 2016) (indefiniteness under § 112); Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1188 (Fed. Cir. 2014) (enablement under § 112). This has sowed indeterminacy in patent eligibility doctrine, as inventors and companies in the innovation industries are left with little predictability concerning when or how courts will dissect claims and make conclusory assertions that they are patent ineligible under § 101.

To read the amicus brief, please click here.

Categories
Innovation Patent Law

CPIP Scholars File Amicus Brief Urging Supreme Court to Fix Section 101

dictionary entry for the word "innovate"On December 4, 2017, CPIP Founder Adam Mossoff and CPIP John F. Witherspoon Legal Fellow David Lund filed an amicus brief urging the Supreme Court to grant certiorari in RecogniCorp. v. Nintendo. The amicus brief was joined by several law professors, including Richard Epstein and Michael Risch, as well as CPIP Senior Scholars Chris Holman, Kristen Osenga, Mark Schultz, and Ted Sichelman. Bob Sachs of Robert R. Sachs P.C. served as counsel of record.

The technology at issue involves a method of encoding and decoding composite facial images on a computer. The invention solved the problem of decreased image quality when such images are transmitted digitally. RecogniCorp sued Nintendo for patent infringement, and Nintendo challenged the eligibility of the patent under Section 101. Applying the Mayo-Alice framework, the district court held that invention was ineligible subject matter because it was directed to an abstract idea and lacked an inventive concept. Agreeing with that analysis, the Federal Circuit affirmed.

The amici argue that the Supreme Court should grant certiorari in this case in order to correct the continued misapplication of the Mayo-Alice test by the Federal Circuit, the district courts, and the Patent & Trademark Office. By breaking down claims into individual elements and then generalizing them in broad terms, the lower courts and the PTO are failing to properly consider the claimed invention as a whole.

The Summary of Argument is copied below:

SUMMARY OF ARGUMENT

This Court has repeatedly reminded the Court of Appeals for the Federal Circuit, district courts, and the United States Patent & Trademark Office (“PTO”) that § 101 of the Patent Act is a key requirement in assessing the validity of both patent applications and issued patents. In doing so, this Court set forth a two-part test for assessing whether an invention is patentable subject matter (the “Mayo-Alice test”). See Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014); Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). These cases build upon prior cases such as Diamond v. Diehr, 450 U.S. 175 (1981), which held that a software-based method for operating a rubber mold is patent eligible under § 101.

Unfortunately, the lower courts and the PTO have misunderstood how to apply the Mayo-Alice test. Specifically, the lower courts and the PTO have adopted an indeterminate and overly restrictive approach, invalidating legitimate patented innovation under § 101 with little predictability for inventors or patent attorneys. This frustrates the constitutional function of the patent system in promoting the “Progress of . . . useful Arts.” U.S. Const. art. 1, § 8, cl. 8.

This case exemplifies both of these fundamental problems—indeterminacy and over-restrictiveness—because the lower courts held that a claim is patent ineligible as an “abstract idea” merely because the process was implemented through the use of computer software. These problems undermine inventors’ ability to use the patent system to protect computer-mediated processes that are exactly the kind of innovation that the patent system is designed to promote.

Petitioner details the substantial confusion in the application of the Mayo-Alice test in this case, as well as at the PTO and in the lower courts. Amici here identify a further key insight: when lower courts and the PTO apply the Mayo-Alice test to only individualized elements of a claim, generalizing these elements into a broad, categorical description and not evaluating the claimed invention as a whole, they are using a methodological approach that conflicts with this Court’s existing precedents on determining patent eligibility under § 101.

In this case, the Federal Circuit held that a software-based method of producing images of faces on a computer screen is an “abstract idea.” RecogniCorp, LLC v Nintendo Co., 855 F.3d 1322, 1327 (Fed. Cir. 2017). It reached this conclusion by dissecting the claim into its separate elements and ignoring other key elements, ultimately finding the claimed invention is ineligible under § 101. By reducing the claim to “encoding and decoding data,” the court ignored the invention as a whole that improves the way computers generate digital representations of faces for display.

This Court can easily remedy this problem by (1) recognizing the role of the patent system in protecting computer-implemented innovation, a key driver of modern technological progress, and (2) providing further instructions to lower courts and to the PTO that they should apply the Mayo-Alice test only to the claimed invention as a whole. This is a predicate legal requirement in assessing novelty under § 102 and in assessing nonobviousness under § 103 of the Patent Act. It is also a fundamental legal requirement for asserting patents for both literal and equivalents infringement under § 271. In all of these other patent doctrines, this Court has maintained the basic requirement of assessing patentability or limiting assertion of patents to the claimed invention as a whole, as this avoids the same policy problems of indeterminacy and over-restrictiveness (or over-inclusiveness, depending on the perspective) in these other patent doctrines. Thus, this Court should grant the petition for certiorari, reverse the Federal Circuit, and provide further instructions for applying the Mayo-Alice test only to the “claimed invention as a whole.”

To read the amicus brief, please click here.

Categories
Innovation Patent Law

An Ever-Weakening Patent System is Threatening the Future of American Innovation

dictionary entry for the word "innovate"Over the past ten years, the United States patent system has been transformed by new legislation, regulatory actions, and numerous decisions by the Supreme Court addressing nearly every area of patent doctrine. The many disruptive legal changes have affected infringement remedies, licensing activities, and what types of inventions and discoveries are eligible for patent protection, resulting in a profound sense of uncertainty for most stakeholders. This current state of doubt about the American patent system is pushing investors to look outside of the US for less risky ventures. And because investors are shifting their focus overseas, foreign countries are for the first time poised to bypass the US as the forerunners of innovation.

Last month, the United States Patent & Trademark Office (USPTO), along with the University of Texas Law School and Antonin Scalia Law School, George Mason University, hosted the 12th annual Advanced Patent Law Institute in Alexandria, Virginia. The program featured a distinguished panel of patent experts discussing “current issues around patenting, licensing, enforcing, and monetizing patents in the U.S., and look[ing] at what the UK, EU, and China are experiencing and the impact on U.S. patent practice.” Titled The Current Patent Landscape in the US and Abroad and focusing on the economic factors that spur invention, the consensus was that dramatic changes to the US patent system are driving investment in research and development outside the country and threatening the future of American innovation.

US Patent System No Longer Adequately Incentivizes Investment

Serving as co-moderator with the Hon. Paul R. Michel, Robert Sterne—a leading patent attorney and founding partner of Sterne, Kessler, Goldstein & Fox—kicked off the panel with an overview of a patent system that is falling behind China and the European Union as a driver of innovation. Questioning the Supreme Court’s radical distortion of patent law over the last ten years and the institution of post-grant review, Sterne pointed out that the Patent Trial and Appeals Board (PTAB) has produced over 6,000 proceedings, with patent owner success rates hovering between a meager 30 to 40%. Because of these discouraging numbers, and because injunctive relief has become almost impossible to obtain for patent owners, Sterne warned that critical investment in small and medium-sized companies and universities is rapidly declining.

Judge Michel echoed many of the same sentiments, expressing concern with the “health and vitality and effectiveness of the patent system.” Michel stressed that the principle goal of the patent system is to incentivize investment, but that continued assaults on the system are driving investors to foreign jurisdictions and moving the US in the direction of “off-shore invention.” Citing studies by the Kauffman Foundation and US Census Bureau, Michel explained that most new jobs come from small start-up companies dependent on technology, and that without adequate incentives to invest in these job creators, the patent system and economy are in serious danger.

Expanding on the problem of investment incentivizes, Paul Stone—a partner at venture capital firm 5AM Ventures—discussed his backing over 60 life science startups in the last 15 years, all of which specialized in therapeutics aimed at developing life-saving drugs and drug delivery technologies. Stone offered the following three points to consider regarding the current innovative investment landscape: (1) 60% of the new drugs approved in 2016 came from venture capital-funded small biopharmaceutical companies, not pharma industry giants, (2) of these new approvals, the origin of half the molecules are outside the United States, a much higher percentage than ten years ago, and (3) personalized medicine and the influence of information technology on biotech is leading to smaller market sizes, and a weaker patent system is threatening the ability to realize a return on investments in this area.

Innovation is Moving Overseas

Damon Matteo of Fulcrum Strategy, an IP asset management firm, began his comments with an ominous warning: “Be afraid, be very afraid.” As a practicing IP attorney, Matteo noted that he has seen clients increasingly interested in securing their IP in Europe and China rather than the US, and that China specifically is embracing the software and business method patents that have been abandoned by the US system. Investment has been moving overseas because that’s where patents still have value. Matteo also pointed out that China has been much more favorable to patent owners in IP litigation, as plaintiffs in infringement suits prevail 60% of the time. And injunctive relief—which has become a completely improbable outcome in US litigation—is granted in upwards of 90% of infringement cases in China when there’s been a finding of infringement.

Peter Detkin, founder of the IP development and licensing company Intellectual Ventures, weighed in on some of the “alternative facts” and hysteria that have resulted in the current state of the US patent system. Despite claims over the last 15 years that extortionary demand letters were being sent by the thousands, patent ligation had gotten out of control, and patents were killing investment in R&D and startups, Detkin pointed to multiple analyses by government agencies such as the FTC and the Government Accountability Office that revealed no such exceptional activity. Unfortunately, policymakers took the bait, and entrepreneurs in Silicon Valley have suffered as a result of over-reactive legislative and judicial efforts.

As in-house Chief Intellectual Property Officer of Vivant, a fast-growing home security technology company, Paul Evans provided more insight into how absolutely vital patents are to investments and private equity–backed tech startups, emphasizing how “patents have historically created an important competitive advantage in the marketplace.” Sharing a recent professional anecdote, Evans recounted a conversation with the managing director of a private equity firm with $10 billion in assets in which they discussed the past successful sale of a company based largely on its strong patent portfolio. The two agreed that the transaction would never have happened today due to the immeasurable decline in the value of patents. Evans noted that about 85% of small businesses in the US are now technology based, and that if our patent system can’t protect the inventions they rely on, investments and jobs will be reallocated to jurisdictions that will.

Shifting the discussion to the effect innovation uncertainty is having on universities, patent law and tech transfer expert Chris Gallagher warned that university research funding is at risk, and that the system of grants can no longer be relied upon. Despite a recent case that found the 11th amendment shielded state-chartered schools from IPR exposure, Gallagher encouraged all stakeholders to reach out to Congress to push back on the persistent troll narrative that continues to affect university research.

Efficient Infringement is Devaluing Patents

The panel then moved into a discussion of the increasingly common practice of “efficient infringement,” where companies choose to infringe patents instead of licensing, understanding that the current system has made enforcing patents too expensive and risky. Damon Matteo likened the practice to robbing a bank, getting caught, and as a punishment, only having to return a fraction of the money. Peter Detkin then expanded on the analogy:

It’s a great analogy — the bank robbery — because you not only get to say whether you get caught, but if you get caught, you’ll then be able to argue to the Federal Reserve that the bank really shouldn’t have existed in the first place. Then if that fails, you get to argue to them again that their certificate never should have issued, because it’s a different ground than the first time you argued. Then you could argue that the money was improperly issued to the bank… you have all these administrative ways.

Commenting on efficient infringement, Paul Evans explained that bringing a suit for patent infringement now makes no sense, as the current ecosystem demands high costs to defend patents subject to inter partes review (IPR). According to Evans, the cost of each IPR is between $200,000 and $300,000. IPRs are instituted 70% of the time, and of those cases, 80% of the challenged claims are invalidated. Evans noted that investors are aware of these realities and are hesitant to back certain patent-reliant companies. As a result of the uncertain innovative economy in the US, Peter Detkin noted that patent application filings are down, as well as enforcement actions. Alternatively, countries in Asia and the European Union that have embraced software and biotech patents have seen an increase in filings, enforcement actions, licensing, and investment.

Judge Michel then identified software and health science technology as suffering the most under the current “huge cloud of uncertainty,” and pointed out that China and Europe have broadened patent eligibility in these two tech fields as the US Supreme Court has narrowed it. Michel questioned how anyone could make a eligibility determination given the vague standard set by the Mayo and Alice decisions, and expressed frustration in the Supreme Court’s denial of cert in Sequenom v. Ariosa—a case that would have given the Court an opportunity to correct or at least clarify the Section 101 eligibility analysis. With the Supreme Court unwilling to clean up its mess, Judge Michel expressed support for statutory amendments to 101 recently proposed by the Intellectual Property Owners Association (IPO).

Confidence Must Be Restored in the US Patent System

Wrapping up the panel, Robert Sterne made clear that the patent troll narrative that contributed to so many drastic changes in the US patent system is outdated and no longer relevant. While uncertainty about Section 101 eligibility is ubiquitous, Sterne asserted that “[w]hat is clear is that things are not getting better for innovators in the United States who are relying on the U.S. patent system and who are creating a large bulk of the innovation in our country.” And in addition to losing an edge to foreign jurisdictions in industrial competiveness and job creations, Sterne warned that missing out on innovations in the technology the US employs to protect itself could have dire consequences for national security.

In conclusion, Sterne asked each panelist—as practitioners working in the innovation economy—what they would suggest to bring a sense of confidence back to the bleak patent law landscape. Judge Michel encouraged writing to bring awareness to the situation, including articles, op-eds, and direct letters to members of Congress. Paul Stone urged all stakeholders to focus on quality—specifically on the quality of patents reviewed and the quality of advice given to clients. Damon Matteo suggested adopting a financial mindset that considers the dynamics of returns on investments, which would help stakeholders see patents for the commercial instruments they are and should be. Peter Detkin stressed the importance of relying on hard, verifiable data, not anecdotes and hysteria. Paul Evans discussed the need to create an ecosystem that can be viewed by the investment community with some sense of understanding and confidence. Finally, Chris Gallagher insisted that, no matter the excuses of not having enough time, or not wanting to offend the wrong people, everyone must get involved to insert integrity back into the innovative ecosystem.

The concerns expressed by this panel are being echoed by stakeholders in almost every section of the innovation economy, and without a concerted effort to bring sense and clarity back to the patent system, the US is in danger of losing its competitive and innovative edge.

Categories
Innovation Patent Law Supreme Court

CPIP Scholars File Amicus Brief Urging Consideration of Claimed Inventions as a Whole

U.S. Supreme Court buildingLast week, CPIP Senior Scholar Adam Mossoff and I filed an amicus brief on behalf of 15 law professors, including CPIP’s Devlin Hartline, Chris Holman, Sean O’Connor, Kristen Osenga, and Mark Schultz. We urge the Supreme Court to grant certiorari in TDE Petroleum v. AKM Enterprise and reaffirm that any analysis of an invention must be of the claimed invention as a whole.

Unfortunately, lower courts and the Patent & Trademark Office have been applying a test of patent eligibility that allows breaking up an invention into parts and then analyzing the parts separately. Sometimes, as in the case here, a court will completely ignore an element of the invention. This needs to be fixed. Any invention is defined by its entirety, not by its isolated parts.

As I discussed before, TDE Petroleum’s patent claims a method of operating an oil rig. Part of the method uses software. But as the claim discussed in our brief makes clear, the end result of the method is control of a physical well with a drill running inside the earth. However, the courts that have looked at this patent so far have only considered the function of certain software elements and pretend the oil rig is not important. Such unimpeded dissection of claims makes it easy to invalidate important patented innovation notwithstanding the contribution to the field.

The full amicus brief can be found here. In addition to showing that the claimed invention is a method of operating an oil rig, we show why the claim precisely parallels a claim to a method of molding rubber found patent eligible by the Supreme Court 36 years ago.