Category: Patent Law

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Copyright Innovation Patent Law

VIDEOS: Panel Presentations from the CPIP 2018 Fall Conference

2018 Fall Conference flyerOn October 11-12, 2018, CPIP hosted its Sixth Annual Fall Conference, IP for the Next Generation of Technology, at Antonin Scalia Law School, George Mason University, in Arlington, Virginia.

After the breakthrough technology that gave us the mobile technology revolution of the past fifteen years, another leap forward in technology is about to break out into consumer products and services. Our panelists addressed how IP rights and institutions can foster and support this technological advance and considered how IP helps creators, inventors, the creative industries, and the innovation industries move forward.

We are grateful for the panelists, moderators, and audience members who made our Sixth Annual Fall Conference such a huge success, and we hope you will enjoy the videos!

PANEL 1: NEW TECHNOLOGIES, BUSINESS MODELS, AND STANDARDS

  • Jim Harlan, Senior Director, Standards and Competition Policy, InterDigital
  • Anne Layne-Farrar, Vice President, Charles River Associates
  • Robert Sachs, President, Robert R. Sachs PC
  • Prof. Ted Sichelman, University of San Diego School of Law, Senior Scholar, Center for the Protection of Intellectual Property
  • Moderator: Prof. Kristen Osenga, University of Richmond School of Law, Senior Scholar, Center for the Protection of Intellectual Property

PANEL 2: NEW/SHIFTING BUSINESS MODELS FOR THE CREATIVE INDUSTRIES

  • Troy Dow, Vice President & Counsel, The Walt Disney Company
  • Prof. Eric Priest, University of Oregon School of Law, Senior Scholar, Center for the Protection of Intellectual Property
  • Jessica Richard, Vice President, Federal Public Policy, Recording Industry Association of America
  • Nicola Searle, Digital Economy Fellow & Senior Lecturer, Goldsmiths, University of London
  • Moderator: Prof. Sandra Aistars, Antonin Scalia Law School, George Mason University, Director of Copyright Research and Policy & Senior Scholar, Center for the Protection of Intellectual Property

PANEL 3: NEW/SHIFTING BUSINESS MODELS FOR THE INNOVATION INDUSTRIES

  • Prof. Jonathan Barnett, USC Gould School of Law, Senior Scholar, Center for the Protection of Intellectual Property
  • Henry Hadad, Senior Vice President & Deputy General Counsel, Bristol-Myers Squibb
  • Prof. Erika Lietzan, University of Missouri School of Law, Senior Scholar, Center for the Protection of Intellectual Property
  • Jake Mace, Vice President of Licensing, Dominion Harbor
  • Moderator: Prof. Christopher Holman, University of Missouri-Kansas City School of Law, Senior Scholar, Center for the Protection of Intellectual Property

PANEL 4: A DIFFERENT PERSPECTIVE ON BIG DATA

  • Prof. Ryan Abbott, School of Law, University of Surrey
  • Robert Atkinson, Founder & President, Information Technology and Innovation Foundation
  • Prof. Michael Smith, Heinz College, Carnegie Mellon University
  • Marian Underweiser, Senior Counsel, IBM Research
  • Moderator: Prof. Robert Ledig, Antonin Scalia Law School, George Mason University

PANEL 5: THE FUTURE OF STANDARD SETTING, 5G, AND WHERE IT’S ALL HEADED

  • Kirti Gupta, Senior Director of Economic Strategy, Qualcomm
  • Prof. Adam Mossoff, Antonin Scalia Law School, George Mason University, Founder, Executive Director, & Senior Scholar, Center for the Protection of Intellectual Property
  • Richard Taffet, Partner, Morgan Lewis & Bockius LLP
  • Gregory Werden, Senior Economic Counsel, Antitrust Division, U.S. Department of Justice
  • Moderator: Prof. Sean O’Connor, Antonin Scalia Law School, George Mason University, Director of International Innovation Policy & Senior Scholar, Center for the Protection of Intellectual Property

PANEL 6: THE HISTORY OF IP AND TECHNOLOGICAL SHIFTS: LESSONS FROM THE ANCIENT HISTORY OF THE 1990S AND BEFORE

  • Prof. Bruce Boyden, Marquette University Law School
  • Prof. Joseph Gabriel, Florida State University College of Medicine
  • Prof. Justin Hughes, Loyola Law School, Los Angeles
  • Ron Katznelson, Founder & President, Bi-Level Technologies
  • Moderator: Prof. Ross Davies, Antonin Scalia Law School, George Mason University

Categories
Innovation Patent Law

Proposal for Drug Price Controls is Legally Unprecedented and Threatens Medical Innovation

dictionary entry for the word "innovate"By Adam Mossoff, Sean O’Connor, & Evan Moore*

The price of the miracle drugs everyone uses today is cause for concern among people today. The President has commented on it. Some academics, lawyers, and policymakers have routinely called for the government to “do something” to lower prices. The high prices are unsurprising: cutting-edge medical treatments are the result of billions of dollars spent by pharmaceutical companies over decades of research and development with additional lengthy testing trials required by the Food & Drug Administration. Earlier this year, though, the New York Times called for the government to use a federal law in forcing the sale of patented drugs by any private company to consumers in the healthcare market, effectively creating government-set prices for these drugs.

The New York Times proposal was prompted by an article in the Yale Journal of Law and Technology, which asserts that this law (known as § 1498) has been used by the federal government in the past to provide the public with lower-cost drugs. This claim—repeated as allegedly undisputed by the New York Times—is false. In fact, the proposal to use § 1498 for the government to set drug prices charged by private companies in the healthcare market would represent an unprecedented use of a law that was not written for this purpose.

Let’s first get clear on the law that the New York Times has invoked as the centerpiece of its proposal: § 1498 was first passed by Congress over a hundred years ago. It was a solution to a highly technical legal issue of how patent owners could overcome the government’s immunity from lawsuits when the government used their property without authorization. What ultimately became today’s § 1498 waived the federal government’s sovereign immunity against lawsuits, securing to patent owners the right to sue in federal court for reasonable compensation for unauthorized uses of their property.

This law resolved vexing legal questions about standing and jurisdiction, securing to patent owners the same right to constitutional protection of their property from a “taking” of their property by the government under the Fifth Amendment as all other property owners. This short summary makes clear that § 1498 is solely to provide compensation for government use of patented invention; it is neither a price control statute nor a general license for government agencies to intervene in private markets.

This is confirmed by the text of § 1498, which provides that when a patented invention is “used or manufactured by” the government, the patent owner is owed a “reasonable and entire compensation.” Thus, § 1498 acknowledges that the government has the power to use a patent for government use as long as it pays reasonable compensation to the patent owner. The predecessor statute was initially limited to direct government use of the invention. But in 1918 it was amended to cover government contractors as well. The issue was that patentees were suing and obtaining injunctions for infringement by private contractors, which slowed important production of war materials during World War One.

Just as the initial statute precluded an injunction against the government—providing only for “reasonable and entire compensation” as the sole remedy—the amended statute further shielded government contractors by placing the sole remedy for the latter’s infringement on the government as well. This makes sense given that the private company was working at the behest of the government itself. Thus, central to any such defense was that the contractor needed to show that it was infringing the patent on the “authorization and consent” of the government. And, just as for the government’s direct infringement, the contractor’s infringement was covered only to the extent it was for legitimate government use. Any private market use by the private company placed its infringing uses outside the statute and thus the company was fully liable for regular patent remedies, including injunctive relief.

The article published in the student-edited law journal that precipitated the New York Times proposal misconstrues § 1498 because it engages in an economic sleight of hand, characterizing pharmaceutical patents as an unwarranted tax paid by the public. The underlying argument is that drugs are expensive due to monopoly pricing and any drug sold above its basic cost of production represents economic deadweight loss. This argument ignores one of the key economic functions of the patent system, which is to secure the opportunity for innovators to recoup extensive costs in R&D expenditures and which are not reflected in costs of production themselves, such as the more than $2 billion in R&D spent by innovative pharmaceutical companies in creating a new drug.

The argument by the journal article thus applies to any patent (and has been made against all patents by other critics of the patent system), but the authors limit their proposal to cases of “excessive” prices for certain drugs, such as the cutting-edge, groundbreaking Hepatitis C treatment that ranges from $20,000-$90,000 for a 12-week treatment plan. Section 1498, they argue, should be used not just for the government’s own use of patented drugs for military personnel or other public employees, but for any infringement of the patent approved by the government in the name of providing lower prices to the public.

If the article authors and the New York Times had their way, the federal government would simply declare that a drug is too expensive and thus it would preemptively authorize any private company to make and sell the drug more cheaply. The pharmaceutical company would sue the companies for patent infringement, and the government would intervene under § 1498, claiming that these companies are essentially contractors acting at the behest of the government. Under the legal rules governing payment of “reasonable compensation” under § 1498 and payment of “just compensation” under the Fifth Amendment, the property owner receives the “fair market value” for the unauthorized use.

To the article authors and the New York Times this means a minimal royalty based off the mistaken premise that the price comparison would be retail price of the drug if it were not covered by a patent (like a generic). But instead, § 1498 procedures routinely rule that the government must compensate the patent owner the full measure of patent damages as would have been awarded in a regular patent infringement trial. Section 1498 does not provide a back door, cheaper “compulsory license” even for appropriate government use. The article authors and the New York Times would like to ignore the innovating pharmaceutical company’s R&D expenditures incurred beforehand and have the government compensate the company at significantly less than what it would receive under normal circumstances.

Aside from the flawed economic and legal argument underlying this price-control proposal, it represents an unprecedented use of § 1498, despite the claims by the article authors to the contrary. In the article, the authors assert that § 1498 was used exactly in this way in the 1950s and 1960s. But this is false: the federal government has never used § 1498 to authorize private companies to sell drugs to private consumers in the healthcare market in the United States. In these cases, the Department of Defense (“DoD”) relied on § 1498 to purchase military medical supplies from drug companies that infringed patents. Statements from agency heads during congressional hearings at the time confirm that the DoD, NASA, and the Comptroller General all understood the law as applying to procurement of goods for government use.

In other words, the government has never relied on or argued that § 1498 applies outside of the federal government procuring patented goods and services for its own use by its own agencies or officials. This is also true for government contractors: § 1498 shields a contractor’s infringement only while it is working directly for the federal government, and thus the private company cannot deliver the goods or services directly to private markets. If the contractor does this, its infringement falls outside the scope of § 1498, and it can be sued as a matter of private right directly for patent infringement under the patent laws.

Despite this significant commercial and legal difference between private companies working as contractors for the federal government and private companies selling products in the marketplace, the article authors (and thus the New York Times) claim otherwise. The New York Times, for instance, asserts that “In the late 1950s and 1960s, the federal government routinely used 1498 to obtain vital medications at a discount.” The New York Times further asserts that § 1498 “fell out of use” due mainly to the lobbying efforts of pharmaceutical companies. This is false. The historical record is absolutely clear that government agencies and courts have all applied § 1498 only to situations of government procurement and its own direct use. It has never been used to authorize private companies infringing patents for the sole purpose of selling the patented innovation to consumers in the free market.

The question then becomes whether § 1498 permits the federal government to simply declare certain patented products to be “too expensive” and this then justifies the government to indemnify private companies under its sovereign immunity to infringe the patent in selling the drug in the private healthcare market on the basis of this allegedly public purpose. Section 1498 has never been used in this way before, including when the government purchased drugs in the 1950s and 1960s. The authors of the article in the Yale Journal of Law and Technology claim they “recover this history and show how § 1498 can once again be used to increase access to life-saving medicines.” But § 1498 was never used in this way historically—the federal government has never used this law to permit private companies to sell drugs to private consumers in the private healthcare market. This proposal is an unprecedented use of a law in direct contradiction to its text and its 100+ years of application by federal agencies and courts.

Perhaps the most surprising aspect of the New York Times proposal is that it refers to § 1498 as an “obscure” provision of the patent law. First, it is not a statutory provision in the Patent Act, but rather is part of the federal statutes authorizing the judiciary to hear lawsuits. This underscores the early point that § 1498 was merely a technical fix to an unintended loophole existing since the 19th century that prevented, or at least complicated, patent owners suing the government for unauthorized uses by officials or agencies—even as the courts routinely opined that patents are property and that government should have to pay for their use. Second, while § 1498 may be “obscure” to the public at large, patent lawyers and government lawyers know this law very well. It is the bread and butter of government contract work and the legal basis of hundreds, if not thousands, of lawsuits against the federal government for over a century.

As the courts have long recognized, § 1498 is an eminent domain law. It provides a court with the authority to hear a lawsuit and award just compensation when the federal government or a person acting directly at its behest as its agent or contractor uses a patent without authorization. Section 1498 does not grant the government a new power to authorize infringement of a patent for the sole purpose of a company selling a product at a lower price in the market, effectively imposing de facto government price controls on drugs. The proposal in an academic journal and repeated by the New York Times to use § 1498 in this way is unprecedented. Even worse, it threatens the legal foundation of the incredible medical innovation in this country created by the promise to pharmaceutical companies of reliable and effective patent rights as a way to secure to them the fruits of their innovative labors.

*Evan Moore is a 2L at Antonin Scalia Law School, and he works as a Research Assistant at CPIP.

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
Patent Law Pharma

New CPIP Policy Brief: An Unwise Move to Discriminate Against Pharmaceutical Patents

enlarged image of a moleculeCPIP has published a new policy brief entitled An Unwise Move to Discriminate Against Pharmaceutical Patents: Responding to the UN’s Guidelines for Pharmaceutical Patent Examination.

The brief, written by CPIP Senior Scholar and UMKC Professor of Law Chris Holman, analyzes the UN’s recent Guidelines for Pharmaceutical Patent Examination, which are influential in the policy debates regarding the role of patented pharmaceuticals in public health. Professor Holman critically examines the Guidelines, pointing out that they “put a thumb on the scale in favor of generic medications” while failing to adequately consider “the development and incremental improvement of innovative pharmaceutical products.”

The Executive Summary is copied below:

EXECUTIVE SUMMARY

Recently, United Nations agencies have encouraged countries to make it harder to get patents on pharmaceuticals. The primary vehicle for this policy has been the Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective (the “Guidelines”). The Guidelines advocate excluding entire categories of pharmaceutical inventions from patentability.

This new approach represents a departure from past patent policy. The patent system has long applied the same rules to everybody instead of discriminating against particular types of technologies or industries. Ordinarily, each invention is judged on its individual merits based on neutral and generally-applicable rules for patentability.

The aim of the Guidelines is to make medicines cheaper, which is a laudable goal, but the kind of goal that has long been kept out of patent examination for good reasons. If a government objects to the prices of a product or how a business behaves in the marketplace, it applies other laws after the patent is granted. But when governments interject politics and policy before a patent is granted, the patent system as a whole becomes unreliable and unpredictable. Businesses are reluctant to invest in unreliable property rights and in the markets that make them unreliable. They either stop investing in innovation or avoid the markets where their innovations are unprotected.

The Guidelines contend that many forms of pharmaceutical innovation are inherently routine and hence unpatentable by default. Consequently, they demand exceptional circumstances from pharmaceutical inventions not required in other fields. The Guidelines would also restrict patents on innovations that occur later during drug development, including after the initial launch of a product.

This Policy Brief provides an evidence-based review of the categories of pharmaceutical innovation addressed by the Guidelines and dismissed as undeserving of patents. These include “Markush claims,” selection patents, patents on different forms of the drug, prodrugs and metabolites, compositions, combinations, doses, and new medical uses. Many of these categories of inventions are rather technical, so the Policy Brief attempts to briefly illuminate what each is and why it matters to the process of discovering and bringing new drugs to patients.

Once each category is carefully explained and examined, one finds real innovations. As illustrated by the decisions surveyed in this Policy Brief, when courts delve deeply into the substance of these inventions, they are often struck by the unpredictability and difficulty inherent in pharmaceutical innovation. These innovations can provide new and beneficial ways to formulate, prepare, and deliver the drugs as well as different ways to use the drugs.

Considered in the abstract, it is easy to devalue the inventiveness of the categories of pharmaceutical innovation targeted by the Guidelines. However, it is hoped that this Policy Brief and the full-length version, In Defense of Secondary Pharmaceutical Patents: A Response to the UN’s Guidelines for Pharmaceutical Patent Examination, will provide some counterweight to balance some of the more radical, and in my view unwarranted, recommendations set forth in the Guidelines. The interested reader should consult the full-length article for an expanded explanation including examples and citations to primary sources.

To read the policy brief, please click here.

Categories
Patent Law Pharma

CPIP Scholars Examine the Flaws in the Term “Evergreening”

scientist looking through a microscopeIn their new paper, Evergreening of Pharmaceutical Exclusivity: Sorting Fact from Misunderstanding and Fiction, Professors Kristina Acri née Lybecker and Mark Schultz, along with CPIP John F. Witherspoon Legal Fellow David Lund, analyze how the term “evergreening” is used in the context of pharmaceuticals.

After sorting through the vagaries and rhetorical excesses that restrict meaningful discussion, they identify seven categories that capture typical uses of the term:

  • The assertion that the duration of existing patents can generally be “renewed” or “extended,” for very long or indefinite periods;
  • Obtaining additional patents related to a particular pharmaceutical or treatment;
  • The use of laws that allow patent owners to restore some portion of their term lost due to governmental delays;
  • The use of laws that give companies a limited term of exclusive time to market a drug;
  • Regulatory barriers that frustrate potential generic competitors’ ability to enter a market;
  • Business practices that largely rely on marketing to advantage innovators; and
  • Settling lawsuits with generic manufacturers that seek to invalidate a patent.

In addition to identifying practices claimed to be “evergreening,” this paper also discusses the impact and value of these practices. For most situations, the practices reflect specific policies that are having their desired effect, such as the increase in studies of drug safety and efficacy in children brought about by pediatric exclusivity. In some cases, the practices are simply legal impossibilities. Only in a few specific situations related to regulatory requirements do the authors observe strategic opportunities that could plausibly be considered problematic.

Because of the number of practices and the diversity of value those practices bring to pharmaceutical commercialization, the term obscures far more than it illuminates. Discussions about patents, exclusivities, and public health would benefit greatly from discussing the practices and policies specifically, rather than attempting to use a nebulous term such as “evergreening.”

The paper, which started as part of Professor Acri’s work through CPIP’s Thomas Edison Innovation Fellowship, can be found here. The abstract is copied below.

***

Evergreening of Pharmaceutical Exclusivity: Sorting Fact from Misunderstanding and Fiction

Abstract

When people use the term “evergreening” to describe pharmaceutical industry practices, they typically display an unwarranted confidence that they know exactly what they mean both descriptively and normatively. However, a consistent and coherent definition of “evergreening” does not appear to exist.

This article surveys legal, academic, trade, and popular sources that use the term “evergreening” to develop a taxonomy of the policies and actions to which the term is applied. We find that the term is used to cover roughly seven categories of circumstances. Our review finds that the use of the term, taken as a whole, is more typified by the diversity of practices to which it applies rather than any consistent meaning. There are some commonalties, but they exist mostly at a general level.

We then analyze these seven categories to determine if the rhetoric matches the reality. Evergreening is most frequently used as a pejorative term, with a common implication that the “evergreener” is engaged in some sort of strategic behavior at least, or perhaps an immoral if not illegal practice. However, the categorical application of a pejorative term such as “evergreening” to any of the general policies and types of actions we examine is unwarranted and inappropriate. Proponents often apply the term to ordinary use of legal rights as they were designed and the concept makes no meaningful distinction between beneficial and problematic actions.

Unfortunately, “Evergreening” is a key concept in health policy that obscures far more than it illuminates. Once the term is stripped of misunderstandings and loose rhetoric, little of value remains. This is not to say that all policies and actions that extend or preserve exclusive rights are prudent or defensible in individual cases. Rather, the discussion regarding patents and public health would gain much clarity and rationality from addressing the disparate things labeled as “evergreening” on their individual merits.

To read the paper, please click here.

Categories
Legislation Patent Law

The STRONGER Patents Act: The House Receives Its Own Legislation to Protect Our Innovation Economy

U.S. Capitol buildingToday, Representatives Steve Stivers (R-OH) and Bill Foster (D-IL) introduced the Support Technology & Research for Our Nation’s Growth and Economic Resilience (STRONGER) Patents Act of 2018. This important piece of legislation will protect our innovation economy by restoring stable and effective property rights for inventors. This legislation mirrors a bill already introduced in the Senate, which I have previously discussed.

The STRONGER Patents Act accomplishes three key goals to protect innovators. First, the Act will make substantial improvements to post-issuance proceedings in the USPTO to protect patent owners from administrative proceedings run amok. Second, it will confirm the status of patents as property rights, including restoring the ability of patent owners to obtain injunctions as a matter of course. Third, it will eliminate fee diversion from the USPTO, assuring that innovators are obtaining the quality services they are paying for.

First and foremost, the STRONGER Patents Act aims to restore balance to post-issuance review of patents administered by the USPTO’s Patent Trial and Appeal Board (PTAB). The creation of the PTAB was a massive regulatory overreach to correct a perceived problem that could have been better addressed by providing more resources towards initial examination. While the USPTO has long been responsible for issuing patents after a detailed examination, it has recently taken on the role of killing patents the same USPTO previously issued. What the USPTO gives with the one hand, it takes with the other.

Data analyzing PTAB outcomes demonstrates just how dire the situation has become. Coordinated and repetitive challenges to patent validity have made it impossible for patent owners to ever feel confident in the value and enforceability of their property rights. In some cases, more than 20 petitions have been filed on a single patent. Although recent headway has been made to address this issue in the administrative context, it only listed factors to be used when evaluating serial petitions. A more complete statutory solution that prohibits serial petitions except in limited circumstances is necessary to fully protect innovators and provide certainty that these protections will continue.

The kill rate of patents by the PTAB is remarkable. In only 16% of final written decisions at the PTAB does the patent survive unscathed. The actual impact on patent owners is far worse. Disclaimer and settlement are alternate ways a patent owner can lose at the PTAB prior to a final written decision. Thus, the fact that only 4% of petitions result in a final written decision of patentability is more reflective of the burden patent owners faced when dragged into PTAB proceedings.

For these reasons, the PTAB has been known as a “death squad.” This sentiment has been expressed not only by those who are disturbed by the PTAB’s behavior, but also those—such as a former chief judge of the PTAB—who are perpetuating it. The list of specific patents that have been invalidated at the PTAB is mind-boggling, such as an advanced detector for detecting leaks in gas lines.

There are even examples where the PTAB has invalidated a patent that had previously been upheld by the Federal Circuit Court of Appeals. One recent examination further found that there have been at least 58 patents that were upheld in federal district courts that were invalidated in the PTAB on the same statutory grounds. The different results are not mere happenstance but are the result of strategic behavior by petitioners to strategically abuse the procedures of PTAB proceedings.

It has been well known that the procedures have been stacked against patent owners from day one. We and others have noted how broadly construing claims, multiple filings against the same patent by the same challengers, and the inability to amend claims, among other abuses, severely disadvantage patent owners in PTAB proceedings.

With the STRONGER Patents Act, these proceedings will move closer to a fair fight to truly examine patent validity. There are many aspects to this legislation that will improve the PTAB, such as:

  • Harmonizing the claim construction standard with litigation, focusing on the “ordinary and customary meaning” instead of the broadest interpretation a bureaucrat can conceive. This will promote consistent results when patents are challenged, regardless of the forum, by assuring that a patent does not mean different things to different people. Sections 102(a) and 103(a).
  • Confirming the presumption of validity of an issued patent will apply to the PTAB just as it does in litigation. This will allow patent owners to make investments with reasonable security in the validity of the patent. Sections 102(b) and 103(b).
  • Adding a standing requirement, by permitting only those who are “charged with infringement” of the patent to challenge that patent. This will prevent the abusive and extortionate practice of challenging a patent to extract a settlement or short a company’s stock. Sections 102(c) and 103(c).
  • Limiting abusive repetitive and serial challenges to a patent. This will prevent one of the most common abuses, by preventing multiple bites at the apple. Sections 102(d), (f) and 103(d), (f).
  • Authorizing interlocutory review of institution decisions when “mere institution presents a risk of immediate, irreparable injury” to the patent owner as well as in other important circumstances. This change will allow early correction of important mistakes as well as provide for appellate review of issues that currently may evade correction. Sections 102(e) and 103(e).
  • Prohibiting manipulation of the identification of the real-party-in-interest rules to evade estoppel or other procedural rules and providing for discovery to determine the real-party-in-interest. Because many procedural protections depend on identifying the real party-in-interest, this change will assure that determining who that real party is can occur in a fair manner. Sections 102(g) and 103(g).
  • Giving priority to federal court determinations on the validity of a patent. Although discrepancies will be minimized by other changes in this Act, this section assures that the federal court determination will prevail. Sections 102(h) and 103(h).
  • Improving the procedure for amending a challenged patent, including a new expedited examination pathway. This section goes further than Aqua Products, prescribing detailed procedures for adjudicating the patentability of proposed substitute claims and placing the burden of proof on the challenger. Sections 102(i) and 103(i).
  • Prohibiting the same administrative patent judges from both determining whether a challenge is likely to succeed and whether the patent is invalid. This section will confirm the original design of the PTAB by assuring that the decision to institute and final decision are separate. Section 104.
  • Aligning timing requirements for ex parte reexamination with inter partes review by prohibiting requests for reexamination more than one year after being sued for infringement. This section will prevent abuses from the multiple post-grant procedures available in the USPTO. Section 105.

Second, the STRONGER Patents Act will make other necessary corrections to allow patents to promote innovation. For example, as Section 101 of the Act confirms, patents are property rights and deserve the same remedies applicable to other kinds of property. In eBay v. MercExchange, the Supreme Court ignored this fundamental premise by holding that patent owners do not have the presumptive right to keep others from using their property. Section 106 of the STRONGER Patents Act will undo the disastrous eBay decision and confirm the importance of patents as property.

Third, the STRONGER Patents Act will once and for all eliminate USPTO fee diversion. Many people do not realize that the USPTO is funded entirely through user fees and that no taxpayer money goes to the office. Despite promises that the America Invents Act of 2011 would end fee diversion, the federal government continues to redirect USPTO funds to other government programs. This misguided tax on innovation is long overdue to be shut down.

Each of the steps in the STRONGER Patents Act will help bring balance back to our patent system. In addition to the major changes described above, there are also smaller changes that will be important to ensuring a vibrant and efficient patent system. CPIP co-founder Adam Mossoff testified to Congress about the harms being done to innovation through weakened patent protection. It is great news to now see Congress taking steps in the right direction.

Categories
Innovation Patent Law

U.S. Innovation Economy Falls Even Further in Latest GIPC Patent Rankings

hand under a lightbulb drawn on a chalkboardThe Global Innovation Policy Center (GIPC) at the U.S. Chamber of Commerce has just released the sixth edition of its International IP Index. Unfortunately, the report finds that the United States is now tied for 12th place in its patent rankings. This is down from 10th place last year, and it’s down from 1st place just two years ago. The recent downward trend of the U.S. innovation economy is rather alarming, and it is further evidence that the U.S. is quickly abandoning its gold standard patent system.

GIPC notes that the U.S. patent system has faltered due to two key indicators: patentability requirements and patent opposition. As to the former, the report cites the Supreme Court’s recent Section 101 jurisprudence, which has created much uncertainty for innovators about what even constitutes a patent-eligible invention. These findings comport with the newly-published paper by CPIP’s Adam Mossoff & Kevin Madigan highlighting the Court’s troublesome approach to patent eligibility and its profound effect on our innovation economy. As to patent opposition, GIPC cites the ease of challenging patents that have already been issued through mechanisms such as inter partes review (IPR). Indeed, several CPIP scholars authored a recent white paper detailing how these IPR proceedings have become an existential threat to the very patent system they were meant to promote.

U.S. falls to 12th place in ranking of patent system strength. 2018 Chamber index marks further from for U.S. Category 1: Patents, Related Rights, and Limitations. 1. Singapore; 2. France; 3. Germany; 4. Ireland; 5. Japan; 6. Netherlands; 7. South Korea; 8. Spain; 9. Sweden; 10. Switzerland; 11. UK; 12. United States / Italy. ("Create," Global Innovation Policy Center, U.S. Chamber International IP Index, Sixth Edition, February 2018))

To read GIPC’s International IP Index, 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
Administrative Agency Innovation Patent Law

The PTAB’s Regulatory Overreach and How it Cripples the Innovation Economy

files labeled as "patents"On August 14, 2017, the Regulatory Transparency Project of the Federalist Society published a new white paper, Crippling the Innovation Economy: Regulatory Overreach at the Patent Office. This white paper examines how an administrative tribunal created in 2011—the Patent Trial and Appeal Board (PTAB)—has become “a prime example regulatory overreach.” Several CPIP scholars are members of the Intellectual Property Working Group in the Regulatory Transparency Project that produced the white paper, including Professors Adam Mossoff, Kristen Osenga, Erika Lietzan, and Mark Schultz, and several are listed as co-authors.

Among the sweeping changes to the U.S. patent system included in the America Invents Act (AIA) was the creation of the PTAB, a new administrative body within the U.S. Patent and Trademark Office (USPTO). The PTAB hears petitions challenging already-issued patents as defective. Anyone can file a petition to have a patent declared invalid. The original idea was that this would help to weed out “bad patents,” i.e., patents that should not have been issued in the first place.

In the past five years, however, it has become clear that the PTAB has become an example of an administrative tribunal that has gone too far. Lacking the proper procedural and substantive restraints that constrain courts and even other agencies in respecting the rights of citizens brought before them, the PTAB is now “killing large numbers of patents and casting a pall of uncertainty for inventors and investors.”

In just a few years, the laudable goal of the PTAB in providing a cheaper, faster way to invalidate “bad patents” has led to a situation in which all patents now have a shroud of doubt around them, undermining the stable and effective property rights that serve as the engine of the innovation economy. The former chief judge of the court that hears all patent appeals recently said that the PTAB is a “patent death squad,” and confirming that this is not extreme rhetoric, the first chief judge of the PTAB responded to this criticism by embracing it: “If we weren’t, in part, doing some ‘death squadding,’ we would not be doing what the [AIA] statute calls on us to do.”

The white paper briefly discusses the history and purpose of the U.S. patent system and describes the PTAB and how it operates. The substance of the white paper details extensively the procedural and substantive problems in how the PTAB has failed to respect both the basic requirements of the rule of law and the rights of patent owners. The concern is that this undermines the stable and effective platform that patent rights provide as the engine of the innovation economy.

To read the white paper, please click here.