Law Commons^™

The Patent Option, Daniel J. Gervais

Daniel J Gervais

There is a shift in the shape of intellectual property (IP) tools used to strengthen and lengthen the right of pharmaceutical companies to exclude others from making and marketing their products. Patents have traditionally been the tool of choice. Over the past two decades, however, pharmaceutical companies have increased their degree of reliance on a right known as “data exclusivity.” This right, which now exists in most major jurisdictions, is the right to prevent third parties from relying on the clinical trial data submitted by another pharmaceutical company to obtain marketing approval for a bioequivalent or biosimilar product. The right …

Exploring The Interfaces Between Big Data And Intellectual Property Law, Daniel J. Gervais

Daniel J Gervais

This article reviews the application of several IP rights (copyright, patent, sui generis database right, data exclusivity and trade secret) to Big Data. Beyond the protection of software used to collect and process Big Data corpora, copyright’s traditional role is challenged by the relatively unstructured nature of the non-relational (noSQL) databases typical of Big Data corpora. This also impacts the application of the EU sui generis right in databases. Misappropriation (tort-based) or anti-parasitic behaviour protection might apply, where available, to data generated by AI systems that has high but short-lived value. Copyright in material contained in Big Data corpora must …

Disguised Patent Policymaking, Saurabh Vishnubhakat

Faculty Scholarship

Patent Office power has grown immensely in this decade, and the agency is wielding its power in predictably troubling ways. Like other agencies, it injects politics into its decisions while relying on technocratic justifications. It also reads grants of authority expansively to aggrandize its power, especially to the detriment of judicial checks on agency action. However, this story of Patent Office ascendancy differs from that of other agencies in two important respects. One is that the U.S. patent system still remains primarily a means for allocating property rights, not a comprehensive regime of industrial regulation. Thus, the Patent Office cannot …

Overlapping Intellectual Property Doctrines: Election Of Rights Versus Selection Of Remedies, Laura A. Heymann

Laura A. Heymann

Overlaps exist across various doctrines in federal intellectual property law. Software can be protected under both copyright law and patent law; logos can be protected under both copyright law and trademark law. Design patents provide a particular opportunity to consider the issue of overlap, as an industrial design that qualifies for design patent protection might also, in particular circumstances, qualify for copyright protection as well as function as protectable trade dress.

When an overlap issue arises—that is, when an intellectual property rights holder asserts rights under more than one doctrine—the question then becomes how courts should respond. One response, of …

Renewed Efficiency In Administrative Patent Revocation, Saurabh Vishnubhakat

Faculty Scholarship

Administrative patent revocation in the U.S. is poised to enter a new period of efficiency, though ironically it will be an efficiency that the America Invents Act originally put in place. The Court’s recent approval of the constitutionality of Patent Trial and Appeal Board ("PTAB") proceedings was blunted by the Court’s accompanying rejection of partial institution. This Patent Office practice of accepting and denying validity review petitions piecemeal had been a key part of the agency’s procedural structure from the start. As a result, the Court’s decision in SAS Institute v. Iancu to require a binary choice — either fully …

A Collision Course Between Trips Flexibilities And Investor-State Proceedings, Cynthia M. Ho

Cynthia M Ho

This Article discusses an important, yet understudied threat to patent, as well as other intellectual property sovereignty under TRIPS: pending and potential challenges by companies under international agreements protecting investments. Although such agreements have existed for decades, Philip Morris and Eli Lilly are blazing a new path for companies to sue countries they claim interfere with their intellectual property rights through so-called investor-state arbitrations. These suits seek hundreds of millions in compensation and even injunctive relief for alleged violations of internationally agreed intellectual property norms. The suits fundamentally challenge TRIPS flexibilities at the very time the Declaration on Patent Protection …

The Patentability Of Genetic Therapies: Car-T And Medical Treatment Exclusions Around The World, Luis Gil Abinader, Jorge L. Contreras

Utah Law Faculty Scholarship

More than eighty countries, including the members of the European Patent Convention, the United States, Canada, New Zealand, China, Japan, and India, currently exclude or limit the patentability of methods of medical treatment. CAR-T and other recent gene and cell therapies, which operate based on the extraction of genetic or cellular material from a patient, the alteration of such material, and the reintroduction of such material to the patient’s body, should, under most or all of these legal regimes, be considered medical treatments that are thus excluded from patentability, or as to which patent enforcement is limited. Accordingly, we urge …

The Mixed Case For A Ptab Off-Ramp, Saurabh Vishnubhakat

Faculty Scholarship

This Essay begins from the emerging agenda in the political branches for reforming various aspects of the USPTO Patent Trial and Appeal Board, and focuses on a particular reform: the creation of a PTAB off-ramp whereby a patent being challenged in an administrative revocation proceeding could be removed into a system primarily aimed at amending its claims and preserving its validity. To put the proposal into perspective, the Essay presents specific empirical trends, largely unexplored until now, that implicate patent reliance interests to which the PTAB has done injury. Ultimately, because the benefits and costs from a PTAB off-ramp are …

Patents As Credentials, Jason Rantanen, Sarah E. Jack

Washington and Lee Law Review

The conventional explanation for why people seek patents draws on a simple economic rationale. Patents, the usual story goes, provide a financial reward: the ability to engage in supracompetitive pricing by excluding others from practicing the claimed technology. People are drawn to file for patents because that is how these economic rewards are secured. While scholars have proposed variations on the basic exclusionary mechanism, and there is a general acknowledgement that patents can affect a firm’s reputation, the actual mechanisms of patents’ effect on individuals — human beings — remains relatively uncharted. In this Article we offer a concrete theory …

That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn

Concordia Law Review

By their very nature, patents are exclusionary. A patent grants the right to exclude others from making use of an invention or process. But patents are also tools to promote innovation. However, when an invalid patent is granted, the patent becomes an exclusionary tool that also chills innovation. Invalid cannabis patents may be chilling innovation in the cannabis market, but they may not be the only thing. While the Controlled Substances Act continues to prohibit cannabis at a federal level, researchers and medical professionals will be unsure of the legality of their actions. This naturally leads to another chilling effect …

Brief Of The R Street Institute As Amicus Curiae In Support Of Petitioner, Charles Duan

Amicus Briefs

It is a common but misleading premise of cases such as this one that the disappointed patent applicant has two options for judicial review: a 35 U.S.C. § 145 district court action and an appeal under 35 U.S.C. § 141. The applicant also has a non-judicial option: administrative remedies within the U.S. Patent and Trademark Office.

These administrative remedies add an important dimension to this case. The Court of Appeals adopted what it conceded was an atextual construction of § 145 expense recovery provision in order to ensure that § 145 actions were not cost-prohibitive to “small businesses and individual …

A Few Words And A Brief Recap Of The Jptrca’S Journey, David R. Irvin

Journal of the Patent and Trademark Resource Center Association

The Journal of the Patent and Trademark Resource Center has transitioned to TigerPrints at Clemson University. Here we offer some insight about why the Publications Committee recommended the move.

Thoughts On Patents And Information Literacy, Dave Zwicky

Journal of the Patent and Trademark Resource Center Association

Patents are an under-used information source, in part because of an often-narrow focus by patent librarians on the tools and techniques of patentability searching. This approach can ignore a range of potential applications of patent information, using patents in their contexts as technical, design, historical, legal, and commercial documents. This paper suggests the adoption of a flexible approach, viewing patents and patent information in the greater context of information literacy, including that of the Association of College and Research Libraries’ Framework for Information Literacy for Higher Education, more commonly known as the ACRL Framework.

The Patent Option, Daniel J. Gervais

Vanderbilt Law School Faculty Publications

There is a shift in the shape of intellectual property (IP) tools used to strengthen and lengthen the right of pharmaceutical companies to exclude others from making and marketing their products. Patents have traditionally been the tool of choice. Over the past two decades, however, pharmaceutical companies have increased their degree of reliance on a right known as “data exclusivity.” This right, which now exists in most major jurisdictions, is the right to prevent third parties from relying on the clinical trial data submitted by another pharmaceutical company to obtain marketing approval for a bioequivalent or biosimilar product. The right …

The Patent Option, Daniel Gervais

Daniel J Gervais

Is Dna Really A Natural Product? It's Time To Separate Fact From (Legal) Fiction: An Examination Of Dna Patentability As A Biological Algorithm In The Post-Myriad Era, Nicholas Ulen

Chicago-Kent Law Review

In 2013, the United States Supreme Court delivered its landmark decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., holding isolated DNA unpatentable, thereby invalidating the claims of thousands of DNA patents in the process. The opinion, delivered by Justice Thomas, reasoned that the act of separating DNA from the body did not sufficiently transform the molecule beyond what naturally exists. Yet the Court found that line to be crossed when it held certain artificially synthesized complementary DNA molecules coding for the exact same gene patentable. Unlike the Federal Circuit, the Court focused its analysis not on the …

Consequences For Patent Owners If A Patent Is Unconstitutionally Invalidated By The Patent Trial And Appeal Board, Mark Magas

Chicago-Kent Law Review

There have been many constitutional challenges against the Patent Trial and Appeal Board (“PTAB”) since it was created by the America Invents Act in 2011. While the merits of these challenges have been widely debated, there has been little analysis of what would happen if one of these challenges succeeded and patents are found to have been unconstitutionally invalidated. This note examines how issues with waiver, retroactivity, and finality may prevent patent owners from getting their patent rights back, considering the type of constitutional challenge and the different stages of the PTAB process. While the odds are stacked against patent …

Enhanced Patent Infringement Damages Post-Halo And The Problem With Using The Read Factors, Betul Serbest

Chicago-Kent Law Review

The United States Patent Act allows a patent holder to recover treble damages for “willful infringement.” The standard for willful infringement has changed over the years, with the United States Supreme Court providing the most recent explanation of what is “willful” in Halo Electronics, Inc. v. Pulse Electronics, Inc. in 2016. Courts, however, continue to use a set of factors set forth in Read Corp. v. Portec, Inc. in 1992 to aid their discretion in awarding willful infringement enhanced damages. In this article, I argue that at least two of the Read factors are inconsistent with the Supreme Court’s Halo …

The Non-Doctrine Of Redundancy, Saurabh Vishnubhakat

Faculty Scholarship

This Article explores and evaluates a controversial practice that the Patent Office undertook beginning early in the post-AIA regime, the practice of denying otherwise meritorious requests for review because of what the Office termed "redundant" grounds. The controversy over redundancy-based rejections had several sources. One was that making such rejections required the Patent Office to decide petitions piecemeal—and, indeed, the agency claimed that power for itself—even though it was not clear that this power lay within the statute. Another source was that the Patent Office persistently declined to explain what, in the agency's view, did or did not constitute redundancy. …

Private Law, Conflict Of Laws, And A Lex Mercatoria Of Standards-Development Organizations, Jorge L. Contreras

Utah Law Faculty Scholarship

Technical standards created by industry standards-development organizations (SDOs) enable interoperability among products manufactured by different vendors. Over the years, SDOs have developed policies to reduce the risk that SDO participants holding patents covering the SDO’s standards will disrupt or hinder the development and deployment of these standards. These policies, including commitments to license standards-essential patents (SEPs) on terms that are fair, reasonable and non-discriminatory (FRAND), gain transnational application given the international character of SDO activities and are most effectively interpreted and applied on the basis of private law (contractual) principles. However, SDO policies are typically embodied in an SDO’s governing …

The Football As Intellectual Property Object, Michael J. Madison

Book Chapters

The histories of technology and culture are filled with innovations that emerged and took root by being shared widely, only to be succeeded by eras of growth framed by intellectual property. The Internet is a modern example. The football, also known as the pelota, ballon, bola, balón, and soccer ball, is another, older, and broader one. The football lies at the core of football. Intersections between the football and intellectual property law are relatively few in number, but the football supplies a focal object through which the great themes of intellectual property have shaped the game: origins; innovation and …

The Fallacy Of Defensive Protection For Traditional Knowledge, Margo A. Bagley

Faculty Articles

Proponents of databases as defensive protection posit that having sources of traditional knowledge easily accessible to, and searchable by, examiners during the prosecution process should minimize the grant of patents covering traditional knowledge, and avoid the problems such erroneously granted patents may produce. Some countries, such as India, which support an international sui generis positive protection instrument, also support the use of traditional knowledge databases, as the two approaches are not mutually exclusive. India's CSIR, which created and maintains the TKDL, asserts that the database has thwarted the grant of scores of patents in IP offices across the globe, although …

Attacking Innovation, Jeffrey A. Maine

Faculty Publications

Economists generally agree that innovation is important to economic growth and that government support for innovation is necessary. Historically, the U.S. government has supported innovation in a variety of ways: (1) a strong legal system for patents; (2) direct support through research performed by government agencies, grants, loans, and loan guarantees; and (3) indirect support through various tax incentives for private firms. In recent years, however, we have seen a weakening of the U.S. patent system, a decline in direct funding of research, and a weakening of tax policy tools used to encourage new innovation. These disruptive changes threaten the …

Brief For The R Street Institute As Amicus Curiae In Support Of Respondents, Charles Duan

Amicus Briefs

The government and its agencies should be treated as a “person” that may petition to institute post-issuance review proceedings under the America Invents Act, for two reasons. First, permitting the government to seek review of patents under these proceedings best realizes the intent of Congress to make those proceedings widely available. Second, compared to the government’s alternative option for administratively challenging patents, AIA post-issuance review better serves important norms of procedure and governance, including transparency, due process, and separation of functions.

Institutional Design For Innovation: A Radical Proposal For Addressing § 101 Patent Eligible Subject Matter, Kristen Osenga

Law Faculty Publications

The doctrine of patent-eligible subject matter is a mess, and it is weakening patent rights in this country. Nearly everyone, from the bar to the bench and from academia to industry, has called for reform. Multiple proposals to amend 35 U.S.C. § 101 have been drafted, each aimed at trying to make the doctrine more workable. Although offered with the best intentions, the proposals to fix patent-eligible subject matter are doomed to fail because none of the proposals address which institution is best suited to determine patent eligibility.

This Article takes a different, and perhaps radical, tactic. Specifically, patent-eligible subject …

A Patent Reformist Supreme Court And Its Unearthed Precedent, Samuel F. Ernst

Fordham Intellectual Property, Media and Entertainment Law Journal

How is it that the Supreme Court, a generalist court, is leading a project of innovation reform in our times while the court of appeals established to encourage innovation is having its precedent stricken down time and again? This decade the Supreme Court has issued far more patent law decisions than in any decade since the passage of the Patent Act of 1952. In doing so, the Supreme Court has overruled the Federal Circuit in roughly threequarters of the patent cases in which the Supreme Court has issued opinions. In most of these cases, the Supreme Court has established rules …

Sovereign Immunity For Rent: How The Commodification Of Tribal Sovereign Immunity Reflects The Failures Of The U.S. Patent System, Katrina G. Geddes

Fordham Intellectual Property, Media and Entertainment Law Journal

Last year, a Fortune 500 pharmaceutical company attempted to rent the sovereign immunity of an American Indian tribe in order to shield its patents on a dry-eye drug from invalidation by generic competitors in inter partes review. Pharmaceutical firms are notorious for pursuing unconventional methods to extend the duration of their patents and, in this sense, the maneuver is unsurprising. The exploitation, however, of an historically disenfranchised community with limited economic opportunities is particularly unsettling. This Article will provide, firstly, a factual summary of the legal background of this case; secondly, a review of the February 2018 decision of the …

Attacking Innovation, Xuan-Thao Nguyen, Jeffrey A. Maine

Articles

Economists generally agree that innovation is important to economic growth and that government support for innovation is necessary. Historically, the U.S. government has supported innovation in a variety of ways: (1) a strong legal system for patents; (2) direct support through research performed by government agencies, grants, loans, and loan guarantees; and (3) indirect support through various tax incentives for private firms. In recent years, however, we have seen a weakening of the U.S. patent system, a decline in direct funding of research, and a weakening of tax policy tools used to encourage new innovation. These disruptive changes threaten the …

Patenting The Unexplained, Sean B. Seymore

Vanderbilt Law School Faculty Publications

It is a bedrock principle of patent law that an inventor need not understand how or why an invention works. The patent statute simply requires that the inventor explain how to make and use the invention. But explaining how to make and use something without understanding how or why it works yields patents with uninformative disclosures. Their teaching function is limited; one who wants to understand or figure out the underlying scientific principles must turn elsewhere. This limited disclosure rule does not align with the norms of science and tends to make patent documents a less robust form of technical …

The Federal Circuit As An Institution, Ryan G. Vacca

Law Faculty Scholarship

The Court of Appeals for the Federal Circuit is a unique institution. Unlike other circuit courts, the Federal Circuit’s jurisdiction is bound by subject area rather than geography, and it was created to address a unique set of problems specific to patent law. These characteristics have affected its institutional development and made the court one of the most frequently studied appellate courts. This chapter examines this development and describes the evolving qualities that have helped the Federal Circuit distinguish itself, for better or worse, as an institution.

This chapter begins with an overview of the concerns existing before creation of …