Law Commons^™

Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part Ii, Christopher M. Holman

Faculty Works

A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision …

The Data Exclusivity Debate In India: Time For A Rethink?, Prashant Reddy T.

Indian Journal of Law and Technology

Data exclusivity or regulatory marketing exclusivity is a concept that has been subject to much debate in the Indian context – with specific reference to the Indian pharmaceutical and agro-chemical industries. This debate has been carried on in the backdrop of obligations under the TRIPS as well as the Indo-EU Free Trade Agreement. In this paper, the author discusses the concept of data exclusivity in the light of the existing regulatory regime for pharmaceuticals and agro-chemicals in India. He also examines various Committee reports to glean the Indian stance on data exclusivity for agro-chemicals as well as pharmaceuticals and the …

Is The National Pharmaceutical Policy, 2012 Really Cheering The Pharma?, Dipika Jain

Indian Journal of Law and Technology

The National Pharmaceutical Policy was approved by the Cabinet and notified in 2012. Based on this policy, a new Drugs Price Control Order was notified in May, 2013. As a result, several drugs will come within the ambit of price control under the National list of Essential Medicines (NLEM). The primary purpose of NLEM is to facilitate the rational use of medicines which will allow for cost effective, safe and drugs with efficacy. This paper critically evaluates the provision on exclusion of patented drugs in the recent National Pharmaceutical Policy, 2012 from the Drug Pricing Policy for five years. The …

India’S Tryst With Trips: The Patents (Amendment) Act, 2005, Shamnad Basheer

Indian Journal of Law and Technology

The Patents (Amendment) Act, 2005 introduces pharmaceutical product patents in India for the first time. This Act attempts to balance out competing interests of a variety of stakeholders, including domestic generic medicine producers, foreign multinational pharmaceutical companies and civil society groups concerned with access to medicines. Although this dexterous manoeuvring around competing interests deserves praise, the net result of such a compromise has been a lack of clarity in the law. While highlighting the key aspects of the 2005 amendments and this lack of clarity, this article also focuses on the vexed issue of the likely impact of the new …

Race And Regulation Podcast Episode 6 - Race, Social Inequalities, And Clinical Drug Trials, Jill A. Fisher

Penn Program on Regulation Podcasts

As mandated by the U.S. Food and Drug Administration, clinical trials for new pharmaceuticals enroll healthy people as paid research participants to test for drug safety and tolerability. But the social injustices from these trials are too often overlooked. Drawing on her award-winning book, Adverse Events, Jill Fisher of UNC-Chapel Hill’s Center for Bioethics explains how clinical drug trials attract disproportionate participation by racial and ethnic minorities who then disproportionately assume risks of participating in these trials, often just to stay financially afloat.

Beefing Up Skinny Labels: Induced Infringement As A Question Of Law, Garrett T. Potter

Notre Dame Law Review

This Note proposes a novel argument for improving the application of induced infringement by splitting its elements into separate questions of fact and law, incorporating the relevant perception and reasoning of both judge and jury. Part I provides a primer of the Hatch-Waxman Act and interactions (and lack thereof) between the USPTO and FDA in regulating pharmaceutical compositions. Part II assesses the historical landscape that led to the codification of induced infringement. Part III concludes by proposing an alternate approach by treating an element of induced infringement as a question of law, rather than a question of fact, and sets …

Eviscerating Patent Scope, Shahrokh Falati

Articles & Chapters

The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …

A Modest Proposal: Leveraging Private Enforcement Mechanisms And The Bayh-Dole Act To Reduce Drug Prices In The U.S. Healthcare Industry, Brittany Day

Duke Journal of Constitutional Law & Public Policy Sidebar

The United States healthcare system is one of the most expensive in the world. Unlike other products, when drug prices skyrocket, people may die. While advocating for various solutions, both the Biden and Trump administrations have recognized the importance of halting the rise of prescription drug prices. Most of the solutions advanced are focused on government-side initiatives, such as allowing Medicare to directly negotiate with pharmaceutical companies. Yet, the "march-in rights" built into the Bayh-Dole Act create an opportunity to set up a mechanism that would invite private actors to sue pharmaceutical companies for unconscionable drug pricing. The Bayh-Dole Act …

The Necessity In Antitrust Law, Gregory Day

Washington and Lee Law Review

Antitrust rarely, if ever, gives primacy to a dispute’s subject matter. For instance, exclusionary conduct that raises the price of a lifesaving drug receives the same analysis as a restraint of baseball cards. Since antitrust’s purpose is to promote consumer welfare, the equal treatment of important and mundane goods might appear perplexing. After all, competition to produce affordable foods, medicines, and other necessities would seem to foster consumer welfare more than inane products do.

In fact, defendants generally win antitrust lawsuits even when monopolizing necessities because the primary method of antitrust review is notably deferential to defendants. To explain this …

Biotechnology Patent Law Top Ten Of 2019: Secret Sales, Denied Appeals, And The Promise Of Coronavirus Cures, Kevin E. Noonan, Andrew W. Torrance

The University of New Hampshire Law Review

No abstract provided.

Please Consult Your Lawyer Before Taking Sorrell: How The Fda Should Approach Social Media For Prescription Drug Advertising, Steven Valentino

Upper Level Writing Requirement Research Papers

No abstract provided.

Branded Drug Companies Are Successfully Asserting The Doctrine Of Equivalents In Hatch-Waxman Litigation, Christopher M. Holman

Faculty Works

This article reports the results of a study analyzing every Federal Circuit decision the author could find dating back to 2005 that applies the doctrine equivalents (DOE) in the context of pharmaceutical patent litigation, and in particular infringement lawsuits brought against Abbreviated New Drug Application (ANDA) applicants by branded drug companies under the Hatch-Waxman Act. The results of this study show that pharmaceutical innovators were prevailing against would-be generic competitors under the DOE both prior to, and subsequent to, a 2007 article by Professors Lemley and Allison describing the demise of the doctrine equivalents, but that patentees’ success rate has …

Government Involvement In Pharmaceutical Development Can Come Back To Haunt A Drug Company, Christopher M. Holman

Faculty Works

The U.S. government has long played a significant role in pharmaceutical innovation, often through the funding of research, or collaboration in clinical trials. Unfortunately, government involvement can come at a cost for innovative drug companies, leading to allegations that taxpayers are being required to “pay twice” for the resulting drugs, particularly when the drug is considered essential and is offered at a price that is seen as “unreasonably” high. This Article discusses two aspects of ongoing efforts to leverage government involvement in pharmaceutical development and commercialization as a means for regulating of drug prices. The first is the assertion that …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …

Distorted Drug Patents, Erika Lietzan

Faculty Publications

Drug patents are distorted. Unlike most other inventors, drug inventors must complete years of testing to the government’s specifications and seek government approval to commercialize their inventions. All the while, the patent term runs. When a drug inventor finally launches a medicine that embodies the invention, only a fraction of the patent life remains. And yet, conventional wisdom holds — and empirical studies show — that patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other inventive industry. Congress tried to do something about this in 1984, authorizing the Patent and Trademark Office to …

Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley

Articles

As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

Michigan Law Review Online

In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …

The Cost Of Novelty, Will Nicholson Price Ii

Articles

Patent law tries to spur the development of new and better innova­tive technology. But it focuses much more on “new” than “better”—and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innova­tion”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not only …

The Pharma Perspective: The Double-Edged Sword Of Direct-To-Consumer Advertising, Ela H. Yalcin

Health Law Outlook

No abstract provided.

Tell Me How It Ends: The Path To Nationalizing The U.S. Pharmaceutical Industry, Fran Quigley

University of Michigan Journal of Law Reform

The U.S. medicines system is broken. Millions of Americans suffer and some even die because they cannot afford medicines discovered by government-funded research. At the same time, corporations holding monopoly patent rights to those medicines collect some of the largest profits in modern capitalist history.

It does not have to be this way. The global legacy of treating essential medicines as a public good and the robust U.S. history of government seizure of private property for the public interest reveals a better path: the United States should nationalize its pharmaceutical industry.

U.S. statutory law already provides broad powers for the …

Congress Should Decline Ill-Advised Legislative Proposals Aimed At Evergreening Of Pharmaceutical Patent Protection, Christopher M. Holman

Faculty Works

There is a widespread perception that drug prices in the U.S. are much higher than they should be, and that the problem is only getting worse. Critics argue that the pharmaceutical industry is improperly gaming the system in a manner that takes advantage of legal loopholes and administrative limitations to the detriment of patients and third-party payers. Both houses of Congress responded in 2019 with a slew of hearings focused on pharmaceutical pricing, and dozens of bills have been introduced that would attempt to bring down the cost of drugs. Much of the discussion, and some of the proposed legislation, …

Prescription Restriction: Why Birth Control Must Be Over-The-Counter In The United States, Susannah Iles

Michigan Journal of Gender & Law

This Note argues that it is harmful and unnecessary to require women to obtain prescriptions for access to hormonal birth control. Requiring a prescription is necessarily a barrier to access which hurts women and hamstrings the ability to dictate their own reproductive plans. It is also an irrational regulation in light of the relative safety of hormonal birth control pills, particularly progestin-only formulations, compared to other drugs readily available on the shelves.

Leading medical organizations, including the American College of Obstetrics and Gynecologists, advocate for over-the-counter access to hormonal birth control. While acknowledging that not every woman will have positive …

The Death Of The Genus Claim, Dmitry Karshtedt, Mark A. Lemley, Sean B. Seymore

GW Law Faculty Publications & Other Works

The central feature of patent law in the chemical, biotechnology, and pharmaceutical industries is the genus claim – a patent that covers not just one specific chemical but a group of related chemicals. Genus claims are everywhere, and any patent lawyer will tell you they are critical to effective patent protection.

But as we show in this article, the law has changed dramatically in the last twenty-five years, to the point where it is no longer possible to have a valid genus claim. Courts almost always hold them invalid. Remarkably, they do this without having acknowledged that they have fundamentally …

The Problem With Relying On Profit-Driven Models To Produce Pandemic Drugs, Ana Santos Rutschman

All Faculty Scholarship

The longstanding problems of relying on a market response to a pandemic are becoming readily apparent in the United States, which has quickly become the epicenter of the COVID-19 outbreak. The problems are particularly pronounced in pharmaceutical markets, where we are pinning our hopes for both cures and vaccines. In previous work we have shown how characteristics of healthcare markets in the United States create a divergence between the private incentives of for-profit companies and public health needs, leading to sub-optimal health outcomes in what is a uniquely market-driven healthcare system. In this Essay, written as the COVID-19 pandemic unfolds, …

A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho

Indiana Law Journal

Is more information always better? First Amendment commercial speech jurisprudence takes this as a given. However, when information is only available from a self-interested and marketing-savvy pharmaceutical company, more information may simply lead to more misinformation. Notably, doctors are also misled. This can result in public health harms when companies are promoting unapproved uses of prescription drugs that the Food and Drug Administration (FDA) has approved for other purposes—commonly referred to as “off-label” uses. Contrary to judicial presumptions, as well as the presumptions of some doctors and scholars, doctors are not sophisticated enough to always discern what is true versus …

India's Compulsory License Model: Increased Pharmaceutical Access And Innovation Coexist, Bela Gandhi

Brigham Young University Prelaw Review

India faces a drug access issue. By using compulsory licenses India can increase access to pharmaceuticals through generics and protect innovation of pharmaceutical patents. Similarly situated countries will benefit from India’s model to improve affordable generics while requiring strict voluntary license application requirements and drug trials for biosimilars.

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …

Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth

Marquette Intellectual Property Law Review

This Comment will address two primary issues. First, it will analyze the basis of sovereign immunity rights of tribes, with a focus on the relationship between intellectual property rights and sovereignty. Second, it will discuss whether this arrangement violates the antitrust laws of the United States. This Comment concludes that even if a claim of tribal sovereign immunity is legitimate, it is likely that such an arrangement still violates the relevant antitrust claims.

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …

Computational Experimentation, Tabrez Y. Ebrahim

Faculty Scholarship

Experimentation conjures images of laboratories and equipment in biotechnology, chemistry, materials science, and pharmaceuticals. Yet modern day experimentation is not limited to only chemical synthesis, but is increasingly computational. Researchers in the unpredictable arts can experiment upon the functions, properties, reactions, and structures of chemical compounds with highly accurate computational techniques. These computational capabilities challenge the enablement and utility patentability requirements. The patent statute requires that the inventor explain how to make and use the invention without undue experimentation and that the invention have at least substantial and specific utility. These patentability requirements do not align with computational research capabilities, …