U.S. Patent and Trademark Office building

Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, and the Economy

By Jorge L. Contreras, JD

The U.S. patent system gives inventors a 20-year exclusive right to their inventions to incentivize the creation of new technologies.

But what if you have a great idea for a new technology, but never actually create it, test it, or determine that it works? Is that patentable? Conversely, should the U.S. Patent and Trademark Office (PTO) grant patents covering imaginary, fraudulent and otherwise non-existent inventions? Probably not, but it happens with alarming frequency, and it is causing serious problems.

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Introducing New Contributor Jorge Contreras

Jorge Contreras.Jorge Contreras is joining Bill of Health as a regular contributor.

Jorge L. Contreras is a Presidential Scholar and Professor of Law at the University of Utah with an adjunct appointment in the Department of Human Genetics. His research focuses on intellectual property, technical standards and science policy, and he is one of the co-founders of the Open COVID Pledge, a framework for contributing intellectual property to the COVID-19 response. Professor Contreras is the editor of six books and the author of more than 100 scholarly articles and chapters appearing in scientific, legal and policy journals including Science, Nature, Georgetown Law Journal, NYU Law Review, Iowa Law Review, Harvard Journal of Law and Technology and Antitrust Law Journal.  He has served as a member of the National Institutes of Health (NIH) Council of Councils, the Advisory Councils of the National Human Genome Research Institute (NHGRI) and the National Center for Advancing Translational Sciences (NCATS), and as the Co-Chair of the National Conference of Lawyers and Scientists. He is a graduate of Harvard Law School (JD) and Rice University (BSEE, BA).

Doctor or nurse wearing PPE, N95 mask, face shield and personal protective gown standing beside the car/road screening for Covid-19 virus, Nasal swab Test.

COVID-19 Highlights Need for Rights to Repair and Produce in Emergencies

By Joshua D. Sarnoff

In response to the COVID-19 pandemic, companies, organizations, and individuals have sought to address supply chain gaps for needed medical equipment. Spare parts and products created during the COVID-19 pandemic include ventilator tube splitters, nasopharyngeal swabs, and face shields.

In the past, outside of the context of a public health crisis, I have discussed the need to adopt legislation to create a narrow exemption from design patent liability to assure a competitive supply of automobile repair parts. The current pandemic makes a stronger case for the need to explicitly incorporate into our legal system a right to repair and supply products in emergencies.

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part III)

By Jonathan Darrow

This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part III considers a path forward in the regulation of biologics.  For Part I, click here.  For Part II click here.

A Path Forward

The small number of biosimilar approvals compared to generic drug approvals cannot establish the failure of the BPCIA due to differences in industry familiarity with each follow-on pathway, the number of reference products available for copying, patient population sizes, patent barriers, and drug costs. The later arrival of US laws and guidance documents—not inadequate legal design—is the most straightforward explanation of why the first US biosimilar approvals were delayed compared to those in Europe.

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part II)

By Jonathan Darrow

This is Part II in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part II covers some key considerations and factors that impact the biologics market and regulation.  For Part I, click here.

Reference Products Available for Copying in 1984

Because most post-1962 drugs enjoyed a 17-year patent term (changed to 20 years in 1995), there was little need for an abbreviated pathway in the years immediately following the Kefauver-Harris Amendments. But as patents expired, increasing numbers of post-1962 drugs became available for copying yet were ineligible as reference products under the 1970 ANDA regulations. On the eve of the Hatch-Waxman Act, Congress estimated that approximately 150 post-1962 drugs were off-patent but had no generic equivalent. This backlog of available reference products produced a surge in ANDA approvals following enactment of the new law (Exhibit 1).

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part I)

By Jonathan Darrow

This is Part I in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already-approved biological medicines.  This Part briefly covers the history of American regulation of biologics and touches briefly on the European experience.

The Biologics Price Competition and Innovation Act (BPCIA), part of the 2010 Affordable Care Act, sought to drive down prices for biologics, much as the 1984 Hatch-Waxman Act did for small-molecule drugs. By allowing manufacturers of follow-on products to rely in part on the clinical data of the brand-name reference product, both laws were designed to lower development costs and attract competitors.

Since the BPCIA’s enactment, however, scholars have compared it unfavorably to the Hatch-Waxman Act, criticized its pathway as “obstructed” and lacking in sufficient incentives, lamented the scarce approvals it has produced, and recommended that it be “abandoned.” Although criticisms of the law are not without basis, their collective implication—that the BPCIA is irredeemably defective and will never yield robust competition—may be wrong.

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Researcher works at a lab bench

Do Pharmaceutical Patents Generate Unique Global Health Duties?

By Govind Persad

Imagine a Harvard MBA graduate trying to decide between jobs at Pfizer and at Snapchat. Both are immensely wealthy firms. Many of Pfizer’s products benefit global health. Snapchat’s are at best neutral and may even harm health. Yet many see Pfizer as distinctively culpable for global health deficits. These arguments often depend on the fact that Pfizer holds intellectual property (IP) in pharmaceuticals, whereas Snapchat holds cash and non-pharmaceutical IP.

In a recent paper in the Yale Journal of Health Policy, Law, and Ethics, Examining Pharmaceutical Exceptionalism: Intellectual Property, Practical Expediency, and Global Health, I argue for two conclusions:

  1.  Holders of pharmaceutical IP (like Pfizer) aren’t uniquely culpable for global health deficits. Other actors (like Snapchat) who fail to use available resources–including ordinary property and non-pharmaceutical IP–to address health deficits, or who affirmatively cause health deficits, also bear responsibility.
  2. But laws requiring pharmaceutical IP holders, but not others, to address global health deficits are nevertheless justifiable. Legal responsibility needn’t perfectly mirror moral responsibility.

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U.S. Patent and Trademark Office building

Laws and Facts of Patent Eligibility and Medical Diagnostics

This post is part of our Eighth Annual Health Law Year in P/Review symposium. You can read all of the posts in the series here. Review the conference’s full agenda and register for the event on the Petrie-Flom Center’s website.

By Jacob S. Sherkow

For this year’s Health Law Year in P/Review, I’ll be talking about § 101, that most enigmatic of laws from the patent statute. Like many other areas of intellectual property, patent law has a threshold subject matter inquiry embodied in statute—this is § 101—which reads, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” But because any “competent draftsman” of patent applications could claim an invention as, say, “a process” rather merely an idea, courts have, almost since the statute’s first enactment in 1790, ignored the language of the text entirely. You should too. Instead, it has for almost all of its history, been interpreted in the following manner: “Anything under the sun made by man” is patentable subject matter, save “abstract ideas” or “natural laws, phenomena, or products.” Sure: defining what is a “natural” law is tough, but it’s not a phrase so devoid of application as to make it nonsense. (Unless you’re a complexity theorist.) Read More

Close up of a computer screen displaying code

What Google Isn’t Saying About Your Health Records

By Adrian Gropper

Google’s semi-secret deal with Ascension is testing the limits of HIPAA as society grapples with the future impact of machine learning and artificial intelligence.

I. Glenn Cohen points out that HIPAA may not be keeping up with our methods of consent by patients and society on the ways personal data is used. Is prior consent, particularly consent from vulnerable patients seeking care, a good way to regulate secret commercial deals with their caregivers? The answer to a question is strongly influenced by how you ask the questions.

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