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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Pipette and test tubes in a rack

Novartis, Dana Farber, Oregon Health & Science University Wait 18 Years to Disclose NIH Funding in Key Gleevec Patent

By James Love

This is a story about U.S. patent number 6,958,335, and how it took more than 18 years for Novartis to acknowledge National Institutes of Health (NIH) funding in a key patent for Gleevec, allowing Novartis to shape the narrative regarding its role in the development of Gleevec, and also to avoid demands that Novartis make the invention “available to the public on reasonable terms,” which is an obligation under the Bayh-Dole Act.

On May 10, 2001, the United States FDA approved a new drug, imatinib, initially for the treatment of a rare indication: chronic myeloid leukemia (CML). The drug was registered by Novartis, which sold the drug under the brand name Gleevec in the United States and several other markets, and as Glivec in others.

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A graphic that reads "United States Mexico Canada Agreement"

USMCA Agreement and the Remedies for Patent Infringement

The United States Trade Representative has published a statement regarding the proposed U.S., Mexico and Canada (USMCA) trade agreement drug prices. According to USTR:

“nothing in the newly negotiated USMCA will require changing U.S. laws on pharmaceutical intellectual property rights or lead to higher prices on drugs for U.S. consumers.”

There are several complaints against the USMCA on this issue, including that it both will lock in bad features of current laws, and is inconsistent with U.S. law. Read More

Abstract representation of DNA double helix

Gene Editing and Intellectual Property: A Useful Mix?

The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations.

They are organized by the Harvard Medical School Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.

A light lunch will be provided. This event is free and open to the public, but space is limited and registration is required. Please note that attendees will need to show ID in order to enter the venue. Register now!

 

One way of thinking about genome editing is through the lens of the legal and ethical obligations of ensuring the technology is deployed safely and accurately, for the betterment of human society.

Or, if that’s a mouthful for you, genome editing’s rights—and wrongs. Which brings me to a talk I’ll* be giving at Harvard Medical School on March 8: “Genome Editing: Rights and Wrongs” I feel obligated, however, to asterisk the personal pronoun (“I”) because, in truth, what I’ll be doing is sharing the stage with one the world’s most celebrated scientists, George Church, world-renowned bioethicist, Jeantine Lunshof, and moderated by health policy guru, Aaron Kesselheim. Read More

The cost of drug monopolies in the United States

By James Love

The United States, like other countries, uses the grant of legal monopolies as the incentive to reward successful R&D investments. The legal mechanisms are varied, and include most importantly patents on medical inventions, but also a variety of regulatory exclusivities in a patchwork of programs that address (for example) delays in regulatory approval, testing for pediatric patients, development of treatments for rare diseases, rights in test data used to provide new drugs and vaccines, and the development of new antibiotic drugs.

Each of these legal mechanisms that are used to block competition can be evaluated separately, but it is also useful to look at the big picture, and ask – what is the cost of the drug monopolies in the United States?

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Opportunities and challenges for user-generated licensing models in gene-editing

By Timo MinssenEsther van Zimmeren & Jakob Wested 

An earlier version of this contribution had been published in Life Science Intellectual Property Review (LSIPR).

A voluntary pool or clearinghouse model may give rise to a robust commercial ecosystem for CRISPR and could include special provisions for royalty-free research use by academics. Hence, there may be a path through the CRISPR patent jungle. But, there are many obstacles still in the way.

The revocation of Broad Institute’s patent EP2771468 reported and discussed here, marks the latest major development in a series of patent battles over the revolutionary and highly lucrative CRISPR-Cas9 technology (and other gene editing technologies) in the US and Europe.

While this is the first EPO decision in an opposition procedure concerning the Broad patent portfolio, the outcome may have implications for other related patents as the rationale for the revocation reflects a larger, systemic challenge based on the different rules regarding priority claims in different jurisdictions.

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Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle?

By  Jakob Wested, Timo Minssen & Esther van Zimmeren

Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR).

The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred to the Enlarged Board of Appeal. However, this might require a significant amount of legal and rhetorical agility.

“The Opposition Division’s interpretation of the EPC [European Patent Convention] is inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe.”

This was the rather strong reaction of the Broad Institute after the EPO’s Opposition Division’s (OD) decision to revoke one of their CRISPR patents. It could, however, also be argued that the case presents a simple failure of the patent applicants to comply with the long-standing European practice to apply an “all applicants” approach when claiming priority under article 87 of the European Patent Convention.

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