Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

Clash of Titans? A Brewing Dispute between Telehealth Giants

By Vrushab Gowda

Competition between rival telehealth providers spilled into open conflict last month, as incumbent Teladoc Health, Inc. (Teladoc) filed a patent infringement suit against relative upstart American Well Corporation (Amwell).

This development marks a significant escalation in what has been a lengthy arms race between the two publicly traded entities. Both having witnessed skyrocketing sales in recent months, aided by a shift to virtual care and a host of regulatory flexibilities, although neither has turned a profit to date.

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Vaccine.

Compulsory Licensing for Pharmaceuticals in the EU: A Reality Check

By Caranina (Nina) Colpaert

As pharma races to develop a COVID-19 vaccine, researchers and governments are working in parallel to pinpoint strategies to secure its widespread access.

To that end, many countries plan to seek refuge in a long-existing strategy: compulsory licensing.

In the European Union (EU), however, compulsory licensing is not as self-evident as it might seem. This blog post focuses on four specific challenges that come with compulsory licensing in the EU and potential alternative solutions.

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Researcher works at a lab bench

Deconstructing Moderna’s COVID-19 Patent Pledge

By Jorge L. Contreras, JD

On October 8, Cambridge-based biotech company Moderna, Inc., a leading contender in the race to develop a COVID-19 vaccine, publicly pledged not to enforce its COVID-19 related patents against “those making vaccines intended to combat the pandemic.”

It also expressed willingness to license its intellectual property for COVID-19 vaccines to others after the pandemic. In making this pledge, Moderna refers to its “special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.”

Moderna holds seven issued U.S. patents covering aspects of an mRNA-based candidate vaccine directed to COVID-19 which entered Phase III clinical trials in July. The potential market for a COVID-19 vaccine is potentially enormous. As of this writing, the U.S. government has committed approximately $1.5 billion to acquire 100 million doses of Moderna’s vaccine if it proves to be safe and effective (with an option for 100 million more), and the Canadian government has agreed to purchase 20 million doses for an undisclosed amount.

In the high-stakes market for COVID-19 vaccines, it is worth considering the full range of factors that might motivate a private firm to relinquish valuable intellectual property rights for the public good. A better understanding of these factors could help policymakers to secure additional pledges from firms that have not yet volunteered their intellectual property in the fight against the pandemic.

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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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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

Tertiary Patents: An Emerging Phenomenon

By Jonathan J. Darrow

Brand-name pharmaceutical manufacturers have long been known to try to protect and extend their market exclusivity periods by obtaining patents on a drug’s substance (“primary patents”) and also on its peripheral features, such as formulations or methods of manufacture (“secondary patents”). A new study describes an emerging phenomenon of “tertiary patents,” which have the potential to further delay and discourage market entry in the context of drug-device combination products.

Combination products are defined by the U.S. Food and Drug Administration (FDA) to include therapeutic products that combine a drug with a device, such as an inhaler or injector pen. These products can sometimes offer life-changing or life-sustaining treatment, as with naloxone (Narcan) for opioid overdose or epinephrine (EpiPen) for severe allergic reactions. In recent years, these and other similar products have been the subject of substantial controversy related to their prices and prolonged lack of generic competition.

To investigate the potential role of patents on the prices and exclusivity periods of drug-device combination products, two researchers at the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School (where I hold a faculty appointment) conducted a comprehensive evaluation of drug-device combination patents registered with the FDA. They found that patents related to drug delivery devices have tripled since the year 2000 and contribute a median of five years of additional market exclusivity to those products (subject, of course, to potential judicial or administrative patent invalidation). Furthermore, the researchers identified a subset of 31 products having only device patents (i.e., having no primary or secondary patents), and found that these patents were scheduled to expire a median of 17 years after FDA approval. Read More