HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Wednesday, April 30, 2014

Guest Blogger Gaia Bernstein - Patients: the New Unexpected Players in Patent Litigation

Bernstein GaiaWhen people think about patent litigation they think about patent owners, they think about savvy technological competitors – they do not think about patients. For sure, everyone realizes that patients have strong interests in patented products, such as drugs or medical tests. And all agree that the goal of the patent system is to encourage innovation and eventually benefit patients. But, no one thinks of patients as active players in the patent playfield.

It is time to change the way we view patent litigation. In my article: The Rise of the End User in Patent Litigation, which is forthcoming in the Boston College Law Review, I show that end users are playing an increasingly growing role in patent litigation. End users are those who use patented technologies for personal consumption or in business. End users do not manufacture or sell patented technologies. Patients are prominent among these end users. 

Patients were among the plaintiffs suing to invalidate Myriad Genetics’ patents on several breast cancer genetic mutations in order to increase public access to the genetic tests. The tests at that time cost around $3000. The Supreme Court decided the case – Association for Molecular Genetics v. Myriad Genetics – in 2013. Patients also repeatedly challenge settlement agreements  -- called pay for delay agreements – between manufacturers of patented drugs and generic manufacturers. Under these agreements, patented drug manufacturers compensate generic manufacturers not to enter the market to the detriment of patients who now cannot benefit from lower priced drugs. And, in another example, a group of Fabry disease patients asked the National Institute of Health (”NIH”) to use its march-in power to grant licenses to other producers to address manufacturing problems at the patent owner’s facilities that caused a shortage of the patented drug. When the NIH refused the patients filed suit for damages against the patent owner and others in federal court.

My article shows that end users, including patients, are unique players in the patent playfield.  First, they lack the technological expertise that is critical in patent cases, where showing patent invalidity or non-infringement depends on sophisticated technological understanding of the patented invention and any competitive products. Second, they are usually unaware of the existence of the patented technology until later in the life of the patent, when the technology achieves mainstream adoption. Because of that they are limited in their ability to use the less expensive Patent Office procedures in lieu of litigation. Third, they are usually (although not in cases of patients of chronic diseases) one-time players and would prefer to settle with patent owners than endure the exorbitant costs of patent litigation.

Since patients, like other end users of patented technologies, are uniquely situated, they tend to be at a disadvantage compared to the traditional players of the patent playfield – the patent owner and her competitors.  My article argues for the need for procedural reforms to place patients, among other end users, on equal footing in patent litigation.  For more on ways to address the imbalance – see my follow up post.

-Guest Blogger Gaia Bernstein

[cross posted on Health Reform Watch]

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