Melissa Brand is Intellectual Property Counsel at Radius Health. In this role, Ms. Brand leads global patent portfolio development, counsels on freedom to operate and enforcement issues, and provides strategic support for transactional matters.
Prior to her role at Radius, Ms. Brand served as the Assistant General Counsel for Intellectual Property at the Biotechnology Innovation Organization and worked in private practice at Latham & Watkins and Wilson Sonsini Goodrich & Rosati. Ms. Brand also served as a law clerk to the Honorable Kimberly A. Moore at the United States Court of Appeals for the Federal Circuit. She also teaches a course on Intellectual Property & Medicines as an adjunct professor at the Georgetown University Law Center.
While the discussions around waiving intellectual property (IP) rights set forth in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) are currently (and somewhat amorphously) limited to COVID-19 related drug and medical products, it is probably shortsighted to ignore the implications for other technologies critical to sustaining our environment and advancing a more healthful world. In fact, if we want to ensure continued investment in these technologies, we should be very concerned about the message conveyed by the international political tide: if you overcome a challenging scientific problem and your solution has the potential to save lives, be prepared to be subjected to intense political pressure and to potentially hand over your technology without compensation and regardless of the consequences.
The Biotechnology Innovation Organization (BIO) recently submitted comments in support of a National Institute of Standards and Technology [NIST] rulemaking on “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions.” The proposed rule caps a nearly three-year effort by NIST, through engagement with stakeholders, to improve federal technology transfer and the commercialization of federally funded inventions. That effort resulted in a comprehensive Green Paper, “Unleashing American Innovation” in April 2019, which reviewed federal research efforts and made detailed recommendations to maximize the taxpayers’ return on investment.
In the spring of 2018, a district court invalidated a patent claiming methods of manufacturing a pickup truck drive shaft for failure to recite patent-eligible subject matter. Industry stakeholders, scholars, and legal commenters were more than a little incredulous, since methods of manufacturing such tangible objects have long been patentable in the United States. In due course, the Federal Circuit (in a 2-1 decision) drew even more exasperation when it affirmed the district court’s holding. If the ensuing stream of bewildered blog posts, amicus briefs, and statements by public officials are anything to go by, many viewed the case as another high water mark in our uniquely American Section 101 jurisprudence…. Then, enter the July 31, 2020 re-written majority opinion in American Axle. Rather than allow the case to go to the full court for consideration, the majority decided to edit some of the troubling language from the original panel opinion.
Since Merck & Co. v. Teva Pharmaceuticals, blocking patent arguments have arisen in the Federal Circuit primarily in the pharmaceutical patent context, and until now have largely been limited to undermining evidence of commercial success. But just like gremlins fed after midnight, this doctrine inevitably spawned unwanted offspring that are now wreaking havoc… Assuming that no one would ever develop a product that might infringe a patent is inconsistent with numerous Federal Circuit realities. It’s right up there with the Tooth Fairy (sorry, kids).
Hindsight bias, the phenomenon that things seem more predictable and obvious after they have occurred, is one of the most widely-studied “decision traps” in psychology… Patent litigation plays right into such human limitations, which affect judges and jurors alike. Patents are often litigated many years after the invention was made, and very often those who are accused of patent infringement will argue that the invention was obvious at the time it was made and a patent was applied for… And we accept a surprising amount of other conjecture in this analysis. For example, judges and jurors are told about a contemporaneous hypothetical person that – despite having only ordinary skill in the relevant technology – would have had super-human knowledge of all then-existing technical information, was fluent in every language under the sun, and would have done insane things to access information sources.
Imagine this: you become aware of a patent that might cover your products, so you reach out to the patentee to secure a license agreement. After negotiating and entering the agreement, you later decide you’d like to pay less or no royalties. So you threaten to file some IPR and PGR petitions, and when that fails to secure more favorable terms, you breach the contract. If you find yourself sued for patent infringement you protest to the court that as the agent of public interest, you must be allowed to simultaneously challenge the validity of the patents not only before that court, but also before the PTAB. On the same grounds. At the same time. This is what at least one licensee is trying, and the Federal Circuit may soon provide guidance on the viability of this double-adjudication-for-the-public-good-tactic.