Melissa Brand is the former Associate Counsel and Director for Intellectual Property Policy at the Biotechnology Innovation Organization (BIO), a major trade association with over 1,000 members in the biotechnology industry. At BIO, Professor Brand advises on domestic and international intellectual property matters, with a particular emphasis on patent law.
Previously Professor Brand worked as an attorney at Latham & Watkins and Wilson Sonsini Goodrich & Rosati. In private practice, she focused on high stakes patent litigations and patent strategy matters. 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 graduated magna cum laude from the University of San Diego School of Law where she was a member of the Order of the Coif and served as a Comments Editor for the San Diego Law Review. She graduated cum laude with a degree in Biomedical Engineering from Vanderbilt University.
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).