Congressional Hearing Highlights Need for Strong IP Protections
Today, the House Judiciary Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet is holding a hearing titled, “Medicines and IP: Balancing Innovation and Access.” While lawmakers such as Sen. Elizabeth Warren (D-Mass.) and U.S. Rep. Pramila Jayapal (D-Wash.) have slammed drug companies for “repeatedly abus[ing] the patent system to stifle competition and prolong their market power, [and] showing no regard for the harm done to patients through sustained high prices,” these sweeping charges are baseless. Intellectual property (IP) protections are critical for continued biopharmaceutical innovation, and any attempts to weaken IP rights will result in fewer new cures and treatments for patients.
Millions of patent owners rely on IP protections to create game-changing and life-saving products, including breakthrough medicines and treatments that patients depend on. Unfortunately, the previous administration attempted to undermine patent rights and make it more difficult for drug producers to improve their products for patients. Former President Biden’s July 2021 Executive Order entitled “Promoting Competition in the American Economy” (fortunately revoked by President Trump) empowered the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to collaborate in undermining innovators’ IP rights. This has included efforts to limit drug sponsors’ ability to make incremental patents on small but significant components of life-saving therapies.
The Biden administration’s efforts were motivated by a fear of “patent thicketing,” or the alleged practice of drug companies obtaining and maintaining a significant number of overlapping, interconnected patents around a medication, ostensibly making it difficult for competitors to enter the market without risking patent infringement. However, the patents comprising these so-called “thickets” protect genuine follow-on innovation that occurs after the invention of the original medication. Improvements such as safer formulations and longer-lasting dosages can require substantial R&D investment and deserve patent protection on their own merits. Eliminating or weakening these patents simply because they surround a successful product would reduce incentives to make incremental but critical improvements that benefit patients.
The real problem is that patents are too easy—not too difficult—to invalidate. Under the flawed framework developed by the 2011 America Invents Act, the Patent Trial and Appeal Board (PTAB) allows patent challengers an easy avenue to challenge (or petition) patents already held by innovators. In the resulting Inter Partes Review (IPR) process, the patent challenger and patent holder make their respective cases before a panel of PTAB administrative law judges (ALJs). These ALJs decide on claim validity based on limited discovery, briefing, testimony, and oral arguments. As noted by former chief judge of the Federal Circuit Randall Rader, these ALJ panels are “patent death squad[s]” because roughly 4 in 5 IPR proceedings result in at least one claim being held unpatentable.[1]
Rather than undermining IP rights, lawmakers should address these issues and focus on comprehensively safeguarding patent protections.