is a Partner with Kramer Levin, where she represents pharmaceutical, biotech and medical device companies in patent litigation, advising both plaintiffs and defendants in every stage of the litigation process from pre-suit investigation through trials and appeals. She litigates a wide range of subject matters including small molecule drugs, antibodies, manufacturing processes, point-of-care diagnostics, gene-editing technology, gene therapies, and drug-eluting coatings. She has a particular depth of experience in litigation under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA). In addition, she represents clients in inter partes reviews and high-stakes license disputes. Irena also provides strategic counseling in the area of biologics and pharmaceuticals and advises clients on contractual and licensing issues.
To read more about Ms. Royzman or to contact her, please visit her firm profile page.
The AIA and its legislative history do not provide clear and convincing evidence that Congress intended ultra vires agency action by the PTO in holding claims unpatentable to be exempt from judicial review on appeal from a final written decision in an IPR. The Supreme Court should make clear that if the PTO holds claims unpatentable on grounds not set forth in the petition, then that ultra vires conduct is subject to judicial review, not exempt from it.
The NYIPLA asks the Court to grant the petition in order to make clear that judicial review is available when the PTO institutes an IPR proceeding and invalidates patent claims in violation of its statutory authority, and to determine the claim construction standard that the PTO should apply to determine patent validity. The NYIPLA explains that the Supreme Court’s review of both questions is critical at this juncture since to a large and increasing extent, IPRs are supplanting district court litigation as the forum for resolving issues of patent validity based on the prior art, and in proceedings below the Panel was split 2-1 with a vigorous dissent on both issues, and the Federal Circuit then split 6-5 in denying a petition for rehearing en banc.
While Mayo and Alice presented a two-part “framework” to address when a particular claimed invention preempts a “fundamental principle,” neither case purported to have that framework replace a preemption inquiry nor authorize a court to ignore the ultimate question, i.e., does the claim preempt a fundamental principle instead of merely claim a practical application of such a principle? The failure to consider preemption has resulted in courts and the PTO over-using §101 in a gatekeeper or threshold fashion for which it was never intended to be used, either as enacted by Congress or as interpreted by the Supreme Court.