Inventing and “Reinventing” Under Patent Law
Presented by Notre Dame Law School, co-sponsored by Locke Lord
Organized by Locke Lord Partner and Notre Dame Alumna, Carolyn Blessing
September 17, 2020
3:00 p.m. CST/4:00 p.m. EDT
Welcome/Introductory Remarks (3:00 – 3:15 p.m.)
The Hatch-Waxman Act: The Role of Generics in Patent Law (3:15 – 3:45 p.m.)
The Hatch-Waxman Act frames the relationships between pharmaceutical companies that produce generic drugs and the first-mover pharmaceutical companies who invent brand-name drugs on the market. Abbreviated New Drug Applications (ANDA) filed by pharmaceutical companies who wish to produce and sell generic versions may lead to questions of validity for the patent first issued to the brand-name pharmaceutical company. ANDAs may also lead to negotiations brought on by the exclusivity promised by the Hatch-Waxman Act. How does the Hatch-Waxman Act work in practice and what are the most recent case law developments? How is the Hatch-Waxman Act perceived by policy-makers and might there be future revisions to it on the horizon? What are the litigation trends as more and more companies increasingly become “generic players”? The discussion will also explore the current Hatch-Waxman issues related to the coronavirus, such as how postponements of hearings have affected regulatory stays related to the approval of ANDAs for generic products.
BREAK (3:45 – 4:00 p.m.)
Keynote Address, Patent Incentives, Patent Litigation, and Small Molecule Drug Development (4:00 – 4:30 pm)
Patent incentives are widely considered critical to drug development. Critics charge, however, that firms sometimes use low-quality patents to extend patent term unduly. This talk will present empirical data on the types of patents that firms seek and how those patents are litigated, whether in district court or at the Patent Trial and Appeal Board (PTAB). It will also discuss the important and complex public and private collaboration play in patent development.
BREAK (4:30 – 4:45 p.m.)
Inventions at the “Litigation” Stage: Inter Partes Review and/or District Court (4:45 – 5:15 p.m.)
Companies and inventors developing pharmaceuticals will often strategically decide whether to ask for inter partes review at the Patent Office to address patentability or to litigate patentability and other issues in district court. Different results in each of these venues, often based on the application of different standards of review, make these strategic decisions important for the scope of patent protection and the validity of patents themselves. How is patent validity best litigated in district court and what methods of advocacy are effective? What are the nuances of inter partes review of which attorneys practicing before the PTAB should be aware? Is engaging in forum shopping uniquely beneficial to certain claims? The discussion will also touch on novel issues that have arisen in IP litigation due to the coronavirus and the need to work remotely. Having to conduct depositions, for example, from multiple locations and participate in hearings and oral arguments remotely are new facets of IPRs and litigation in district court.
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