Strategic Considerations for Life Sciences Claim Drafting

Strategic Considerations for Life Sciences Claim Drafting

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Over the past 80 years, about 40% of all FDA-approved pharmaceutical products have been in the form of pharmaceutical salts. The typical route for claiming such salts in patents involves claim cascades beginning with the ubiquitous “and pharmaceutically acceptable salts thereof” and often ends by naming the particular salt species of interest. Examples of such salts include sodium or hydrochloride salts of particular active pharmaceutical ingredients. There is room, however, to add an additional layer of claim coverage. Because salts can have solid-state structures, claim sets covering those structures may be constructed using the appropriate data. Moreover, and under the right circumstances, patents containing such claims may expire substantially after the expiration of the other corresponding salt patents.

Patent claim drafting techniques for Life Sciences will also be discussed.  Recent caselaw that discusses Markush Groups, Dependent Claim invalidation, Negative Limitations and other subjects will be covered, as well as claim drafting considerations when prosecuting a worldwide portfolio.

Materials*

Overview of Claim drafting Issues for Biotech, Chemical and Pharma Patent Applications

Debora’s PowerPoint: Claim Drafting: Biotech/Pharma/Chemical

Eyal’s PowerPoint: Solid Form Patent Strategy

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