Protecting Biotech Innovation in the Platform Knowledge Era

Partner Aisha Hasan authored an article for Law360 entitled "Protecting Biotech Innovation in the Platform Knowledge Era."

The article noted that draft guidance released in June by the U.S. Food and Drug Administration on how sponsors may use prior knowledge to advance product development signals a broader shift in biotechnology toward leveraging prior knowledge and platform knowledge wherever scientifically appropriate.

"That shift has important implications for intellectual property strategy because, as more innovation builds on existing knowledge, companies must be able to show where prior knowledge ends and their own inventive contribution begins," Hasan wrote. "Therefore, companies operating in this environment should be more deliberate about identifying, documenting and protecting the innovations that remain uniquely theirs: first by guarding against obviousness challenges, and second by treating the entire development pipeline — rather than just the end products — as a source of patentable innovation."