Double-Patenting: Impact of Gilead on Bio and Pharma

Double-Patenting: Impact of Gilead on Bio and Pharma

Double-Patenting: Impact of Gilead on Bio and Pharma

The Federal Circuit decision twenty months ago in Gilead v. Natco arose out of ANDA litigation over patents on anti-viral drugs, and it is widely seen as expanding the universe of patents vulnerable to charges of double patenting in the pharma and biotech industry. However, life sciences companies are not the only ones to find themselves with Gilead’s problem. After asserting a patent in litigation, some high-tech companies have discovered that the defendant can use one of the plaintiff’s later issued, but earlier expiring patents, to knock out a patent that was issued earlier but expires later.

Like drugmakers, some tech companies may come to regret relying heavily on continuations in their patent prosecution, using a “more is more” strategy to grow large patent families. Ex parte reexamination has emerged as the proceeding of choice for tech patent challengers, with at least a dozen patents invalidated by the USPTO’s Central Reexamination Unit for double patenting since Gilead.

This panel will focus on tips for patent prosecution after Gilead, as well as the litigation outlook with a particular focus on biosimilars. Because many branded pharma companies are entering the biosimilar market, they are finding themselves combing the portfolios of competitors for double patenting weakness, much as generic companies are doing. Our panel features the lawyer who argued for Natco at the Federal Circuit, a law firm biotech lawyer who is an expert on patent term adjustment, and the vice president of IP at a drug development company.

 

Speakers:

Tim Babcock, Akros Pharma Inc.
Jack Brennan, Fish & Richardson
Jeremy Lowe, Axinn Veltrop

Intellectual Property Owners Association
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