In most circles the words “obviousness-type double-patenting” (“ODP”) will earn you—at best—a quizzical look. That is not the case in the world of Biologics. Janssen Biotech is the latest life science company to have a key patent invalidated by other patents in the same family because of this doctrine. Federal courts have long recognized a prohibition against double patenting, which is based on a core tenet of the U.S. patent system. In exchange for the limited monopoly granted to an inventor, she must fully enable and describe her invention, and “promise to permit free use of it” once her patent expires. But when there is a family of related patents claiming similar subject matter, it can get a bit tricky to determine when the “bargained-for right held by the public” kicks in. The double patenting doctrine applies not only to the exact invention that is claimed in a patent, but also to obvious modifications that are not “patentably distinct improvements.”
In March of 2015, Janssen sued competitors, Celltrion and Hospira, who planned to launch a biosimilar in the U.S. The innovator product? Remicade®, which is a therapeutic antibody approved for the treatment of a variety of autoimmune diseases. It is an extremely successful therapy, generating billions of dollars annually. Janssen alleged that defendants had failed to comply with disclosure and notice provisions in the Biologics Price Competition and Innovation Act (“BPCIA”), and also alleged infringement of six patents covering the antibody itself, cell culture media, and methods of manufacturing, purification and treatment. The district court recently determined that the antibody patent was invalid for ODP in view of three other patents in the same family. Each of the three invalidating patents (or “reference patents”) had expired before Janssen even filed suit.
What lessons can be learned from Janssen and other recent ODP cases?
For patent challengers:
- Consider whether there is a patent family member that issued later than the patent-in-suit, but expired earlier. The later-issuing patent may serve as an invalidating reference patent in an ODP analysis if the Uruguay Round Agreements Act (URAA) applies when calculating its term.
- Determine whether the patent-in-suit merely claims the use of a previously claimed compound. If so, assess whether the reference patent claiming the compound also discloses exactly the same, later-claimed utility or use.
For patent holders:
- Determine whether the safe harbor provision applies, which prevents a related patent from being used as a reference patent when the patent-in-suit issued from a divisional application.
- Ask whether the reference and asserted patents are directed— respectively— to a genus and species, and assess whether the species that is claimed reflects results that are unexpected relative to the genus.
- When faced with the argument that reference and asserted patents claim a compound and an obvious (and disclosed) use of that compound, consider whether that description can be re-framed. For example, a patent holder prevailed on an ODP challenge when it had asserted a patent on a chemotherapeutic compound, but there was a reference patent claiming an intermediate to the compound, and describing its use in synthesizing the final compound. In that case, what was claimed were actually “two separate and distinct compounds,” so ODP did not come into play.
Janssen’s patent loss puts a significant share of the Remicade® market at risk. The company was already facing stiff competition outside of the U.S., and saw an additional biosimilar approved in Europe this May. In the U.S., Celltrion began shipping its biosimilar shortly after the district court’s ODP ruling. Analysts predict that Janssen will lose just over $1 billion dollars in sales next year.
