The United States Court of Appeals for the Federal Circuit has
ruled that obviousness-type double patenting does not invalidate an
otherwise validly obtained patent term extension (PTE) under 35
U.S.C. § 156. The decision in
Novartis AG v. Ezra Ventures LLC affirmed the Delaware
District Court's similar judgment, and demonstrates that a
patent with an earlier expiration date, including one that is
terminally disclaimed over other patents, can be extended beyond
one or more patents with later expiration dates.
In the U.S., a single patent covering a pharmaceutical product
can be extended for up to five years to make up for patent term
lost during clinical trials for regulatory (i.e., FDA) approval.
This was part of the landmark Hatch-Waxman Act of 1984, which
balanced branded drug exclusivity with generic competition.
However, there are statutory and judicial doctrines that prevent a
patent owner from extending the life of a first patent to an
invention with further
