The Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. The case confirms that amending an Abbreviated New Drug Application (ANDA) to address a patent issued after the original ANDA’s filing can infringe the later-issued patent. The decision also upheld the district court’s decision finding Vanda’s personalized medical treatment claims patent eligible under § 101.
Much of the decision compares Vanda’s claims to those found ineligible for patent protection in the U.S. Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, 132 S. Ct. 1289 (2012). While the ultimate patentability conclusions are opposite, the claims in Vanda and Mayo are very similar, highlighting the thin—and often unpredictable—line that divides eligible and ineligible subject matter. Generic drug manufacturers must account for this unpredictability in gauging their litigation risks. …
Excerpted from IP Watchdog. To read the full article, click here.