Posts Tagged: "New Drug Application"

Delisting Counterclaims in Hatch-Waxman Cases: An Ineffective Weapon to Address Improper Patent Listing

The Hatch-Waxman Act (“the Act”) was designed to strike a delicate balance between pharmaceutical innovation and faster access to affordable drugs. However, one aspect of the Act, the patent listing process, when used improperly, can knock this balance out of whack. Unfortunately, in the present environment, the potential for improper patent listing is high, and current remedies are insufficient.

CAFC Affirms Mixed Ruling on Pulmonary Hypertension Drug Patent, Noting ‘Safety and Efficacy’ is for FDA

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Monday issued a precedential decision affirming a district court’s mixed ruling in a patent infringement case involving two patents owned by United Therapeutics on the pulmonary hypertension drug, Tyvaso.
U.S. Patent 10,716,793 and U.S. Patent 9,593,066 cover methods of treating pulmonary hypertension and pharmaceutical compositions comprising treprostinil—Tyvaso is an inhaled solution formulation of treprostinil. United Therapeutics also owns a new drug application (NDA) for Tyvaso, No. 022387.

Blockbuster Restasis Patent Goes Down at Federal Circuit a Victim of Rule 36

Without any explanation, analysis or justification, Chief Judge Prost, and Judges Reyna and Hughes affirmed the decision of colleague Judge Bryson. A patent to a blockbuster drug like Restasis, which has over $1.4 billion in annual sales in the United States, deserves greater consideration than a once sentence disposition that simply says: “Affirmed.”… It is one thing to use Rule 36 to dispose of an appeal that should never have been brought relating to an invention of modest or no commercial success. But there is something fundamentally arrogant about using Rule 36 to finally strike a fatal blow to a patent covering a blockbuster drug responsible for more than $1.4 billion in annual sales in the United States. And given that the district court judge was Judge Bryson, the lack of an opinion only raises further questions.

Petitioner Has Standing to Appeal PTAB Decision Where Litigation is Inevitable

Altaire filed two complaints against Paragon: (1) alleging a breach of the non-disclosure clause of the Agreement, and (2) seeking declaratory judgment that the ‘623 patent was invalid. Paragon, in turn, alleged a material breach of the same clause and sought the termination of the Agreement. Altaire also sought post-grant review of the ‘623 patent, arguing that the patent was obvious over two production lots of its products. After the PTAB issued a final written decision determining that Altaire failed to prove that the asserted claims were obvious, Altaire appealed. The Federal Circuit reversed-in-part, vacated-in-part, and remanded for further proceedings. Circuit Judge Schall disagreed.

Vanda v. West-Ward: This Time, Dosage Adjustment Claims are Patent Eligible Subject Matter

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. 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.