Posts in Pharmaceuticals


IPR Outcomes of Orange Book Patents and its Effect on Hatch-Waxman Litigation

Out of the 230 Orange Book patents challenged in IPR proceedings, 90.4% (208) of these patents were also challenged in Hatch-Waxman litigation perhaps due to the lucrative 180-day exclusivity incentive …
By Tulip Mahaseth
19 days ago 3

In Sickness and In Health: Comparing Patent Protection for Pharmaceuticals and Dietary Supplements

Once composition of matter claims have been obtained for a new compound, or the composition of matter claims for an old compound have expired, what is next? …

Compulsory Licensing for Medicare Drugs– Another Bad Idea from Capitol Hill

Rep. Lloyd Doggett (D-TX) recently introduced the Medicare Negotiation and Competitive Licensing Act of 2018. Lest the title confuse you, by "competitive licensing" Rep. Doggett means compulsory licensing …
By Joseph Allen
2 months ago 42

Federal Circuit Treatment of ‘Commercial Success’ in Hatch-Waxman Cases

In order to establish that the commercial success factor supports a non-obviousness finding, the patentee must establish that a connection (or nexus) exists between the novel aspects …
By Theodore Chiacchio
2 months ago 1

Federal Circuit Affirms District Court’s Finding of Validity of Claims Directed to Aveed®

When relying on scientific guidelines to support an obviousness rationale, practitioners should offer evidence for why contradictory guidelines should be discounted. A claimed constituent is not “necessarily …

Expectation of Success – How Much is Reasonably Needed for Obviousness

How much is needed to reasonably prove obviousness? In UCB, the majority found UCB, Inc.’s asserted claim nonobvious under non-statutory double patenting.  The dissent, however, found …

Prescription Tracking Patents Confirmed as Unpatentable After IPR Appeal

The Federal Circuit reviewed whether certain prior art was “publicly accessible,” because Jazz alleged the material was not a “printed publication” under Section 102(b). Jazz argued that …

Reflections on Drug Patents and the High Cost of Healthcare

The Hatch-Waxman Act and the Biologic Price Competition and Innovation Act are both forged from a noble ideal, grounded in a commitment to a robust and earnest …
By Arie Michelsohn
3 months ago 1

FTC v. Actavis: Where We Stand After 5 Years

It has been five years since FTC v. Actavis. In that landmark ruling, the Supreme Court held that settlements by which brand-name drug companies pay generics to …
By Michael Carrier
4 months ago 4

Mayo/Alice ‘Directed to’ Inquiry and a Split Federal Circuit: Vanda Pharma v. West-Ward Pharma

In Vanda, Chief Judge Prost, one of the judges on the CellzDirect panel, dissented from the majority’s decision that found claims patent eligible for not being …

The Myth of ‘Trivial’ Drug Patents

Critics of drug patents often claim that when initial drug patents expire, drug companies stuff their patent portfolios with “trivial” patents that unjustifiably extend their patent monopoly …
By David Forman
5 months ago 6

China extends drug patent exclusivity to 25 years

Among members of the news media, patents have been a popular whipping boy when contemplating why Americans pay higher drug prices relative to the rest of the …
By Steve Brachmann
5 months ago 0

Federal Circuit Affirms Dismissal of Patent Challenges Filed by Drug Consumer

AIDS Healthcare Found., Inc. v. Gilead Scis., Inc., the Federal Circuit affirmed the dismissal of patent challenges filed by drug consumers. The Court noted that a declaratory …

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 …

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 …
By Stephanie Sivinski
5 months ago 18

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