Posts Tagged: "FDA"

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 present” if the prior art reference lists several alternative constituents and a skilled artisan could not reasonably deduce that the authors of the prior art reference used the claimed constituent.

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 the material, meeting minutes, transcripts, and slides pertinent to an FDA advisory meeting scheduled during the review process for a particular “sensitive drug” (Xyrem), failed to meet a “searchability or indexing” requirement and that the Board erred by “equating the constructive notice provided by the Federal Register with the legal standard for prior art.” The Court rejected both arguments, relying on three precedents, MIT, Klopfenstein, and Medtronic, to analogize and proceed on a “case-by-case” analysis of the facts and circumstances surrounding the disclosure to the public – the proper inquiry for determining if a reference is a “printed publication.” The Court looked at three factors: the breadth of the dissemination; the amount of time the materials were available before the critical date; and, the presence or absence of an expectation of confidentiality. Comparing the facts to its three precedents, the Court found that each of the three factors supported the conclusion that the materials were printed publications and thus prior art.

Nasal Spray Patents Covering Migraine Drug Zomig Not Invalid As Obvious

The sole question on appeal was whether it would have been obvious to make zolmitriptan into a nasal spray. The Federal Circuit agreed with the district court that the prior art taught away from formulating zolmitriptan for intranasal administration.

Denying Inducement to Infringe in Face of a Drug Label: A Fool’s Errand?

Proving inducement to infringe requires showing that the accused infringer possessed “specific intent” to infringe. In pharmaceutical cases, particularly those arising in the Hatch-Waxman framework, specific intent may be supplied by the wording of a drug label. Vanda sheds light on several issues relevant to inferring inducement to infringe based on a drug’s label. For example, can a label’s clear recommendations on ultimate dosage be negated by how a medical provider arrives at the dosage? Or, does finding specific intent require that every practitioner prescribe an infringing dose? Or, can evidence of substantial non-infringing use negate a finding of inducement when the drug’s label instructs performing the patented method?

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 world. Meanwhile, the Chinese national government extended the period of exclusivity on pharmaceutical patents from 20 years up to 25 years. While China makes moves to embrace further innovation in the pharmaceutical sector by extending exclusivity for drug developers, the United States has evidenced an incredible amount of skepticism regarding the activities of pharmaceutical patent owners trying to protect their property.