Jazz v. Amneal: Public Accessibility of Prior Art v. Reasonable Pertinence of Analogous Art

July 26, 2018

Earlier this month, the Federal Circuit issued an opinion in Jazz Pharmaceuticals v. Amneal Pharmaceuticals, upholding the PTAB's finding that certain materials related to the FDA regulatory review process for Xyrem® were sufficiently accessible to the public to constitute prior art to seven Jazz patents. These materials (the "ACA materials") were accessible via a link on the FDA website "where background material would be posted before the meeting, and the meeting minutes, transcript, and slides would be posted after the meeting."... Read more

Tribal Immunity in IPR is Dealt a Death Blow by The Federal Circuit

July 26, 2018

The Federal Circuit issued its decision in Saint Regis Mohawk Tribe et al v. Mylan Pharmaceuticals Inc., et al (18-1638) on July 20, 2018. The central question addressed in the Federal Circuit's decision was whether the principal of sovereign immunity can be asserted by a patent owner to avoid their patent being subjected to the Inter Partes Review (IPR) process. The decision hinged on whether the IPR process is more akin to the civil litigation-like proceedings in adjudications before the Federal Maritime Commission in which state sovereign immunity was held to apply (Fed. Maritime Comm'n v. S.C. State Ports Auth., 535 U.S. 743, 754–56 (2002) ("FMC") or whether IPR is a traditional agency action in which it has been previously held that sovereign immunity does not typically apply (see, for example, Pauma v. NLRB, 888 F.3d 1066 (9th Cir. 2018); Karuk Tribe Hous. Auth., 260 F.3d at 1074; and Fed. Power Comm'n v. Tuscarora Indian Nation, 362 U.S. 99, 122 (1960)). It is important to note, however that there is no blanket rule that immunity does not apply in federal agency proceedings.... Read more

The Federal Circuit Lays Out What Does and Does Not Meet the Standard of Inherency, Motivation to Combine and Burden of Proof in Challenging Validity of Issued Claims

July 20, 2018

Endo Pharmaceuticals Solutions, Inc et al v. Custopharm, Inc. (Fed. Cir. July 13, 2018), is an appeal of a Delaware District Court rejecting Custopharm's validity challenge to patents covering Endo's Aveed® testosterone undecanoate (TU) intramuscular injection as part of a Paragraph IV ANDA filing.... Read more

Decs, Slides, and Video[tape]: Utilizing non-patent literature in IPR

June 18, 2018

In Medtronic, Inc. v. Barry (2017-1169 and 2017-1170), the Federal Circuit (Circuit Judges Taranto, Plager, and Chen, decision authored by Judge Chen, hereinafter "the panel") vacated the PTAB's finding in IPRs2015-00780 and -00783 that Medtronic's slides and videos constitute "printed publications" within the meaning of 35 U.S.C. §102(b). Since only patents and printed publications are eligible as prior art in inter partes review ("IPR"), the question whether non-patent literature ("NPL") such as slides and videos distributed at a conference constitute printed publications is clearly of interest to those in the medical device field.... Read more

Is Real and Positive Change Coming for Patent Owners?

June 11, 2018

New USPTO Director Andrei Iancu provided the Intellectual Property Track plenary lecture at the 2018 BIO International Convention last week. As has been a common theme since being sworn in to office in February, Director Iancu's focus was on changes to provide greater certainty and quality for applicants and patent owners. Yes, we have heard this before, but the time is ripe for real change that positively impacts applicants and patent owners.... Read more

Federal Circuit Distinguishes Between Enablement and Reasonable Expectation of Success

June 11, 2018

In the recent UCB v. Accord opinion, a panel of the Federal Circuit drew a distinction between (i) the enablement of a patentee's claims, and (ii) a reasonable expectation of success in an obviousness analysis. The majority found that the presumption of enablement for a claimed genus of compounds did not preclude a finding that there was not a reasonable expectation of success in creating a species falling within that genus.... Read more

Ex Parte Jadran Bandic – Patent Eligibility Analysis After Berkheimer

June 4, 2018

In Ex Parte Bandic, the PTAB ("the Board") has given an insight into how the Office intends to examine patent eligibility under the two-step Alice test, considering the Memorandum published by the USPTO on April 19, 2018 explaining "Changes in Examination Procedure Pertaining to Subject Matter Eligibility" in view of Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).... Read more

The POPR and Expert Declarations

June 4, 2018

The PTAB in the past year has loosened rules governing IPR practice. In most cases the changes have been good for the process. However, some of the changes while introducing a greater degree of fairness into the system have created traps for the unwary. One such trap is allowing patentees to submit declarations with the POPR (Patent Owner's Preliminary Response). Contrary to what many practitioners expect, the submission of a declaration actually increases the probability of the petition being instituted. Indeed, it might even guarantee institution.... Read more

Sequenom v. Ariosa: The Saga Continues…

May 21, 2018

      Three years after a previous legal battle between Sequenom and Ariosa ended in a difficult loss for Sequenom (in what some commentators have characterized as a misapplication of the holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)), Sequenom and its exclusive licensee Illumina have just this week filed a new patent infringement case against Ariosa Diagnostics, its parent Roche Molecular Systems, Inc. and sister company Roche Sequencing Solutions, Inc.,  in the US District Court for the Northern District of California San Francisco Division, for patents covering DNA testing in pregnant women. <... Read more

Anacor Pharmaceuticals, Inc. v. Iancu

May 17, 2018

On May 14, 2018, in Anacor v. Iancu, the Federal Circuit issued its opinion affirming the Board's invalidation of Anacor's tavaborole patent. The patent-in-suit, U.S. Patent No. 7,582,621, entitled "Boron-containing Small Molecules," is directed to the use of tavaborole to treat fungal infections. According to the disclosure, tavaborole can be used to treat a fungal infection known as onychomycosis, which is a nail disease responsible for approximately half of all nail disorders in humans. In an inter parties review, the Patent Trial and Appeal Board found all of the claims of the '621 patent unpatentable for obviousness. Anacor appealed with respect to only one of the claims and the Federal Circuit affirmed.... Read more