New Developments in Obviousness-Type Double Patenting and Original Patent Requirements — Patents: Post-Grant Podcast
Inter Partes Review: Validity Before the PTAB
In Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior...more
ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more
On September 3rd, the Federal Circuit affirmed under Rule 36 the decision by the District Court of Nevada (Du, J.) in March that the claims asserted by Amarin Pharma against West-Ward Pharmaceuticals International Ltd., Hikma...more
On October 29, 2019, the Federal Court issued its final decision under the pre-amended Patented Medicines (Notice of Compliance) Regulations: Janssen Inc v Apotex Inc, 2019 FC 1355. Justice Phelan granted Janssen’s...more
In a precedential decision delivered this week, the Federal Circuit shot down arguments from Appellants BTG International Limited; Janssen Biotech, Inc.; Janssen Oncology, Inc.; and Janssen Research & Development, LLC (BTG),...more
Before Judges Reyna, Taranto, and Chen. Appeal from the U.S. District Court for the District of New Jersey. Summary: There may be no reasonable expectation of success in producing a specific polymorph of a compound when...more
On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of Health from issuing a notice of compliance to Generic Partners for its generic version of Valeant’s GLUMETZA,...more
PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more
Federal Circuit Summary - Before Newman, Hughes, and Stoll. Appeal from the United States District Court for the District of Delaware Summary: Objective indicia of nonobviousness cannot be dismissed merely because all...more
Distribution Agreements Can Constitute Offers for Sale Under Section 102(b) - In The Medicines Company v. Hospira, Inc., Appeal Nos. 2014-1469, 2014-1504, the Federal Circuit held that a distribution agreement qualified as...more
In Bayer v. Watson, the panel throws out Bayer’s patent to its Staxyn erectile dysfunction drug as being obvious, noting that the district court focused too heavily on the commercial availability of the prior art. The panel...more
The Federal Circuit continues its explication of the law of obviousness post-KSR Int'l. v. Teleflex Inc. (and Judge Pauline Newman continues to disagree with her brethren in some regards) in a decision handed down last...more
In Merck v. Hospira, the only precedential case decided this week, a majority of the panel affirms a determination of obviousness, noting that despite the objective indicia supporting patentability, the claimed process was...more
MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC - (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) - This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...more
On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more
With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more
Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more
Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more