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On December 20 the Federal Circuit in Teva Branded Pharmaceutical Products R&D, Inc. (Teva) v. Amneal Pharmaceuticals (Amneal) affirmed the district court's decision that medical devices were not listable in [...]

In Astellas Pharma Inc. v. Sandoz Inc,, et al, following a five-day patent claims bench trial the court found asserted claims 5, 20, and 25 invalid under 35 U.S.C. § [...]

In Allergan USA, Inc v Sun Pharmaceutical Indus. Ltd, Appeal No. 2024-1061, August 13, 2024, the Federal Circuit reversed the district court's holding that Allergan patent, U.S.P. 7,741,356 ('356) was [...]

The Federal Circuit on February 9 decided another written description case involving a range not found in ipsis verbis in the patent specification in RAI Strategic Holdings Inc. v. Philip [...]

In Corcept Therapeutics, Inc. v. Teva Pharmaceuticals U.S.A., Inc., C.A. 18-03632, December 29, 2023, the Chief Judge Bumb of the New Jersey District Court wrestled with the question of infringement [...]

The Federal Circuit in In re Cellect, Appeals Nos. 2022-1293, 2022-1294, 2022-1295, 2022-1296 held that the earliest patent to expire in a series of patents subject to obviousness-type double patenting [...]

The Federal Circuit on June 30 granted a petition for re-hearing en banc of its per curiam decision in LKQ Corp. v. GM Global Tch. Operations, LLC. finding the PTAB [...]

Orphan drug exclusivity was created in 1983 to encourage pharmaceutical companies to develop drugs for diseases which affect less than 200,000 persons in the U.S. Jazz Pharmaceuticals developed Xwav® to [...]

The USPTO has opened the discussion on its fees to be effective in 2025. While the PTO is to be applauded for getting ahead of the fee curve, unfortunately some [...]

On May 16, the Supreme Court distributed the CareDX cert petition for consideration at the June 1 conference since the Respondents waived filing a reply. The CareDX family of three [...]

On April 28 the Supreme Court heard oral arguments on Amgen's petition of the Federal Circuit's decision affirming the district court's decision on JMOL that Amgen's antibody claims lacked an [...]

The Federal Circuit on February 24th affirmed the Delaware District order in Jazz Pharm., Inc. v. Avadel CNS Pharm., LLC., 2023-1186, that Jazz delist from the Orange Book its Patent [...]

While an adequate written description is essential for patentability, 35 U.S.C. § 112(a), like everything else too much can have adverse consequences as uniQure biopharma recently learned in IPR2021-00926 (IPR) [...]

Just two days after the Federal Circuit denied a stay of its mandate in Novartis v. HEC Pharm Co., Ltd., the Supreme Court granted a stay of the mandate pending [...]

On August 11, 2022, the Federal Circuit issued its opinion in the remand of Hologic, Inc. v Minerva Surgical, Inc. from the Supreme Court's decision limiting the application of assignor [...]

When it comes to IPR petitions filed in the Bio/Pharma space, USPTO data tells us that while Bio/Pharma petitions make up only 8% of the total petitions filed for the [...]

On July 11, Teva filed its petition for certiorari from the Federal Circuit's second decision in its 'skinny label' litigation with GSK, 7 F.4th 1320 (Fed, Cir. 2022). The petition [...]

On July 18 the Federal Circuit in Cardex, Inc. v. Eurofins Viracor, Inc., affirmed the district court decision finding that diagnostic method claims directed to detecting organ transplant rejections in [...]

On the last day of June to the dismay of many, the Supreme Court denied cert in yet another Federal Circuit patent eligibility decision, American Axle. Many had been hopeful [...]

On June 21, 2022, the Federal Circuit acting on a request for panel rehearing in the decision by the Federal Circuit in Novartis v. Accord Health Care, Inc., 21 F.4th [...]

Congress sought to keep Patent Office delays from prejudicing a patentee by granting PTA to compensate for the Patent Office delays. While one might expect the Patent Office to work [...]

At the close of last year, the Federal Circuit affirmed a decision by the PTAB in IPR2019-00329 that a claimed range created from examples was not patentable because it lacked [...]

In Chemours Co. FC LC v. Daikin Industries Ltd. et al., 4 F.4th 1370 (Fed. Cir. 2021) reversed a PTAB decision finding the following claim to be unpatentable as obvious: [...]

This week saw two cases reported with possible implications for skinny labels. The first was a recommendation be Magistrate Judge Hall, District of Delaware, that Hikma Pharmaceuticals could not dodge [...]

On April 23 President Biden signed into law changes narrowing the scope of eligibility for the non-patent 'new chemical entity' (NCE) 5-year exclusivity provisions of 21 U.S.C. §301 et seq. [...]

The decision in GlaxoSmithKline LLC. V Teva Pharms. (976 F.3d 1347 (Fed. Cir. 2020) has caused panic in the generic industry because it has been interpreted as killing the 'skinny [...]

In GSK v Teva the Federal Circuit reversed the district court's JMOL and reinstated the jury's verdict awarding $235 million in damages to GSK for Teva's sale of $75 million [...]