According to the Federal Circuit, $173 million was the right damages award for almost three years of patent infringement resulting from Baxalta’s sale of its biologic product Adynovate® (Antihemophilic Factor (Recombinant),...more
The fight over proposed Enbrel® (etanercept) biosimilar Erelzi® continues. Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (“Sandoz”) recently filed a petition for certiorari requesting review of the judgement of the...more
The last two years saw the launch of several biosimilars. Looking ahead to 2021, several others may be on the horizon. In 2019-2020, the FDA approved thirteen biosimilars directed to seven reference products. Eight of the...more
On October 2, 2020, India and South Africa urged the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council to temporarily waive the obligation of member states under the TRIPS...more
On November 5, 2020, in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where...more
The U.S. Patent and Trademark Office has announced that it will defer application fees for certain inventions relating to the fight against COVID-19. In its September 16 announcement, the PTO acknowledged its role in...more
Last month, Judge Manish Shah of the United States District Court of the Northern District of Illinois dismissed an antitrust complaint brought by indirect purchasers of AbbVie’s blockbuster rheumatoid arthritis drug,...more
Recently, in Amgen Inc. v. Hospira, Inc., the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods....more
As 2019 draws to a close, a handful of actions regarding biologics are pending in the federal courts. The current cases are listed below, in order from most-recently-filed to oldest....more
Earlier this week, the Federal Circuit declined to further extend the patent term of an antibody patent held by the Mayo Foundation. In Mayo Foundation v. Iancu, the court held that the time spent on a request for continued...more
In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment...more
In Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, the Supreme Court suggested that whether inter partes reviews (“IPRs”) apply to pre-AIA patents is an open constitutional question....more
On July 23, 2019, Amgen, maker of the cancer treatment drug Neupogen (filgrastim), filed patent infringement claims in the Southern District of California against Tanvex Biopharma over Tanvex’s proposed filgrastim biosimilar...more
8/6/2019
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Food and Drug Administration (FDA) ,
Patent Infringement ,
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Popular
Amgen Inc. v. Coherus Biosciences Inc., No. 2018-1993, Slip op. at 6 (Fed. Cir. July 29, 2019) stems from a Biologics Price Competition and Innovation Act action brought by Amgen against Coherus seeking FDA approval to market...more
At the end of 2017, inter partes review (IPR) proceedings for biosimilar products were on the rise. 2018 and the first half of 2019, however, have seen a dip in the number of new filings. And looking back at biosimilar IPRs...more
In Enzo Life Sciences v. Roche Molecular Systems, No. 2017-2498, 2017-2499, 2017-2545, 2017-2546, Slip op. (Fed. Cir. July 5, 2019), the Federal Circuit affirmed summary judgment of invalidity for lack of enablement of Enzo’s...more
On April 17, 2019, several lawmakers from the Senate and House of Representatives released a bipartisan, bicameral framework for statutory reform of 35 U.S.C. § 101....more
On February 6, 2019, the Federal Circuit issued its latest opinion on patentable subject matter under 35 U.S.C. § 101 in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 2017-2508, slip. Op. (Fed. Cir. Feb. 6,...more
Last week, the Federal Circuit issued its long-awaited opinion in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 2017-1694, slip op. (Fed. Cir. Feb. 7, 2019). ...more
On January 7, 2019, the United States Patent and Trademark Office (USPTO) published new guidance for patent examiners intended to address concerns expressed by Federal Circuit judges, industry stakeholders, and others about...more
Two cases decided by the Federal Circuit in 2018, Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, en banc rehearing denied, 890 F.3d 1354 and Berkheimer v. HP Inc., 881 F.3d 1360, en banc rehearing...more
In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal a PTAB decision upholding the validity of BMS’s patent relating to a...more
Earlier this month, AbbVie filed suit against Sandoz’s proposed biosimilar to AbbVie’s HUMIRA® (adalimumab). Invoking the Biosimilar Price Competition and Innovation Act (“BPCIA”), AbbVie asserts two patents protecting...more
On July 20, 2018, FDA approved Pfizer’s biosimilar of Amgen’s Neupogen® (filgrastim). Pfizer’s product, Nivestym™, is the second biosimilar of Neupogen to be approved after Sandoz’s Zarxio®, the first approved biosimilar in...more
8/10/2018
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Allergan’s attempt to shield its Restasis patents from inter partes review by assigning the patents to the Saint Regis Mohawk Tribe was rejected last week by a unanimous Federal Circuit panel. The Federal Circuit affirmed...more