Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more
Confronting a life sciences patentee with its statements to regulatory bodies (such as the FDA) is a textbook defense strategy in patent litigation. After all, communications with regulatory bodies are often performed by...more
BELCHER PHARMACEUTICALS v. HOSPIRA, INC. Before Reyna, Taranto, and Stoll. Appeal from the District of Delaware. Summary: A patentee committed inequitable conduct by advancing an argument during patent prosecution...more
On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s...more
At the end of last month, Judge Connolly denied defendants Hospira and Pfizer’s motion to dismiss following a telephone conference with the parties. We previously reported back in February 2020 that Amgen sued Pfizer and its...more
Adrenalin® (epinephrine injection) - Case Name: Par Pharm., Inc. v. Hospira, Inc., No. 2020-1273, 2020 WL 6846347 (Fed. Cir. Nov. 23, 2020) (Circuit Judges Dyk, Taranto, and Stoll presiding; Opinion by Taranto, J.)...more
It has long been understood that claim construction can, and frequently is, dispositive in patent litigation. This truism was the basis for the Federal Circuit affirming the District Court's decision against a generic drug...more
The U.S. District Court for the District of Delaware has denied Amgen’s motion to consolidate a recently filed action against Pfizer and its affiliate Hospira relating to Hospira’s filgrastim biosimilar with an ongoing...more
Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322 (Fed. Cir. Jan. 9, 2020) (Circuit Judges Lourie, Dyk, and Moore presiding; Opinion by Lourie, J.) (Appeal from N.D. Ill., Pallmeyer, J.)....more
Case Name: Belcher Pharms., LLC v. Hospira, Inc., No. 17-775-LPS, 2020 WL 1650535 (D. Del. Mar. 31, 2020) (Stark, J.) - Drug Product and Patent(s)-in-Suit: epinephrine injection; U.S. Patent No. 9,283,197 (“the ’197...more
Last week, Amgen filed a new complaint against Pfizer and Hospira under the BPCIA for infringement related to Hospira’s filgrastim biosimilar. The action is related to newly granted U.S. Patent No. 10,577,392, which is...more
Recently, the Federal Circuit has taken up issues relating to infringement under the doctrine of equivalents (DOE) and a related doctrine, prosecution history estoppel (PHE), that limits the scope of equivalents that can be...more
About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation. Allergan USA, Inc. v. Prollenium US Inc. 1-20-cv-00104; filed January 23, 2020 in the District Court of Delaware...more
We previously reported that Hospira filed a petition for rehearing en banc of the Federal Circuit’s affirmance of a $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s RETACRIT (epoetin...more
As we previously reported, Amgen sued Pfizer and its affiliate Hospira in July 2018 based on Hospira’s submission of an aBLA for a biosimilar of NEULASTA (filgrastim). That same month, Pfizer obtained FDA-approval and, in...more
On February 11, 2020 Amgen sued Pfizer and its affiliate Hospira for patent infringement based on their proposed biosimilar of NEULASTA (pegfilgrastim). Pegfilgrastim is indicated for decreasing the incidence of infection in...more
In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation. ...more
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more
Last week, the Federal Circuit affirmed invalidation of claims to methods for reducing Protein A leaching in affinity column chromatographic methods important inter alia in purifying monoclonal antibodies, in Genentech, Inc....more
It seems that memes can be as compelling in the law as in social media, and the meme of the moment in patent law is inherency, particularly as applied to obviousness determinations (see, for example, Persion Pharmaceuticals...more
The US Court of Appeals for the Federal Circuit held that data obtained after an asserted patent’s priority date may be used to demonstrate what is “necessarily present” in a prior art embodiment. Although the district court...more
Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein...more
HOSPIRA, INC. V. FRESENIUS KABI USA, LLC - Before Lourie, Dyk, and Moore. Appeal from the U.S. District Court for the Northern District of Illinois. Summary: Evidence of the properties of claimed embodiments may be...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
On December 16, 2019, the Federal Circuit affirmed a Delaware jury verdict finding that Hospira infringed Amgen’s method of manufacturing patent on erythropoietin (EPO) and that Amgen was entitled to $70 million in damages...more