News & Analysis as of

Pharmaceutical Patents Summary Judgment Patent Litigation

Robins Kaplan LLP

Metacel Pharms. LLC v. Rubicon Rsch. Priv. Ltd.

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Nature of the Case and Issue(s) Presented: Ozobax is indicated for treatment of spasticity resulting from multiple sclerosis, and particularly flexor spasms and concomitant pain, clonus, and muscular rigidity. While the use...more

Venable LLP

Court Finds bluebird bio’s Gene Therapy Zynteglo® (betibeglogene autotemcel) Does Not Infringe San Rocco Therapeutics’ Patents

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On May 16, 2025, the Court in Case No. 1:21-cv-01478 (D. Del.) granted bluebird bio’s motion for summary judgment, finding that its gene therapy Zynteglo® (betibeglogene autotemcel) does not infringe San Rocco Therapeutics‘...more

McDonnell Boehnen Hulbert & Berghoff LLP

Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd. (Fed. Cir. 2025)

The Federal Circuit affirmed a District Court decision that the label for a generic drug obtained from an ANDA would not induce infringement by reciting optional drug storage conditions the read on the NDA holder's Orange...more

Venable LLP

The Perils of Procedural Misadventure and Unclear Claim Drafting in Patent Litigation

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On Friday, March 14, 2025, Delaware's own Judge Andrews provided important guidance on key patent issues, relevant to pharmaceutical and technology companies alike: (1) the decisive impact of local patent rules on summary...more

McDonnell Boehnen Hulbert & Berghoff LLP

DNA Genotek Inc. v. Spectrum Solutions LLC (Fed. Cir. 2025)

Sometimes important contributions to innovation can come from the mundane rather than the extraordinary. One (perhaps apocryphal) example comes from the story of the early development of television by Philo Farnsworth (the...more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

Proskauer - Minding Your Business

Scope of Issued Patents May be Limited by Prosecution Estoppel Created in Child Cases

Cell therapy products in the U.S. are estimated to be worth approximately $4.5 billion currently and expected to grow to over $30 billion in the next ten years. As market value increases litigation is bound to heat up....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2022 #4

Mosaic Brands, Inc. v. Ridge Wallet LLC, Appeal Nos. 2022-1001, -1002 (Fed. Cir. Dec. 20, 2022) - In our Case of the Week, the Federal Circuit discussed the corroboration requirement concerning the amount of evidence...more

Smart & Biggar

Ontario Superior Court dismisses Apotex’s Statutes of Monopolies and Trademarks Act claims regarding olanzapine

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Update: Apotex has appealed. On March 8, 2021, the Ontario Superior Court of Justice granted Eli Lilly’s (Lilly) motion for summary judgment and dismissed Apotex’s claims under the Statutes of Monopolies, Trademarks Act, and...more

Smart & Biggar

Federal Court holds section 8.2 of the PMNOC Regulations does not impose a limitation period

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On December 22, 2020, the Federal Court issued its decision holding that section 8.2 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) does not impose a limitation period either the same as or...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - February 2021 #2

Amgen Inc. v. Sanofi, Appeal No. 2020-1074 (Fed. Cir. Feb. 11, 2021) - In this week’s Case of the Week, the Federal Circuit affirmed a district court’s JMOL ruling that asserted claims of two related pharmaceutical patents...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #3

C.R. Bard Inc. v. AngioDynamics, Inc., Appeal No. 2019-1756, -1934 (Fed. Cir. Nov. 10, 2020) - Our Case of the Week is one of two cases decided this week in which the Federal Circuit finds that a district court jumped the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Idorsia Pharmaceuticals, Ltd. v. Iancu (Fed. Cir. 2020)

This week, in Idorsia Pharmaceuticals, Ltd. v. Iancu, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia granting summary judgment in favor of the U.S. Patent and Trademark...more

McDonnell Boehnen Hulbert & Berghoff LLP

Valeant Pharmaceuticals Int'l v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

Summary judgment, while clearly advantageous, requires that there be no disputed question of material fact and that the moving party is entitled to judgment as a matter of law.  When a district court grants judgment...more

McDermott Will & Schulte

Doctrine of Equivalents: Prosecution History Estoppel Can Be Both Amendment and Argument-Based

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In a case involving at-home glucose monitoring systems, the US Court of Appeals for the Federal Circuit found the patent owner was estopped from asserting a doctrine of equivalents theory of infringement based on subject...more

Robins Kaplan LLP

ANDA Litigation Settlements - Fall 2019

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Please see full Chart below for more information....more

McDermott Will & Schulte

Definiteness, Drug Labels and Diclofenac, Oh My

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The US Court of Appeals for the Federal Circuit affirmed a district court’s invalidity and infringement judgments for patents directed to a topical nonsteroidal anti-inflammatory drug, finding that a patent claim reciting a...more

Akin Gump Strauss Hauer & Feld LLP

“Consisting Essentially Of:” Expanding the Scope of Indefiniteness

The Federal Circuit recently affirmed a district court’s determination, holding a group of patents invalid for indefiniteness. In December 2014, HZNP Medicines LLC (“Horizon”) brought suit against Actavis Laboratories UT,...more

McDermott Will & Schulte

Maintaining Order in Process Claims

The US Court of Appeals for the Federal Circuit affirmed a summary judgment non-infringement ruling, finding that where both the claim language and the specification require that the disclosed steps be performed in the order...more

McDermott Will & Schulte

“Equal to” Means “Not Exceed” when Determining Patent Term Adjustment

The US Court of Appeals for the Federal Circuit found that the US Patent and Trademark Office (PTO) erred in calculating a patent term adjustment (PTA) for a patent covering an oral osmotic form of an antihypertensive drug,...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - February 2019

PATENT CASE OF THE WEEK - Duncan Parking Techs., Inc. v. IPS Group, Inc. and IPS Group, Inc. v. Duncan Solutions, Inc. et al., Appeal Nos. 2018-1205, -1360 (Fed. Cir. January 31, 2019) - The Court this week provided a...more

Foley & Lardner LLP

District Court Finds PK Targets Of VIMOVO Patents Indefinite

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In an opinion issued November 19, 2018, Judge Chesler of the U.S. District Court for the District of New Jersey found two Orange Book-listed patents for VIMOVO® invalid for indefiniteness in the way certain pharmacokinetic...more

Schwabe, Williamson & Wyatt PC

Latest Federal Circuit Court Cases - October 2018 #3

PATENT CASE OF THE WEEK - Data Engine Technologies, LLC v. Google LLC, Appeal No. 2017-1135 (Fed. Cir. Oct. 9, 2018) - In one of two Section 101 cases this week, the Federal Circuit affirmed-in-part, reversed-in-part, and...more

Foley & Lardner LLP

Federal Circuit Finds Detection Claims Invalid Under 101

Foley & Lardner LLP on

In Roche Molecular Systems, Inc. v. Cepheid, the Federal Circuit affirmed the summary judgment decision of the U.S. District Court for the Northern District of California that held nucleotide primer claims and detection...more

Goodwin

Biosimilar Litigation Updates

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Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of...more

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