News & Analysis as of

Pharmaceutical Patents Patents Jurisdiction

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more

DLA Piper

Delaware Court of Chancery Patent Ownership Dispute Addresses Jurisdiction for Pharmaceutical Companies

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A litigation regarding patent ownership rights is heating up in the Delaware Court of Chancery, a court of equity that is an atypical forum for pharmaceutical company and intellectual property disputes. CyDex Pharmaceuticals,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Patent Luminaries Try to Set Congress Straight on Drug Price Controls

Over the past few years the drumbeat regarding the cost of healthcare in general and drugs in particular has steadily mounted (see "Faux-Populist Patent Fantasies from The New York Times"). Patents are often (and quite...more

Mintz - Intellectual Property Viewpoints

Can Enablement and Written Description Bars be Lower for Method-Of-Treatment Patent Claims?

Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application. In the U.S., such...more

Akin Gump Strauss Hauer & Feld LLP

Generic’s Conversion from Paragraph IV to Section viii Upends Subject Matter Jurisdiction on Declaratory Judgment Counterclaims

The District Court of Delaware dismissed a generic drug company’s declaratory judgment counterclaims of non-infringement and invalidity, finding that the court no longer had subject matter jurisdiction after the generic...more

Knobbe Martens

No Standing in IPR Appeal for Sublicensee’s Speculative Royalty-Based Injuries

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MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION - Before Lourie, O’Malley, and Stoll.  Appeal from the Patent Trial and Appeal Board. Summary: Sublicensee’s theory of royalty-based injury was too speculative to...more

Knobbe Martens

Federal Circuit Review - August 2021

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It’s No Secret That a Related Company’s Physical Presence in a Jurisdiction May Not Be Enough For Proper Venue - In Andra Group, LP v. Victoria’s Secret Stores, LLC, Appeal No. 20-2009, The Federal Circuit held that an...more

Smart & Biggar

PMPRB Update: Jurisdiction extends to CSPs effective June 30; coming into force of Patented Medicines Regulations and Guidelines...

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The coming into force of the amended Patented Medicines Regulations has been delayed a third time, now until January 1, 2022. The amendments, once in force, will add new price regulatory factors, revise the list of...more

Smart & Biggar

PMPRB update: Revised compliance timelines for grandfathered and gap medicines and proposed regulatory amendments directed to CSPs

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Revised compliance timelines for Grandfathered and Gap medicines - On April 16, 2021, in view of COVID-19, the Patented Medicine Prices Review Board (PMPRB) reversed its position on compliance timelines for Grandfathered...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - March 2021: GW Pharma Seeks Dismissal of Patent Suit Filed in Texas by Canopy Growth

We have been keeping a close eye on the patent suit filed by Canopy Growth against GW Pharma in the Western District of Texas’s Waco Division, a venue that has attained recent fame for its speed to trial in patent litigation....more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - March 2021

The March 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses fair use cases for photographs and three recent developments in the cannabis space. We also highlight recent accolades earned by Sterne Kessler's...more

McDermott Will & Emery

No Concrete Controversy if There Are No Claims

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In reversing a district court decision as to whether a validity issue remained justiciable after the challenged claims were disclaimed, the US Court of Appeals for the Federal Circuit explained that the patent owner’s...more

Goodwin

Federal Circuit Dismisses Momenta’s Appeal of Adverse Final Written Decision in Abatacept IPR

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This morning, the Federal Circuit issued a precedential opinion dismissing Momenta’s appeal from the PTAB’s final written decision upholding the patentability of Bristol-Myers Squibb’s abatacept patents against Momenta’s IPR...more

Smart & Biggar

Amended PMNOC Regulations: First Anniversary Update

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As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...more

Knobbe Martens

Federal Circuit Review - May 2018

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Priority Claims Cannot Be Incorporated by Reference - In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, Appeal Nos. 2016-2707 and 2016-2708, the Federal Circuit held that when a patent for a...more

Knobbe Martens

Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited

Knobbe Martens on

Federal Circuit Summaries - Before Prost, Lourie and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: When another patent for a drug issues after an ANDA is filed, there can...more

Knobbe Martens

The Federal Circuit Stays IPR Pending Review of the PTAB’s Denial of St. Regis Mohawk Tribe’s Sovereign Immunity

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The PTAB ruled that the Saint Regis Mohawk Tribe could not assert sovereign immunity in IPRs of patents that Allergan had assigned to the Tribe relating to Restasis®. See The Saint Regis Mohawk Tribe is not entitled to...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Smart & Biggar

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

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The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Goodwin

Genentech Moves To Dismiss Amgen’s California Bevacizumab DJ Action

Goodwin on

We previously reported on Amgen’s complaint in the Central District of California seeking a declaratory judgment that 27 Genentech patents are not infringed by Genentech’s bevacizumab biosimilar (Mvasi®). On November 15,...more

Smart & Biggar

RX IP Update - January 2017

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Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld - As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more

Robins Kaplan LLP

Allergan, Inc. v. Teva Pharmaceuticals USA, Inc.

Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Civ. No. 15-cv-1455 (WCB), 2016 U.S. Dist. LEXIS 51851 (E.D. Tex. Apr. 19, 2016) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine...more

Knobbe Martens

Federal Circuit Review | December 2015

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Expert Testimony Not Always Necessary to Establish Prima Facie Obviousness Case in Inter Partes Review - In Belden Inc. v. Berk-Tek LLC, Appeal Nos. 2014-1575, 2014-1576, on appeal from an IPR, the Federal Circuit...more

McDermott Will & Emery

ANDA Update - October 2015

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Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Troutman Pepper

Analysis of Inter Partes Review and Post-Grant Review in the Life Sciences Industry Through First Quarter 2015

Troutman Pepper on

The recently established inter partes review (IPR) and post-grant review (PGR) of the America Invents Act have been in the spotlight lately, especially now that the life sciences industry has begun to utilize these...more

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