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Venable LLP

The First Biosimilar Disputes at the Unified Patent Court (UPC)

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As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - March 2024

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Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more

Axinn, Veltrop & Harkrider LLP

Puma and the Pitfalls of the “Narrow” Exclusive License

8 Puma Biotechnology is the latest victim of standing requirements in patent cases that continue to wreak havoc on plaintiffs’ ability to recover a full measure of damages. In Puma Biotechnology, Inc. v. AstraZeneca...more

Venable LLP

PTAB Issues Final Written Decision Finding Seagen’s Adcetris® Patent Claims Unpatentable

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On January 16, 2024, the PTAB issued a Final Written Decision in a post-grant review (“PGR”) of claims in U.S. Patent No. 10,808,039 (the “’039 patent”) owned by Seagen Inc. (“Seagen”). PGR2021-00030 was filed by Daiichi...more

Hogan Lovells

Dutch Supreme Court: Patentee not liable against health insurer for patent enforcement against generic

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On 3 November 2023, the Dutch Supreme Court upheld the decision of the Court of Appeal of The Hague  in which life sciences company AstraZeneca (“AZ”) was held not to be liable towards health insurer Menzis for the...more

Goodwin

Bristol-Myers Squibb and AstraZeneca Settle Anti-PD-L1 Antibody Product Litigation

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We previously reported on Bristol-Myers Squibb’s (“BMS”) complaint alleging AstraZeneca’s PD-L1 antibody product, IMFINZI (durvalumab), infringed U.S. Patent No. 9,402,899 (“the ’899 patent”). BMS alleged that the ’899 patent...more

Goodwin

Bristol-Myers Squibb Files Patent Infringement Complaint Against AstraZeneca Regarding Anti-PD-L1 Antibody Product

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On April 25, 2023, Bristol-Myers Squibb (“BMS”) filed a complaint in the District of Delaware against AstraZeneca related to AstraZeneca’s anti-PD-L1 antibody product, IMFINZI (durvalumab), alleging willful infringement of...more

WilmerHale

Federal Circuit Patent Watch - December 2021 #2

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Precedential Federal Circuit Opinions - TEVA PHARMACEUTICALS USA v. CORCEPT THERAPEUTICS, INC. [OPINION] (2021-1360, 12/07/2021) (MOORE, NEWMAN, and REYNA) -   Moore, C.J. The Court affirmed the PTAB’s IPR decision...more

Robins Kaplan LLP

AstraZeneca AB v. Mylan Pharms. Inc.

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Symbicort® (budesonide and formoterol fumarate dihydrate) - Case Name: AstraZeneca AB v. Mylan Pharms. Inc., No. 1:18CV193, 2021 WL 798856 (N.D.W.V. Mar. 2, 2021) (Keeley, J.) - Drug Product and Patent(s)-in-Suit: Symbicort®...more

Robins Kaplan LLP

AstraZeneca AB v. Mylan Pharms. Inc.

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BECAUSE DELAWARE WAS AN IMPROPER VENUE FOR DEFENDANT MYLAN, AND DEFENDANT 3M DEMONSTRATED THAT VARIOUS FACTORS WEIGHED IN FAVOR OF A TRANSFER, THE CASE WAS TRANSFERRED TO THE NORTHERN DISTRICT OF WEST VIRGINIA. Case...more

Smart & Biggar

2018 Highlights in Canadian Life Sciences IP

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In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Smart & Biggar

No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding

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What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations against a generic entrant, but subsequently prevails in an infringement action...more

Smart & Biggar

Accounting of profits offers significant benefits to patent owners

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The Canadian “accounting of profits” remedy for patent infringement, which is not available in the U.S., provides a potentially significant opportunity for companies with Canadian IP rights. Recent court decisions have...more

Smart & Biggar

Top 10 Highlights of Canadian IP Law and Practice in 2017

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2017 was a year of significant developments to Canadian IP law and practice, with important court decisions and numerous legislative amendments. We have taken the opportunity to review the top 10 highlights from the past...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

Smart & Biggar

Rx IP Update - October 2017

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Pfizer obtains orders of prohibition on polymorphic form patent - On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more

Smart & Biggar

Update on AstraZeneca SCC and developments on “overpromising” under grounds other than utility

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SCC Update. On October 23, 2017, the Supreme Court of Canada dismissed Apotex’s motion to amend the Supreme Court of Canada’s judgment in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (reported here, relating to...more

Smart & Biggar

AstraZeneca succeeds in omeprazole patent infringement profits case

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The Federal Court has issued its Public Judgment and Reasons concerning the financial compensation to be paid to AstraZeneca as a result of Apotex’s infringement of the omeprazole formulation patent (AstraZeneca’s LOSEC) in...more

McDonnell Boehnen Hulbert & Berghoff LLP

Mylan Pharm. v. AstraZeneca AB (PTAB 2017)

The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office recently issued a Final Written Decision in an inter partes review styled Mylan Pharm. v. AstraZeneca AB affirming the patentability of all challenged...more

Smart & Biggar

Rx IP Update - August 2017

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Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more

Smart & Biggar

Rx IP Update - July 2017

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Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Blake, Cassels & Graydon LLP

Supreme Court of Canada Promises New Utility Test for Patents

What does “useful”, one of the basic requirements for the patentability of an invention, mean in Canadian patent law? On June 30, 2017, in AstraZeneca Canada Inc. v. Apotex Inc. (AstraZeneca), the Supreme Court of Canada...more

McDermott Will & Emery

Court Construes “Hydrate” to Require Crystalline Form Following Battle of the Experts

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Addressing the issue of the proper construction of claims to a trihydrate compound, the US District Court for the District of New Jersey concluded that a person of ordinary skill in the art (POSA) would understand “hydrate”...more

Bennett Jones LLP

Procure and Enforce—Canada's Highest Court Hands IP Owners Two Wins in Three Days

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The Supreme Court of Canada has issued two IP decisions in the span of three days—both of which spell victory for IP rights-holders. One case confirms the availability of a novel form of worldwide injunction where a non-party...more

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