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License Agreements Pharmaceutical Industry

Dechert LLP

Affaire Servier : la Cour de justice de l’Union censure l’arrêt du Tribunal et lui renvoie la balle

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Le 27 juin 2024, le laboratoire pharmaceutique Servier – qui, entre 2005 et 2007, avait conclu plusieurs accords transactionnels en matière de brevets impliquant des paiements inversés avec des génériqueurs (Niche/Unichem,...more

Dechert LLP

The Servier Case: The Game isn’t Over Yet

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The ECJ confirms its intolerance against conduct that is viewed as originator companies buying off competition from generic companies about to enter the market and thereby unduly prolonging their monopoly. Such conduct, which...more

Jones Day

NIH Seeks Comments on Patient Access Plan Requirements in Patent License Agreements

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The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more

ArentFox Schiff

Breaking: Third Circuit Declares Mallinckrodt’s Future Royalty Payment Obligations Dischargeable – Caution, Warning, and Options

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On April 25, the US Court of Appeals for the Third Circuit issued its precedential opinion in Mallinckrodt v. Sanofi-Aventis, Case No. 23-1111, reminding everyone that “creditors take on risks” when it ruled that the debtor...more

Goodwin

Janssen and Samsung Bioepis Settle STELARA (Ustekinumab) Litigation

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Samsung Bioepis recently reported that it has signed a settlement and license agreement with Johnson & Johnson (“J&J”) in the United States relating to SB17, Samsung Bioepis’s ustekinumab biosimilar to J&J’s STELARA®. If SB17...more

Goodwin

Formycon Enjoined From Manufacturing FYB202 Biosimilar of STELARA in Germany

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​​​​​​​As previously reported, in February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize FYB202, a ustekinumab biosimilar of Janssen’s STELARA, in key global markets after...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - September 2023

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This marks the first issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more

Goodwin

Genentech Files Lawsuits Against Biogen and Millennium for Past Royalties on the Cabilly Patents

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This week, Genentech filed separate lawsuits against Biogen and Millennium, alleging breach of a license agreement to the Cabilly patents (U.S. Patent No. 6,331,415 and 7,923,221)....more

Goodwin

Alteogen and Sandoz Enter a Biosimilars Agreement Relating to Subcutaneous Products

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​​​​​​​Alteogen Inc. announced that it entered an exclusive license agreement with Sandoz AG pursuant to which Sandoz will have world-wide rights to use Alteogen’s ALT-B4 hyaluronidase, derived using Hybrozyme™ Technology, to...more

Goodwin

Biosimilars Licensing Agreement Updates

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Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market. Pursuant to...more

Goodwin

Organon and Henlius Entered into a Global License Agreement for Henlius’s PERJETA® (Pertuzumab) and PROLIA®/XGEVA® (Denosumab)

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Organon announced yesterday that it has entered into an agreement with Henlius, whereby Organon will license commercialization rights for biosimilar candidates referencing PERJETA® (pertuzumab) and PROLIA®/XGEVA®...more

Goodwin

Deal Watch: Henlius Licenses Rituximab and Trastuzumab Products to Abbott in Brazil

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Earlier this week, Shanghai Henlius Biotech, Inc. announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay S.R.L. for the commercialization of HANLIKANG (rituximab) and HANQUYOU...more

Knobbe Martens

Pfizer Australia Announces Deal to Acquire ResApp Health

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ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of...more

Goodwin

Biocon Biologics Ltd. To Acquire Viatris Biosimilars Portfolio

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On Monday, Biocon Biologics Limited (Biocon) announced that it will acquire Viatris’ rights in biosimilars assets for up to $3.3 billion. Viatris and Biocon previously partnered to bring SEMGLEE to market in the U.S. ...more

Goodwin

Biogen and Xbrane Enter into Worldwide Commercialization and License Agreement for Certolizumab Pegol Biosimilar

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On February 7, 2022, Biogen Inc. and Xbrane Biopharma AB announced that they had entered into a commercialization and license agreement related to Xcimzane, a certolizumab pegol biosimilar referencing CIMZIA. Under the...more

Goodwin

Alvotech and BiosanaPharma Enter Exclusive Global Licensing Agreement for AVT23

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Alvotech Holdings S.A. (“Alvotech”) announced that it has entered into an exclusive global licensing agreement with BiosanaPharma to co-develop AVT23 (also called BP001), a proposed biosimilar to Xolair® (omalizumab). Xolair®...more

Goodwin

Bio-Thera Solutions and Hikma Pharmaceuticals Enters Into Ustekinumab Biosimilar Agreement

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Last week, Bio-Thera Solutions and Hikma Pharmaceuticals announced they have entered into an exclusive commercialization and license agreement to commercialize the proposed ustekinumab biosimilar product, BAT2206. According...more

Proskauer - Life Sciences

"Commercially Reasonable Efforts” Clauses in Drug Development Deals: What Level of Protection Do They Really Provide?

Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad...more

Goodwin

Theramex announces license agreement for Prolia biosimilar in Europe and Australia

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On Thursday Theramex announced that it has entered into an agreement to register and commercialize denosumab, a biosimilar of Enzene Bioscience’s Prolia®, which treats osteoporosis by decreasing bone absorption. The agreement...more

Goodwin

Recent Biosimilars Deals

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On January 13, 2021, EVOQ announced a license and collaboration agreement with Amgen for the development of new drugs for autoimmune disorders. According to the press release, Amgen and EVOQ will collaborate on preclinical...more

Smart & Biggar

Federal Court orders Minister of Health to issue NOC to Fresenius Kabi for its biosimilar IDACIO following filing of consent...

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On October 29, 2020, Justice Manson of the Federal Court ordered the Minister of Health to issue a notice of compliance (NOC) to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie’s HUMIRA: Fresenius Kabi v...more

Goodwin

Medicure International Enter Agreement with Reliance Life Sciences for Cardiovascular Biosimilar

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Yesterday, Medicure, Inc. announced that its wholly-owned subsidiary, Medicure International Inc., has entered into a license, manufacture and supply agreement with Reliance Life Sciences Private Limited for a cardiovascular...more

Skadden, Arps, Slate, Meagher & Flom LLP

Diligence Clauses and the Management of Uncertainty in Life Sciences Agreements

In times of uncertainty and disruption, setting expectations for performance with business partners and contractual counterparties can be more complicated than ever. Companies that develop drugs, biologics and medical devices...more

Goodwin

STADA and Xbrane Ink Commercialization Deal with Bausch + Lomb for LUCENTIS Biosimilar Candidate

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On May 6, 2020, Bausch + Lomb and co-development partners STADA and Xbrane announced that they have entered into an exclusive licensing agreement with one another under which Bausch + Lomb will commercialize Xlucane, STADA...more

Goodwin

Biosimilar Market Updates: Canada, US, China

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Below are some recent developments in the biosimilar industry from around the globe: On January 14, 2020, Alvotech announced that it entered into a partnership with Canada-based JAMP Pharma for the supply and...more

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