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Kilpatrick

7 Key Takeaways - The Federal Circuit's New § 112 Attack on Biotechnology: Diagnosis and Prescription

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Kilpatrick attorneys Yifan Mao and Stuart Pollack recently attended the 20th annual KTIPS (Kilpatrick Townsend Intellectual Property Seminar) to discuss the “The Federal Circuit’s New § 112 Attack on Biotechnology: Diagnosis...more

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

Polsinelli

Federal Circuit Clarifies Rules for Skinny Labeling for Generics and Biosimilar Companies

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Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more

Goodwin

Amgen and Sandoz Settle Denosumab BPCIA Litigation

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As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab...more

BakerHostetler

[Podcast] Biotechnology, Chemical and Pharmaceutical: Supreme Showdown

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In 2023, a lawsuit that had wound its way through the judicial system for nearly 10 years finally had its day in the U.S. Supreme Court – and made waves in the biotechnology, chemical and pharmaceutical communities. Our...more

Latham & Watkins LLP

Healthcare and Life Sciences Trends and Developments Across MENA

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The healthcare and life sciences ecosystem is witnessing significant growth in the Middle East as the GCC continues to seek economic diversification. The United Arab Emirates (UAE) and Kingdom of Saudi Arabia (KSA) are...more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

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As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Venable LLP

Celltrion Submits an aBLA for Actemra® (tocilizumab) Proposed Biosimilar CT-P47

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On January 28, 2024 Celltrion announced the submission to the FDA of an aBLA for CT-P47, a proposed biosimilar of Genentech’s Actemra® (tocilizumab). This is the third publicly announced aBLA filing for an...more

Goodwin

Life Sciences Companies Make Up a Small Portion of the Companies Opting-In to the Unitary Patent; Ireland Announces Referendum...

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Life sciences companies continue to make up a small portion of the companies registering for Unitary Patents. Per the European Patent Office’s statistics portal, as of January 30, 2024 there have been 18,721 registered...more

Smart & Biggar

Twice is not nice – second notice of allegation may be abusive

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On December 23, 2023, the Federal Court of Appeal (FCA) held that it was an abuse of process for Apotex to raise invalidity in defending actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations)...more

Goodwin

Federal Circuit Remands to USPTO to Clarify Analysis of Jepson-Format and Means-Plus-Function Claims in the Field of Biotechnology

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On January 23, 2024, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) issued its decision granting the USPTO’s request to remand Xencor’s appeal of the rejection of U.S. Patent App. No 16/803,690 (“’690...more

American Conference Institute (ACI)

[Event] 2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities - May 20th - 21st, Boston, MA

Hosted by American Conference Institute, the 2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities returns for another exciting year with curated programming that will highlight leveraging...more

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Topics in 2024

What should in-house counsel be on the lookout for in 2024? As we begin a new year, our attorneys look ahead at intellectual property topics they expect will be trending in 2024. They cover areas including life sciences,...more

Goodwin

Federal Government Releases Proposed Guidance for Exercising “March-In” Rights Under the Bayh-Dole Act: Implications for...

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On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The Bayh-Dole march-in...more

Goodwin

Genentech, Roche, and Biogen Sue Dr. Reddy’s and Fresenius for a Proposed Biosimilar of Rituxan in District of New Jersey

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​​​​​​​Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey, alleging infringement of 15 patents under...more

Goodwin

European Biologics Regulatory Updates

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Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Life Sciences IP Due Diligence - November 28th - 29th, Boston, MA

ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more

Goodwin

Celltrion Expands Access to YUFLYMA (adalimumab-aaty)

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On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA)...more

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

Linda Liu & Partners

CNIPA’s Requirements on Supplementary Experimental Data and Inventiveness Evaluation of CN Patent Application in Biology and...

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On December 14, 2020, the China National Intellectual Property Administration released “Announcement about Amendments to the Guidelines for Patent Examination (Announcement No. 391)” on its website, showing that the amended...more

BakerHostetler

Now What? The Supreme Court Addresses Enablement

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What do telegraphic communications, incandescent lamps, wood veneering glues, and antibodies have in common? Nothing. That is of course, until May 18, 2023, when the Supreme Court ruled that Amgen’s antibody claims, like...more

Burns & Levinson LLP

Amgen v. Sanofi and Points Beyond

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A week ago Thursday, the Supreme Court issued its decision in the Amgen v. Sanofi case, affirming the judgment of the Court of Appeals for the Federal Circuit, that the claims of the two patents Amgen asserted against Sanofi...more

Wilson Sonsini Goodrich & Rosati

Broad Genus Patents Must Be Enabled over the Full Scope of the Claims

Amgen Inc. et al. v. Sanofi et al., No. 22-157 (U.S. 2023) - The U.S. Supreme Court, in a unanimous decision, has affirmed the Federal Circuit’s decision invalidating Amgen’s patent claims covering a genus of antibodies...more

Dorsey & Whitney LLP

Supreme Court Upholds Patent Law Precedent

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The case of Amgen Inc. v. Sanofi, U.S., No. 21-757 dealt with patent law’s “enablement” requirement. Essentially, the Court affirmed 150 years of precedent requiring the invention to be described “‘in such full, clear,...more

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