News & Analysis as of

Life Sciences Patent Applications Pharmaceutical Patents

Robins Kaplan LLP

Generic Launches - Abbreviated New Drug Applications and 505(b)(2) Applications

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This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

Robins Kaplan LLP

ANDA Approvals - New Drug Applications and 505(b)(2) Applications: Third Quarter

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This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Jones Day

U.S. Senate Unanimously Passes Bill Limiting Number of Patents Asserted Against Biosimilar Applicants

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The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more

Goodwin

Eight on AI: Quick Considerations on Patenting Drug Discovery Therapeutics using Artificial Intelligence (AI) and Life...

Goodwin on

Many life science companies are using AI/ML to identify new disease targets and new therapeutics, predict the efficacy and toxicity of potential clinical therapeutic candidates, design clinical trials and dosing or treatment...more

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

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

Goodwin

Federal Government Releases Proposed Guidance for Exercising “March-In” Rights Under the Bayh-Dole Act: Q & A

Goodwin on

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 following Q&A, in...more

Goodwin

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

Goodwin on

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

Fenwick & West LLP

FTC Employs New Tactic in Effort Against Drug Makers Alleged to Have Improperly Listed Patents in the FDA’s Orange Book

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On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...more

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in ANDA Litigation - October 31st, 1:00 pm - 2:00 pm ET

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We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...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

McDonnell Boehnen Hulbert & Berghoff LLP

United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)

In earlier times, the Federal Circuit, responding to efforts by the U.S. Patent and Trademark Office to reject patent applications directed to biotechnology-related inventions, held (In re Brana) that utility of such...more

Sunstein LLP

Enablement Enigma: The Supreme Court Weighs In

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In a unanimous decision, the Supreme Court has affirmed the lower court’s ruling that Amgen’s broad genus claims to cholesterol-lowering antibodies are invalid for lack of enablement....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

American Conference Institute (ACI)

[Event] 21st Advanced Summit on Life Sciences Patents - May 18th - 19th, New York, NY

ACI’s 21st Advanced Summit on Life Sciences Patents returns to New York City, this May, to provide practical insights on how to maximize your patent term and develop strategies to enhance global protections for your patent...more

Procopio, Cory, Hargreaves & Savitch LLP

[Webinar] Is Your Life Sciences Patent Enabled? - March 14th, 12:00 pm PT

U.S. Supreme Court Will Decide This Year - In this year’s foray into patent law, the Supreme Court will decide whether Amgen’s patent that claims antibodies by functional antigen binding and does not disclose the full...more

McDonnell Boehnen Hulbert & Berghoff LLP

Junior Party Broad Files Reply to Sigma-Aldrich Opposition to Broad Contingent Motion No. 2

On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Contingent Preliminary Motion No. 2 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party),...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sigma-Aldrich Files Reply to Broad’s Opposition to Sigma's Substantive Preliminary Motion No. 1 to Deny Priority Benefit in...

On December 3rd, Senior Party Sigma-Aldrich filed its Preliminary Motion No. 1 that asked the Board to deny the Broad Institute, Harvard University, and MIT (collectively, Broad) benefit of its U.S. Provisional Application...more

American Conference Institute (ACI)

[Event] 20th Advanced Summit on Life Sciences Patents - June 2nd - 3rd, New York, NY

ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senior Party Sigma-Aldrich Files Reply to Junior Party CVC'S Opposition to Its Substantive Preliminary Motion No. 1 to Change...

On November 19th, Senior Party Sigma-Aldrich filed its Substantive Preliminary Motion No. 1 in CRISPR Interference No. 106,132, asking the Board to substitute the Count pursuant to 37 C.F.R. §§ 41.121(a)(1)(iii) and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senior Party Sigma-Aldrich Files Opposition to Junior Party Substantive Preliminary Motion No. 1 in Interference No. 106,133

On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Substantive Preliminary Motion No. 1 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party),...more

AEON Law

Patent Poetry: Dispute over COVID Vaccine Shows Importance of Inventorship

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Moderna has been engaged in a patent dispute with the National Institutes of Health (NIH) over whether three NIH scientists should be named as inventors for discovering the genetic sequence that’s central to the vaccine. ...more

Knobbe Martens

Cancer Drug Patent Not Dead Yet

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(Mar. 31, 2022) Last Friday, ImmunoGen won an appeal at the Federal Circuit in ImmunoGen, Inc. v. Hirshfeld. The lawsuit is a civil action to order the granting of U.S. Application No. 14/509,809 (‘809), titled “Anti-FOLR...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senior Party Sigma-Aldrich's Opposition to CVC's Substantive Preliminary Motion No. 3 in Interference No. 106,132

On February 18th, Senior Party Sigma-Aldrich filed its Opposition to Substantive Preliminary Motion No. 3 from the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively,...more

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