News & Analysis as of

IP License Patents Biologics

Morgan Lewis - As Prescribed

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A)....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)

[Complimentary Conference] Pharma & Biotech Patent Litigation - February 23rd - 24th, 9:00 am - 5:00 pm CET

15 Years of Pharma & Biotech Patent Litigation in Europe - C5’s Pharma & Biotech Patent Litigation in Europe will take place 23–24 February, 2022 in Amsterdam, the Netherlands. This is the only industry-shaping event that...more

Morgan Lewis

Taking Advantage of the New Purple Book Patent Requirements for Biologics

Morgan Lewis on

New federal legislation will take effect this year that will require a reference product sponsor to submit to the FDA a list of any patents identified to a biosimilar applicant during the patent dance. The FDA is required to...more

American Conference Institute (ACI)

[Virtual Event] 11th Summit on Biosimilars & Innovator Biologics - September 23rd - 24th, 7:45 am - 5:00 pm ET

This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more

American Conference Institute (ACI)

[Webinar] Gauging the Impact of COVID-19 Across the Global IP Market: Lessons Learned from the Novel Coronavirus - June 24th,...

Hear from the FDA and the leaders of the biosimilars and innovator biologics industries about the impact of the pandemic on the global IP market and gain practical guidance for what is coming down the pipeline. The novel...more

Kramer Levin Naftalis & Frankel LLP

CAR T-Cell Therapy Takes Off and Brings on Patent Litigation

CAR T-Cell therapy, a new biologic therapy, is taking off. As companies continue to develop this new and promising therapy, patent litigation inevitably follows.  ...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...more

Jones Day

Supreme Court: Biosimilar Applicants May Provide Commercial Marketing Notice Before FDA Approval

Jones Day on

On June 12, 2017, the U.S. Supreme Court decided two important questions under the Biologics Price Competition and Innovation Act ("BPCIA"), which provides an abbreviated pathway for the approval of generic biologics: (i) the...more

Mintz - Intellectual Property Viewpoints

Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling

In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195...more

Snell & Wilmer

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

Snell & Wilmer on

On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

Jackson Walker

SCOTUS Simplifies Market Entry Process for Biosimilar Products

Jackson Walker on

Yesterday’s unanimous ruling by the U.S. Supreme Court in Sandoz v. Amgen injects much needed certainty into a difficult statute and streamlines the process for biosimilar products to enter the marketplace following FDA...more

Foley & Lardner LLP

Supreme Court Decision Largely Favors Biosimilar Applicants

Foley & Lardner LLP on

The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen v. Sandoz Update -- Supreme Court Seeks Views of United States

In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United...more

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