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Biotechnology Patents Biologics

Goodwin

Where were biologics-related patents involved in BPCIA litigation invented?

Goodwin on

Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national...more

Goodwin

Amgen and Sandoz Settle Denosumab BPCIA Litigation

Goodwin on

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

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

Mayer Brown

BioUtah Podcast with Vera Nackovic

Mayer Brown on

Join BioUtah president & CEO Kelvyn Cullimore and Mayer Brown’s Vera Nackovic in a discussion about current trends and issues in the life sciences industry....more

Venable LLP

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

Venable LLP on

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

Morgan Lewis

Blockbuster Biologics Review | Issue 17

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

McDonnell Boehnen Hulbert & Berghoff LLP

Penguin Genetics Suggests Complex History

Penguins are unique among bird species, having lost the ability to fly more than 60 million years ago and adopting a "hyperspecialized marine body plan" consistent with their unique habitat in the higher latitudes of the...more

Morgan Lewis

Blockbuster Biologics Review | Issue 16

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Morgan Lewis

Blockbuster Biologics Review Issue 15

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends: Case Studies and Trends at the PTAB Involving 35 U.S.C. § 112

Over the last 20-plus years, US Court of Appeals for the Federal Circuit cases concerning written description and enablement have become a hot-button issue in the chemical and life sciences practices. The year 2021 was no...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...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

MoFo Life Sciences

Traversing Higher Hurdles For Functional Limitations Under Section 112

MoFo Life Sciences on

Genus claims have long been an important component of patent strategy, extending coverage around a lead compound to stop would-be competitors. Recent decisions from the Federal Circuit, however, highlight a tightening...more

Kilpatrick

The Federal Circuit Continues to Invalidate Genus Claims Defined by Function

Kilpatrick on

In our earlier post, we questioned whether the Federal Circuit would continue to invalidate genus claims directed to biologics, and the answer is yes. Not surprisingly, the Federal Circuit panel in Amgen v. Sanofi affirmed...more

McDonnell Boehnen Hulbert & Berghoff LLP

BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver

One year ago today, World Health Organization Director-General Tedros Adhanom declared the COVID-19 outbreak to be a pandemic.  At the time of the announcement, the WHO noted that there were 118,000 cases reported globally,...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser

Our “Innovation Conversations” series continues with our guest Dr. Claire Fraser, President of the American Association for the Advancement of Science (AAAS) and Director of the Institute for Genome Sciences at the University...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser (transcript)

Our “Innovation Conversations” series continues with our guest Dr. Claire Fraser, President of the American Association for the Advancement of Science (AAAS) and Director of the Institute for Genome Sciences at the University...more

Herbert Smith Freehills Kramer

BPCIA Scope Widens: 2020 Spending Bill Moves Chemically Synthesized Polypeptides to Biologic Status

Buried in a 2020 spending bill passed in December 2019 is a provision that amends the definition of “Biological Product” in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and thereby expands the products...more

American Conference Institute (ACI)

[Event] Biosimilars Summit – Legal, Regulatory, and Commercial Strategies – June 24th-25th, New York City, NY

2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA). ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we...more

Jones Day

Clarifying or Conforming? The EPO Bows to the European Commission

Jones Day on

In December, we reported that the European Commission ("Commission") had issued an Interpretive Notice (2016/C 411/03) stating products produced by essentially biological processes should not be patentable. The notice came as...more

Knobbe Martens

Inherent Anticipation for Biotechnology Inventions

Knobbe Martens on

Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more

Foley & Lardner LLP

EPO Stays Proceedings Over Patentability Of Plants And Animals

Foley & Lardner LLP on

While the U.S. is still sorting out “natural products” jurisprudence under 35 USC § 101, the European Patent Office (EPO) is wrestling with the patentability of plants and animals, and has announced an immediate stay on all...more

McDonnell Boehnen Hulbert & Berghoff LLP

Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term

Ever since the Biologics Price Competition and Innovation Act (BPCIA) was passed along with the rest of the healthcare law commonly called "Obamacare" in 2010, the Obama Administration has included in every budget a proposal...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Obama Administration Releases Much Anticipated Text of the Trans-Pacific Partnership Agreement

This client alert examines intellectual property proposals in the Trans-Pacific Partnership from the perspective of biotechnology, pharmaceutical, and chemical industries. On November 5, 2015, the U.S. trade...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: High Court Rules Myriad's BRCA Genes Not Patentable Subject Matter in Australia

Just over one year after the Full Federal Court of Australia unanimously upheld an earlier Federal Court decision that naturally occurring nucleic acid molecules are patentable in Australia, the High Court of Australia has...more

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