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Wolf Greenfield Attorneys Preview What’s Ahead in 2024
5 Key Takeaways | Hot Topics in Biopharma
Business Better Podcast Episode: Accelerating Life Sciences: How Accelerators and Education Are Joining Forces to Catapult the Life Sciences Industry
Is Your Life Sciences Patent Enabled? The U.S. Supreme Court Is Considering That Question
Webinar: Orange Book listing sheets under the microscope
Federal Appeals Court Hears Arguments on CAR T-Cell Therapy Patent Dispute
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Enforcing IP in a Pandemic: Considerations, Risks, Strategies
[IP Hot Topics Podcast] Innovation Conversations: Walter Isaacson, Part 1
Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
IP(DC) Podcast: Patent Battles – New Patent Initiatives on the Hill & Notable CAFC/SCOTUS Decisions
Patent law in Europe: What pharmaceutical companies need to know
A data-driven era: Why digital tools are critical to life sciences players
IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Copan Italia SPA v. Puritan Med. Prods. Co. LLC, Appeal No. 2022-1943 (Fed. Cir. May 14, 2024) The Federal Circuit’s only precedential opinion concerning a patent case this week had nothing to do with patent law....more
Partner Dan Shores will present a webinar titled "The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more
Summary - The U.S. International Trade Commission (USITC) is soliciting public comment on the proposed expansion of a June 2022 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property...more
It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market. While there have been challenges over this time, the U.S. biosimilar...more
On February 1, the World Health Organization (WHO) released a "zero draft" of a WHO convention, agreement, or other international instrument on pandemic prevention, preparedness, and response (or "WHO CA+") for the...more
Key Points - On December 6, days before a deadline for WTO members to decide whether to expand the TRIPS waiver for COVID-19 vaccines to cover COVID-19 diagnostics and therapeutics as well, the Office of the USTR...more
Moderna has sued Pfizer and BioNTech in Massachusetts and Germany (where the defendants are based), claiming that the companies violated three of its patents related to mRNA technology used to develop COVID-19 vaccines....more
USPTO Launches Webpage on PTE Applications and Patent Terms Extended under 35 U.S.C. § 156 - In a Patent Alert email distributed to stakeholders last week, the U.S. Patent and Trademark Office announced the launch of a...more
On June 16, 2022, the World Trade Organization (WTO) agreed to a partial waiver of intellectual property rights related to COVID-19 vaccines. The agreement came on the heels of an all-night negotiating session. The agreement...more
Last month, a leaked document regarding the TRIPS Waiver revealed a breakthrough between the EU, South Africa, India and the United States. After 18 months of negotiations, the four parties now have reached a high-level...more
We first posted about a potential waiver of patent rights related to COVID-19 medical tools on May 6, 2021 (Patents on COVID-19 Vaccines Feel free to infringe (kilpatricktownsend.com)). A recent version of the waiver released...more
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
In the first major patent infringement lawsuit in the mRNA space, on February 28, 2022, Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences GmbH (“Genevant”) sued Moderna, Inc. and ModernaTX, Inc. (collectively...more
As posted Monday, BIO (the Biotechnology Innovation Organization) provided a link to the supposed compromise agreement reached recently to permit WTO member states to waive patent protection for "subject matter required for...more
In April of 2021, we provided a three-part series relating to the IP and Competitive Landscape for the mRNA market. In this post we provide a 2021 year in review update on mRNA pioneers and key players and offer additional...more
Last week the Federal Circuit was gearing up for its December argument sitting, but the Court still found time to issue several decisions. Below we provide our usual weekly statistics and our case of the week—our highly...more
Four months ago, the U.S. became one of 100 countries supporting the proposal presented a year ago to the World Trade Organization (WTO) by India and South Africa that intellectual property protection for COVID-19 vaccines be...more
In this new episode of OnAir: Health Care, Akin Gump health care senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Akin Gump public law and policy partner Clete Willems and Centrient...more
The Therapeutic Products Directorate (TPD), the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), and the Natural and Non-Prescription Health Products Directorate (NNHPD) have released their Drug Submission...more
On May 11, 2021, the Federal Circuit affirmed the District Court of Delaware’s judgment that patents belonging to Pacific Biosciences of California (“PacBio”) were invalid for lack of enablement under 35 U.S.C. § 112. A...more
In the first half of 2021, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more
On June 8-9, 2021, the World Trade Organization’s (WTO) TRIPS Council will hold their first meeting in the wake of the U.S. Trade Representative (USTR) announcing “the Biden-Harris Administration’s support for waiving...more
Recently, the U.S.’s changed position on IP Waiver for patent protection of the COVID-19 vaccines and technology grabbed the headlines. It was an about-face from its previous stance. But what does it all mean? From Facebook...more
Earlier this month, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines." One day prior to Ambassador...more
Dennis Crouch, our colleague at Patently-O, tweeted last week that there have Dennis Crouch, our colleague at Patently-O, tweeted last week that there have been 148 U.S. patents granted having disclosure related to (COVID-19...more