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On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
A North Carolina federal judge on Friday denied NASCAR‘s motion to dismiss a lawsuit lodged by two racing teams that accused the organization of maintaining a monopoly, saying it is too early to determine a dismissal because...more
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big...more
Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna. The FDA approved a New Drug Application from...more
Multistate employers with employees in Texas are subject to state laws regarding employment agreements. Whether your business is large or small, specific provisions within your agreements could render your agreements...more
Integrating AI tools into drug discovery introduces a mix of opportunities and challenges for startups and large pharmaceutical companies. These challenges often center on intellectual property (IP) risks, licensing...more
I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more
The recent decision by the Federal Circuit in Honeywell International Inc. v. 3G Licensing, S.A., issued on January 2, 2025, overturned the Patent Trial and Appeal Board’s (“the Board”) factual and legal holdings in the final...more
The second half of 2024 saw a myriad of Artificial Intelligence (AI) related legal and regulatory developments for the EU and UK, critically with the EU AI Act coming into force on 1 August 2024. This has been followed by...more
In a judgment of 23 December 2024, the Dutch-speaking Enterprise Court of Brussels followed the reasoning of a Dutch court earlier in 2024, ruling that (i) manufacturers are not obliged to provide the reference number of...more
The USPTO has announced fee increases and new fees for patents and trademarks to take place on January 18, 2025, for trademarks, and January 19, 2025, for patents. The increase in fees and the introduction of new fees by the...more
The United States Patent and Trademark Office (USPTO) has issued a final rule setting out patent fee increases that will come into effect on January 19, 2025. The USPTO states that costs justify an increase of 10% for...more
In re Entresto (Sacubitril/Valsartan), Appeal Nos. 2023-2218, -2220, -2221 (Fed. Cir. Jan. 10, 2025) In our Case of the Week, the Federal Circuit revived Novartis’s US Patent No. 8,101,659 by reversing the district...more
The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription to switch to OTC where a...more
Welcome to WilmerHale’s bulletin on recent trade secret case law and relevant news items. We’ve affectionately nicknamed it “Readily Ascertainable” because, unlike a trade secret, it should be easy to figure out....more
Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
CeramTec v. Coorstek Bioceramics, Case No. 2023-1502 (Fed. Cir. Jan. 3, 2025) - Colors are generally permitted as source identifiers for trademarks or trade dress because they are typically perceived as an ornamental...more
In the last couple of months of 2024, the FASB issued some “invitations to comment” intended to allow FASB stakeholders to express their views on whether or not the FASB should pursue the projects identified. It could well...more
Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Effective January 18, 2025, the U.S. Patent and Trademark Office (USPTO) will implement a new fee schedule for trademark filings. ...more
From potential legal challenges to Chinese biopharma supply chains, Europe’s new Unified Patent Court (UPC), landmark decisions in life sciences, pharma’s Orange Book listings, design patent rejections, and likely shifts at...more
Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more
For wineries, managing intellectual property (IP) is crucial to maintaining brand identity and protecting creative investments. While general IP principles apply across many sectors, wineries face unique challenges and...more