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6.08.26
U.S. Supreme Court Addresses Liability for Patent Infringement by Generic Pharmaceuticals
In a unanimous opinion by Justice Ketanji Brown Jackson, the U.S. Supreme Court held that Amarin, the developer of Vascepa® (reference listed drug), failed to plausibly allege that Hikma actively induced infringement of Amarin’s method of use patents based on Hikma’s statements and materials related to its generic version of Vascepa®, reversing the decision by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit). Although much of the import of this decision will not be fully understood until lower courts interpret this ruling, the Supreme Court provided guidance regarding one of the requirements for alleging a claim for induced patent infringement—one must plausibly allege that the defendant actively encouraged infringing use, not merely whether others could plausibly read statements by the defendant as instructions to infringe.
Newsletters
6.03.26
The Life Sciences Report – June 2026
This latest edition features articles on accelerating new therapies under the new FDA administration, cash-pay healthcare companies possibly facing kickback and fee-splitting risk under federal and state laws, building in-house legal teams for biotech, digital health, and medical devices companies, and life sciences venture financings for firm clients across 1H2025 and 2H2025.
Alerts
4.06.26
Double Dose of New Tariffs: President Prescribes New Pharmaceuticals and Metals Tariffs
On April 2, 2026, President Trump issued two presidential proclamations: a proclamation imposing Section 232 tariffs on certain branded pharmaceutical products and associated active pharmaceutical ingredients (APIs) (the Pharmaceuticals Proclamation), and a proclamation modifying the Section 232 steel, aluminum, and copper tariffs (the Metals Proclamation).
Client Highlights
10.01.25
Wilson Sonsini Defends Win in Xarelto Appeal
On September 23, 2025, the U.S. Court of Appeals affirmed a decision of the Patent Trial and Appeal Board (PTAB) holding key patent claims covering Bayer's Xarelto product unpatentable. Wilson Sonsini represented Mylan Pharmaceuticals in the challenge before the PTAB and at the Federal Circuit.
Client Highlights
6.24.25
Wilson Sonsini Convinces Federal Circuit to Vacate and Remand Adverse PTAB Decision
On June 20, 2025, Wilson Sonsini obtained a significant Federal Circuit victory on behalf of Mylan. A team of the firm’s patent litigators successfully appealed an adverse decision by the Patent Trial and Appeal Board (PTAB) concerning a foundational patent protecting the brand product Trulance®. In a unanimous panel opinion, the Federal Circuit vacated the adverse decision and remanded the case to the PTAB.
Newsletters
9.13.23
2023 Mid-Year Technology and Life Sciences PIPE and RDO Report
We present analysis related to 87 private investments in public equity (PIPEs) and registered direct offerings (RDOs) by U.S.-based technology and life sciences companies between January 1 and June 30, 2023. The report is limited to transactions in which the company raised at least $10 million and had at least one closing in the first half of 2023.
News Articles
7.21.22
Wilson Sonsini Honored at 2022 LMG Life Sciences Americas Awards
On September 8, 2022, Wilson Sonsini was named “Hatch-Waxman Litigation Firm of the Year – Generic” at the 2022 LMG Life Sciences Awards. The firm was also recognized under “Hatch-Waxman Impact Cases of the Year” for its work on Celgene v. Mylan (Federal Circuit, 2021), “Patent Impact Cases of the Year” for its work on ModernaTx v. Arbutus (Federal Circuit, 2021), and “Impact Deals of the Year – United States” for its role in Sanofi’s $6.15 billion collaboration with IGM Biosciences. Additionally, Wilson Sonsini partner Michael Rosato was named “Post-Grant Proceedings Attorney of the Year.” Now in its 10thyear, LMG's annual awards program honors the top firms and legal professionals in the life sciences market. Awards are based on interviews and surveys completed by active industry participants.
Alerts
6.29.22
Negative Claim Elements and the Importance of Complete Patent Disclosures: How Novartis Lost a $2.8 Billion Drug to Generic Drug Makers
On June 21, 2022, Novartis Pharmaceuticals Corp.'s patent for a method of treating multiple sclerosis with fingolimod (Gilenya®) was held invalid for lack of written description under 35 U.S.C. § 112(a).1 Gilenya® was Novartis' third bestselling pharmaceutical drug in 2021, and represented a total revenue for the company of about $2.8B globally.2 The decision is a win for the generic drug makers engaged in the instant Hatch-Waxman litigation with Novartis, and will likely result in hundreds of millions of dollars in lost revenue for Novartis when the other patents listed in the Orange Book for this product expire in 2026.
Client Highlights
12.29.21
Firm Secures Federal Circuit Ruling for Mylan in Insulin Glargine Appeals
On December 29, 2021, Wilson Sonsini secured another win for Mylan as the U.S. Court of Appeals for the Federal Circuit affirmed eight decisions from the Patent Trial and Appeal Board (PTAB) holding patent claims for five Sanofi device patents unpatentable. Sanofi had asserted the patents against Mylan in the U.S. District Court for the District of New Jersey. Both the district court and the PTAB held the claims unpatentable, leading to 11 appeals consolidated into four groups. The Federal Circuit heard argument in a marathon session on December 6, 2021, and issued short but strong opinions on December 29 categorically rejecting Sanofi's arguments in eight PTAB appeals and dismissing the remaining appeals as moot in view of the affirmances.
This latest success follows previous wins against Sanofi's insulin glargine formulation patents. Insulin glargine is used to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. In November, Viatris launched branded and unbranded versions of insulin glargine, the first-ever interchangeable biosimilar.
Wilson Sonsini represents Mylan in patent matters, including those related to this litigation. The team representing Mylan in these appeals includes Rick Torczon, Ellie Steiner, Tasha Thomas, Wes Derryberry, and Steffen Johnson.
This latest success follows previous wins against Sanofi's insulin glargine formulation patents. Insulin glargine is used to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. In November, Viatris launched branded and unbranded versions of insulin glargine, the first-ever interchangeable biosimilar.
Wilson Sonsini represents Mylan in patent matters, including those related to this litigation. The team representing Mylan in these appeals includes Rick Torczon, Ellie Steiner, Tasha Thomas, Wes Derryberry, and Steffen Johnson.
News Articles
8.03.21
Viatris Receives FDA Approval for First Interchangeable Biosimilar
On July 28, 2021, the U.S. Food and Drug Administration (FDA) announced a landmark approval of Viatris Inc.’s Semglee® as the first interchangeable biosimilar product. Semglee® (insulin glargine-yfgn), indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes, is the first biosimilar that can be substituted at the pharmacy counter for its reference product, Lantus®.