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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®.
Alerts
4.18.21
Fifth Circuit Upholds Federal Trade Commission Ruling in Impax Laboratories, Inc. v. Federal Trade Commission and Grants Substantial Deference to the FTC
On April 13, 2021, the U.S. Court of Appeals for the Fifth Circuit issued an opinion in Impax Laboratories, Inc v. Federal Trade Commission, affirming the Federal Trade Commission's (FTC) unanimous decision that Endo Pharmaceuticals, Inc.'s settlement with Impax Laboratories, Inc. constituted a reverse payment and violated Section 5 of the FTC Act. In so doing, the Fifth Circuit reiterated the rule-of-reason burden-shifting framework for reverse payment cases, and also granted considerable deference to the FTC.
Client Highlights
5.20.20
Firm Represents CG Oncology in Agreement with Kissei Pharmaceutical
On March 26, 2020, CG Oncology, Inc. announced an exclusive license, development, and commercialization agreement with Kissei Pharmaceutical Co., Ltd. (Kissei) for its oncolytic immunotherapy drug CG0070 for Japan, South Korea, Taiwan, and other Asian countries with the exception of China. CG Oncology has completed an investigational Phase 2 study of CG0070 in the United States in patients with BCG-unresponsive, non-muscle-invasive bladder cancer (NMIBC). In addition, CG Oncology is studying the use of CG0070 in combination with immune checkpoint inhibitors in bladder cancer and other solid tumors. Wilson Sonsini Goodrich & Rosati represented CG Oncology in the transaction.
Client Highlights
3.12.20
Wilson Sonsini Secures District Court Win for Mylan
On March 10, Wilson Sonsini secured a major win for Mylan in its efforts to provide a lower cost alternative to Sanofi’s Lantus SoloSTAR insulin glargine product. Following a week-long trial in December, Judge Chesler of the U.S. District Court of New Jersey ruled that the sole remaining device patent of the 16 initially asserted by Sanofi against Mylan’s proposed insulin glargine pen product was not infringed and invalid for lack of written description.
Press Releases
7.15.19
Wilson Sonsini Adds John Wehrli to its Technology Transactions Practice
PALO ALTO, CA (July 15, 2019) – Wilson Sonsini Goodrich & Rosati, the premier provider of legal services to technology, life sciences, and growth enterprises worldwide, announced today that John Wehrli has joined the firm's technology transactions practice as a partner in the San Diego office, where he will focus on representing life sciences clients.
Alerts
6.25.19
FDA Updates Paragraph IV Certification to Spur Development Investment
Recently, the U.S. Food and Drug Administration, or the FDA, announced enhancement of the FDA's Paragraph IV Patent Certification List (the List) as part of the agency's stated goal of bringing more generic drugs to market faster in the United States.
Alerts
2.21.19
FDA Issues Guidance Covering CGT Designation, Approvals, and Exclusivity
Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are not likely (at least in the short term) to face generic competition.