Philip Katz

Blue Bell

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Articles

The Family Court Assigned Counsel Panel: If Not You, Who?

Sep 27, 2024 | law.com | Philip Katz

Who Got The Work Joseph J. Mueller and Rachel Bier of Wilmer Cutler Pickering Hale and Dorr have entered appearances for Omachron Alpha, Omachron Intellectual Property and SharkNinja Operating in a pending patent infringement lawsuit. The action, filed Sept. 16 in Massachusetts District Court by Kirkland & Ellis, asserts three patents in connection with SharkNinja's sale of the 'Vertex' and 'Stratos' cordless vacuum cleaners. The case, assigned to U.S. District Judge Allison D.
FTC continues to focus on competition in pharmaceutical markets, supports FDA guidance on biosimilars

Aug 29, 2024 | lexology.com | Philip Katz |Chuck Loughlin |Gary Veron |Komal Karnik Nigam |Ilana Kattan |Jason Conaty | +3 more

This is the fourth comment related to the pharmaceutical industry the FTC has submitted to various agencies since the beginning of 2024, and part of a broader effort by the FTC to prioritize “safeguarding fair competition and rooting out unlawful business practices in health care markets.”[1] FTC says FDA’s Draft Guidance on interchangeability will increase competition in biologic marketplaces Under the Public Health Service Act, the standard for interchangeability is that a biosimilar “can...
FTC disputes new slate of Orange Book patents for weight loss, diabetes, asthma, and COPD drugs

May 6, 2024 | lexology.com | David Fox |Philip Katz |Chuck Loughlin |Gary Veron |Jason Conaty |Ilana Kattan | +2 more

On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the FTC has notified the Food and Drug Administration (FDA) that the Commission is disputing 300 allegedly “improper or inaccurate” patent listings in the FDA Orange Book.
Jason Conaty - Concurrences

Apr 29, 2024 | concurrences.com | David Fox |Philip Katz |Chuck Loughlin |Gary Veron

Hogan Lovells (Washington) Counsel Jason Conaty is counsel at Hogan Lovells, based in the firm’s Washington D.C. office. He counsels clients on the regulations and policies affecting complex drug and biotechnology products from the laboratory bench to the marketplace. Jason handles FDA approvals and lifecycle management for complex and advanced therapies.
David Fox - Concurrences

Apr 29, 2024 | concurrences.com | David Fox |Philip Katz |Chuck Loughlin |Gary Veron

Hogan Lovells (Washington) Partner David Fox is a partner at Hogan Lovells based in the firm’s Washington DC. office. He is a leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products, and controlled substances.
Gary Veron - Concurrences

Apr 29, 2024 | concurrences.com | David Fox |Philip Katz |Chuck Loughlin |Gary Veron

Hogan Lovells (Washington) Partner Gary Veron is a partner at Hogan Lovells, based in Washington. For more than 20 years, Gary has advised clients regarding the development, approval, and marketing of pharmaceutical and biological products. Gary is committed to helping life science companies successfully manage legal and business complexities to achieve their goals.
FDA ends interchangeability statement requirement for biosimilar labels

Oct 17, 2023 | lexology.com | Philip Katz |David Fox |Jason Conaty |Deborah Cho

The U.S. Food and Drug Administration (FDA) recently issued new revised draft guidance on “Labeling for Biosimilar and Interchangeable Biosimilar Products,” which most notably dispenses with any recommendation that interchangeable biosimilars include an “interchangeability statement.” Instead, it recommends that biosimilar labeling – interchangeable or otherwise – include a “biosimilarity statement.” As we discuss below, this change may be part of an effort by FDA to place greater reliance on...
Parlez-Vous 'Due Process'?

Sep 6, 2023 | law.com | Philip Katz |Andrew Denney

With this subscription you will receive unlimited access to high quality, online, on-demand premium content from well-respected faculty in the legal industry. This is perfect for attorneys licensed in multiple jurisdictions or for attorneys that have fulfilled their CLE requirement but need to access resourceful information for their practice areas. View Now Our Team Account subscription service is for legal teams of four or more attorneys.
SCOTUS won’t hear Teva v. GSK: Where does that leave us on FDA labeling carve-outs? | JD Supra

Jun 1, 2023 | jdsupra.com | Deborah Cho |Jason Conaty |Philip Katz

BackgroundTo promote generic competition, the Hatch-Waxman Act established a pathway through which the U.S. Food and Drug Administration (FDA) may approve an abbreviated new drug application (ANDA) for a reference listed drug (RLD) protected by a listed patent if the ANDA applicant submits a statement certifying that it will omit or “carve out” from its labeling information pertaining to a protected use.