Why Leading Biotech and Life Science Companies Turn to Axinn
Axinn understands the development, approval pathways, and monetization of life science products, enabling us to find creative legal ways to achieve a client’s business goals in the face of major obstacles. Axinn is regarded as a “go-to” patent litigation firm with significant trial experience in controversies involving pharmaceutical, medical device, and life science patents. Axinn provides counseling services, pre-litigation strategies, and advice on the benefit of filing IPR petitions to assist clients in the selection, development, approval, and marketing of a broad range of technologies and therapies including cancer, autoimmune disease, and reconstructive biomaterials.
Having litigated patents related to biotechnology and life sciences for over 20 years, Axinn is well prepared as the biosimilars industry develops. Our commitment to seek client-driven, practical solutions remains a constant in this rapidly developing field. Axinn’s biotechnology and life sciences team is well-versed in all aspects of the Biologics Price Competition and Innovation Act (BPCIA), and regularly guides clients through the complex patent and noticing provisions of the BPCIA. We regularly present at biosimilars conferences and participate in committees that review and respond to FDA draft guidances regarding provisions of the BPCIA. Axinn has successfully litigated a variety of FDA issues, including labeling carve-outs, marketing exclusivities and scientific standards of equivalence, and has actively represented clients before FDA both informally and formally through the Citizen Petition process. In addition, Axinn regularly counsels clients on regulatory issues related to the Hatch-Waxman Act and the BPCIA, including requirements for the demonstration of biosimilarity and/or interchangeability, the identification and characterization of active ingredients, patent term extensions, and oversight and enforcement related to stem-cell based products and HCT/Ps. Lawyers in Axinn’s FDA Practice Group frequently negotiate shared REMS programs and navigate antitrust and regulatory implications of restricted drug distribution systems.
By coupling the firm’s in-house scientific capability with its patent litigation prowess and knowledge of the regulatory landscape, the firm offers a comprehensive team that identifies and assesses patents and patent applications, including patent strength, claim scope and potential for design-arounds. Axinn, thus, helps clients bring biologic-based drug products and reconstructive biomaterials to market in the most efficient, competitive, and profitable manner.
Attributes of Our Biotechnology and Life Science Team
Roughly half of Axinn’s IP attorneys hold advanced technical degrees as well as hands on experience working in life science labs, research facilities, or universities in the biomedical area. In addition, many of our IP attorneys are registered to practice before the U.S. Patent and Trademark Office. Axinn’s life science team includes attorneys who have garnered experience as bench scientists; teachers of medicine and medical device invention and design; research and formulation scientists; biomedical, genetic and process development engineers; members of professional societies for engineers and scientists; scientific authors and quoted experts; and litigators with extensive trial experience.
- Supreme Court Confirms Full Scope Enablement Standard in Amgen v. Sanofi
- Axinn IP Update: The Supreme Court Hears Arguments About the Enablement Standard in Amgen v. Sanofi
- The Center for Biosimilars Interview Series: Legal Perspectives in Biosimilars
- New U.S. Legislation Creates Momentum for Biosimilars
- What the Potential Elimination of the Biologics Price Competition and Innovation Act Means for Pharmacy
- Legal Opinion: BPCIA is Likely to Survive Latest ACA Challenge
- Axinn Patent Attorneys Discuss Insulins Under the BPCIA vs Hatch-Waxman
- Old Drug, New Tricks? How the BPCIA Could Increase Generic Competition for Insulins
- Axinn Patent Attorneys Talk ACA Pushback and the BPCIA
- Insulin Under the BPCIA: Opportunities and Obstacles
- What ACA's Uncertain Future Means for Biologics Patents
- Axinn IP Update: Federal Circuit Addresses BPCIA Safe Harbor, Damages
- Little Impact Post-Arthrex for Biologic Patents at the PTAB
- Can the FDA Salvage Interchangeable Follow-On Biologics?
- Axinn IP Update: Section 287(c) Immunity Has Its Limits
- Axinn IP Update: No Collateral Estoppel after PTAB Ruling on IPR
- Failure to Launch: The Patent Thicket Delay of US Biosimilars
- FDA Doubles Down in Its Updated Biologics Naming Guidance
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Speaking Engagements & Seminars
- Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies 2023
- GRx+Biosims Conference 2023
- ACI 14th Annual Summit on Biosimilars & Innovator Biologics
- ACI 13th Annual Summit on Biosimilars & Innovator Biologics
- Navigating Patent Thickets in BPCIA Litigation
- GRx+Biosims Conference
- 2019 Festival of Biologics: World Biosimilar Congress Europe
- ACI 10th Annual Summit on Biosimilars Conference
- 2019 Festival of Biologics: World Biosimilar Congress USA
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