Biosimilar Counseling and Litigation

With growing societal pressure for more affordable health care and lower-cost biopharmaceuticals, the global demand for effective biosimilars continues to expand. To capture valuable market share and achieve profitability, biosimilar product sponsors need legal counsel with experience in patent law, government regulation, and both biological and chemical sciences. Farney PC is at the forefront of this burgeoning industry. Our attorneys provide creative solutions that take into account short-term practicalities and long-term considerations, and offer valuable guidance in determining the patent and trademark landscape as well as litigation and licensing opportunities for each biologic target. Farney PC attorneys frequently become involved in the product development process, helping clients design patent and licensing strategies while assessing the intellectual property rights of competitors.

In addition to pre-suit diligence, our seasoned trial team is well versed in the complexities of the applicable federal regulations, and experienced in developing the efficient and flexible litigation strategies that can help assure success.

Farney PC was pleased to advise its client Fujifilm Kyowa Kirin Biologics (FKB), a joint venture between Fujifilm Holdings Corp, and Kyowa Hakko Kirin Co. Limited, in establishing a joint venture to execute AztraZeneca’s first entry into the biosimilars market.

The FKB-Astrazeneca joint venture will develop the biosimilar of Avastin, called FKB238. The agreement was handled by Shareholder Michael Siem and Associate Aya Cieslak-Tochigi, of Farney PC, along with attorneys from the UK Office of Olswang, LLP. Click here to read more.