Biologics & Biosimilars

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The U.S. biologics and biosimilars industry is expanding faster than any other region in the world. Biosimilars are associated with the reduction of healthcare costs, and the race to enter the market as the first-to-launch is considered the cornerstone of seizing majority market share. The FDA is poised to support a robust biosimilars market through competition and oversight of fair play among originator biologics and biosimilars. With FDA biosimilar approvals on the rise, industry optimism drives not only additional investment, but also accelerated R&D.

In the race for new discoveries and market advantage, it is imperative for industry pioneers and thought innovators to identify, own, and safeguard biosimilar advancements. Rothwell Figg delivers both the experience and depth of technical knowledge required to develop comprehensive and successful IP strategies for the most sophisticated biologic and biosimilar products. Our experience in the biologics and biosimilars market ranges from advising on regulatory issues and conducting freedom-to-operate and due diligence studies, to securing essential patent rights and other IP, to providing counseling and opinions, advocating in post-grant challenges, and aggressively asserting and/or defending against patent infringement actions. We leverage our decades of pharmaceutical litigation experience to advise on, advocate, and resolve FDA and Hatch-Waxman claims, as well as advise on BPCIA litigation issues.

Our team is well-versed in the large molecule drugs already on the market today, as well as fluent in how such drugs are manufactured, formulated, and purified. We are well positioned to advise on the viability of prospective new patent applications and on the validity and scope of competitor patents. We prosecute patents both for innovator companies with new biologics and pioneering biosimilar products, with an understanding of how to structure strong claims and maximize patent term. We know the history and prior art of the industry and make educated predictions as to which types of claims will likely be upheld by the courts.

Clients benefit from our more than three decades of focused IP legal counsel in biotech disciplines such as genetic engineering; monoclonal, chimeric, humanized, and fully human antibodies; proteomics; recombinant DNA; siRNA; viral replication; receptor technology and cell signaling; and molecular diagnostics and other research tools. Notably, many of our lawyers have first-hand industry experience and/or advanced degrees in areas such as microbiology, genetics, biochemistry, immunology, bioinformatics, chemistry, biotechnology, pharmacology, biology, zoology, and related fields.




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