The biologics industry faces an impending “patent cliff” when products comprising over $50 billion in global sales lose patent protection and exclusivity. As competition ramps up in anticipation of this opportunity, innovators and biosimilars applicants will need legal counsel with the requisite technical knowledge, regulatory understanding, and global platform to protect their investments.
K&L Gates has a deep understanding of biologics from a legal, science, and regulatory perspective. With top-ranked patent prosecution, patent litigation and FDA practices, we provide comprehensive counsel to biosimilar applicants desiring to launch products to market in the U.S. and abroad and innovators of biological products desiring to delay biosimilar competition.
We recognize that the regulatory pathway for biologics under the Biologics Price Competition and Innovation Act (BPCIA) or the Public Health Service Act (PHSA) differ in significant ways from the corresponding procedures available under the Hatch-Waxman Act regarding abbreviated new drug applications (ANDAs). As such, K&L Gates’ biosimilars/follow-on-biologics practice was uniquely built to leverage our nationally-ranked patent prosecution, patent litigation, and regulatory practices to benefit from the numerous intersections of these areas of experience. The unique make-up of our practice has several advantages including allowing us to draw on our expertise in patent litigation and post-grant tactics at strategic times to best protect our client’s interests.
Our practice is distinguished by:
We understand that an effective strategy for innovators of biological products and biosimilar applicants requires an integrated approach that employs several available procedures and tactics tailored exclusively for the unique challenges posed by biological products. For example, the Leahy-Smith America Invents Act (AIA) established several new proceedings such as inter-partes review, ex-parte reexamination, post-grant review, and supplemental examination that can be effectively employed with other litigation strategies to defend or challenge a patent that protects a biological product or a process/method for manufacturing such biological product. Additionally, patent litigation centered around biological products increasingly involves Section 337 Investigations at the International Trade Commission (ITC). We understand the strategic interplay between all of these proceedings and regularly employ them both in the context of protecting a branded biological product or assisting a biosimilar applicant in bringing a biosimilar to market.
Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product Draft Guidance, May 2014
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants, Draft Guidance, March 2013
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Draft Guidance, February 2012
Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, Draft Guidance, February 2012
H. R. 3590 Improving Access to Innovative Medical Therapies