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Life Sciences Patent

Patents are the lifeblood of life sciences companies and are valuable assets to many research institutions and universities. Patents also are of critical importance to life sciences companies seeking to enter competitive markets. Proskauer’s collaborative Life Sciences Patent practice focuses on partnering with leading biologics, pharmaceutical, biotechnology, and medical device clients to meet their business objectives by developing and executing market exclusivity and freedom-to-operate strategies. We employ comprehensive strategies that draw from our deep knowledge of and extensive experience with patent litigation, contested patent office proceedings, FDA regulations, patent prosecution and patent transactions, including licenses and assignments.

We have been very successful with this approach for biologic and small molecule franchises, among others. Furthering our clients’ business interests using comprehensive “big picture” strategies allows us to achieve the most desirable results in the most cost-effective manner.

Proskauer’s industry experience in the life sciences area is second to none, with members of the Life Sciences Patent practice having worked at companies such as Amgen, Chiron, Life Technologies and Affymetrix. We understand our clients’ businesses and develop and execute practical solutions to their problems. Our deep knowledge of the most important therapeutic areas, such as immunology, oncology and neurology, has allowed us to successfully represent our clients in the courtroom as well as the patent office, including against some of the industry’s most aggressive companies and institutions. Proskauer lawyers secured the very first inter partes review (IPR) institution decisions involving biosimilars and monoclonal antibodies.

Partners Sige Gutman (Chair) and Fangli Chen, Ph.D. (Vice Chair), head up this multi-office team with key areas of focus that include:

Litigation

The patent litigators on our team are experienced trial lawyers and have sophisticated backgrounds in relevant technologies, including molecular and cell biology, biochemistry, medicinal chemistry and pharmacology. We have substantial experience litigating patent cases in the district courts with the most active pharmaceutical dockets, including Delaware, New Jersey, Southern District of New York and Northern District of Illinois. We also have offices in New Jersey, New York, Illinois, Massachusetts, California and Florida — all of which are popular venues for life sciences patent litigation — which allows us to minimize expenses associated with local counsel representation. We know the judges in these districts very well.

Contested Patent Office Proceedings and IPRs

We represent both petitioners and patent owners in inter partes reviews (IPRs), where we have extensive experience driving strategy, addressing issues such as joinder and real parties-in-interest, taking and opposing discovery, taking and defending depositions, and arguing before the PTAB. We also have handled scores of inter partes and ex parte re-examination proceedings and interferences.

FDA Regulatory

The life sciences industry is among the most highly regulated. Accordingly, any comprehensive strategy for maintaining exclusivity or enhancing freedom-to-operate in the marketplace must include an FDA regulatory component. We have a wealth of experience developing arguments that form the bases of citizen petitions as well as responses to citizen petitions, particularly when patent litigation is on the horizon, or co-pending, and consistent messaging is of critical importance. We also are adept at developing strategies for drafting product labeling to either reduce or enhance the risk of indirect patent infringement, depending on whether our client desires to challenge or bolster market exclusivity.

Patent Prosecution and Counseling

Proskauer’s patent prosecutors focus on the strategic development of complex patent portfolios for our life sciences clients. We prepare and prosecute life sciences patent applications, including in the fields of biochemistry, molecular and cell biology, immunology, biochemical and molecular diagnostics, pharmaceuticals, microbiology, molecular genetics, pharmacogenomics, recombinant technologies, enzyme replacement therapy, gene therapy, bioinformatics, drug discovery, medical devices and chemistry. Our team effectively identifies and transforms technological developments into valuable intellectual property assets and specializes in the strategic development of complex IP portfolios that align with our clients’ business goals. We have substantial experience seeking and obtaining accelerated examination for our clients. We also conduct freedom-to-operate, infringement, invalidity and patent landscape analyses.

Technology Transactions and Licensing

Members of our life sciences patent practice help our clients identify targets for acquisition and licensing in order to strategically strengthen their own portfolios or create leverage for freedom-to-operate. We also perform due diligence investigations and otherwise participate in transactions in which patents may be a significant component, including corporate mergers and acquisitions, strategic alliances and technology development transactions.

Read about the latest intellectual property developments and cases impacting technology and life sciences companies in our New England IP Blog.

Representative Clients

  • Abraxis
  • Affymax 

  • Alethia Therapeutics
  • Amgen
  • A.P. Pharma

  • APP Pharmaceuticals
  • Aptalis

  • Ariad Pharmaceuticals

  • Boehringer Ingelheim

  • Celgene

  • Fresenius Kabi

  • Geron Corporation

  • Immunex

  • Momenta Pharmaceuticals

  • NeuroHabilitation

  • Novartis

  • Oxford Immunotec

  • Pall Corporation

  • Reliant Pharmaceuticals

  • Sanofi Pasteur

  • Shire

  • Vertex Pharmaceuticals

  • Watson Pharmaceuticals