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Pharmaceuticals and Biosimilars

Leydig is exceptionally poised as a resource in traditional pharmaceuticals and cutting-edge biosimilars. At Leydig, we recognize that advancements in pharmaceuticals and biosimilars not only transform lives, but are also critical to the companies that devote millions of dollars and years of research in developing and bringing products to market. Whether such endeavors are profitable or simply a dead end depends on how effectively the company navigates through the complex legal and regulatory framework that essentially governs the industry. The quality of intellectual property counsel retained is essential to the success of such efforts.

At Leydig, our robust patent practice in pharmaceuticals and biosimilars is an invaluable resource for those seeking to maximize the return on their substantial investment in these technologies. For multinational pharmaceutical companies and biosimilar startups alike, Leydig’s professionals – many have advanced degrees and extensive backgrounds in pharmaceuticals and biotechnologies – provide the depth of legal and technical expertise needed to develop strategies best suited to accomplishing clients’ objectives.

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Leydig’s considerable experience in representing pharmaceutical companies in the development and patenting of new products and treatment methods, as well as our long history of representing generic drug and biosimilar manufacturers, provides us with invaluable insights on all aspects of establishing, enforcing, and challenging patent rights across the globe.  Leydig represents clients in all facets of patent law across the entire spectrum of pharmaceutical products, including those related to:

  • Investigational new drug applications
  • New drug applications
  • Abbreviated new drug applications
  • 505(b)(2) applications
  • Animal drug applications
  • Biologic licensing applications
  • Biosimilar 351(k) applications

A significant part of our pharmaceutical practice involves representing clients in the generic drug industry in matters arising under the Hatch-Waxman Act. For decades, Leydig has paved the way for pharmaceutical companies to obtain approval for generic versions of branded drugs ranging from niche-market drugs to blockbusters.

Our professionals have a recognized expertise in litigation in the U.S. courts, and in inter partes reviews, reissues, post-grant reviews, and derivation proceedings before the U.S. Patent and Trademark Office. We also represent clients internationally in opposition, enforcement and invalidity proceedings before non-U.S. tribunals in cooperation with our numerous international colleagues.

On the innovation side, we structure and manage patent portfolios, and draft and prosecute patent applications, covering small molecules (including organic synthesis), biologics, medical devices, membranes and polymers (biological and synthetic), providing clients with an integrated business approach that extends throughout the product lifecycle.

Our services also include providing legal opinions concerning freedom-to-operate (infringement clearance), patent validity, and patent enforceability; handling intellectual property due diligence investigations, such as those associated with technology and company acquisitions, financing, and the like; consulting on license agreements; and preparing patent landscape reports.

Pharmaceuticals and Biosimilars

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Managing IP