Pharmaceuticals and Biopharmaceuticals Litigation and Regulatory

The pharmaceutical, biotechnology, medical device and pharmacy industries have far-reaching scope and are integral to our daily lives. Duane Morris attorneys counsel clients in these industries on IP and regulatory matters in virtually all aspects of their business and at all stages of the client’s product lifecycle, from product selection and bringing new products to market to maintaining pharmacovigilance and regulatory compliance to due diligence on products to be acquired.

Duane Morris has a proven track record of success helping clients in the pharmaceutical and biotechnology industries create coordinated IP and regulatory strategies for products in development, and then implementing those strategies to get products on the market as quickly and efficiently as possible. This holistic approach is focused on solutions that achieve our clients’ business goals. We deliver value to our clients by assisting them in developing unique patent or regulatory strategies to gain a competitive advantage in the marketplace.

Pharmaceutical and Biotechnology IP Strategy and Litigation

We have significant experience helping clients in the biotechnology and pharmaceutical industries to resolve trade secret and patent infringement matters, and developing best practices and strategies for protection of intellectual property to help our clients favorably position themselves within their respective fields. The technical and legal experience of the attorneys in the IP Pharmaceutical group is an invaluable resource to help companies avoid, resolve and where necessary litigate disputes over theft and ownership of intellectual property rights, including rights to trade secrets, patent rights and rights to use of biological material. 

Our attorneys handle market-defining pharmaceutical patent litigations for global pharmaceutical manufacturers with decades of experience in trying cases to verdict in industry-defining cases. Many of the best results achieved for our clients, however, were accomplished through resolution before litigation, unique patent and regulatory strategies, and favorable settlements that did not require taking a case all the way through trial. Our clients benefit from this perspective and insight, which can only be gained from years of “on-the-ground” experience in patent trials in virtually every major jurisdiction in the United States. 

Duane Morris has established itself as a market leader for inter partes review (IPR) petitions before the Patent Trial and Appeal Board (PTAB). Especially in the pharmaceutical industry, IPRs can present a strong strategy option in the right scenario. We have helped many clients achieve business objectives that may not have otherwise been possible by counseling on strategic timing and choices of patents to challenge through an IPR petition. Our attorneys are experienced in the nuanced intricacies of IPR practice that make for a successful challenge or defense of a patent in front of the PTAB.

Hatch-Waxman Practice and Litigation

Duane Morris lawyers can help clients identify the best regulatory pathway and patent strategy to bring a product to market under the Hatch-Waxman amendments to the Federal Food, Drug and Cosmetic Act. We counsel on drug approvals and market entry strategies—including Abbreviated New Drug Applications (ANDAs), 505(b)(2) NDAs and ANDA suitability petitions—working through answers to questions related to eligibility for the various approval pathways, labeling, patent certifications, the scope of various nonpatent exclusivity provisions and Risk Evaluation and Mitigation Strategies (REMs).

Biologics and Biosimilars (BPCIA)

Biologics and biosimilars products have provided many new opportunities for life sciences companies to develop a product in a multibillion dollar market. Under the Biologics Price Competition and Innovation Act (BPCIA), the pathway for approval of biosimilars in the United States has developed over the last few years, presenting both challenges and opportunities. Our attorneys provide advice on leveraging clients’ technical strengths and capabilities to take advantage of the opportunities in this still developing market. 

Regulatory Advice and Counseling

In the pharmaceutical industry, a holistic approach to successful IP strategies necessarily includes regulatory matters involving agencies such as FDA, DEA and state boards of pharmacy. We assist pharmaceutical manufacturers and compounding pharmacies with regulatory compliance and investigations, and help develop policies that avoid regulatory pitfalls that can interfere with an otherwise successful IP strategy.     

Antitrust

The pharmaceutical industry is under a microscope more than ever in terms of pricing and overall healthcare costs to consumers. This scrutiny can often give rise to potential antitrust issues. Our attorneys are well-versed in the business of the pharmaceutical industry, and have a depth of knowledge from which to advise clients on avoiding pitfalls of potential antitrust concerns, and also affirmatively seeking remedies from potential antitrust violations from others in the industry.

Technical Experience and Capabilities

Our attorneys collectively have an extraordinary depth of technical insight and practical industry experience in many areas, including chemistry, chemical engineering, organic chemistry, biochemistry, biophysics, pharmacology, pharmacy, molecular biology, genetics, genomics and bioinformatics. 

For Additional Information

For more information, please contact Patrick C. Gallagher, Ph.D., Frederick R. Ball or any of the lawyers referenced in the Attorney Listing.

Representative Matters