Intellectual Property: Generic Pharmaceuticals and Biosimilars

Duane Morris lawyers have significant experience with the complexities involved in bringing generic pharmaceuticals to market, including issues related to patents, FDA regulation, litigation, inter partes review, products liability, trademarks and copyright, and life sciences.


Duane Morris is recognized as one of the United States’ most active law firms in terms of patent filing and protection. National publications, including U.S. News and World Report, have ranked Duane Morris among the leading law firms handling patents and patent-related issues. Clients rely on the specific knowledge of Duane Morris’ registered patent attorneys and agents to obtain patentability opinions, prepare and file U.S. patent applications in all subject matters and disciplines, and render validity and infringement opinions.

Our roster of attorneys includes patent lawyers and agents with science or engineering backgrounds, many with Ph.D.s and other advanced degrees in disciplines such as pharmacology, biology, biochemistry and medicine. Most also have significant industry experience, including:

  • Advanced materials
  • Biochemistry
  • Biotechnology
  • Pharmaceuticals
  • Abbreviated New Drug Application (ANDA)
  • Small molecule chemistry
  • Combinatorial chemistry
  • Formulations
  • Organic chemistry/synthetic pathways
  • Medical and mechanical devices
  • Nanotechnology
  • Genetics biochemistry and biotechnology

Biochemistry and Biotechnology

With respect to biologic drugs, our registered patent attorneys and agents have experience related to recombinant protein and antibody engineering technologies, rationally designed polypeptides and polynucleotides, production of biologic drugs, targeted drug delivery, and optimization and humanization of immunotherapeutics, to name a few. Duane Morris’ attorneys are skilled in evaluating the impact of third party intellectual property and legal developments on intellectual property strategy for biologic and biosimilar products. Our pharmaceutical team has experience in areas related to biologic drugs, including:

  • Immunology
  • Antibody engineering, rational antibody design and phage display
  • Therapeutic recombinant polypeptides and fusion proteins
  • Production of recombinant biologic drugs
  • Bioprocessing technologies for recombinant antibodies and proteins
  • Posttranslational modification and glycosylation
  • Oncology
  • Signal transduction and receptor/ligand interactions
  • Pharmacogenomics and companion diagnostics
  • Inflammation, including TNF-alpha
  • Reproductive biology
  • Recombinant monoclonals (mAb), scFV, SMIP, murine Ab, chimeric recombinant Ab, fully Human Ab phage display synthetic Ab and CRD grafted Ab
  • Genetic engineering and expression systems
  • Stem cell technologies, including neuroregenerative methods and treatment
  • Regenerative medicine and stem cell technology
  • Vaccine development
  • Epigenetics including histone acetylation

Duane Morris’ Patent Watch Program

We have collaborated with clients over the years to offer on-point, targeted solutions to assist in their efforts to increase efficiencies. Duane Morris’ Patent Watch Program (PWP) provides an in-depth review of the happenings at the PTO and FDA to keep clients apprised of any major developments. This allows key deadlines and timing parameters to be met more efficiently.

FDA Regulation of Generic Pharmaceuticals and Biosimilars

Duane Morris lawyers advise clients on how to bring generic drugs 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 abbreviated and 505(b)(2) application processes, labeling, patent certifications, 180-day exclusivity provisions, the scope of various non-patent exclusivity provisions, and REMS. We also provide counseling on FDA’s regulation of biosimilars under the Biologics Price Competition & Innovation Act of 2009 (BPCIA), which represents new opportunities to bring lower-cost safe and effective biologics to the market by leveraging prior FDA approvals of innovator biopharmaceuticals, as well as the litigation framework created by BPCIA.

Hatch-Waxman Litigation

Our attorneys handle multibillion-dollar, market-defining pharmaceutical patent litigations for global pharmaceutical manufacturers. Duane Morris’ intellectual property litigation practice is distinct in that our attorneys have decades of experience in trying cases to verdict, including those in the chemical/pharmaceutical arts. Our clients benefit from this perspective and insight, which can only be gained from years of “on-the-ground” patent trial experience in virtually every major jurisdiction in the United States.

Inter Partes Review

Our IP team uses its extensive trial experience as lead counsel in litigation before federal courts and unique trial experience within the U.S. Patent and Trademark Office (USPTO) to help clients take advantage of, and respond to, the inter partes review (IPR) procedure before the U.S. Patent Trial and Appeal Board. Introduced by the America Invents Act (AIA) in 2012, IPR allows a petitioner to challenge the propriety of a patent claim after it has been granted by the USPTO. This increasingly important strategy—a majority of filings at the USPTO are currently in parallel litigation—is viewed as a less costly and a more expeditious method than litigation in federal district court. Filing for IPR may also provide leverage in settlement negotiations, and often proceeds more expeditiously than traditional Hatch-Waxman litigation.

Trademark, Copyright, Entertainment and Advertising

Duane Morris’ full-service Trademark, Copyright, Entertainment and Advertising practice provides clients with day-to-day counseling regarding selection, procurement, registration, licensing and enforcement of their trademarks and copyrights on a worldwide level. We prosecute, maintain and manage nearly 20,000 trademarks for hundreds of clients in more than 200 jurisdictions, earning rankings and recognition from a number of publications, including Managing Intellectual Property and World Trademark Review.  

Recognizing that there is no one-size-fits-all approach to procuring, maintaining, enforcing and commercializing trademarks and copyrights, Duane Morris attorneys understand our clients’ businesses and competitive landscapes. This enables us to collaborate with clients to develop best practices that suit their portfolios and business needs.  

We have extensive experience in all facets of trademark and copyright law and have the insight and legal skills to advise clients in a variety of industries, including:

  • Consumer products
  • Technology
  • Entertainment, gaming and sports
  • Financial services
  • Hospitality
  • Life sciences, medical devices and pharmaceuticals
  • Professional services
  • Restaurants, food and beverage
  • Retail, fashion and luxury goods
  • Education

Products Liability and Toxic Torts

Duane Morris has many lawyers with extensive trial experience in the products liability and toxic torts arenas. Our attorneys have counseled generic drug companies on issues of failure-to-warn, improper design and consumer protection statutes, as well as the federal preemption of such claims. We have represented generic drug clients on labeling and marketing matters in the preparation of licensing, manufacturing and supply agreements; joint venture, confidentiality and non-disclosure agreements; and interactions with the FDA.

Life Sciences

Duane Morris attorneys understand the issues that innovators in the life sciences industry face from every angle: from the science and technology, to the business realities, to potential legal challenges. We know because we have been there. Many of our life science attorneys have been in-house counsel at life sciences companies and/or have worked as scientists in research laboratories.

For Additional Information

For more information, please contact Vincent L. Capuano, Ph.D. or any of the lawyers referenced in the Attorney Listing.

Representative Matters