RatnerPrestia works closely with clients in the pharmaceutical and biopharma sectors to provide the counseling and support they need to secure IP protection and develop sound business strategies for their products. Our clients range from start-ups to large multinational pharmaceutical companies and also include universities, API manufacturers, medical device manufacturers, and formulation companies specializing in drug delivery technology. We have education, training, and experience in such diverse areas as medicinal chemistry, biochemistry, immunology, oncology, biotechnology, cell and molecular biology, pharmacology, pharmaceutical science, and chemical engineering. In addition, our professionals have university and industry experience in research and development, business operations, and legal departments in the pharmaceutical field, and our attorneys regularly handle a wide variety of complex patent matters in the pharmaceutical field, including:

• Strategic portfolio planning and management, including advice on product lifecycle management and implementation of advanced, cutting-edge patent prosecution strategies to harvest and protect clients’ innovations.
• Specific life-cycle strategies regarding new indications, polymorphs, metabolites, and formulations.
• Advice to help clients assess the inherent risks in developing and marketing new pharmaceuticals
• Patent landscape searches and analyses of patents covering specific technologies in the pharmaceutical space.
• Freedom-to-operate assessments and counseling to minimize commercial risk and provide a level of confidence regarding third party patent positions.
• Patent validity opinions and infringement opinions.
• Assessment of the potential licensing value of third party patents and guidance regarding decisions to license.
• Due diligence and risk assessments in connection with licensing, M&A, and other business transactions.
• Preparation and negotiation of license agreements, research agreements, co-development agreements, and other commercial agreements.
• Strategic advice regarding potential litigation, including:
  • Hatch-Waxman Paragraph IV certifications.
  • Biosimilar notification procedures and exchange of patent information under the Biologic Price Competition and Innovation Act (BPCIA).
• Full Litigation services, including representing clients as Delaware counsel in complex Hatch-Waxman litigation.
• Advice and representation of clients in the various Patent Office procedures for contesting patent validity, such as inter partes reviews (IPRs) and post-grant reviews (PGRs).
• Pre-litigation due diligence.
• Expertise regarding issues at the interface of patent law and FDA regulatory law.
• Assessments and counseling regarding non-patent exclusivities.
• Trademark prosecution and counseling services.

In terms of technical subject matter, our work in the pharma sector routinely includes:

• Small molecule pharmaceuticals, including chemotherapeutics, antivirals, and antibiotics.
• Biologics, including antibodies, vaccines, and biosimilars.
• Organic synthesis and purification of active pharmaceutical ingredients (APIs).
• Genetic engineering.
• Delivery systems for APIs.
• Pharmaceutical formulations, including sustained-release products.
• New polymorphs.
• Excipient preparation and processing.
• Methods of treatment.
• New dosage regimens.
• Combination products.
• Chemical and biotech process technology.
• Diagnostics.
• Medical devices.