Intellectual property is the lifeblood of businesses in the life sciences industry: obtaining, protecting, and monetizing IP assets is essential to maintaining or gaining a competitive foothold in the market.
Our IP attorneys include PharmDs and PhDs with extensive experience advising life sciences clients with legal issues affecting brand name and generic drug companies in patent counseling, opinions, prosecution, licensing transactions, Abbreviated New Drug Application (“ANDA”) litigation, and the Biologics Price Competition and Innovation Act.
For pharmaceutical products in development, we work with our clients to identify inventions worthy of patent protection, and we prepare and prosecute patent applications for those inventions that have been listed in the FDA Orange Book and asserted. We work with you to understand your current and future business needs, allowing us to recommend strategies to enhance your IP positions and minimize costs.
We also advise generic pharmaceutical companies on developing the most economical approach for commercializing their products. It is not unusual to have multiple filers for a generic product, which can have a significant economic impact. We take this into account when developing a strategy for generic pharmaceutical litigation. Similarly, where we need to move aggressively to get to market, our attorneys know how to apply pressure and litigate through trial and appeal.
Blank Rome has earned a reputation as one of the country’s top law firms in intellectual property. 2019 U.S. News & World Report—Best Lawyers (Woodward/White, Inc.) ranked the Firm Tier 2 in Litigation – Intellectual Property, Litigation – Patent, Patent Law, and Trademark Law. 2011–2017 World Trademark Review (Globe Business Media Group) also recognized the Firm for its trademark practice.
How We Can Help
- procurement of patents for pharmaceuticals, biologics, and medical devices
- identification of potential targets for paragraph IV certifications, including analysis of Orange Book patents and analysis of generic competition for near-term paragraph IV submissions
- rendering of non-infringement, invalidity, and freedom-to-operate opinions with respect to the paragraph IV target selection, as well as continued monitoring of generic competition and potential late-listed patents
- trial and litigation in pharmaceutical and biotech patent cases in federal courts
- U.S. Patent Office proceedings, such as inter partes reviews and interferences
- managing strategic acquisition of IP rights to resolve and avoid litigation
We also help life sciences companies grow through technology transfer transactions, including patent and technology licenses, CRADAs, MTAs and sponsored agreements, co-development and joint marketing agreements, and manufacturing agreements.
What Sets Us Apart
- We add value for our clients by leveraging relationships within the life sciences and financial industries, as well as the government, to facilitate key introductions that create business opportunities and solve problems.
- Our life sciences industry team is bolstered by a deep bench of recognized intellectual property leaders with significant experience in acquiring, defending, enforcing, and invalidating medical device and pharmaceutical patents.
- We have achieved numerous wins in high-profile life science disputes and have extensive trial and appellate experience in federal and state courts across the country.
- We advise on compliance strategies with respect to global data protection laws and the processing of human biological samples, including transparency initiatives in clinical research.