Experience

Pharmaceutical

About

Pharmaceutical is part of our work in Life Sciences.

Breakthrough discoveries and innovations require strong protection

People rely on the pharmaceutical industry for life-saving drugs and treatments, as well as those that improve the quality of life. Even with billions of dollars invested in research and development, few drugs make it through clinical trials and stringent regulatory clearances necessary to get to market. For those that do, it is crucial that the companies have protected the intellectual property (IP) underlying new drugs and treatments. Finnegan has a long history of working with innovative pharmaceutical companies to protect and maximize their valuable IP rights and assets, strategizing prosecution pathways and portfolio planning.

Understanding the law, science, and technology

Our clients’ business and IP assets are global; protecting these assets across jurisdictions is increasingly challenging. With offices around the world and experience with multinational companies, Finnegan has the resources and experience to formulate and execute global strategies for pharmaceutical companies. The fast pace of new discoveries and their commercial applications require a comprehensive grasp of the IP legal issues and the industry insight to understand the scientific and strategic implications of the advancements.

With experience addressing virtually every type of IP issue for our pharmaceutical clients, we help by:

Representing clients in complex pharmaceutical patent infringement and trade secret cases, including Hatch-Waxman litigation
Litigating high value products in district and appellate courts with experienced trial and appellate teams
Developing and executing prosecution strategies to both protect a client’s products and analyze those of its competitors, thus helping ensure that the client realizes value from its IP assets
Preparing and negotiating licenses, assessing the licensing value of competitors’ patents, and guiding clients in decisions to license
Providing due diligence for merger and acquisition and partnership targets
Providing counsel on business-related matters, including antitrust and competition issues
Determining priority in complex interferences
Advising on potential litigation strategies, and asserting and defending patents in court
Providing trademark prosecution and counseling services

We work with clients innovating and advancing science in myriad fields, including:

Antibody therapies—small and large molecules
Atypical antipsychotic drugs
Sustained-release formulations
Vaccines

Everyone in this industry

Experience

Finnegan is lead and preferred IP transactions counsel for one of the largest pharmaceutical companies in the world, handling more than 50 diligence projects each year, including all IP and related transactional aspects of the matters. The transactions span the full gamut of technologies from small molecule through biologics such as antibodies, oligonucleotides, and gene therapies. Finnegan also provides extensive assistance with post-deal integration procedures and subsequent global prosecution and portfolio strategy, ensuring a seamless transition of IP assets to the company and maximum value from acquired IP.

Finnegan is lead and preferred IP strategy counsel for one of the largest pharmaceutical companies in the world, handling all aspects of prosecution and portfolio management for multiple top-tier products for the client. The work spans the gamut from drafting and prosecution through larger strategic planning, patent term extension, and pre-litigation preparation on blockbuster small molecule and biologic products in the oncology, rheumatology, immunology, neuromuscular, and cell and gene therapy spaces.

Finnegan represented Bausch & Lomb’s licensee Eye Therapies, LLC in an appeal at the U.S. Court of Appeals for the Federal Circuit from a Patent Trial and Appeal Board (PTAB) decision finding Eye Therapies’ patent directed to a low-dose brimonidine treatment for eye redness (Lumify®) to be unpatentable. In a precedential decision, the Federal Circuit agreed with Finnegan’s arguments and found that the Board had wrongly invalidated the patent based on an incorrect claim construction, vacating and remanding the case back to the PTAB. The proceeding settled shortly thereafter

23-2173, Fed. Cir., Judges Taranto, Stoll, Scarsi

Successfully represented Bausch & Lomb and Eye Therapies in a Hatch-Waxman patent infringement litigation and parallel PTAB challenges concerning an ANDA for generic versions of over-the-counter Lumify® ocular drops. The cases settled favorably for our clients.

3:21-cv-16766, D.N.J., Judges Kirsch, Singh
IPR2022-00146, PTAB, Judges Hulse, New, Pollock
IPR2024-00467, PTAB, Judges Flax, Pollock, Yang
IPR2022-00142, PTAB, Judges Flax, Hulse, New, Pollock

Represented Bausch Health et al. in Abbreviated New Drug Application (ANDA) litigation involving Trulance® (plecanatide) tablets for the treatment of irritable bowel syndrome and chronic idiopathic constipation, resulting in favorable settlement post-trial.

2:23-cv-00170, D.N.J., Judge Chesler
1:21-cv-00611, D. Del., Judge Stark
1:22-cv-00085, N.D.W. Va., Judge Kleeh
2:21-cv-00573, W.D. Pa., Judges Cercone, Hardy
1:22-cv-00020, N.D.W. Va., Judge Kleeh
2:21-cv-10057, D.N.J., Judge Chesler
2:21-cv-10403, D.N.J., Judge Chesler
2:23-cv-03333, D.N.J., Judge Chesler
1:24-cv-00036, N.D.W. Va., Judge Kleeh
2:24-cv-07182, D.N.J., Judge Chesler
2:24-cv-11179, D.N.J., Judge Chesler
1:25-cv-00003, N.D.W. Va., Judge Kleeh
IPR2023-00016, PTAB, Judges Hardman, Hulse, Valek
IPR2022-00722, - 01102, -01103, -01104, -01105, PTAB, Judges Hardman, Hulse, Snedden, Valek

Representing Mitsubishi Tanabe Pharma in litigation matters related to Radicava ORS (edaravone) used to treat patients with amyotrophic lateral sclerosis (ALS).

2:25-cv-03326, D.N.J., Judge Cecchi
1:23-cv-00759, D. Del., Judges Burke, Connolly, Hall
1:24-cv-01423, D. Del., Judge Hall
1:24-cv-00549, D. Del., Judge Hall