Life Sciences - Intellectual Property

Overview

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.

Experience

  • Represented Glenmark Generics, in a patent interference with another generic pharmaceutical company. Blank Rome successfully invalidated all of the other generic pharmaceutical company’s patent claims in the interference. 
  • Represented Ascio Pharmaceuticals, Inc., in a declaratory judgment action against Three Rivers Pharmaceuticals, LLC, which was filed on the day the Three Rivers’ patent was issued. Within a week, Blank Rome also filed two summary judgment motions seeking findings of invalidity and unenforceability. The case settled favorably for our client.
  • Represented Glenmark Generics Inc., U.S.A., in a Hatch-Waxman litigation (where Glenmark was the only first-filer) over the blockbuster drug ezetimibe (Zetia®) obtaining a favorable settlement for Glenmark on the eve of trial, and successfully invalidating key claims of the patent on summary judgment.
  • Represented Axcan Pharma (now known as Aptalis Pharma), in an intellectual property due diligence review resulting in the $583 million acquisition of Eurand N.V.
  • Represented a brand name pharmaceutical companies in patent prosecution matters. Successfully prosecuted patents listed in the FDA Orange Book covering brand name products and their use.

Hatch-Waxman Litigation

Blank Rome has acted as lead defense counsel for generic pharmaceutical clients in numerous Hatch-Waxman litigation cases, including those involving:

  • A generic version of lurasidone (Latuda®)
  • A generic version of pemetrexed (Alimta®)
  • A generic version of mycophenolate (Myfortic®)
  • A generic version of bortezomib (Velcade®)
  • A generic version of clofarabine (Clolar®)
  • A generic version of propofol (Diprivan®)
  • A generic version of aripiprazole(ABILIFY®)
  • A generic version of lacosamide (Vimpat®)
  • A generic version of pioglitazone (ACTOS®)
  • A generic version of ranitidine oral syrup (Zantac®)
  • A generic version of omeprazole (Prilosec®)
  • A generic version of rilutek (Riluzole®) (D. Del.  2004)

Blank Rome has acted as defense co-counsel for generic pharmaceutical clients in numerous Hatch-Waxman litigation cases, including those involving:

  • A generic version of ezetimibe (Zetia®);
  • A generic version of bendamustine (Treanda®);
  • A generic version of zoledronic acid (Zometa®); and
  • A generic version of quetiapine fumarate (Seroquel XR®).

Other Hatch-Waxman Litigation Representations

  • Acted as lead counsel for a generic pharmaceutical client in a patent interference filed with the U.S. Patent and Trademark Office against another generic pharmaceutical company regarding the drug aprepitant. 
  • Acted as lead counsel for a developer of pharmaceutical-type supplements in a patent infringement case seeking declaratory judgment relief in connection with a nutritional supplement.
  • Acted as lead defense counsel for a generic pharmaceutical client in a patent infringement litigation brought by Teva Pharmaceuticals USA, Inc. involving a generic version of Pfizer Inc.’s blockbuster depression drug, Zoloft®.
  • Served as co-counsel for a biotechnology company in three separately filed Hatch-Waxman litigations seeking declaratory judgment relief in connection with a generic version of treprostinil sodium (Remoudulin®).
  • Served as defense co-counsel for a specialty pharmaceutical company in a Hatch-Waxman litigation involving a generic version of methotrexate (Rasuvo®).