Hatch-Waxman Litigation

 


Blank Rome attorneys regularly advise multinational life science companies on the various stages of product development, including all aspects of Hatch-Waxman litigation. Members of our Hatch-Waxman practice include lawyers with advanced degrees in areas such as pharmacology, biomedical engineering, and organic chemistry, and former agency officials with regulatory and antitrust experience. This potent combination of technical, legal, and regulatory experience allows us to offer effective, comprehensive advice and guidance on all aspects of Hatch-Waxman matters. We also help life science 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.

For products in pharmaceutical development, we work with our life science clients at each stage of development to identify inventions worthy of patent protection, and prepare and prosecute patent applications for these inventions. We have successfully prosecuted numerous patents directed to pharmaceuticals products and method of treatment, which have been listed in the FDA Orange Book and asserted. Additionally, we work with life science clients to develop the most economical approach for commercializing a generic product.

We also understand that not all patent litigation for our life science clients is the same. Nowadays, it is not unheard of to have ten or more first filers for a product, which can obviously have a significant economic impact for a specific generic product. As a result, we work closely with our clients' legal and technical personnel and senior management to understand and meet their specific needs in developing a strategy for generic pharmaceutical litigation. Our frequent client contact allows us to stay on top of our clients' current and future business plans, allowing us to recommend strategies to enhance their intellectual property positions while minimizing costs where appropriate. Similarly, where we need to be aggressive to get a product on the market, our attorneys know how to apply pressure and aggressively litigate through trial and appeal.

For each of our life science clients, we have extensive expertise with the following:

  • procurement of patents for pharmaceuticals, biologics, and medical devices;
  • pre-litigation patent strategy and counseling on potential pharmaceutical products, including identification of potential targets for Paragraph IV certifications, including analysis of Orange Book patents;
  • advising on the statutory and regulatory scheme governing FDA approval of patented and generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation;
  • rendering of non-infringement, invalidity, and freedom-to-operate patent opinions and Paragraph IV notice letters, as well as continued monitoring of generic competition and potential late-listed patents;
  • representation in proceedings before the U.S. Patent and Trademark Office, such as inter partes reviews and interferences; and
  • handling all aspects of Paragraph IV ANDA litigation in pharmaceutical and biotech patent cases in federal courts and before the U.S. Patent and Trademark Office, including claim construction ("Markman") hearings and patent litigation trials and appeals.

Select Engagements in Hatch-Waxman Litigation

  • 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.
  • Lead defense counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of pemetrexed (Alimta®) (S.D.Ind. 2014).
  • Lead defense counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of mycophenolate (Myfortic®) (D.Del. 2014).
  • Lead defense counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of bortezomib (Velcade®) (D.Del. 2014).
  • Lead defense counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of clofarabine (Clolar®) (D.N.J. 2014).
  • Lead defense counsel for a generic pharmaceutical client in two separately filed Hatch-Waxman litigations involving a generic version of propofol (Diprivan®) (D.N.J. 2014; D.Del. 2014).
  • Lead defense counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of aripiprazole (ABILIFY®) (D.N.J. 2014).
  • Lead defense counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of lacosamide (Vimpat®) (D.Del. 2013).
  • Lead defense counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of pioglitazone (ACTOS®) (S.D.N.Y. 2009).
  • Lead defense counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of ranitidine oral syrup (Zantac®) (D.N.J. 2008).
  • 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® (D.N.J. 2007).
  • Lead defense counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of omeprazole (Prilosec®) (S.D.N.Y. 2007).
  • Lead counsel for a developer of pharmaceutical-type supplements in a patent infringement case seeking declaratory judgment relief in connection with a nutritional supplement (E.D. Tex. 2006).
  • Lead counsel for a generic pharmaceutical client in a Hatch-Waxman litigation seeking declaratory judgment relief in connection with a generic version of rilutek (Riluzole®) (D. Del. 2004).
  • Defense co-counsel for a generic pharmaceutical client in a Hatch-Waxman litigation (where our client was the only first-filer) involving a generic version of the blockbuster drug, ezetimibe (Zetia®) (D.N.J 2007).
  • Defense co-counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of quetiapine fumarate (Seroquel XR®) (D.N.J 2008).
  • Defense co-counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of zoledronic acid (Zometa®) (D.N.J. 2012).
  • 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®) (D.N.J 2012; D.N.J. 2014).
  • Defense co-counsel for a specialty pharmaceutical company in a Hatch-Waxman litigation involving a generic version of methotrexate (Rasuvo®) (D.N.J. 2014).
  • Defense co-counsel for a generic pharmaceutical client in a Hatch-Waxman litigation involving a generic version of bendamustine (Treanda®) (D.Del. 2014).


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