Hatch-Waxman Litigation: the Fish & Richardson Differential

Pharmaceutical litigation at Fish & Richardson

Fish & Richardson is distinct from other law firms in three critical respects: history, experience, and knowledge. We have been litigating patent cases since the 19th century, when our founders represented Thomas Edison and Alexander Graham Bell. It is probably safe to say we have the most institutional patent litigation knowledge of any firm, and year after year surveys indicate we handle more patent litigation than any other firm in the country. And not surprisingly we have more PhD’s – 80 as of this writing – and Federal Circuit clerks – 30 – than any other firm.

For well over a century Fish & Richardson has been helping pharmaceutical and other life sciences clients through waves of change within their industries and counseling them on the respective laws and governing regulations. This brochure highlights some of the legal strategies and techniques that we deploy to leverage our advantages – our unrivaled patent litigation experience, our noteworthy PhD’s, our regulatory experts, our patent prosecutors, and our former Federal Circuit clerks – in the service of our pharmaceutical and life sciences clients facing challenges under Hatch-Waxman.

Protecting our clients’ intellectual property and market share through a unique multidisciplinary team approach

Throughout our history we have maintained a simple but deeply rooted objective: protecting our clients’ intellectual property to allow them to maximize their market share and obtain a fair return on their hard work, investment, and innovation.

We do this by taking a unique team approach. In the Hatch-Waxman context this means that from the earliest stages we bring together litigators, patent prosecutors, and regulatory experts to strategize the best course of action to achieve our clients’ objectives. We draw upon our PhD’s and Federal Circuit clerks for insight into the underlying science and broader legal issues.

This fully integrated approach – everything from pre-suit investigations to PTO actions, Orange Book tactics and FDA affairs – has proven invaluable to our clients in pharmaceutical litigation.

The rules have changed

Where biological and pharmaceutical products are involved, disputes can frequently involve complex subject matter and interrelated areas of law. Decisions made in a patent dispute can implicate a company’s bottom line in not immediately foreseeable ways. It is vital for a life sciences company in a competitive sector to retain counsel that understands the broader legal, scientific, and regulatory landscape in which the company operates.

Maximizing market exclusivity

Fish & Richardson attorneys have successfully tried numerous high-profile biopharma cases. Because we place Hatch-Waxman issues properly into the broader context of pharmaceutical competition and the regulatory and commercial infrastructure of drug innovation, we employ a multidisciplinary legal strategy for maximizing market exclusivity for clients. Indeed, sometimes solutions to Hatch-Waxman disputes can come from outside the Hatch-Waxman framework.

Biopharma and pharmaceutical litigation experience

Biopharma and Hatch-Waxman litigation evolved dramatically over the early years of the 21st century. Clients of Fish & Richardson know they can rely on the world’s most experienced patent litigators to handle their cases. Because of our unmatched volume of patent litigation experience, we have deep institutional knowledge and insight into translating the language of patents and FDA applications into a language judges and juries can understand.

Fish & Richardson attorneys have litigated Hatch-Waxman and other patent cases for leading pharmaceutical companies. A sampling of our attorneys’ biopharma litigation experience:



  • Multiple ANDA and paper NDA litigations over the glaucoma medications ALPHAGAN and ALPHAGAN P
  • Multiple ANDA litigations over the pain medication OXYCONTIN
  • Multiple ANDA litigations over the transdermal nitroglycerin patch NITRO-DUR
  • Multiple ANDA litigations over the hepatitis C drug REBETOL
  • Multiple ANDA litigations over the attention-deficit drug FOCALIN
  • ANDA litigation over the antinausea agent ZOFRAN
  • ANDA litigation over the antischizophrenia agent ABILIFY
  • ANDA litigation over the hepatitis C drug ribavirin


Other pharmaceutical related litigation


  • Rheumatoid arthritis drug ORENCIA
  • Second-generation pegylated interferon alpha-2b PEG-INTRON
  • Pegylated liposomal doxorubicin DOXIL
  • Cell lines used to manufacture the highly publicized cancer drug ERBITUX
  • First-marketed CFC-free metered-dose inhaler formulations VENTOLIN HFA and QVAR
  • Metabolic tests for IMURAN and other 6-mercaptopurine drugs
  • Process for manufacturing chemical intermediate tic-d for making anti-AIDS protease inhibitors saquinavir and nelfinavir
  • Cataract medication diclofenac
  • Patents covering a modified tissue plasminogen activator used as a thrombolytic agent in acute myocardial infarction
  • Patents covering transgenic animals and cell lines having the well-known Swedish mutation, used for the discovery of potential Alzheimer’s disease therapeutics


Over a century at the forefront of evolutionary change in technology and patent law

Since the earliest days of the industrial and technological revolutions, Fish & Richardson has been at the center of the patent litigation world.

Today the small-molecule business is clearly changing. Biologics are on the rise. A new genomic and proteomic era has begun. The cutting-edge discussions about human health presume that a transformative level of custom medicine and systems biology is in our very near future.

Traditional small-molecule pharmaceutical companies – which have done so much to benefit mankind – are changing, adapting, as they must. And Fish & Richardson, led for over a century by principles of integrity, hard work, creativity and deep respect for innovation, has responded.

Biopharma client stories

Below are two “Biopharma client stories” that detail creative Fish & Richardson solutions to common Hatch-Waxman problems.

Early stage Orange Book strategy comes into play in ANDA litigation
We represented a branded drug company facing generic competition on a key product. Relying on our multidisciplinary expertise and technical knowledge of the underlying patent rights, we counseled the company on an aggressive posture with respect to Orange Book patent listing and, subsequently, advanced an equally novel theory of infringement in district court. During the litigation, we counseled the client on its withdrawal of the listed drug in favor of a new formulation that was protected by three-year Hatch-Waxman exclusivity. We then assisted the client in the subsequent citizen petition filed by the generic manufacturer on the withdrawal issues while, at the same time, the FDA awaited a ruling by the Federal Circuit on the novel issues raised in litigation before approving any ANDAs. Thus, through a combination of litigation acumen and regulatory strategies, we assisted our client in lawfully dealing with the challenge of generic competition, thereby allowing our client to maximize its market opportunities through the assertion of its underlying patent rights.

Technical mastery fends off a “citizen petition”
We represented a manufacturer endeavoring to bring a low-cost version of an “old antibiotic” to market. The manufacturer retained Fish to navigate the difficult regulatory approval process and defend any litigation that might arise. When the original drug manufacturer sought to extend its market exclusivity with a blocking maneuver before the FDA and a threat of related patent litigation, our multidisciplinary team devised a creative counterstrategy for the client. Relying on our deep understanding of the drug’s complex chemistry (provided by our in-house PhD’s), we devised a two-pronged approach: first, to avoid claims of infringement, we presented the FDA with a novel patent carve-out theory to alter the client’s drug label; and second, to end-run a regulatory stalling tactic, Fish attorneys presented the FDA staff with what was essentially a mini-trial on the issues, which ultimately resulted in swift approval of the client’s product.