Hatch-Waxman/ANDA Litigation

Hatch-Waxman/ANDA Litigation

Our Hatch-Waxman/ANDA team has decades of experience litigating cases for some of the largest innovative pharmaceutical companies in the world, mid-sized pharmaceutical companies, and companies starting out with their first U.S. product. We have deep experience guiding our innovator clients through the intricacies of the Hatch-Waxman Act and federal court litigation. Our Hatch-Waxman litigation approach is founded on collaboration and team work with our clients. Our practice includes a substantial focus on assisting clients from other countries in navigating the very complex Hatch-Waxman litigation framework, including numerous successful Hatch-Waxman matters assisting clients where the research and key documents have been in a foreign language. Our lead trial lawyers have in-depth knowledge of the strategies and complexities of Hatch-Waxman/ANDA and patent infringement litigation, with a demonstrated track record of success. McCarter team members have been lead counsel in Hatch-Waxman cases in the District of New Jersey, the District of Delaware, the Southern District of New York, and the Northern District of West Virginia. McCarter also represents branded pharmaceutical companies in more than 80 active Hatch-Waxman litigations as local counsel or participating co-counsel.

McCarter was recently ranked among the top 10 firms that have handled the most patent litigation, and prior to that, we were ranked among the top 10 busiest patent practices in the United States. Our firm has offices from Washington, DC, to Boston, including Wilmington, DE; Newark, NJ; and New York City, which are among the busiest patent litigation dockets in the country. Our lawyers resident in these offices have successfully represented clients before nearly all district judges, and equally important, the magistrate judges who oversee discovery issues and alternative dispute resolution.

We have litigated hundreds of patent cases through claim construction and summary judgment, and through bench and jury trials in jurisdictions throughout the country. We have argued dozens of appeals before the Court of Appeals for the Federal Circuit.

Integration of Technical Experience

In handling Hatch-Waxman and other patent litigation, we combine experienced mastery of litigation strategy and trial skills with a thorough understanding of Hatch-Waxman and patent law, including the intricacies of the USPTO, and deep technical and scientific knowledge. These essential components for success in complex patent litigation are combined within our firm to provide our clients with sharp strategic focus on client objectives and optimum prospects for a successful outcome. McCarter’s life science patent counseling and prosecution group provides technical litigation support second to none. With 30 PhDs in fields such as microbiology, molecular biology, cell and developmental biology, organic chemistry, biochemistry, and related fields, and former patent office examiners, wise in the intricacies of the United States Patent Office, our group regularly counsels branded pharmaceutical companies on the full range of issues related to prospective and ongoing Hatch-Waxman litigation. Hatch-Waxman/ANDA and 505(b)(2) litigation is a significant component of our comprehensive intellectual property services supporting major branded pharmaceutical companies and emerging life science innovators.

Our Approach

McCarter’s IP team works with branded pharmaceutical companies to anticipate challenges to their patents and products, including:

• Building out existing patent portfolios to protect innovations in existing products
• Advising pharma companies on Patent Term Extension issues
• Anticipating Hatch-Waxman related issues during the drug development and clinical trial process, and the patent prosecution process

When ANDA actions are taken against our innovator clients’ biggest successes, McCarter is ready to assist by:         

• Preparing clients for the various procedural stages of litigation
• Preparing and educating clients on important aspects of litigation such as document holds, discovery, and witness depositions
• Working with leading experts in the applicable fields on scientific and legal issues relating to our clients’ important innovations
• Guiding our clients through the planning and preparation stage in advance of potential Hatch-Waxman litigation
  • substantial work must be undertaken well before the NCE-1 date (where applicable), in order to prepare and be ready for potential litigation
  • quite substantial preparation and planning necessary by the innovator company before then
  • once Paragraph IV notices are received, evaluating Paragraph IV notices, and determining whether and where to file suit

Our team’s extensive experience in Hatch-Waxman litigation enables us to guide our clients through hotly-litigated discovery, Markman proceedings, trial, and appeal, as well as evaluating and negotiating successful settlements where appropriate. Our Hatch-Waxman team has had many outstanding successes at every stage of Hatch-Waxman litigation.

Representative Matters*

We litigate cases to successful conclusion at Federal District Courts, Patent Office Trial & Appeal Board (PTAB), and the US Court of Appeals for the Federal Circuit. We have set precedent in ANDA cases and achieved District Court, PTAB, and Federal Circuit victories. Our team members have had substantial experience in cases, such as:

• In litigation against nine generic pharmaceutical companies, successfully enforced patent protection covering a popular statin. Favorably settled seven of the litigation matters, prevailed at trial against the remaining two defendants. Prevailed on appeal to the Federal Circuit.
• Successfully protected patent coverage for antidiabetic drug against 17 different sets of defendants in 20 cases. Cases successfully resolved preserving valid patent protection at a value reportedly in the billions.
• After successful trial on the merits resulting in judgment in our client’s favor against attacks under the Hatch-Waxman Act on the validity and enforceability of its patent on a popular oral antidiabetic agent, our client was awarded all of the attorneys’ fees and expenses it sought.
• In a litigation involving an extended release formulation drug product comprising an antidiabetic drug, successfully enforced patent coverage against defendant ANDA filer, resulting in favorable settlement.
• After a lengthy trial, a US federal judge issued a 156-page decision in favor of our client, in its patent infringement battle over a direct thrombin inhibitor drug, forbidding production of a generic versions of the drug until after our client’s patent expired. The decision was affirmed on appeal to the Federal Circuit.
• Hatch-Waxman action seeking to prevent defendants from infringing patents covering our client’s drug product approved to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction.
• Hatch-Waxman action seeking to prevent defendant from infringing patents covering a branded drug for the treatment of adults with type 2 diabetes or with a type of heart failure. Won judgment in favor of our client, where in a post-trial decision, the court found that each of the asserted claims were infringed and that the defendant failed to prove any of the asserted claims were obvious.
• We serve as co-counsel in a number of patent infringement and Hatch-Waxman litigations:
• Multi-district Hatch-Waxman litigation against 13 defendant groups who are seeking to market generic versions of our client’s branded heart failure medication.
• Hatch-Waxman litigation against multiple defendants who are seeking to market generic versions of a novel pharmaceutical product for the treatment of dry eye disease.
• Hatch-Waxman litigation against defendants seeking to market generic versions of a treatment for metastatic breast cancer.
• Hatch-Waxman litigation against multiple defendants who are seeking to market generic versions of our client’s branded drug for treatment of leukemia and mastocytosis.
• Defending patent infringement action relating to our client’s multiple sclerosis drug.
• 505(b)(2) patent litigation against another pharmaceutical company and affiliates relating to New Drug Application to market a version of our client’s blockbuster drug.
• Co-counsel in Hatch-Waxman litigation against multiple defendants who were seeking to market generic versions of our client’s branded multiple sclerosis medication. The court found our client’s patent valid and held that a planned generic infringed.
• We represent an innovative pharma company in Hatch-Waxman litigation seeking to protect its innovative drug products for treatment of human immunodeficiency virus type 1 (HIV-1).
• We represent a large Japanese company and its affiliates as co-counsel in a patent infringement action against multiple defendants related to the Abbreviated New Drug Applications seeking FDA approval to market generic pharmaceutical versions of an overactive bladder treatment.

* Clients represented by the firm or by Attorneys presently at the firm.