Generic Pharmaceuticals and IP Issues

Merchant & Gould has a long-standing and active practice serving the global generic pharmaceutical industry. As a powerhouse intellectual property law firm with an illustrious history and an innovative culture, we have ample resources to effectively assist any size generic pharmaceuticals company with the development and protection of all types of generic pharmaceutical products. Many of our lawyers have technical degrees and are admitted to practice before the United States Patent and Trademark Office.

ANDA Applications and Patents for Generic Pharmaceutical Products

We do our best work when we collaborate with our pharmaceutical industry clients from the very beginning stages of product development. We are skilled at evaluating patents listed by brand-names pharmaceuticals for a given product with the FDA in the Orange Book for non-infringement and/or invalidity.

An Abbreviated New Drug Application (ANDA) filed under the Drug Price Competition and Patent Term Restoration Act (informally known as the Hatch-Waxman Act), allows manufacturers to bring generic drugs to market at a lower cost to the public.

Our team can advise our pharmaceutical industry clients as to what specific content to include in their Abbreviated New Drug Applications (ANDAs). In addition, we often recommend whether a particular ANDA should contain a certification that one or more of the Orange Book patents for a given product is invalid or will not be infringed by our client's proposed product. (This certification is known as a Paragraph IV certification.)

We also represent manufacturers of approved pharmaceutical ingredients (APIs) with respect to issues regarding process and composition of matter patents for pharmaceutical products.

Filing the ANDA and the Paragraph IV Certification: "First to File"

Strategic timing is critical when submitting an ANDA containing a Paragraph IV certification. We work closely with our clients on strategic plans that allow them to reap the benefits of being the "first to file" an ANDA for a given branded product. Moreover, we understand the importance of securing, maintaining and preserving a generic company’s exclusivity in the market. Our attorneys prepare a focused strategy to, first and foremost, coincide with and honor that business purpose.

Litigation: Protecting Your Business Goals

In the event Hatch-Waxman Act litigation commences after an ANDA is submitted to the FDA, our clients' legal team immediately expands to include dynamic, experienced and results-oriented trial attorneys who are well versed in all phases of pharmaceutical industry patent litigation. These attorneys have tried major Hatch-Waxman cases on behalf of several generic pharmaceutical industry companies. 

We also have significant experience handling pharmaceutical patent litigation unrelated to the Hatch-Waxman Act, including proceedings before the United States Patent and Trademark Office and its various boards before the International Trade Commission, in federal district courts, and before the Court of Appeals for the Federal Circuit. 

We fully appreciate that the cost of litigation can be counterproductive to the business purposes of our clients. Accordingly, we strive to achieve predictability for our clients by undertaking a serious budgeting analysis prior to litigation. Our Midwestern rate structure is extremely competitive with other firms working in this area. More importantly, we will develop a case strategy and a coordinating budget with your participation and upon which you can rely.