Federal Circuit Sides with District Court, Rules Pharma Patent Claims Indefinite

On Wednesday, an opinion was issued in a Federal Circuit case brought by Horizon Pharma, Inc. against Dr. Reddy’s Laboratories, Inc. The case originated with two patent claims that were invalidated for indefiniteness after a summary judgment motion in the District of New Jersey. The claims both concerned the timed release of drugs used in the treatment of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis.

The opinion explained that non-steroidal anti-inflamatory drugs (NSAIDS) are used in the treatment of a variety of conditions involving pain or inflammation. However, taking these drugs directly frequently causes gastro-intestinal complications as well as spikes in the amount of relief immediately after taking the medication, while causing ebbs toward the end of the dose period. Typical solutions for these issues have involved delivery methods that moderate the amount that is released into the patient over a longer period of time, or “extended release”. The two patents, 9,220,698 (the ’698 patent) and 9,393,208 (the ’208 pa-tent), involved this type of extended release formulation. However, the language of the claim was found to be indefinite by the district court as it hinged on the interpretation of the word “target”.

The court cited a prior case that held that judges, not juries evaluate and decide the meanings of terms used in a patent prior to juries determining if a patent was infringed upon. When the district court held such a hearing in this case, the court found that the term “target” was not sufficient to describe the method or intent of the patent as the term itself could be fulfilled in numerous ways, making it impossible to determine if a competitor’s method was infringing directly, or was merely offering an alternative method. The appellate court concurred, indicating that the direct meaning of terms chosen in a patent are applied, and that if a term is indefinite in a particular claim, it cannot be saved by more specific language in other clauses or claims of the patent.

The plaintiff-appellants were represented in this action by Finnegan, Henderson, Farabow, Garrett & Dunner. The defendant-appellees were represented by Windels Marx Lane & Mittendorf and Kirkland & Ellis