Galderma, a Swiss pharmaceutical company majoring in dermatological preparations, has been doing the rounds in the global intellectual property circuit regarding its recently invalidated patents concerning its popular anti-acne drug Differin®.

Differin®, a gel product containing 0.3% by weight of adapalene as the active ingredient was protected by Galderma under five different US patents. Tolmar Inc., a contract pharmaceutical manufacturing and packaging company originating from the United States, filed for an Abbreviated New Drug Application (ANDA) in order to seek FDA approval for its generic version of Differin®. Galderma instituted ANDA litigation against Tolmar alleging that the generic version of Differin® would infringe multiple claims of Galderma’s patents. Tolmar in return challenged the validity of Galderma’s claims. The District Court held Galderma’s claims valid, which egged Tolmar to approach the Federal Circuit.

In a surprising turn of events, the Federal Circuit reversed the District Court’s decision as it found Tolmar’s appeal to be a straightforward case of obviousness. It was established that while scoping claims for an invention pertaining to 0.1% by weight of adapalene, Galderma, in order to seek the broadest possible protection, had covered a concentration ranging from 0.01 to 1% by weight of adapalene. Little did Galderma know that such a seemingly prudent drafting strategy might sometime in the future backfire on its own inventions. In the course of time, certain benefits of the 0.3% by weight adapalene formulation became apparent to Galderma and they filed separate patent applications relating to the same which subsequently got granted. However, it was when Tolmar instituted an appeal against Galderma that the validity of the claims of the afore-stated patents got scrutinized and it was substantiated that the 0.3% by weight adapalene concentration was already covered in its previous patents.

Tolmar submitted that Galderma’s claims covering the 0.3% product were obvious in view of U.S. Patent No. 4717720, U.S. Reissue Patent No. 34,440 and the Differin® 0.1% Gel Data Sheet. Tolmar contended that US 4717720 and US Reissue 34,440 straightaway disclosed use of adapalene at concentrations ‘preferably between 0.01 and 1% by weight’. Tolmar also submitted certain references that disclosed testing a 0.3% by weight adapalene composition in an animal model and a 0.3% by weight adapalene composition for other purposes without intolerable irritability.

Galderma tried to turn the case in its favor by citing points such as the commercial success of its product (Differin®) and the unexpected results shown by the 0.3% by weight adapalene. However, the Federal Circuit established that when the evidence of obviousness is based on prior art and is genuinely conclusive, considerations such as teaching away, unexpected results and commercial success bear little weight. Thus, what began as a Hatch Waxman patent infringement suit rebounded in Galderma losing validity of some of its claims concerning its popular pharmaceutical formulation.

Furthermore, this case is of particular significance as far as the Indian patent legislation is concerned. Section 3(d) of the Indian Patents Act, 1970 states that subject matters that are, “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant” are not inventions and therefore, cannot be patented. In view of this clause and the claims of the patent application pertaining to 0.1% by weight adapalene; the subject matter relating to use of 0.3% by weight adapalene for the management of acne would be considered as new use of a known substance; thereby rendering it not patentable.

The present case and more significantly its outcome is nothing less than a startling wake-up call for every patent attorney. It calls for the re-evaluation & reconsideration of the practice of claiming a wide range in the absence of sufficient enablement.