The Product Patent Rule in India

Ortho-McNeil Pharmaceutical brought the lawsuit against generic-drug maker Caraco Pharmaceutical Laboratories alleging infringement of its U.S. Patent No. 5,336,691. Ortho's patent covered a pain reliever composed from two well-known analgesics; tramadol and acetaminophen.

At issue in the case was the patent's claim number 6, which covered a composition "wherein the ratio of the tramadol material to acetaminophen is a weight ratio of about 1:5."

Ortho contended that Caraco's drug would infringe its patent.

The district court granted summary judgment and Ortho appealed to the Federal Circuit.

Accepting this construction meant that Caraco's product did not literally infringe Ortho's patent. Ortho's patent covered a ratio of up to 1:7.1, while Caraco's started at 1:7.5. One expert, Dr. Stanski, opined that a weight ratio of 1:8.76 is substantially similar to a weight ratio of 1:5.

But the district court disagreed.

For these reasons, the court said, it concluded that Caraco's drug could not infringe Ortho's patent and that the district court properly granted summary judgment of non-infringement.

Ortho-McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd., Case No. 06-1102 (Fed.

Patent filing process can be carried on different patent offices located at Delhi, Chennai and Mumbai. The applicants can also take help from patent consultancy India for information on newly amended product patent rule.