Local drug maker shatters Merck patent ambush

Prior to its launch of a new drug treating male hair loss, Henan Topfond Pharmaceutical found Merck patented the process of making the drug 10 years ago. Hanging in for four years of exhaustive legal battle, Topfond has the U.S. big pharmaceutical company's patent invalid and eventually saw the light for its product.

Topfond developed the drug Finasteride tablet after four years in-house R & D and obtained the Chinese FDA's approval for manufacture in 2004. Moments before manufacturing and distributing the product, it found Merck patented the method of treating hair loss with 5-α reductase inhibitors in 1994 and acquired patent right in 2002.

Topfond, June 18, 2004, sought invalidation of the Merck patent at the Patent Reexamination Board (PRB) under the State Intellectual Property Office (SIPO) on the ground of failing novelty and inventive step. After rounds of evidence presentation, cross examination and debate, Merck proposed settlement which was denied by Topfond.

PRB then nullified the Merck patent in all. Merck went all the way to the Beijing No.1 Intermediate Court and to the appellate High Court. Both courts upheld PRB's decision.