24
Jan
By Eric Schweibenz
On January 20, 2011, Eli Lilly and Company of Indianapolis, Indiana (“Lilly”) filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.

The complaint alleges that Jiangsu Hansoh Pharmaceutical Co., Ltd. of China (“Hansoh”), Intas Pharmaceuticals Ltd. of India (“Intas”), ChemWerth, Inc. of Woodbridge, Connecticut (“ChemWerth”), and Hospira, Inc. of Lake Forest, Illinois (“Hospira”) (collectively, the “Proposed Respondents”) unlawfully and without authorization import into the U.S., sell for importation, and/or sell within the U.S. after importation certain gemcitabine and products containing same that infringe U.S. Patent No. 5,606,048 (the ‘048 patent).

According to the complaint, the ‘048 patent relates to a method of preparing gemcitabine, which is a synthetic analog of naturally occurring nucleosides that are the building blocks of DNA and RNA.  The U.S. Food and Drug Administration (FDA) has approved the use of gemcitabine in the treatment of ovarian cancer, non-small cell lung cancer, metastatic breast cancer, and pancreatic cancer.  The ‘048 patent covers a key reaction for manufacturing gemcitabine (referred to as the Sn2 process) which involves fewer steps, higher yields, and lower costs than a previously known process that the complaint characterizes as not commercially viable (referred to as the Sn1 process).

The complaint alleges that the gemcitabine active pharmaceutical ingredient is manufactured outside the United States by Hansoh using the infringing Sn2 process, which is then shipped to India for formulation into Hospira’s generic gemcitabine pharmaceutical product by Intas, finally being imported into and sold in the United States by Respondents, including at least ChemWerth and Hospira.

Regarding domestic industry, Lilly asserts that because the manufacturing process for a new pharmaceutical composition is a necessary part of a new drug application (NDA) with the FDA, the costs Lilly incurred in researching and developing the ‘048 patent’s process are directly attributable to Lilly’s research and development of gemcitabine and its NDA, and these costs constitute part of Lilly’s domestic industry.  Lilly also licensed the ‘048 patent to a domestic manufacturer exclusively for Lilly’s use and sale, and Lilly itself performs substantial processing and formulation activities in Indianapolis related to gemcitabine, and Lilly and its licensed domestic manufacturer have made significant investments in their facilities and personnel to maintain and run these operations.

With respect to related litigations, the ‘048 patent is the subject of a declaratory judgment action filed by Hospira against Lilly in the Northern District of Illinois on October 1, 2010.  Additionally, Lilly has filed several litigations regarding the foreign counterparts to the ‘048 patent against Hospira’s foreign entities in Canada, Singapore, Denmark, United Kingdom, and Australia.  Lilly also filed an infringement action against Hansoh in China in connection with the Chinese counterpart of the ‘048 patent.

With respect to potential remedy, Lilly requests that the Commission issue a permanent exclusion order and a permanent cease and desist order directed at the proposed Respondents.