Eli Lilly Joins Glaxo, Withdraws Application for Osteoporosis Drug

Eli Lilly & Co. has voluntarily withdrawn its Application No. IN/PCT/00/00118 filed July 05, 2000 at Kolkata Patent Office for a stable crystalline form of osteoporosis drug Teriparatide (rDNA origin), globally marketed as Forteo with worldwide annual sales of US $ 600 million. According to the Patent Office, Lilly has withdrawn its application under section 11B (4) of the Patents Act, 1970. The Application claims earliest priority from US provisional application No. 60/069,875 filed December 18, 1997 against which US Patent No. 6,590,081 is issued on July 08, 2003. Earlier in August 2007, Kolkata Patent Office rejected Lilly’s Application for same drug following a pre-grant opposition from a Mumbai-based generic drug manufacturer USV Ltd. The rejection was made on the grounds of prior knowledge, incremental innovation and failure to establish enhancement of known efficacy. Teriparatide is a parathyroid hormone (PTH (1-34) (SEQ. ID NO:2)), a secreted 84-amino acid product of the mammalian parathyroid gland that controls serum calcium levels through its action on various tissues, including bone. Although not very sure about the Application number which got rejected by the Patent Office, but I guess it would be the Application No. IN/PCT/00/00119 filed July 26, 2000 for stabilized parenteral composition of Teriparatide (rDNA origin) claiming earliest priority from US provisional application No. 60/069,075 filed December 09, 1997 against which Orange Book listed US Patent Nos. 6,770,623 and 7,144,861 are issued. There is one more Application No. IN/PCT/00/00336 filed January 09, 2003 which is pending with the Patent Office which claims earliest priority from US provisional application Nos. 60/097,151 and 60/099, 746 filed November 08, 1998 and October 09, 1998 respectively and against which Orange Book listed US Patent Nos. 6,977,077 and 7,163,684 are issued. The Application IN/PCT/00/00336 seems to cover a method for increasing the toughness and/or stiffness of bone and/or reducing the likelihood and/or severity of bone fracture using Teriparatide, which is unlikely to receive a patent in India, as indication and method of treatment are excluded from patentability under section 3(e) of the Patents Act, 1970. So, most likely either Lilly will too withdraw the third application or it would be humbly rejected by the Patent Office.