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Wyeth gets favourable order on a patent for antibiotic Tigecycline

The Patent Office refuses pre-grant opposition from Natco Pharma, does not consider Lupin's opposition

Gireesh Babu Chennai
Last Updated : Aug 31 2015 | 8:25 PM IST
Wyeth, part of global pharma major Pfizer now, has received a favourable order for a patent application on its Tigecycline Composition, an antibiotic drug, against pre-grant opposition from Natco Pharma and Lupin Ltd. Wyeth sells tigecycline drug as Tygacil, which is used to treat drug-resistant bacteria. It has been shown to work where other antibiotics have failed, claims the company.

The company claimed that the composition for which the patent was applied has improved stability in both solid and solution states, and is thus different compared to other formulations, which have to be used immediately since they have lower stability. The application was filed on August 27, 2007 and was published in December 28, 2007.

Natco filed its opposition in July 5, 2008, alleging lack of novelty, lack of inventive step and non-patentability under various sections of the Patent Act. Lupin filed its opposition on November 26, 2008. The statement of invention also took some grounds of opposition such as inventive step, insufficient disclosure, not an invention within the meaning of the Act, failure to disclose information under section 8, and furnishing false information.

According to a copy of the order, the procedure was delayed due to various reasons and it has resulted in further litigation between the parties. The patent official also observes that while Lupin was active in the early stage of the pre-grant opposition, while hearing was fixed they did not turn up in the hearing. The official, therefore, concentrated the hearing attended by the Natco and discuss the issues and arguments raised by them only while issuing the order.

In an order issued on August 25, 2015, D K Chakrabarti, deputy controller of patents & designs, Patent Office, Kolkata, observed that the claimed application does not attract Section 3(d) of the Patent Act, which stipulates that a new form of a known substance cannot be patented.

"Regarding other technical issues as discussed in this decision in different paragraphs, the opponent (Natco) could not establish any of the issues and therefore I dismiss the instant pregrant opposition and order to grant the Patent application with the amended claims as annexed in schedule 1 and further processing of the action of grant is to be taken immediately," said the order.

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First Published: Aug 31 2015 | 7:56 PM IST

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