Apart from Mumbai-based Okasa, Novartis’ move to seek additional patent for the anti-cancer drug Glivec is facing opposition from other quarters too.
MUMBAI: Apart from Mumbai-based Okasa, Novartis’ move to seek additional patent for the anti-cancer drug Glivec is facing opposition from other quarters too.
Hyderabad-based Natco Pharma and Chennai-based activist Shalini Ben have moved the Chennai patent office against the application for additional patent.
Patent attorneys told DNA Money that while Cipla is backing Okasa in the case, it is not clear why Shalini Ben is opposing the patent.
Gopakumar Nair, CEO of Gopakumar Nair Associates, patent attorney representing Shalini Ben, said, “The additional patent is opposed as we believe it is not valid.” Nair said, in 1993, Novartis filed the first patent in the US. The application said there are two ways (base and salts) to make the drug, and both should be considered for the patent.
He said that in the US application Novartis had stated that wherever it mentions base, it is applicable on salts too. Hence domestic companies believe that additional patent that Novartis seeks is invalid as it has already filed patent application for beta crystal form of salt.
In 1998, Novartis had filed a patent application for beta crystal form. “This application stated that beta crystal form is made from alpha crystal.
And, it mentioned alpha crystal is inferior to beta crystal form,” said Nair. When a company has two inventions in one product it files a divisional patent.
In 2004, Novartis filed application for divisional patent for alpha crystal form in India. This application, Nair said, does not contain any indication that the patent is either inventive or more effective than the first patent, as required by regulations.
On contacted, a Novartis spokesperson said, “Although we manufacture and market only the more stable beta crystal form of Glivec, the company felt it was imperative to file patents on other forms of imatinib mesylate (or Glivec). This is done only to protect the integrity of the drug.”
The company said it does not market any product using the alpha formulation anywhere. Novartis expects to have hearing in the next few months. Last month’s oral hearing by the Indian Patent Office was postponed as Okasa filed an opposition.
b_tinesh@dnaindia.net
Since the opposition was filed just prior to the hearing, Novartis asked the court for time to file a reply.
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