Patent war: Dismissing the case last week after a four-year battle, a single bench of the Delhi high court ruled that Roche’s patent on the drug is valid. (Dismissing the case last week after a four-year battle, a single bench of the Delhi high court ruled that Roche’s patent on the drug is valid.)
Patent war: Dismissing the case last week after a four-year battle, a single bench of the Delhi high court ruled that Roche’s patent on the drug is valid.
(Dismissing the case last week after a four-year battle, a single bench of the Delhi high court ruled that Roche’s patent on the drug is valid.)

Roche-Cipla ruling to impact similar cases

Roche has filed patent cases against local drug firms including Natco, Dr Reddy’s and Glenmark Pharma

Mumbai: The court judgement over the patent dispute between Swiss drug maker F. Hoffmann-La Roche Ltd and India’s Cipla Ltd over a cancer drug may have a bearing on 10 similar cases filed against other local drug makers in various courts by Roche, according to legal experts.

Dismissing the case last week after a four-year battle, a single bench of the Delhi high court ruled that Roche’s patent on the drug is valid. However, Justice Manmohan Singh in his 275-page order added that Cipla did not infringe on Roche’s patent as it has been selling a polymorph B (a variant of the basic drug compound) form of the drug, called erlotinib in generic terms.

Even as Roche, which was granted a patent on this drug in India in 2007, can appeal against the ruling in a high court, the legal fraternity agrees it will have an impact on the proceedings in all the pending cases filed by Roche on similar lines against local drug makers including Hyderabad-based cancer speciality company Natco Pharma Ltd, the country’s second largest drug maker Dr Reddy’s Laboratories Ltd, and Mumbai-based Glenmark Pharmaceuticals Ltd.

All these companies currently sell generic copies of erlotinib.

Last month, Roche had also dragged Fresenius Kabi Oncology Ltd, an Indian subsidiary of German drugs and emergency care solutions company Fresenius Kabi AG, to court on a similar charge.

Another case is pending in the Madras high court where Roche has sued Ahmedabad-based Intas Pharmaceuticals Ltd.

All the companies declined to comment on the issue as the cases are pending with the courts.

Most of these companies had challenged the Roche patent on erlotinib in courts as well as the patent offices, after which they decided to go ahead with the launch of the generic copies.

Roche’s patent attorney Suja Subramaniam said on Tuesday that “Roche’s patent claim is on the basic drug compound i.e. erlotinib hydrochloride (EH) on which Roche has patents in many other countries including the US."

“I am unable to comment on the judgement now as it is a long one, and will take at least a few days more to understand the details," she said.

A.A. Mohan, a Chennai-based intellectual property (IP) lawyer, who represents Intas Pharmaceuticals on a similar matter in the Madras high court, said, “The Delhi high court order will definitely have a positive impact on the case."

“Cipla’s victory would have a direct impact on all these companies whose drugs can be sold in the market without threat of infringement," said lawyer Pratibha Singh, who represented Cipla in the Delhi high court.

“While many of us are happy about the ultimate outcome in favour of public health and access, the decision appears puzzling from a jurisprudential perspective. A close reading of the patent would suggest that Roche’s first claim is to the compound itself with a certain chemical formula i.e. erlotinib hydrochloride. The said claim is not limited to any particular polymorphic version," said Shamnad Basheer, a ministry of HRD (human resource development) professor in IP law at the National University of Juridical Sciences, Kolkata.

He said that in an infringement analysis, one has to compare the patent claim with the allegedly infringing product and not engage in a product to product comparison.

“In fact, the law permits patent owners to sue for infringement even without having any product of their own," said Basheer, adding “therefore, the moment Cipla makes a polymorphic version of EH, it invariably infringes Roche’s patent, since its polymorph will also have the same chemical formula as that of erlotinib hydrochloride, as claimed in Claim 1 of the Roche patent."

He pointed out that since the Delhi high court order goes to great lengths to uphold the validity of this claim in toto, it cannot now limit its scope during an infringement analysis.

“The issue of validity is quite distinct from the issue of infringement. If the judge was worried about the scope of the claim, he ought to have limited its scope during the validity analysis.

But given that he upheld the claim in toto, he cannot curb its scope during an infringement analysis," said Basheer.

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