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LATEST NEWS UPDATES | Pharma MNCs use RTI law to protect market for patented drugs & delay entry of generics

Pharma MNCs use RTI law to protect market for patented drugs & delay entry of generics

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published Published on Jan 28, 2013   modified Modified on Jan 28, 2013
-The Economic Times

Pharmaceutical multinationals have begun using the Right to Information law to launch pre-emptive legal action against local generic players to protect the market of patented drugs and delay the entry of low cost generic medicines in the 60,000-crore domestic drug market.

MNCs are using such information to sue generic firms even at a stage when their marketing approval is still pending or during the few months' window between the grant of approval and the actual product launch. This is a marked departure from their earlier strategy of launching patent infringement suit only after a generic firm rolled out a competing drug in the market.

While some MNCs are now going to the extent of obtaining information on which generic firms have applied for a marketing licence for patented drugs, others are launching legal offensive as soon as the marketing nod is granted and made public.

The Delhi High Court alone is hearing eight such patent suits filed by MNCs for drugs which earn the innovator firms over $2.2 billion annually in the global market. For instance, the US-headquartered Bristol-Myers Squib's has filed cases against Hetero Drugs and Natco Pharma over the cancer drug Dasatanib. It has also sued Ranbaxy Labs over Hepatitis B bulk drug Entecavir. While French firm Sanofi Aventis' has sued MSN Labs over cardiac drug Dronedarone,Germany's Bayer Pharma AG has taken Intas Pharma to court over anti-coagulant Rivaroxaban.

"We do not speculate about judicial procedures of generic pharma makers and we do not comment on our legal strategies. Bayer will continue to vigorously defend its patent within the available legal framework," said a Bayer spokesperson.

Natco and Ranbaxy refused to comment on the issue, stating that the matter is sub-judice, while most other firms didn't respond to an ET mail seeking comments on the matter. "Such pre-emptive suits are a recent trend in the country and generic firms must tread very cautiously, stay alert and arm themselves with proper legal backing to face such attacks," said patent lawyer Prathiba Singh, whose firm is defending a few generic firms in such cases.

In some cases, the generic firms are challenging the whole concept of launching a legal offensive against 'paperwork', arguing that a mere application doesn't necessarily have to translate into a product launch. On the contrary, innovator firms in select cases are arguing that mere generic firms' filing application for marketing approval of patented drugs with the DCGI is tantamount to patent infringement.

"A company would not seek such licences or approvals without an underlying commercial interest. The court can infer intention on the part of the generic company to manufacture and market the generic version," said Pravin Anand, a senior intellectual property lawyer, whose law firm is advising MNCs in a few of such cases. In at least two such instances, the generic firms - Natco in case of Dasatanib (albeit after three years of the case being filed) and Ranbaxy in bulk Entecavir - marched ahead with product launches despite the legal suits. Anand says it is very difficult to curtail patent infringement once the drug has been launched.

Patent attorney Rajeshwari H, who is also defending some generic firms, said: "This is an unhealthy trend. Neither local firms nor the courts here are well-equipped to handle these cases." She is particularly wary of cases, where multinationals have sought ex-parte injunctions, which implies the courts would first restrain generic firms from launching their version without having heard the generic firms. Such ex-parte injunctions by courts emerge as an access barrier to affordable drugs, she added.

The Economic Times, 24 January, 2013, http://articles.economictimes.indiatimes.com/2013-01-24/news/36526946_1_generic-firms-generic-version-bayer-spokesperson


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