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SMS, RTI potent tools of drug companies fighting patent battle -Soma Das
-The Economic Times


NEW DELHI: As patent wars heat up in the pharma space, mobile phone messages and Right to Information filings have emerged as potent weapons in the hands of multinationals keen to delay competition from low-cost generic versions of their patented products in India.

Innovator drugmakers, who used to strike with patent suits after generic drugmakers released their versions in the market, have started gleaning information from text messages sent out by rival companies and websites of drug distributors to take a peek at their plans. In a first of its kind, US-headquartered Merck Sharp & Dohme (MSD) last month used a thread of mobile text messages to move the Delhi High Court against Ahmedabad-based Aprica Pharma to prevent it from launching its own generic version of the blockbuster diabetes drug Sitagliptin.

In its complain, a copy of which was reviewed by ET, MSD alleged that on May 17, 2013 Aprica's management sent out a message to its field-force that said "seeds of the future r planted in the present. Another step from Aprica on the path of dynamic growth. New Launch! Ecoglipt, Sitagliptin from Aprica. Be preprd". MSD claimed that the company had sent out a similar text message on May 30. MSD and Aprica did not respond to ET's email seeking information on the matter.

"Innovator drug firms would nab every opportunity to sue generic drug firms before they launch their low-cost version in the market, as the courts view these cases from the angle of balance of convenience," said Shamnad Basheer, a patent expert, adding that the number of such cases could see a steady rise.

Another drugmaker, Bristol-Myer Squibs (BMS), while suing Hyderabad-based Natco at Delhi High Court for patent infringement of its cancer drug Dasatanib (Sprycel), used an RTI application filed with the Drug Controller General of India (DCGI) to claim that Natco intended to launch a generic version of the drug. BMS used a similar strategy to bank on information from the DCGI's office to launch a patent suit against Ranbaxy Labs in case of Entecavir (Baraclude) at a pre-launch stage, highlighting the generic firm's intent to launch, as it had sought market approval. Ranbaxy's counsel refused comment.

Innovator firms are also scanning distributors' websites in other emerging markets, such as Africa and Eastern Europe, for evidence. For instance, in BMS's case against Natco, the former alleged that the generic company's product was advertised on the website of a Kenyan drug distributor, Radiance Pharma, under the brand Dasanat.

India's Rs 60,000-crore drug market is crucial for a large number of multinational pharmaceutical companies. Experts say the count of such pre-launch patent suit filings in India could multiply, considering the chances of innovator firms managing injunctions at that stage is higher. "From that perspective, at a post-launch stage, the scales are usually tipped more in favour of generic players, as multiple factors such as price differences between the patented product and generic variant come into play. At a prelaunch stage, usually the balance of convenience is tilted in favour of innovator," Basheer said.

For instance, while the Delhi High Court had turned down an Merck Sharp & Dohme plea to stop Glenmark from marketing its generic version of Sitagliptin Phosphate in April, in the case of Aprica, which was yet to launch the drug, it took a different view in June, ordering the firm not to launch the drug till the next hearing in August. Both the cases are still being heard in the court.

Lawyers defending generic firms say that courts should only grant injunction in pre-launch cases when the evidence submitted by MNCs is concrete. "There are very stringent established standards in foreign countries regulating pre-launch injunctions. However, not much attention has been paid to this aspect, resulting in suits being filed on basis of minimal evidence, which must be discouraged," said Rajeshwari Hariharan, who represents Natco among other generic drugmakers in few such cases.

"The court can infer intention on the part of the generic company to manufacture and market the generic version," Pravin Anand, an IP lawyer, recently told ET. Anand, whose firm represents many MNCs, including Bristol-Myer Squibs, feels it is difficult to curtail infringement after the generic product is introduced into the market. "Considering the expanse of the market in India, once the generic is launched it is difficult to reverse the process, even if an injunction is granted by court, causing irreparable injury to the patentee," Anand said, adding that if the generic company discloses that it does not intend to launch the product, the (legal) action comes to an end based on an undertaking.