How Novartis Screwed Up In India
2 CommentsBy Ed Silverman // October 3rd, 2007 // 8:16 am
Let us count the ways. The fight beween the drugmaker and New Delhi over its Gleevec patent was a cause celebre this year. But an analysis in IP Law & Business points out that Novartis flubbed it. And it’s a lesson for others…
1 - A crucial mistake made by the drugmaker’s lawyers was to challenge the legitimacy of Indian patent laws, which don’t recognize incremental innovation and require a poorly defined notion of effectiveness. As IPL&B suggests, “had Novartis simply pursued a discreet, technical appeal to the Indian patent office, asking for clarification of ‘effectiveness’ rather than challenging the constitutionality and the validity of India’s patent laws before the WTO, it would have had a better chance to get the Glivec patent.”
2 - Novartis relied on local counsel Remfry & Sagar, a venerable patent prosecution firm, to lead its legal challenge. But most Indian patent firms have little or no experience with litigation. Of roughly 7,000 Indian IP cases in the past 50 years, only 300 involved patents, says litigator Pravin Anand of New Delhi law firm Anand & Anand. Furthermore, Indian prosecution firms working for foreign clients before 2005 often functioned more like clerks, taking the US or European patent application, attaching a cover letter, and walking it over to the patent office.
3 - According to Calab Gabriel, co-founder of IP firm K&S Partners in New Delhi, Novartis tried to bolster its patent litigation team, but was too slow. Generic rivals hired them first. Novartis then opted for big-name litigators in hopes of preventing them from working for the generic companies. There was a catch - these lawyers had star power, but never tried a patent case before.
The upshot: Lawyers with experience in India say that Novartis chose a losing litigation strategy and stuck with it. “The law firm that started the case for Novartis made fundamental errors, and they got creamed,” Mark Pohl, a partner with New Jersey boutique Pharmaceutical Patent Attorneys, who reps several Indian generic drugmakers, tells IPL&B. “This is a classic case of ‘the other side isn’t winning, Novartis is losing.’ ”
Shamnad Basheer, an Indian IP lawyer now teaching at George Washington University, says that by inadvertently letting the patent rejection blow up into an international showdown, Novartis’ attorneys let their opponents gain the moral high ground. The effort to protect prices, however reasonable they may be because of the high costs of developing drugs, can quickly be turned against them with emotionally charged public relations campaigns by patient groups. “With the kind of money Novartis spent on this,” he tells IPL&B, “they could have done a lot better.”
jaideep
don’t u think where the law is such, it is in best interest to challenge the law, novartis wasn’t wrong and i guess at the end of the day, the loss is india’s because novartis has the power to move everything out of the country, and so is happening and novartis is almost settin a precedent, which is bad for indian industry.
Ed Silverman
Hi Jaideep,
Well, I didn’t indicate that I thought Novartis was wrong to challenge the law (I never said one way or the other). The company has every right to do so. My post, which essentially summarized an essay in Intellectual Property Law & Business, was about the approach Novartis took. In that regard, the drugmaker made mistakes.
Perhaps another drugmaker will file a challenge, take a different approach and a different outcome will occur. But whether it makes good business sense to, effectively, retaliate against India for the court ruling isn’t yet clear, at least not to me. But I would agree that it doesn’t benefit India.
Thanks for writing,
ed at Pharmalot