'Certain Inaccuracies Have Crept In'

• Accepting Mashelkar Committee’s conclusion would dilute India’s patent laws, and favour pharma MNCs
  
• It will let MNCs file frivolous patents, retain ‘evergreen’ monopoly. Prices of life-saving drugs will shoot up.
  
• It will help MNCs use the report’s conclusion to force India to change the guiding Section 3(d) in the existing Act
  
• The Mashelkar Committee plagiarised its conclusion from a November 2005 paper by Shamnad Basheer

• It won’t change the existing law; the panel’s terms of reference were only to judge a technical/legal issue
  
• All nations, including India, can set their own benchmarks and threshold limits to prevent this
  
• Section 3(d) is not even mentioned in the report; it says the patent office should have the strictest guidelines
  
• 8-10 sentences were lifted verbatim from Basheer’s paper; it was an error on the part of a subcommittee

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"...certain technical inaccuracies in the Report...haveinadvertently crept in.... (The Committee members) are all of the unanimous opinion thatfollowing the best ethical practices...we should withdraw the Report, re-examine it andresubmit a Report which meets the highest standards...."
—R.A. Mashelkar in a letter (19 February, 2007) to the commerce ministry on why hewas withdrawing his patent law report submitted in December 2006

ith this letter of withdrawal, Mashelkar, the icon of Indian science, hassought to pull the curtains down on the ongoing controversy relating to India's patentlaws. In the past few weeks, charges have been hurled against all the participants.Ranging from plagiarism to character assassination, half-truths to anti-nationalism,conspiracy theories involving MNCs and academics to disrespecting multilateral treaties,the allegations have clouded the facts and highlighted the murkiness in the pharma sector.

But it's not the end of this battle between big business and the poor public. For, it'salso a tussle between ideologies. It's an unending fight for supremacy between politics,economics and social good. For some individuals, who have been forced to defend theircredibility and integrity, it's become a personal struggle.

At the epicentre of this patent tsunami is the former chief of the Council for Scientificand Industrial Research (CSIR), Mashelkar. It started when a committee headed by himsubmitted its report to the government last December. His critics branded him asanti-national, espousing the cause of pharma MNCs and toeing the pro-West line. Hisopponents said if the report was accepted, it would make the prices of life-saving drugsshoot up and render them inaccessible to the poor.

One of the conclusions of the Mashelkar Committee was that India cannot "limitgranting of patents for pharmaceutical substance to new chemical entities only". Sucha stance or law, it said, wouldn't be compliant with the TRIPS (Trade-Related Aspects ofIntellectual Property Rights) agreement under the WTO ambit. Public health groups and NGOsscreamed that this would dilute the provisions of India's patent laws, which were anywaybeing framed under international pressure.

They said allowing limitless patents to pharma firms will lead to what's commonly known as'evergreening'. Globally, most MNCs try to continuously extend their product patents byinstituting small chemistry-related changes. In developed countries, where laws favourinnovation and corporate entities, they succeed too. But in developing nations like India,it can lead to higher prices as the MNCs can charge whatever they wish due to their'ever-green' monopoly over a patent.

In an exclusive interview with Outlook, Mashelkar maintains that neither he nor hisreport are anti-national. "At the end of giving one's best to the country for 64years, I and my family feel deeply pained and grieved. There are several misperceptionsabout Mashelkar," he says. According to him, the general impression is that thereport "should have addressed the issue of how to make drugs available and accessibleto the poor. But that was not the mandate."

As per the committee's terms of reference, it had to look into TRIPS-compatibility of alimited patent regime. "The TOR was whether it was compatible or not. The answer waseither yes or no, and why. It wasn't about public health. It was on a technical and legalissue," explains Mashelkar. He thinks the committee's conclusion will not dilute theexisting laws. "What we have said is that the law can't block out incrementalinnovation and limit itself to only new compounds," he elaborates.

The logic is that the discovery of a new compound or molecule is rare. Most of the newdrugs are developed through incremental innovation. Therefore, these products should not,and cannot, be denied patents as it will scuttle research and prevent new drugs fromentering Indian markets. What India can do—and which is allowed under TRIPS—isto have laws that will increase the benchmarks or threshold limits while granting patents.This is the purpose of Section 3(d) of India's Patent Act, which was introduced in 2005when India shifted from process to product patent regime.

Under the section, patents can be given for incremental innovation only if the pharma firmcan prove that the new drug has higher efficacy levels. It has been able to stall thedrug-makers from filing 'evergreen' patents for those with minor changes. This is wherethe second twist appears in the Mashelkar saga. NGOs and public health bodies feel thatpharma MNCs can use the conclusions of the Mashelkar report to wriggle out of Section 3(d)and even put India under pressure to scrap it.

Since the Mashelkar Committee has commented on a general principle relating to patents,and the guiding principle under Indian laws is Section 3(d), anyone can use the former toattack the latter. Novartis, the Swiss giant—which has dragged the government tocourt on the issue that Section 3(d) violates WTO obligations—has done that. In ane-mail response, Novartis said the report indicates that "Section 3(d) curtails thedefinition of 'invention' under TRIPS and (is) hence non-compliant with TRIPS." Inshort, it implied that India's refusal to grant a patent for its Glivec/Gleevec on thebasis of Section 3(d) was wrong.

Glivec/Gleevec, says Novartis, contains a new salt that has led to a newusage—treating blood cancer patients. The company feels that it is "one of themajor breakthroughs of the 20th century" and, thus, it needs to be patent-protected.Novartis points out that even the Mashelkar Committee "supports our view that India'sdenial of a patent was not in line with international agreements." And the companyadds there will be no impact on Glivec prices even if it won the court case as "thereis no commercial market for Glivec in India."

The anti-MNC lobby disagrees. It contends that the domestic price of Glivec/Gleevec isone-tenth the global cost. More important, it feels that Novartis hasn't innovated its olddrug, or improved it. So, if Novartis wins the case, it will set a precedent for otherdrug MNCs to follow. All of them will inundate the patent office with new, minor forms ofold drugs. Result: evergreening, a dramatic rise in domestic prices of life-saving drugs,and anti-poor policies from a public health perspective.

Mashelkar supports this logic and says that he's "in total agreement with Section3(d). The benchmarks that we set depends entirely on us. It is for any individual countryto decide the threshold limits and it is through these thresholds that the governments canexercise control." He adds that pharmaceutical companies can't use his report tofight Section 3(d). "We have said that the patent office should have the strictestguidelines with regard to what constitutes the criteria (including novelty) of a patent.There's no reference in the report that we should modify 3(d)," he explains.

Now that Mashelkar has withdrawn the report, he hopes the criticism against it will stopand the outcry will die down. Moreover, Novartis will be unable to use Mashelkar's logicduring the Glivic/Gleevec court hearings that started in the Madras High Court last week.That will definitely make the anti-MNC lobby happy. And that should help Mashelkar relax abit. As he ends his interview with Outlook, he makes a last ditch attempt tore-defend himself: "Throughout my life, I have followed my mother's preachings. Thefirst was that one should never do anything in self-interest and, second, that one shouldnever harm anyone."