The price-lowering effect of competition and domestic manufacturing of medicines can transform how diseases get treated in resource-poor settings. Decisions made by Indian patent offices can negatively impact generic competition and supply worldwide, relying on the availability of affordable medicines made in India. Monopolies granted by patent offices on medical products keep prices high and block local manufacturers from supplying low-cost generic drugs.
In 2005, lawmakers from all political parties amended Indian patent law to ensure that the Indian patent office did not grant monopolies on old science or for compounds already in the public domain. The new law now prevents drug corporations from indulging in “evergreening”, a common abusive patenting practice aimed at obtaining separate patent monopolies relating to the same medicine. And to bring this to the notice of the patent examiners, the amended patent law allowed any person to file a pre-grant opposition ‘anytime’ before the patent office decides to grant or reject a patent application.
This week the Economic Times[LM1] reports that the Economic Advisory Council (EAC) to the Prime Minister recommended the period within which patent applications are open to challenge by the public be restricted to a mere six months from the date of its publication.
Since the Indian Patent Offices receive an average of 50,000 patent applications a year, examiners often miss critical information about the patent application under consideration. A recent study on pharmaceutical patent grants in India revealed that 7 out of 10 patents are granted in error by the Indian Patent Office. A robust pre-grant opposition system provides an additional administrative layer of scrutiny that prevents the grant of frivolous patents through third parties’ participation in the review process.
Evergreening monopolies on medical products is a lucrative game for pharmaceutical corporations allowing them to charge high prices. And the Organisation of Pharmaceutical Producers of India (OPPI) — Big Pharma’s association in India — has made several attempts to undermine this safeguard in the patent law and has renewed their efforts.
The commerce ministry, responsible for administering the patents act, is now under pressure to restrict pre-grant patent oppositions.
Pre-grant oppositions
In 2005, the first challenge to a pending patent claim on a medicine was filed by Cancer Patient Aid Association (CPAA) before the Indian patent office. CPAA highlighted that the Swiss corporation Novartis’ patent application on Imatinib Mesylate (Gleevec), a life-saving anti-cancer drug, claims a salt form of old medicine, a common practice within the pharmaceutical industry, and should not be considered patentable. The patent office subsequently rejected the patent, which was later upheld by the High Court and the Supreme Court. The pre-grant opposition by CPAA on the cancer drug protected the price reduction from over ₹14 lakh ($31,000) per patient per year from Novartis to less than ₹40,000 ($800) per patient per year from generic manufacturers.
In the last 17 years, generic manufacturers and people living with HIV, DR-TB, and viral hepatitis have also filed several patent oppositions to safeguard generic competition so that quality, affordable generics can be procured by health programmes. In 2006, PLHIV networks filed the first such opposition to a patent application by Glaxo Group Limited (GSK) for Combivir on a fixed-dose combination of two AIDS drugs, zidovudine/lamivudine. GSK withdrew the patent application in India and several other countries after the patent opposition in India pointed out that the patent claims did not cover a new invention but simply the combination of two existing drugs.
Several such challenges before the patent office have successfully ensured the availability of affordable HIV medicines to millions living across the developing world. The 99% reduction in the prices of antiretrovirals following the generic competition, from $10,000 per person per year down to less than $100, has been a critical factor in the expansion of antiretroviral treatment to millions in low and middle-income countries.
Prescribing a timeline and cutting short the window period for pre-grant opposition makes it difficult to challenge frivolous patent applications on drugs and vaccines. The information in patent applications does not permit the public to rapidly identify the claimed medical product. The identification and further analysis are time-consuming as several applications are pending on the same medicine, vaccine or technology. Reducing the opportunities for filing challenges to pending patent claims will not increase efficiency. On the contrary, pre-grant oppositions provide information to the examiners that can help speed up the examination process and deny invalid patents.
The real challenge
The humanitarian medical organisation, Médecins Sans Frontières (MSF), has supported hundreds of pre-grant oppositions in India, working closely with patient groups to safeguard generic competition to increase access to affordable medicines from India. In our experience, tackling the overwhelming number of evergreening patent claims on known drugs and technologies is the real challenge for the Indian patent office. The attempt to dilute the timeline on pre-grant opposition diverts from the real problem.
( Leena Menghaney and Roshan Joseph are lawyers and work for Access Campaign at Médecins Sans Frontières.)
