Geneva/New Delhi, 9 February 2010 — In a welcome move for access to medicines, the Delhi High Court has rejected the appeal filed by the German pharmaceutical company Bayer Corporation against an earlier court order which had rejected the implementation of a drug regulatory system which essentially linked registration of medicines to their patent status.
In August 2009, the Delhi High Court had rejected the petition filed by Bayer Corporation, seeking to stop the Drug Controller General of India (DCGI) from granting marketing approval to a generic version of a cancer drug patented by Bayer.
“We are delighted with this decision – at the moment in India we are seeing a number of multinational pharmaceutical companies trying to use litigation to stifle generic competition,” said Dr. Tido von Schoen-Angerer of Médecins Sans Frontières’ Campaign for Access to Essential Medicines. “By rejecting Bayer’s attempts to introduce patent linkage, the Indian courts have ensured that public health safeguards like compulsory licensing can be used to open up generic production of life-saving medicines including antiretrovirals for millions in India and beyond. We hope this judicial precedent of safeguarding public health in patent disputes will continue, as matters such as these, and the forthcoming Novartis case go up to the Supreme Court.”
Anand Grover, counsel for Cancer Patients Aid Association added: “In India, we do not have a patent linkage system. The patent system and the drug regulatory system are two separate and independent mechanisms and this is Parliament’s intent. We hope that Bayer and other pharmaceutical companies respect this fact. A patent holder cannot use the DCGI, a government agency, to enforce its private rights. This was an attempt to introduce a TRIPS-plus requirement in India, which has been rejected.”
What was this case about? Bayer was seeking to ensure that the Indian drug regulatory authorities did not start the registration process of a drug, if it was covered by a patent and the patent-holder did not consent.
This is known as ‘patent linkage’ in India. Establishing a link between patent status on the one hand and the registration (or marketing approval) of a medicine on the other hand means that a national drug regulatory authority is required to withhold marketing approval to a generic version of a patented drug, regardless of whether the patent granted is valid or not.
Yet a drug regulatory authority’s role is to ensure that medicines marketed in a country are proved to be of quality, safe and effective: it delivers a necessary greenlight before a drug can be manufactured or marketed. Its role is not to deal with the patent status of the medicines, which is the role of a country’s patent office. Without registration, a drug cannot be sold, so if the drug regulator does not grant approval, it would delay or block other manufacturers from producing the medicine until after the patent expires.
What implications does the decision have? The Court’s decision is very important because it has stopped Bayer’s attempt to introduce a new barrier to generic competition. Generic competition is the only proven means of reducing the prices of medicines to more affordable levels.
The Court’s decision also means that different public health safeguards in India’s patents law remain useable. One safeguard, known as the ‘Bolar’ or ‘early working exception’, allows a generic producer to manufacture a drug even when it is under patent and obtain marketing authorisation in advance, so that a generic can be put on the market as soon as the patent expires.
A second safeguard is compulsory licenses (CLs). CLs can be issued to generic producers if patented essential medicines are not available or affordable in India, or if other countries which lack production capacity order essential drugs from India. But if Bayer had succeeded in introducing patent linkage in India, this could have blocked the marketing approval of the medicines made under the terms of the compulsory licence, thereby rendering the compulsory license useless.
These public health safeguards will become increasingly important, as the effect of the introduction of stricter patent rules for medicines, required in India since it joined the World Trade Organization and began applying the TRIPS Agreement, is felt in the country. We hope this judicial precedent of safeguarding public health in patent disputes will continue.
Chronology of the Bayer case. Bayer first filed a case before the Delhi High Court in 2008, on the grounds that the Drug Controller General of India authorised the application for marketing approval to a generic version of sorafenib tosylate - the anti-cancer drug for which Bayer has obtained a patent in India. The petition was first heard by a single judge bench which dismissed the petition in August 2009 and made it clear that “Bayer’s argument of inferring drug agencies’ role in patent policing or enforcement is unacceptable”.
This is the second case brought by pharmaceutical companies against the Indian government in a bid to enforce greater patent protection in India. In a separate case, Novartis is challenging another vital public health safeguard in India’s Patents Act, and having lost its case in the Madras High Court in Chennai in 2007, the Swiss drug company has taken its appeal to the Supreme Court.