Holding that unpatented (generic) drugs are not spurious drugs, Justice Ravindra Bhat held that this petition was an attempt to tweak public policy. While dismissing the petition, the Court also held that this is a vexatious and luxury litigation which should be discouraged and imposed cost of approximately Rs 6 lakh to be paid by Bayer Corporation to Respondents - Union of India and the Cipla Ltd.
Patent linkage is a system in which the Drug Controller refuses to grant aor delay a marketing approval to a generic drug manufacturer to manufacture and sell a drug if the drug is already patented. Patent linkage is known to be against public health interests as it will delay the entry of cheap, generic medicines into the market and keep medicines out of reach of those who need them.
Hailing the High Court order, Y K Sapru, chairperson of Cancer Patients Aid Association (CPAA), who had intervened in the case filed by Bayer Corporation against the Drug Controller of General of India, said, "We are very glad that the Court has recognized the aspect of access to drugs and has rejected Bayer's attempt to introduce a policy change with adverse public health consequences through the court."
Bayer Corporation had filed a Writ Petition before the Delhi High Court against Union of India, the Drug Controller General of India and Cipla Ltd. seeking an order that the DCGI should consider the patent status of its drug, sorefenib tosylate, before granting a marketing approval to any generic pharmaceutical company and refuse marketing approval to any generic company. Sorefenib tosylate is used to treat kidney cancer and is sold by Bayer at Rs 2,85,000 for 120 tablets for a month dosage.
Delhi High Court had granted an interim injunction to Bayer stopping the DCGI from granting marketing approval to the generic company (Cipla) until a final order is passed in this matter.
CPAA had filed an intervention application to be added as a party, which was allowed by the Delhi High Court. It was pointed out by CPAA that due to the stay in this case, the DCGI is not accepting the applications for marketing approval from any generic companies on any drug. The Court had then clarified that the stay would operate only with respect to the drug in question in the matter, i.e. sorefenib tosylate.
Anand Grover, counsel for CPAA and project director of Lawyers Collective HIV/AIDS Unit, said, "We welcome the High Court's judgment. 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. If introduced, the patent linkage system would have seriously impacted the early entry of generic drugs into the market. Such early entry is possible either through mechanisms such as compulsory licensing within the Patents Act itself, or where there is a bona fide belief that a patent has been wrongly granted. This is especially important as we are now seeing an increase in the number of patents being granted to drugs, which we believe are being wrongly granted. Moreover, a patentee 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."
CPAA had urged that the introduction of patent linkages in India would have adverse public health consequences. It had argued that despite the fact that the Legislature has kept the patent and regulatory systems separate, Bayer is attempting to link the two independent and separate systems and introduce a policy change through the Court.
Kiran Hukku, director, Cancer Patients Aid Association, New Delhi, said "With this rejection, we can hope to have early access to cheaper, generic medicines. This will benefit our patients."
The issue of linking grant of marketing approval to the patent status of a drug is being raised by the multinational drug companies once again in the country. MSD India, the subsidiary of the US multinational Merck, last week sought an injunction in the Delhi High Court against the sale of generic drug, Januvia, launched by Glenmark pharmaceuticals claiming that the Indian company infringed upon its intellectual property. MSD India wanted to block the sale of generic on the ground that it has a valid patent for its diabetic drug, sitagliptin, in India and therefore the marketing approval granted to Glenmark should be disallowed. By moving court against Glenmark, MSD was seeking to establish that patents granted for drugs are not defeated by the marketing approval under the Drugs & Cosmetics Act during the term of the patent. In other words, the MNC wants to link the regulatory approval of a drug product to its patent status through a court intervention. The stand of the MNC would thus mean that the Drugs Controller General of India has to deal with patent issues while processing applications for drug approval.
Patent linkage is considered to be against the public interests as it can delay entry of generics into the market and thus keep cheaper generics out of reach to those who need them. Most drug regulatory authorities including the US FDA do not have the expertise or resources to review patent information. Such a system can, therefore, lead to unfair enforcement of invalid patents in a country. After the new patent regime came into effect in India in 2005, a large number of patents have been issued to pharmaceutical companies and many of them are bogus and frivolous.
The Delhi High Court dismissal of Bayer’s petition is justified because there is no provision for patent linkage either in the Patent Act or in the Drugs & Cosmetics Act, two relevant laws in this regard.