Hope for hep-C patients:
Context and Background
Today, the Bench of Intellectual Property Appellate Board, comprising Justice Prabha Sridevan (Chairperson) and Mr DPS Parmar (Technical Member), set aside the first ever product patent on a medicine granted in India to Roche for Pegasys (a medicine used to treat Hepatitis C) on an appeal filed by a patients’ group.
In 2005, to comply with its international trade obligations, India re-introduced a system of granting product patents on medicines. In 1970, it had changed its patent law to disallow such patents precisely because they had resulted in high prices of medicines in India. This was the first product patent granted under the amended 2005 patent law.
As you know, a product patent on a medicine allows the patentee to prevent others from making or selling the medicine. This means that the patentee is able to set monopolistic prices. In the case of Pegasys, Roche charges approximately INR 4,36,000 for a course of six-months’ treatment. There may also be a relapse in which case the treatment course will have to repeated.
The Indian patent law provides for several tiers of protection to ensure that only genuine inventions are protected by patents. For instance, it allows “any person” to file an opposition challenging its grant. This could prevent a patent from being wrongfully granted in the first place. If a patent is granted, it can still be challenged by a “person interested” in a post-grant opposition or in a revocation proceeding.
The order delivered by Justice Prabha Sridevan is important for several reasons.
Sankalp, a patients’ group, had filed a post-grant opposition, which was rejected by the Patent Office. In the appeal filed by Sankalp before the IPAB, Roche sought to place a narrow interpretation on who a “person interested” could be. It argued that Sankalp is not a “person interested” because it was not a business competitor or a researcher. This issue probably arose for the first time before the IPAB. Rejecting Roche’s contentions, the IPAB held that a patients’ group that is a “person interested” in whether a patent is revoked or not. Justice Sridevan noted that the revocation of a patent could bring down the costs of the medicine as well as increase supply. She also held that public interest is persistently present in intellectual property law.
On the merits, the IPAB revoked the patent on the ground that Roche’s claim of combining interferon (a protein known to treat Hepatitis C) with an inert PEG structure using conventional methods to obtain predictable results was obvious to a person skilled in the art. The IPAB also held that Roche did not show that this pegylated interferon showed enhanced efficacy over other known pegylated interferons – a requirement under section 3(d) of India’s patent law.
By setting aside the patent , this order now paves the way for Indian companies that may decide to launch biosimilars of this medicine in India.
2 November 2012, New Delhi.
In a landmark victory for patients’ groups fighting against patents to ensure access to medicines, the bench of the Intellectual Property Appellate Board (IPAB) comprising Justice Prabha Sridevan (Chairperson) and Mr. D. P. S. Parmar (Technical Member), has revoked a patent granted in India to F. Hoffmann-La Roche AG (Roche) for pegylated interferon alfa-2a (Pegasys, a medicine used to treat Hepatitis C) as well as held that a patients’ group can challenge the validity of granted patents.
Mr. Eldred Tellis, Director of Sankalp Rehabilitation Trust, who had challenged the patent, said, “We hope that the absence of patent barrier will spur generic competition to bring down the price of this much-needed drug for those suffering from Hepatitis C. We also hope that the Government will now take concrete steps to start providing access to this medicine. It is unacceptable that people are dying due to Hepatitis C because they cannot afford to buy the medicine.”
As may be recalled, this patent granted to Roche in 2006 was the first product patent on a medicine in India under the new TRIPS-mandated product patent regime for medicines. The patent granted a monopoly to Roche to market pegylated interferon alfa2a. Patients with chronic Hepatitis C, who need a six-month course of treatment of Roche’s pegylated interferon alfa2a, have to purchase it at a cost of approximately INR 4,36,000 [USD 8,752.38] (available at a discounted price of INR 3,14,496 or USD 6,313.28). Again, it has to be taken in combination with ribavarin, which alone costs INR 47,160 [USD 946.70].
Concerned about the impact of this patent on access to medicines, Sankalp—an organisation that provides treatment and rehabilitation support for injecting drug users—filed a post-grant opposition challenging the grant of the patent with technical and legal aid from Lawyers Collective HIV/AIDS Unit.
Mr Anand Grover, senior counsel and Director of Lawyers Collective HIV/AIDS Unit, who appeared for Sankalp in this matter, said, “This victory will facilitate early entry of generics which is likely to lower the prices. If this happens, millions suffering from Hepatitis C, both in India and globally, will benefit. It is also historic because this was the first ever product patent granted on a medicine in India since 1970.”
Hepatitis C represents a huge public health problem in India and globally. An estimated 10–12 million people in India, including 50% of IDUs nationally and 90% of IDUs in the northeast, are infected with the Hepatitis C virus (HCV). Left untreated, Hepatitis C can lead to liver cirrhosis, liver cancer or liver failure. Hepatitis C is especially of concern for those co-infected with HIV, as several studies have shown that HIV-HCV co-infection leads to increased rates of disease progression. Injecting drug users are especially vulnerable to HIV-HCV co-infection with HIV-HCV co-infection rates as high as 93% among IDUs in Manipur. However, unlike both first- and second-line HIV treatment, which is available to all people living with HIV who need it, Hepatitis C treatment is not available in government hospitals largely due to its high cost and treatment programmes do not even bother to screen patients for HCV due to the unavailability of treatment.
Despite Sankalp’s case that Roche’s clams did not satisfy the patentability requirements under Indian law, in 2009, the Patent Office rejected the post-grant oppositions filed by Sankalp and an Indian company and upheld the validity of Roche’s patent. Sankalp then filed an appeal before the IPAB challenging this decision.
Before the IPAB, Roche also challenged Sankalp’s standing to file the post-grant opposition as well as the appeal. Roche argued that because Sankalp was not a business competitor or a researcher in the sector, it could not have challenged its patent at all. Sankalp argued that its members were directly affected by Hepatitis C as well as that it represented a community of drug users who are particularly at risk to Hepatitis C. The IPAB observed that “public interest is a persistent presence in intellectual property law” and also held that it was against public interest to “allow unworthy patents to be on the Register”. Holding that “the appellant who works for the community which needs the medicine, is definitely ‘a person interested’”, the IPAB noted that a successful challenge would “break the monopoly” and “bring the drug within reach of the community for whom it works, not only by reduction in cost, but also because of increase in supply”.
Mr. Grover said, “We are happy that the IPAB has recognised the element of public interest in setting aside undeserving patents and held that patients’ groups, who are directly impacted by patents on medicines, can challenge granted patents. This will be of import as concerned patients’ groups will now have better clarity in challenging patents on medicines for HIV, cancer and other diseases.”
Setting aside the patent, the IPAB held that Roche’s pegylated interferon was obvious to a person skilled in the art. It also found that Roche has not provided any evidence, in the specification or even otherwise, to prove that pegylated interferon has enhanced efficacy. The IPAB, however, held that Roche’s claims were novel.
Welcoming the findings on obviousness and section 3(d), Mr. Grover said, “The IPAB has rightly observed that the patentee used conventional methods to pegylate interferon and obtained predictable results, thereby rendering it obvious to a person skilled in the art. It also correctly held that the patentee has failed to satisfy the requirement of section 3(d) of showing enhanced efficacy. We hope that the Patent Offices too follow these standards while deciding pre- and post-grant oppositions.”
The text of the order can be accessed at the website of the IPAB. We will upload a copy of the official certified copy on our website as soon as we receive it.
Lawyers Collective HIV/AIDS Unit and Sankalp Rehabilitation Trust
For further information, contact
Anand Grover: +91.9820184788, Eldred Tellis: +91.9820194363
Prathibha Sivasubramanian / Julie George: +91.11.46805506; +91.9968050357