Patently against public health?

Drug-makers are slugging it out over medicine patents, in the process putting the amended Patents Act (2005) to an intense stress test.

By year-end, the Patents Act completes eight years since it was amended to honour product patents in 2005. And within this framework, a handful of patent-related cases are poised at different stages of arguments and judgments in the country’s law courts.

Significant outcomes are expected as the year runs out, and 2013 dawns. The hope is, that the consumer emerges a winner from these legal battles, gaining access to good medicines at the best price.

Benchmark battle

At the Supreme Court, final arguments are under way on a case involving Novartis’ blood-cancer drug Glivec. It is the first patent-related case after India amended its Patents Act. Novartis’ patent application on Glivec was rejected by the Indian Patent Office in 2006, a decision contested by the Swiss drug-maker. But from there on, the Glivec-story has traversed several legal lanes and bylanes, eventually arriving at the apex court for its final leg of arguments.

A judgement on the Glivec case will set a benchmark in the country, further defining the pathway for implementation of the amended law.

The case also has a global audience, across the pharmaceutical industry, governments and healthcare circles — since the issue is inter-twined with concerns on medicine prices. In fact, Governments across the world are grappling with keeping healthcare costs under control, and medicine prices are a key component to that problem.

A patent is granted by the Patent office to a company or innovator for a product that has an inventive step, among other things. In the bargain, the innovator also gets a 20-year exclusive period to market the product, in this case, a medicine. Since the innovator is believed to have invested funds into research, the final product is usually marketed at a premium price, and therein lies the problem when it comes to medicines.

Some patent lawyers argue that medicine pricing and protection of intellectual property through patents are two different tracks. But pro-health groups fear, in the absence of competition, monopolistic tendencies by patent-holders could price a drug beyond the reach of the patient.

First-timers

Besides Glivec, there are other ‘first-timers’ seeking legal recourse. India’s first compulsory licence (CL) granted earlier this year to Natco, for instance, is being contested at the Intellectual Property Appellate Board. The Patent Controller had issued a CL on Bayer’s advanced kidney cancer drug Nexavar, allowing Natco to make a similar version of the drug at a reduced price, but on the payment of a royalty to Bayer.

Last month, the IPAB dismissed a plea to stay the CL and prevent Natco from selling the drug. The IPAB is now set to take up Bayer’s appeal against the issuance of the CL.

Also at the IPAB is a case involving the country’s first post-grant opposition. Non-government organisation Sankalp had opposed the patent granted to multinational drug-maker Roche on Pegylated interferon, used to treat Hepatitis C. Sankalp contested the patent on the grounds that the pegylation process was known. The process helps the drug stay longer in the blood, benefiting the patient as it reduces the frequency of injections to be taken to just one a week, as opposed to three earlier.

The hearings on this case are now complete at the IPAB, and judgement is awaited.

Another case involving a post-grant opposition is set to land at the IPAB’s door-step after Pfizer’s patent on its liver and kidney cancer drug Sutent was recently revoked by the Patent Office, following Cipla’s opposition.

In fact, Cipla is also locked in another patent-infringement battle, at the Delhi High Court, with Roche, involving the latter’s lung cancer drug Tarceva (erlotinib).

Evergreening at work

From appealing the rejection of patent applications, contesting compulsory licences and filing pre and post-grant oppositions — the amended Patent Law is, in a sense, being pushed, poked and prodded by drug companies, testing its resilience.

For instance, during the course of the Glivec case, Novartis has contested Section 3d of the amended Patent Act. A significant safety-catch in the Act, Section 3d does not allow, what is popularly referred to as “ever-greening” of patents — where companies tweak an existing drug molecule and try to get a fresh life of patent exclusivity on it. A company is also expected to establish greater efficacy of the drug that has been modified, to get a patent — an argument that comes up in the Glivec context as well.

Novartis is contesting the rejection of its patent application on Glivec, saying that the drug is innovative, among other things.

That view, though, is not held by the Cancer Patients Aid Association and other local drug companies, including Cipla and Natco, who are fighting it in Court.

The shadow of price also looms over these patent-related cases. Glivec, for instance, is priced at about Rs 1 lakh a month, while the generic company that makes a similar version of the same drug pegged its price at about Rs 10,000, when the issue first went to Court. Novartis, though, has maintained that it runs a patient-support programme to provide free medicines for patients unable to afford the drug.

In the case of Bayer’s kidney-cancer drug Nexavar, the Patent Controller issued a compulsory licence allowing Natco to make a similar version of the drug on the payment of a six per cent royalty.

The crux of the issue here was that Bayer’s Nexavar was priced at Rs 2.8 lakh for a month’s supply of the medicine, it was imported and was not accessible to patients who needed it. Natco promised to make a similar version of the drug at Rs 8,800 per month.

But the case involving Roche’s pegylated interferon traverses new ground, since the drug is a biological product (from a natural source) — not chemically made like a regular allopathic medicine.

The case also clarifies whether an NGO can file an opposition after a patent was granted, as the amended Act allows only an interested party to file a post-grant opposition. In the case of opposition before a patent is granted, the amended law allows anyone to file a pre-grant opposition. Sankalp’s counsel argued that they were interested party, as they represented patients.

As these cases get argued thread-bare at the Court, and final judgements come forth, the shape and contours of the amended Patent Act will get more clearly defined, landing a win for patients and public health.

( >blfeedback@thehindu.co.in )