Historic Ruling Against First Modern Drug Patent In India

from the just-the-start? dept

As Techdirt has reported over the last year, the Indian government is becoming increasingly keen on using cheaper, generic versions of important drugs to treat diseases, rather than paying Western-level prices its people can ill afford. Intellectual Property Watch reports on another instance of the Indian authorities easing the way for low-cost versions by striking down a patent granted to Roche for the treatment of Hepatitis C. As the article explains, it's notable for at least two reasons:

the patent granted to Roche in 2006 was the first product patent on a medicine in India after the country switched to a product patent regime for medicines as mandated by the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It is also India's first successful post-grant opposition case.

Getting rid of the first modern drug patent in this way neatly symbolizes the country's aggressive new attitude to Western-held monopolies on medicines. It's interesting that in this case the opposition came not from the Indian government, but from Sankalp Rehabilitation Trust, a non-governmental organization, which hopes to source the drug from a manufacturer of generics cheaply enough to be able to give it away for free. This may well inspire post-grant opposition from other organizations seeking to provide cheaper drugs to the sick in India through the use of generic versions.

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Filed Under: generics, hepatitis c, india, patents
Companies: roche

Emerging Countries Take Note: Big Pharma's Losing Patent Battles In India

from the this-could-get-interesting dept

Techdirt has been following the important story of the kidney and liver cancer drug marketed under the name Nexavar since March, when India granted a compulsory license for the first time since re-instating patents on pharmaceuticals. Naturally, the patent holder, Bayer, fought back, and appealed against that decision. Now we learn from Intellectual Property Watch that Bayer has lost:

Last Friday (14 September), the Chennai-based Intellectual Property Appellate Board (IPAB) which is responsible for hearing appeals on patent applications, rejected a petition by German pharma major Bayer AG, seeking a stay on an order of India’s Controller of Patents granting a compulsory licence (CL) to Indian generic drug maker Natco Pharma Limited, for a drug used to treat liver and kidney cancer.

It's quite possible that Bayer will try to appeal to a higher court, but what's noteworthy is that this is just one of several other important pharma cases in India at the moment. For example, the Delhi High Court held that Roche’s patent on the cancer drug Tarceva was valid, but that an Indian generics manufacturer had not infringed on it because it had only been selling a variant of the drug. Another high-profile case concerns the blood cancer drug Gleevec, sold as Glivec in India, whose manufacturer, Novartis, is fighting India's refusal to grant it a patent. Here's the background:

The legal dispute in the Glivec case centres around a provision of India’s 2005 patent law, called Section 3(d), which states that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant." The dispute brings to the fore a fundamental question: what is an "invention"? Or more precisely, how much innovation is required to obtain a patent in India?

Novartis insists that it is not fighting in order to get more money, but to vindicate its "honor". What this probably means is that it is trying to establish the principle that patents can be given for new forms of drugs, even if they provide no enhancement over earlier versions. If it loses the Gleevec/Glivec case, that could have serious repercussions for future patent applications by the company in India.

More generally, this current round of high-profile drug patent cases may well have major knock-on effects in other regions of the world. Western pharma companies are probably worried that their recent failures in India to gain certain patents or block local manufacturers of generics could be repeated elsewhere as emerging countries wake up to the flexibilities within the TRIPS agreement that India is currently exploiting. The Intellectual Property Watch article mentions three nations that are already considering this -- Botswana, South Africa and Swaziland.

An article in the leading medical journal The Lancet agrees that India's growing success might well encourage others:

In trying to limit compulsory licences and avoid efficacy tests on products, the Bayer and Novartis cases are seeking to undermine public health considerations aimed at improving access and therapeutic advantage. The TRIPS Agreement does not limit the grounds on which compulsory licences can be granted, and does not prevent patent applicants from having to demonstrate enhanced efficacy for their allegedly new and useful inventions. There are many problems facing access to and rational use of medicines in India but the provisions within the country's patent laws, if more extensively and properly applied, should help rather than hinder such access. India's laws and experiences could provide a useful example for low-income and middle-income countries worldwide.

Watch this space.

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Filed Under: big pharma, drugs, india, patents, pharmaceuticals
Companies: bayer, novartis, roche

The Lobbyists' Ability To Control The Message

from the we-say-what-they-want dept

It certainly won't come as much of a surprise to readers around here that lobbyists from Roche/Genentech were able to get 42 different members of Congress to include text they had written into the Congressional Record. For way too long, we've seen how much politicians seem to rely on lobbyists to write the legislation, create the talking points and (at times) even deferring questions to the lobbyists themselves. Is it any wonder that lobbyists have become the new celebrities?

But what is rather stunning about the NY Times story on how Genentech's talking points were mentioned (with multiple Congressional reps using the exact same language) is how unconcerned everyone is about it. The lobbyists wrote up talking points for both sides of the aisle. It wasn't about being in support or against the current healthcare bill, but just to get these Congressional Reps "on the record" in supporting key concepts, so that those same lobbyists can go back and point to such "bipartisan" support in the future, even if the Congressional reps themselves don't even know what they're talking about.

The NY Times talked to a bunch of Congressional offices about this, and they all seem to admit freely that the language came from Genentech lobbyists, and they incorporated it directly (sometimes with a few minor changes) into the remarks that get put into the Congressional record. This isn't the fault of Genentech or its lobbyists -- who, of course, are going to push for such things. The really damning part is that all of these Congressional reps don't seem to think there's any problem at all with simply taking text directly from a company and putting it into their own remarks as if they agree on the concept, when they don't even seem to understand what they're saying half of the time. Often these sorts of Congressional remarks are later used to show "Congress' intent" in doing certain things. But, perhaps they should just start being upfront and honest about the fact that these remarks are "the industry's intent" and simply signing them with the companies that actually wrote the language (or at least tagging the remarks with the name of the company/industry group that wrote it).

Filed Under: congress, health care, lobbyists
Companies: genentech, roche