Let drug makers slug it out

For most multinationals, India and China are jewels in the crown, holding out the promise of growth in times of slowdown.

But for British drug-maker GlaxoSmithKline, these regions seem to be cause for anxiety.

Last week, India revoked the patent on GlaxoSmithKline’s (GSK) advanced breast cancer drug – Tykerb, the salt form of lapatinib. The Tykerb order echoed an earlier benchmark judgement from the Supreme Court that disallowed patent protection on incremental innovations, if it did not establish increased therapeutic efficacy.

The apex court judgement was in a case involving Novartis blood-cancer drug Glivec — which concluded about four months ago, after seven years of intense legal debate and much attention from across the world.

GSK may not quite want such attention in India, at a time when it is dealing with bribery charges against some of its officials in China.

MNC VS MNC

But luck was not in its favour. The late July order from the Intellectual Property Appellate Board put the spotlight on GSK and its two patents on lapatinib and its salt (sold under the brandname Tykerb). The IPAB order upheld the patent on the base compound, while invalidating the one on its salt.

Critical to the invalidation of the salt patent was Section 3 (d) of the amended Patents Act, that disallows the ever-greening of patents.

Lauded and criticised, depending on which side of the drug debate one is placed, Section 3 (d) is the cornerstone of the Indian patent law. It disallows an extended period of patent protection on a drug, if it is merely a tweaked version of an existing molecule, and unable to establish enhanced efficacy.

But the Tykerb case goes beyond GSK, and its possible plan to appeal the IPAB revocation of its patent. In fact, it is interesting for being both similar and different to the slew of patent-related litigations presently under way in the country.

The Tykerb battle is between two multinationals. The challenge to GlaxoSmithKline’s patents on lapatinib is from Fresenius Kabi, the Indian arm of the German healthcare company.

In the past, multinationals have crossed swords with domestic generic-drug makers in India, as they tested the resilience of the amended Patents Act (2005).

But the IP contours are changing. Take the other recent patent battle between Merck and Glenmark, over diabetes drug Sitagliptin. Merck has a tie-up with local drug-major Sun Pharma on the drug, and as a result, it gets pitted against Glenmark here.

The twist in the Tykerb tale is that multinational Fresenius Kabi is also a generic drug maker, which means it makes medicines that are chemically similar to the drug.

As the two multinationals, albeit with different orientations, slug it out over the breast cancer drug, the clash will explore and enrich the intellectual discussion in the country.

But if the exercise also succeeds in paving the way for less-expensive breast cancer drugs, in this case, to come into the country, at an earlier than expected date – it will bring some cheer too, to patients. After all, breast cancer is reportedly the second largest cause for cancer in women in the country.

Section 3 (d), again

The revocation of Tykerb’s patent has generated a debate, and in the online world, for instance, reactions range from – ‘India does it again’ to ‘Section 3 (d) strikes again’.

From the multinational innovator’s viewing-glass, this could be interpreted as a country dishonouring patents, again, the reference being to earlier cases involving Pfizer’s advanced liver and kidney cancer drug Sutent, or Roche’s hepatitis C drug, Pegasys.

But from the public health, access point of view, India is seen as pushing the bar on innovation just a little higher, by not accepting incremental innovation. Public health is not a bad word, and is not anti-innovation, point out intellectual property lawyers. In fact, India is measuring its cases by an IP yardstick, they observe.

The debate around access to healthcare is not limited to India, but features in political debates in developed markets like the US and the UK, as well. It is just that the patent debate in India is more recent -- since the country amended its Patent Law in 2005, to honour product patents.

The cause for worry here, among healthcare workers, is that a patent awards an innovator a 20 year protection to sell its product. This also means, the innovator can command a premium price on the product, ostensibly to recover its own investments in research.

ACCESS TO MEDICINE

So when it comes to medicines, the patent could price the product beyond the reach of a large patient population, particularly in the case of already expensive cancer drugs. And this is a legitimate concern that drug-makers and Governments cannot ignore.

One such tool that countries use to address access is a compulsory licence (CL), where a third party can make its less expensive version of an innovator’s drug, but on the payment of royalty to the innovator. India issued its first CL to Natco, allowing it to make Bayer’s kidney cancer drug Nexavar, on payment of seven per cent royalty.

Another breast cancer drug, Roche’s Herceptin, is in the centre of a CL debate, as the Government explores options.

Fair game

The patent scenario is still dynamic in India, with cases and appeals, leading to a whole new set of outcomes.

In Tykerb’s case, at present, since GSK’s patent on the base compound (lapatinib) stood the Fresenius challenge – its patent continues till it expires in January 2019.

So, though the patent on the salt version of lapatinib is invalidated, generic drug makers will not be able to launch their versions of this medicine, till 2019 (because the base patent remains). But even this is an advancement for companies looking to launch the drug, as the patent on the salt version (now invalidated) was originally to expire in mid-2021.

Tykerb’s India story is interesting, as the country was part of the global development of the drug. Given its niche significance – it is given to patients in whom Herceptin ceases to work – approvals on Tykerb were fast tracked in the US and in India, say company insiders.

Lauched in 2008, Tykerb came to India, close on the heels of the global launch – within 12 months, to be precise. And, it was one of the earliest to have an India-specific pricing – at Rs 4,000 for 10 tablets, it is at 25 per cent of GSK’s global price.

What the Tykerb case brings to the fore is that, in a sense, all is fair in love and war. Companies will fight or partner with each other – be they local or multinational – to access new markets. But in the process of these no-holds barred battles, if the government gets pushed to spend more on healthcare, or companies forced to explore new options to improve access and bring better and less expensive medicines to patients, then the exercise is fair game and well worth it.

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