Close on the heels of a reasonably successful patent challenge by the German pharma Multinational Corporation (MNC) Fresenius Kabi for the breast cancer drug Tykerb of GlaxoSmithKline (GSK) in India, another MNC Mylan, with its headquarter in the United states, has explicitly expressed its plan to challenge frivolous and weak patents of MNCs, in conformance to the Indian Patents Act, to provide less expensive generic drugs to patients.
This is indeed another interesting development, which could possibly culminate into robust, cleverly crafted and fiercely competitive business strategies of many other MNCs, revolving around patent challenges in India, for business excellence in the country.
Mylan develops new products in India:
Mylan is now reportedly working with the local Indian player Biocon to develop a strong new product pipeline, which would include a portfolio of biosimilar drugs. The advanced breast cancer drug Trastuzumab (Herceptin) of Roche is just one of many in the list. Mylan has also expressed its intent to market ‘Herceptin’ at a price, which will be affordable to many more cancer patients of India.
It is worth mentioning that some other domestic Indian companies like, Reliance Life Sciences and BDR Pharma are reportedly working on generic Trastuzumab (Herceptin), besides some South Korean bio-pharma players.
Mylan has also inked an agreement with Biocon to develop and market an insulin drug derived from the global major Sanofi’s expensive patented product Lantus.
All these developments apparently augur well for India.
Weak patent?…Recapitulating Herceptin saga in india:
Though Roche decided to discontinue its patent rights for Herceptin in India, it reportedly lost this patent earlier in Europe. This vindicates the views of experts that Herceptin patent was weak, as it would probably not be able to clear the litmus test of a stringent patent scrutiny. The report, therefore, argues that core reason for withdrawal of Herceptin patent in India by Roche cannot be attributed, even remotely, to the ‘weak IP ecosystem’ in India.
To extend the patent right for Herceptin, in early September 2013, Roche reportedly announced that the European Commission has approved a new formulation of its breast cancer drug Herceptin, which allows the medicine to be administered more quickly.
A tough market, yet difficult to ignore:
For global innovator pharma majors, India still remains a tough market to crack, despite strong overseas political pressures of various types, intense collective and individual lobbying efforts and deployment of expensive global ‘Public Relations’ firms working in full steam.
Their strong success factors of the yesteryears in this area, which worked so well across the world, are getting mostly negated by the ‘evolving patient friendly IP laws’ of the emerging economies.
Considering the vast business potential of the pharmaceutical market of 1.2 billion people in India, it is now envisaged by many, more like-minded MNCs will gradually jump into this fray with similar intent of patent challenges in conformance with the Indian Patents Act 2005.
If this scenario assumes a cascading effect on a broader canvas, ultimate beneficiary will be the ailing patients, having much greater access to more affordable newer drugs for many dreaded diseases, like cancer.
Other countries too tightening up the patent laws:
To provide less-expensive generic drugs to patients, other countries also have started following India to leash astronomical prices for new drugs, especially for life threatening and intensely debilitating ailments. China has reportedly strengthened its compulsory licensing provisions already for dealing with costly drugs, paving the way to force entry of generic drugs in the Chinese market well before patent expiry.
In 2012, Indian Patent Office, in a path breaking decision granted Compulsory License (CL) to a local company, Natco Pharma, to manufacture the patented kidney-cancer drug, Nexavar of Bayer reportedly at a cost of Rs. 8,800 (around US$ 176) for a month’s therapy of 120 capsule against Bayer’s price of Rs. 280,000 (around US$ 5,600) for the same.
This is the first-ever case of CL granted in India thus far to make life saving drugs affordable to patients.
On September 3, 2012, the Indonesian government took the unprecedented step of overriding the patents on seven HIV and hepatitis treatments, citing urgent need to improve patient access. These drugs were reportedly beyond the reach of most of the patients in Indonesia.
Thailand has also used this provision more than once, and countries like, Brazil has reportedly threatened quite often for invoking CL during price negotiations of such drugs with global pharma majors.
Winds of Change in South Africa:
Now South Africa has also exhibited its firm intent to have a tight leash on the grant of pharmaceutical patents of all types.
A recent report indicates that the Department of Trade and Industry (DTI) of the Government of South Africa is calling for comments on its proposed ‘National Policy on Intellectual Property’ by October 4, 2013, which if implemented, would significantly curb patent evergreening and expand production of generics.
The same report mentions that at present, South Africa does not examine patent applications. Instead, the system allows pharmaceutical companies to obtain multiple patents on the same drug, even for inventions, which do not fall under the country’s definition of innovation. This allows the pharma players to extend their respective patent lives, blocking competition and charging exorbitant prices.
The report also points out, while in 2008, South Africa granted 2,442 pharmaceutical patents, Brazil approved only 278 in the 5 years between 2003 and 2008.
Patents revoked in India:
Since November 2010 following 8 MNC patents have been revoked in India after respective patent challenges:
- Combigan and Ganfort of Allergan (for specified eye conditions)
- Tykerb of GSK (for breast cancer)
- Sutent of Pfizer (for liver and kidney cancer)
- Pegasys of Roche (for hepatitis C)
- Iressa of AstraZeneca (Anti-cancer)
- Anti-asthma FDC aerosol suspension of Merck & Co (Anti-asthma)
- Dulera of Novartis (Anti-asthma)
China and Brazil revoked patents:
In August 2013, just about a year after China introduced the country’s amended patent law, its State Intellectual Property Office (SIPO) has reportedly revoked the patent on HIV/AIDS and hepatitis B drug – Viread (tenofovir disoproxil fumarate) of Gilead Science Inc.
Aurisco, the largest manufacturer of Active Pharmaceutical Ingredients (APIs) in China, challenged this patent. The ground of patent revocation was that the drug lacked novelty and was not entitled to protection.
In 2008 Brazil also declared the patent of tenofovir invalid. It is worth mentioning that tenofovir of Gilead is the third-best-selling drug of the company, clocking sales of US$ 849 million in 2012.
Top 10 ‘jaw-dropping’ most expensive medicines of the world:
|No.||Name||Disease||Price US$ /Year|
|3.||Soliris||Paroxysmal nocturnal hemoglobinuria||409,500|
|8.||Arcalyst||Cold Auto-Inflammatory Syndrome||250,000|
|9.||Ceredase / Cerezyme||Gaucher Disease||200,000|
(Source: Medical Billing & Coding, February 6, 2012)
The good news is, protests against such ‘immoral and obscene pricing’ have started mounting, which are expected to have a snow-balling effect in the years ahead.
Mounting global protests:
Probably due to this reason, drugs used for the treatment of rare diseases are being reported as ‘hot properties for drug manufacturers’, all over the world.
The above report highlighted a changing and evolving scenario in this area.
In 2013, the Dutch Government had cut the prices of new enzyme-replacement therapies, which costs as high as US$ 909,000. Similarly, Ireland has reduced significantly the cost of a cystic fibrosis drug, and the U.K. rejected a recommendation to expand the use of a drug for blood disorders due to high costs.
Soon, the United States is also expected to join the initiative to reduce high prices of orphan drugs as both the government and private insurers increasingly come under the cost containment pressure.
Emerging markets – the Eldorado:
Competition within MNCs is expected to be even more fierce in the coming years as the developed markets continue to slow down, as follows, due to various reasons:
|Global Pharma Market||
Source: IMS Knowledge Link Global Sales 2012
This compelling scenario is prompting a change in the dynamics of competition within MNCs in the emerging pharmaceutical markets. The intents of Fresenius Kabi and Mylan, as enunciated above, I reckon, are just very early signals of this challenge of change.
All these would probably help turning the tide in favor of a seemingly win-win solution to bring down the prices of patented medicines at an affordable level, improving their access to vast majority of patients in the world.
Scope for more patent challenges in India:
Quoting a study, a recent media report highlighted that only 3% of the patent applications filed in India since 2006 were challenged. The study concluded:
“This demonstrates that given the various resource constraints faced by the Indian patent office, one can never really be sure of the patent quality unless the patent is challenged.”
Therefore, this process is expected to gain momentum in the years ahead as more MNCs join the fray of patent challenges, though driven primarily by business interests, but nevertheless, would benefit the patients, in the long run.
Further, as indicated in my previous columns, a study indicates that 86 pharmaceutical patents granted by the IPO post 2005 are not breakthrough inventions but only minor variations of existing pharmaceutical products and demanded re-examination of them.
Since, most of the above patents have not been challenged, as yet, the quality of these patents cannot be ascertained beyond any reasonable doubt, as we discuss today. If challenged, some experts envisage, these patents may not be able to stand the scrutiny of section 3(d) of the Indian Patents Act.
In that sense, if the pharma MNCs with deep pockets, challenge these patents, there stands a good chance of making generic equivalents of those products at affordable prices for the Indian patients.
However, considering different degree and elements of market entry barriers, it appears, most of the patent challenges in India by the MNCs would probably be for biologics, as compared to small molecule chemicals.
Flow of newer drugs in the Indian market is now irreversible:
Taking stock of the emerging scenario, it appears, India will continue to see newer drugs coming into the market at a lower price in the years ahead, come what may. This flow seems to be unstoppable due to the following reasons:
- Stricter implementation of Section (3d) of the Patents Act in India will ensure that NCEs/NMEs not conforming to this act will not be granted patents. In that case, those products will be open to generic copying by all, in India. Thus, in the absence of a market monopoly situation and fuelled by intense price competition, the patients will have access to those newer drugs.
- More patent challenges of already granted patents could lead to revocation of more number of patents paving the way for entry of their generic equivalents.
- If any MNC decides not to launch a new product in India having obtained its patent from the IPO, after three years, as per the statute, the same product becomes a candidate for CL in the country.
- If any patented new product is launched without ‘reasonably affordable price’, again as per statute, the possibility of applications for CL coming to the IPO from the local players will loom large.
Hence, considering all these points, it appears, if the new products do not conform to the Indian Patents Act and are not launched with responsible pricing, the possibility of their generic entry at much lower prices is almost inevitable.
Legal battle is expensive, even in India, and patent challenges are perhaps more expensive. All those new products, which are not patentable in India or may otherwise be challenged against other statutes of the Patents Act, will carry risks of getting caught in protracted litigations or generic competition.
MNCs with deep pockets coming forward with such intent, though may be based purely on their business interest in India, would ultimately offer spin-off benefits of affordable pricing, especially, to the patients suffering from life threatening and fast debilitating illnesses like, cancer.
That said, do all these developments unravel yet another way to improve access to newer medicines in India, signaling a boon for patients?
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.