Figure this

In the Rs 70,000 crore

Indian pharma market,patent wars are heating up. In a landmark judgment,the Supreme Court of India ruled against the patent claims of Novartis on its cancer drug,Glivec. The judgment allows suppliers to continue making generic copies of Glivec,providing relief to around 300,000 patients in India. It is estimated that $150 billion worth drugs will lose patent protection between 2010 and 2017.

Process-to-Product Patent Regime

India’s patent laws allow Indian companies to produce generic versions of drugs that are under patent elsewhere. Competition between manufacturers drives down prices of drugs. Cipla is one of the largest suppliers of low cost generic drugs in the world.

For many years,India didn’t recognise drug patents. In 1994,India signed the TRIPS agreement (Trade Related Aspects of International Property Rights) which gives drug companies a 20-year patent on the production of drugs. TRIPS required India to introduce patents on medicines in 2005. In 2005,India passed the latest amendments to the India Patents Act 1970,shifting over from process- to product-patent regime. This was necessary for India to comply with existing WTO norms.

EVERGREENING

The Supreme Court’s judgment has set a precedent against the practice of “evergreening”—a strategy through which drug manufacturers introduce modifications of drugs to extend the five-year patents on them. ‘Evergreening’ is where a company extends its patent on a drug by re-patenting slightly modified versions of the drug. For example,they might release the original drug in its salt form,even if this does not bring a therapeutic improvement.

India—along with Brazil,Thailand,and South Africa—is one of the few countries with laws against ‘evergreening’. The Indian Patent Act,as amended by the Patents (Amendment) Act 2005 under Section 3(d),states that drugs cannot be patented if they result from “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.” This has allowed the continued production of cheap generic versions of drugs by Indian companies.

OTHER WARS

Glenmark versus Merck: US pharma giant Merck has sued Indian Glenmark to defend its patents on anti-diabetes drug Januvia. Last week,Glenmark launched generic copies of Januvia in India even as the Delhi High Court refused interim relief to Merck in the case. With Merck’s case against Glenmark,patent wars have moved beyond life-saving drugs for AIDS and cancer to include chronic therapy areas like diabetes. While Merck has claimed it has two patents on the original drug Sitagliptin and Sitagliptin Hydrochloride,Glenmark has said that Sitagliptin’s phosphate salt does not fall under the original patent and not patentable under Section 3(d).

November 2012: India’s Intellectual Property Appellate Board (IPAB) revoked Roche’s patent on its hepatitis C drug,Pegasys,on the basis that it contained nothing novel. The

Pegasys patent was the first ever product patent granted in 2006.

September,2012: Supreme Court revoked Pfizer’s patent on Sunitib,citing the absence of any invention. Cipla was producing much cheaper versions of Sunitib when it was banned by the High Court following the revocation. The order was stayed by the Supreme Court.

September 2012: Delhi High Court ruled in favour of Cipla in a patent infringement case,over Roche’s anti-cancer drug Tarceva. Roche’s patent for polymorph B version of Tarceva was rejected on the basis of Section 3(d).

2012: India granted a “compulsory license” to a generic drug manufacturer to begin making copies of Bayer’s cancer drug Nexar and revoked Pfizer’s patent for another cancer drug,Sutent.

IN THE US

Companies can get a new patent for a drug by altering its formula or changing its dosage. Critics say a majority of drug patents given in the US are for tiny changes that give patients few benefits but allow drug companies to charge high prices even beyond the original patent life. Under the “pay for delay” deal,drug companies allow generic versions to be made available five years before their patent expires in mutually settled agreements between brand-names and generic drug makers.

ASTRAZENECA extended its franchise around the best-seller heartburn pill Prilosec by slightly altering chemical structure and renaming the drug Nexium.

AMGEN has won patents on its erythropoietin-stimulating drugs that the firm has kept exclusive sales rights for 24 years,double the usual period.

Trans-Pacific Partnership: The US is negotiating terms of a new Pacific Rim trade agreement,due for completion this year. The agreement will require countries to adopt more stringent patent protection rules.

THEY DON’T COME CHEAP

Novartis’ GLIVEC

Rs 1 lakh per month

Generic versions

Rs 8,000-10,000 per month

Bayer’s Sorafenib Tosylate

Rs 2.8 lakh for 120-capsule pack

Generic version

Rs 8,800 for 120-capsule pack

Roche’s Herceptin

Rs 1.1 lakh per month

Merck’s Januvia

Rs 43 per day per tablet

DEVELOPED COUNTRIES vs DEVELOPING COUNTRIES

Global generic drug market: $225 billion in 2011. US is the largest generics market,constituting 45 per cent of the global market

US $73 billion

China $26 billion

India $11 billion