As pipeline dries, Big Pharma resorts to evergreening

In tough times, get innovative, or fake it. That’s what pharma companies seem to believe in these days. Even as they struggle to bring out new molecules, global pharma firms are reworking existing drugs or pooling together two drugs as innovative products and claiming patents, in a system called evergreening to prevent competition from generics and to extend their market monopoly, say industry experts.

Sometime back, the Delhi Patent Office rejected a series of applications filed by multinationals on grounds that they were mere modifications or extensions of known substances.

Among those rejected were Pfizer’s Caduet (for high cholesterol and high blood pressure), GlaxoSmithKline’s rosiglitazone salt (for diabetes), alpha crystalline form of Novartis’ Glivec (for chronic myeloid leukaemia), and Gilead Science’s bird flu drug Tamiflu and hepatitis B drug Hepsera.

But there were a good number of patent grants, too, said Shamnad Basheer, the human resources ministry’s chair in intellectual property law at the National University of Judicial Sciences.

These included Roche’s pegylated interferon alfa-2a and Schering-Plough’s pegylated interferon alfa-2b, both for hepatitis C, GlaxoSmithKline’s abacavir oral solutions for HIV, Roche’s valganciclovir for viral eye infections, which, say experts, are new forms of known substances or combinations of two existing substances.

A Mumbai based patent expert said about 95% of the patents granted in India ignore the section 3 (d) of the Indian Patent Act of 1970, 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” shall not be treated as an invention within the meaning of the act.

On the condition of anonymity, the expert said, “The interpretation of section 3(d) has been non uniform by the patent offices. There is a very casual approach in the patent office.” According to a New Delhi based patent and intellectual property expert, India has a very low rate of patent application rejections due to poor quality of examiners.

DG Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), said though lawmakers have made provisions against ‘evergreening’ in the Patent Act, several patents granted over the last few years have been to new forms of known substances and combinations of old drugs.

YK Sapru, founder chairman and CEO of Cancer Patients Aid Association (CPAA), said, “After patent for the beta form of Glivec was rejected, Novartis tried to get the alpha form patented. MNCs want to keep prices high by passing off mere modifications as inventions.”

CPAA, a Mumbai based NGO, locked horns with Novartis over the patent for the beta form of Glivec.

According to industry experts, MNCs are pushing hard to extend the patents for their drugs as new molecule pipelines have dried up and multiple patent expiries are facing them.

According to statistics from securities house First Global, in 2008-09, around 11 leading drugs worth $29 billion went off patent in the US. Another $44 billion worth of drugs will do so in 2010, including leading ones like Lipitor (for cholesterol), Cozaar (blood pressure), and Protonix (for stomach acid) in the US, and Keppra (for epilepsy) in Europe.

Further, data by professional services firm PricewaterhouseCoopers (PwC) shows that in 2007, only eight of the 27 new therapies launched globally were the first of their kind, the rest being ‘me too’ treatments with at least 3 predecessors. “So with no novel molecules in sight, companies are left with no option but to bring out a new variant of some already existing molecule and claim a patent on it as is happening nowadays,” said the Mumbai based expert.