Indian pharma may export to Philippines

NEW DELHI: Crucial patent law reforms in Philippines may open up a goldmine of opportunity for India's generic pharma industry to export medicines for treating deadly diseases such as HIV and cancer. Domestic companies including Cipla, Natco Pharma and Strides Arcolab are already exporting anti-HIV drugs to Africa and other countries.

More importantly, these reforms strengthen the case of India's Patent Act, particularly the 'often attacked' provision Section 3(d), which prohibits patenting of known drugs.

Experts say that India's Patent Act has inspired lawmakers in Philippines to ratify new legislation 'Universally Accessible Cheaper and Quality Medicines Act of 2008'. Thanks to this new bill, essential drug prices in the Philippines are expected to go down, and become affordable. The bill aims to increase access to low cost generic medicines.

In developing countries like Thailand, China and Philippines, patents are granted far more widely than in India, heavily restricting local production of affordable generics. Widespread patenting has meant that patients are not able to access affordable generic versions of essential medicines, industry experts say.

The law seeks to prohibit the grant of new patents based only on newly-discovered uses of a known drug; allow early registration of generic versions of patented medicines prior to patent expiration; and allow government to use generic versions of patented drugs when public interest is at stake. The government will also have the power to impose price ceilings on essential drugs, and allow import of expensive drugs if it is found that another country is selling them at a lower price.

"A case in point is Co-trimoxazole an essential drug commonly used for HIV to prevent infections. The drug patented by Roche costs 15.55 pesos (Rs 14) a tablet in the Philippines. The same generic drug costs .69 Philippine pesos (.63 paise) a tablet in India," says an Oxfam official, adding that essential medicines are unaffordable in the absence of generic competition. Another drug Ciprofloxacin costs about Rs.75 in Philippines whereas it costs less than Rs.5 in India.

So, Philippines is amending its Intellectual Property Code to include a provision similar to section 3(d) of India's patent law. This will prevent companies from obtaining patents for drug that are not really new, to extend their monopolies on drugs as long as possible. In 2005, when India ushered in the new patent regime under WTO, it tried to find a balance between its international obligations to grant product patents and the need to make drugs as affordable as possible for patients and the developing world.

So, section 3(d) was introduced, which restricts companies from obtaining patents in India for medicines that are not actual inventions, but slightly improved formulations of existing medicines. "There is a clear message coming from lawmakers in India and the Philippines; fewer patents result in stronger generic competition, which is important for developing countries to increase access to affordable medicines", Shalimar Vatan of Oxfam said in a statement.

The bill also includes a "nondiscriminatory clause" which requires drug stores to carry competing products so that large firms cannot intimidate pharmacies into only carrying their products.