First product-patented medicine; also first to lose post-grant opposition
In a move that could open the door to less expensive Hepatitis C drugs, the Intellectual Property Appellate Board (IPAB) has revoked the patent on Roche’s pegylated interferon alfa-2a.
Roche markets the drug, used to treat Hepatitis C, under the brand name Pegasys, and it costs a patient over Rs 3 lakh for a six-month course.
In a landmark order on Friday, the IPAB set aside Roche’s patent on Pegasys, stating that the “invention is held to be obvious”.
A product needs to have an inventive step, among other features, to get a patent, which in turn gives it market exclusivity for 20 years.
Setting aside the patent on Pegasys would allow other drug companies to make similar versions of the drug, bringing relief to over 12 million Hepatitis C patients in the country. More the makers of a drug, lesser the price, a lawyer familiar with the case observed.
Pegasys was the first medicine to receive a product patent in 2006, after the Indian Patents Act was amended in 2005. The post-grant opposition was filed by Sankalp Rehabilitation Trust, represented by Lawyers Collective.
As seen with other patent cases in the country, Roche could appeal the IPAB order, a lawyer said. Roche representatives did not comment on the development, though.
The case is significant, being the country’s first post-grant opposition. Besides non-governmental organisation Sankalp, Wockhardt too had filed a post-grant opposition, but did not go through with an appeal, the lawyer said.
Sankalp contested the patent on the grounds that the pegylation process was known. The process helps the drug remain longer in the blood, benefiting patients as it reduces the frequency of injections to be taken to just one a week as against three earlier. For an amended patent regime that is being put to test from all quarters, the Roche case also clarifies whether an NGO can file an opposition after a patent was granted, as the amended Patents Act allows only an interested party to file a post-grant opposition.
In the case of pre-grant opposition (before a patent is granted), the amended law allows anyone to file it. Sankalp’s counsel argued that they were interested party, as they represented patients.
The case traverses new ground, also since the drug is a biological product (from a natural source) — not chemically made like a regular allopathic medicine
# Roche’s Hepatitis C drug Pegasys is the first medicine to receive a product patent under amended Patents Act, 2005.
# Treatment cost over Rs 3 lakh for six months.
# Patent granted in India in 2006.
# Sankalp and Wockhardt had field post-grant oppositions.
# It is the first biological drug to be contested, and first post-grant opposition.