Even European Union doesn’t link regulatory approval for generics to innovator patent

German healthcare giant Bayer is determined to introduce in India a system that can prevent early entry of low-cost generics despite the Delhi High Court quashing its plea to link regulatory approval to last week saying the company was trying to “tweak public policy.”

“Bayer HealthCare is disappointed and disagrees with the court’s decision and will consider its legal options in this regard,” the company said after the judgment last week.
Under patent linkage, as sought by the company, the Drugs Controller General of India (DCGI) would not grant approval to a generic version of a drug if the innovator is patented in the country.

Ironically, even the European Union doesn’t have such a system yet.

In fact, going by the European Generic Medicines Association, patent linkage is contrary to EU regulatory law and is one of the key entry barriers for generics.
Why then is the company seeking to introduce such a system in India?

“In the EU, generic companies usually do not launch a generic product while a patent is still valid. In most of the member states of the EU a preliminary injunction keeps patent infringers out of the market until a final decision on the validity of the patent concerned is achieved. Therefore, innovators are protected from the launch of spurious versions of innovative and patent-protected products while patents are still in force,” Aloke Pradhan, vice-president, corporate communications, Bayer Group in India said in an email response.

The use of the word “spurious,” despite Justice Ravindra Bhat holding in last week’s judgment that unpatented (generic) drugs were not spurious, sure reflects the company’s callousness, if not disregard for Indian law.

Alexandra Heumber, intellectual property (IP) policy advisor with humanitarian organisation Medecins Sans Frontieres, said, “Pharma companies are continuing their campaign against legitimate generics by portraying them as spurious drugs and confuse generics with counterfeit and spurious drugs.”

Local IP experts feel the bid to link regulatory approval with patents gives away Bayer’s desire for market monopoly by keeping out generics. 

Currently, the patent and drug regulatory systems are two separate mechanisms in India.
According to Anuradha Salhotra, founding partner, IP law firm, Lall, Lahiri & Salhotra, there is no clause for patent linkage in India and the patent Act is a compete Act in itself. “The drugs controller should not be asked to look into the patent status of drugs.”

Shamnad Basheer, professor in IP law, National University of Judicial Sciences, Kolkata, feels Bayer is pressing for patent linkage in India because the country does not have provisions for ‘data exclusivity’, which the European Union has.

Data exclusivity refers to a period of time during which the regulator cannot rely on an innovator’s clinical trials data pertaining to novel drugs, in order to register a generic version of the drug. This is again said to delay entry of generics in the market, as generic companies would have to conduct the entire expanse of clinical trials, which are time consuming.

“EC has one of the longest data exclusivity provisions, so the generic cannot in any case get drug regulatory approval for about eight years or so after the innovator has introduced the drug,” said Basheer.