Source: The Pharma Letter
The pressure from the US government on India seems to be working. With India’s intellectual property rights (IPR) regime facing flak, and the USA launching an out-of-cycle review of India’s IPR regime, the Department of Industrial Policy and Promotion (DIPP) has set up a think-tank to draft a National Intellectual Property Rights Policy. Work is also on to set up IPR courts to fast track cases, reports The Pharma Letter’s India correspondent.
Prabha Sridevan, a former Judge of the Madras High Court, who was also the former chairman of the Intellectual Property Appellate Board, is to lead the think-tank, and help with the formation of the new policy.
“A pressurized Indian government is getting its act together. Through the new policy, India is aiming to brand itself as pro-IP. And by setting up more courts, the government is keen to show that it means business in resolving IPR cases,” said an official at the DIPP, seeking anonymity.
He added that the foreign media had portrayed India in bad light, reporting that India was issuing several compulsory licenses and was supposedly building its industry on stolen patents. However, he said, India issued only one compulsory license on Bayer’s cancer medicine, Nexavar (Sorafenib).
“US companies have been cross examining India’s IPR laws particularly since the Controller General of Patents decided to grant a compulsory licence to India’s Natco Pharma to sell generic Nexavar,’’ he added.
Pharmacy of the poor
Commerce and Industry Minister Nirmala Sitharaman recently pointed out that developed nations were picking holes in India’s IPR laws, since it did not have any policy. The Minister opined that the USA was intent on undermining India’s role as the pharmacy for the poor.
Speaking at a gathering to mark the completion of 100 days of the Modi government, she said a massive skilling exercise was underway in India, aimed at generating employment in the manufacturing sector, in order to raise its share in the country’s GDP from around 16% to 25% by 2022.
Stating that a strong IPR regime was complementary to this effort, given that Big Pharma has repeatedly said that they would set up R&D facilities as well as manufacturing units in India provided the IPR regime is strengthened, Ms Sitharaman said the IPR policy would not be restrictive or regressive, but would only give clarity and consistency without any overlap or contradictions.
She added that the policy would also protect, at an international level, India’s IPR interests, the country’s heritage, its achievements in pharma, especially generics, and the advances the country had made in science and technology, as well as highlight the numerous patents filed by Indian companies.
Maintaining that the lack of a clear policy was hurting the country, she added that, though there were different laws on patents, copyrights and trade marks, a comprehensive IPR policy did not exist in the country, which would “clearly spell out India’s IPR regime for the entire world to know.”
As a result, arbitration matters and court cases on many IPR issues continue to languish in courts. She said the policy would help in dealing with issues being raised by developed nations, and give directions to protect India’s IPR.
Meantime, India’s pharmaceutical exports registered the slowest growth in at least 15 years at 1.2% to $14.84 billion last fiscal, amidst growing tension with the US over IPR related issues. Experts have noted in a government strategy paper that India’s pharma exports would miss the target of $25 billion set for 2014-15.
Pharma major Cipla has also sought the adoption of a pragmatic IPR policy including in-licensing within the present framework of its international obligations. Cipla Chairman YK Hamied noted in the company’s annual report: “We have always believed that free competition is the only way to ensure fair prices and better availability of drugs. We strongly believe that there should be no monopolies in healthcare; and in that context, India should adopt a pragmatic IPR policy including in-licensing within the present framework of our international obligations.”
Market sources have indicated that the price decontrol of 108 cardiac and diabetes drugs, which was challenged before the Supreme Court, could also have sparked off the decision to set up more IPR courts. The 108 formulations cover a market of $899 million.
A Public Interest Litigation (PIL) alleged that hiking the prices of life saving drugs is against public interest, and would lead to a windfall gain for some pharmaceuticals companies, even as it endangered the lives of millions of Indians. A joint bench of the apex court has said that the PIL would be listed for hearing as expeditiously as possible.
The petitioner advocate ML Sharma noted that India has around 41 million diabetes patients, while another 57 million people have coronary heart disease. Some 2.2 million suffer from tuberculosis, 1.1 million from cancer, 2.5 million from HIV/AIDS and some 60 million blood pressure patients are in dire need of life saving drugs.
Steep drug price hikes
Mr Sharma said the National Pharmaceutical Pricing Authority (NPPA) had hiked drug prices, and alleged a conspiracy between drug companies and government officials. Citing examples of the steep increase in drug prices, he said that the price of Plavix, a blood pressure drug, had risen from $2.40 (147 rupees) to $26.40 (1,615 rupees); that of Glivec, an anti cancer drug, had risen from $138 (8,500 rupees) to $1,766 (108,000 rupees); and that of an anti rabies injection had jumped from $43.65 (2,670 rupees) to $114.45 (7,000 rupees).
He added that the drug industry had hotly contested the NPPA’s earlier decision to impose price controls, which had resulted in the authority withdrawing its guidelines for price control issued under the Drug Prices Control Order (DPCO).
Industry sources said NPPA’s September 15 notification, capping the prices of 43 formulations, including gastrointestinal, anti-infectives and vaccines, which amounted to sales worth $73 million were likely to get impacted by 33% to 40%. Indian drug majors like Ranbaxy, Alkem, Cipla and Lupin would be impacted the most.
Key medicines such as cefotaxime, ciprofloxacin, rifampicin and BCG vaccine are under price control, as are popular medicine brands such as Pfizer’s Gelusil, USV’s Glycomet and Serum’s BCG vaccine.
Understandably, many drug majors have rushed to court. Earlier, the Delhi High Court had also asked Cipla and Novartis India to meet with the government and try and resolve the drug pricing issue and its implementation. The Court was hearing a bunch of petitions moved by drug majors challenging the government’s new drug pricing order, which asked them to slash prices.
However, Justice Sanjay Kishan Kaul of the Delhi High Court recently said Indian Courts were well equipped to handle international cases relating to IPR and copyright, as a plethora of changes have been introduced in the existing laws in the country, as per the Berne Convention and TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement.