US 301 Report another pressure tactic for data protection: Experts

Megha Lodha - Mumbai

The United States government's retention of India on its Trade Representative's (USTR) report's Priority Watch List is a tactic to mount pressure on New Delhi to provide for protection of innovator's proprietary data, say industry representatives. The Priority Watch List includes those countries or economies that do not provide an adequate level of IPR protection or enforcement, or market access for persons relying on intellectual property protection.

The 2004 Special 301 Report also pointed out that the provision for data protection that is still not in place in India is of concern to the US.

Data protection is one issue that has been hotly debated upon with associations like the Indian Drug Manufacturers' Association (IDMA) and the Indian Pharmaceutical Alliance (IPA) going against it and the MNCs favouring it. Though no decision has been reached on the issue yet, there are mixed opinions coming from every direction.

IDMA secretary general Dara Patel said that this report is more of "A pressure tactic by the US and some MNCs to pressurise us to accept their unjust demands for Data Exclusivity and stricter provisions of Patent rules and Act." He said that India should ensure that her provisions are made as liberal as possible to suit the industry and patients. "We will have to counter this by explaining our stand to the lawmakers," said Patel.

On the other hand, companies like Nicholas Piramal have opted for a balanced position and have advocated for data protection.

The company agrees that there is considerable confusion regarding data exclusivity. The big fear that Indian companies who are members of the IPA are saying that data exclusivity will hurt Indian generics exports, said Dr Swati Piramal, director, strategic alliances and communications, Nicholas Piramal India Limited. Commenting on the US Trade Representative's report, she said that USTR is taking action against India but it is better to have a stated position on data protection which is in the best interest of India quickly to protect ourselves.

Elaborating on whether data exclusivity will in any way hurt Indian generics, she said "This is patently not true as data protection is for the territory of India. Indian generic exports are governed by the laws of the country to which goods are being exported to." On the one hand she said there is clear need to protect Indian science and innovation and also give a fillip to the nascent and growing clinical trial business. On the other hand, there is a need to see that the clause is not misused to promote evergreening, or give protection to a product where no patent is filed in India and also apply to pre-1995 molecules, she opined.

The legislative changes proposed by Nicholas is a balanced position which may be in the best interest of India R&D in the future.

The company has proposed a period of five years of data protection for marketing new chemical entities on Indian territory. Dr Piramal said it is important to protect Indian innovation and spur Indian research by giving adequate protection for the innovator. Situations in which a competitor obtains the results of testing data through fraud, breach of confidence or other "dishonest" practices, and uses them to submit an application for marketing approval for their own benefit, should not be allowed.

The government should not provides access to undisclosed testing data, in order to provide an advantage to a firm, which did not produce them, or share their cost for the term of data protection. During this period, any second applicant for marketing authorisation, would only be granted market authorisation, if he submits his own data.

Data protection should end on patent expiry or 5 years after the product is first marketed whichever is earlier. This will not allow evergreening of patents i.e. beyond 20 years.

This protection of data would be available to all pharmaceutical products, which use new chemical entities.

The data will be protected only if a patent is filed in India; i.e. no protection will be given if the innovator does not file for patent approval in India.

The Drugs Controller of India should to keep data submitted for approval for conducting Clinical Trial confidential. For Phase I, II, III approvals (Phase I is allowed only for Indian molecules), safety, toxicity and other human trial data is required to be submitted as the molecule progresses. This will open opportunities in the multi billion dollar drug development market.

Since data protection is for the territory of India, it is unlikely to hurt Indian generic exports. Exports are governed by the laws of the country in which the drugs are being exported to.

This is a "balanced" or middle of the road position that should satisfy current Indian pharma business, as well as provide a fillip to potentially new pharmaceutical businesses, such as Biotechnology, clinical research, contract research, and strongly protect Indian science and technology.

On the other hand, there is the Indian Pharmaceutical Alliance that has issued what it calls the IPA Position paper on data protection. The alliance feels that it would be against public interest to agree to data protection as sought by the PhRMA and IFPMA. It also says that it is against the country's trade interest to bind the national pharmaceutical companies from exporting off - patent generic products. It is against the national interest to protect foreign multinational companies in their home markets from competition from Indian companies; and the TRIPs agreement does not oblige India to concede these demands.

If India succumbs to pressure and makes provision for data protection, the IPA has also highlighted the kind of impact it may have on public health. It would firstly extend the monopoly of the originator, secondly it would deny the consumer access to a cheaper generic product, even if the patent has expired or not even patented.

Such a provision will be an inducement to delay the introduction of new product in India, thereby depriving consumer of access to a new treatment, feels the IPA.

Giving it another view is US patent attorney, Mark Pohl. He opined that data protection was a big issue in the USA as recently as 1980. According to him, the scene changed only after the passing of the Hatch - Waxman Act in 1984, which allows generic companies to use innovator data. Till that time, big pharma companies had the right to keep their clinical data exclusive; which means, generic companies, even US companies could not use that data to show the generic products are safe.

Pohl felt that the 301 report would give the MNCs something to complain about, for data protection. Aside from data protection, however, there are certain factors, which put India on the 301 list: (1) lower-level courts are believed to be biased and unfair, and judges able to be bribed. This means any "IPR" might not in fact be enforceable as a practical matter. (2) Lack of government enforcement against non-approved generics being sold in the internet (we have seen Pfizer suing several India-based internet distributors of Dr. Reddy's Lipitor product). Data exclusivity is but one piece of the 301 picture.

Amidst all the chaos and confusion over one topic, all that can be said is that this is one issue that has to be dealt with very seriously. One cannot make such provision in a very biased manner. It has to be known that while on the one hand, India needs to encourage the generic pharma players all the time, it cannot afford to upset the MNCs and innovator companies, be they Indian or foreign.

If an innovator does not have the right to protect the data on which he has invested time, brains and money; not necessarily in that order, then what is the motivating factor for him to go on and continue his research? Without getting any rewards? With being content just with one patent application which too takes a lot of time to get granted?

If we are to move ahead on the path to intellectual property then we have to use our intellect to see logic and plan practically.