Drug Patent Linkage Controversy: A Middle Path Solution?

The Mint carried an op-ed of mine on the drug-patent linkage controversy. For a good background to this controversy, please see Prashant’s excellent post here.

In this editorial, I’ve opined that linking drug approval to patent status is a bad idea. It delays generic entry and also places a huge burden on the drug controller, who does not have institutional competence to look into complex patent issues. Also, the drug controller cannot frame any rules to mandate such linkage under the present constitutional structure–as a statutory authority, he has to remain within his statutory bounds.

As a “middle path” solution, I’ve recommended that the DCGI (Drug Controller General of India) implement a “notification” system. In other words, the office of the DCGI ought to have a website, where every patent that co-relates to a drug is notified (something the Orange Book) and every drug application is notified as well.

About 2 days back, Mint ran a story stating that the DCGI, Dr Surinder Singh is now backtracking on his earlier initiative to frame rules to bring about a drug patent linkage mechanism. And the report went on to state that the DCGI is now considering a “notification” model, something that I recommend in the Mint article. I quote from the Mint report:

“Singh said he is now considering putting the regulatory stance of not denying marketing approval to generic versions of patented drugs on DCGI’s website so that all global drug makers are aware of the way the system worked, and also informing them if a generic version was going to be approved.

Funnily enough, a previous draft of my now published Mint article had been sent to certain industry insiders for their comments (most prominent amongst them being DG Shah, Secretary General, IPA and Ranga Iyer, OPPI Chairman), and to some government officials. I thank all of them for their excellent comments on the draft. In particular, it was heartening to see DG Shah endorse such a notification model in his interview to Mint, where he states that:

“IPA’s Shah, however, welcomed the sharing of such approval information. The controller “should put up a list or notify all new drugs approved for marketing on its website, whether or not they are patented. Thereafter, companies can keep tracking them” and deal within themselves, he added.”

When I had first sent my draft of this “notification” proposal to him, he appeared to disagreed with the ideas expressed therein.

Unfortunately, for a variety of reasons, Mint could not publish my article earlier, though it was sent several weeks back to them. I’m however pretty certain that the draft of this earlier article recommending the “notification” system reached the office of the DCGI. For those that wish to read the text of the previous article, please see here. In pertinent part, I note in this previous version that:

“In the wake of this controversy, the DCGI, Dr Surinder Singh announced that he would begin formulating guidelines to ensure “drug-patent” linkage in India i.e. that no generic drug would be approved, if there was a valid patent in force covering it. Apart from begging the question of whether or not this would make good “policy” sense, the DCGI’s move to formulate “policy” on his own runs the risk of contravening the Constitution of India. Given his limited role under the statute, (i.e. to ensure that drugs are safe and effective), any move to formulate policy around complex “patent” issues is likely to attract a writ petition, claiming that he has overstepped his statutory limits. Which then leads us to the question: ought Parliament to step in and amend the Drugs and Cosmetics Act of India to provide for such linkage?”

After the announcement by the DCGI as reported in the Mint, I had to change the article submitted to the Mint to reflect this recent announcement. Here is the text of the op-ed that was finally published today.

The potency of a middle path

A fair way out of the drug patent linkages controversy for both patent holders and generics producers

Shamnad Basheer

“The controversial drug “patent linkage” conundrum has finally made its way to Indian shores, pitting big pharma against home-grown generics. In short, “linkage” implies that a generic drug regulatory application submitted to the drug controller general of India (DCGI) will not be approved, as long as a patent covers that drug. In other words, till such time Pfizer has a patent in place that covers a cancer drug in India, the DCGI will not approve a drug regulatory application by Natco which desires to manufacture and sell its own “generic” version of that drug.

The genesis of the controversy in India can be traced back to a landmark judgement in March by justice Ravindra Bhat of the Delhi high court, denying an injunction to a multinational patentee, Roche. In pertinent part, this judgement permitted Cipla to sell a cheaper version of a lung cancer drug on the grounds of “public interest”. Many innovative firms decried this decision, claiming this wouldn’t have happened had the drug controller not approved the generic version of the drug sold by Cipla.

In the wake of this controversy, DCGI Surinder Singh initially announced he would begin formulating guidelines to ensure “drug-patent” linkage in India, i.e., no generic drug would be approved if there was a valid patent in force covering it. However, in a laudable move, he backtracked from this announcement this week. And rightly so, since any move on his part to formulate “policy” in this regard would have risked a writ petition claiming he had overstepped his statutory bounds and, thereby, flouted the Constitution of India.

Many developing countries (and even the EU) have opposed patent linkages for a variety of sound reasons. For one, this delays generics entry by ensuring the approval process can’t even begin till the patent expires. And that process could take anywhere from one to two years. Such delays contradict the spirit of India’s patent law which seeks to facilitate early entry of generics through its Bolar Provision.

Second, it forces the drug regulator, an authority with no specific expertise in patents, to grapple with complex patent issues.

However, the concern of a patent owner who wishes to sue a generic manufacturer in a timely fashion and prevent the flooding of the market with cheaper versions when the patent is in force is genuine, and requires redressal.

How, then, does one go about balancing these competing concerns in a “fair” manner without necessarily co-opting a “linkage” mechanism? One possible via media solution could be to evolve a “notification” mechanism for new drug applications, where the office of the DCGI can list all new applications on its website. An aggrieved originator drug firm can track this database and move the court if it apprehends that a generic product, for which a drug approval application has been filed, is likely to infringe its patent. Do note, however, that the originator would only be able to prevent the introduction of a generic drug in the market — not stop the drug regulator from processing the application of the generic or even granting approval.

In other words, all that the innovator can ask of the court is to declare that the generic product, if introduced, would infringe its patent. If the court finds in favour of a prima facie case, i.e., that the patent is valid and would be infringed by the introduction of a generic product (for which a drug approval application has been filed), it can issue a declaration to this effect. Importantly, issues of patent infringement can be decided solely by the courts and the DCGI is thus not involved at all.

Such a declaration puts the generic manufacturer on notice, and prevents the flooding of the market with generic products upon receipt of drug marketing approval by the manufacturer.
However, as a quid pro quo and in order to provide “notice” to the generic applicant and the public at large, an innovator company that applies for drug approval is obligated to disclose all its patent registrations/applications for products/processes relating to the drug. The office of the DCGI displays this on its website. Much like the Orange Book in the US, the public can access it and check which drugs are covered by what patents.

The benefits of such a database cannot be emphasized enough. Absent such a database, correlating patents with drugs will prove an arduous task, particularly in the context of biopharmaceuticals. It would not only aid transparency around pharmaceutical patents in the world’s largest democracy, but also enable a more effective deployment of the patent opposition mechanism.

To conclude, given the increasing polarization of IP debates in general and pharmaceutical patents in particular, it is critical that innovators, generic manufacturers and patient groups work towards identifying solutions that represent some “middle ground”.

The “notification” scheme suggested here captures such “middle ground” and balances out the interests of innovators and generic manufacturers in a “fair” way. Such a solution seems appropriate in the land of the Buddha — who first demonstrated the wisdom of shunning extremes in favour of a “middle path”.