Drug Regulation Patent

Breaking News: Court Orders Indian Drug Controller to "Police" Patents


I was rather perturbed to learn of a recent Delhi High Court decision which clearly transgressed existing laws/regulations by forcing a linkage between patent and drug regulatory issues. In particular, it directed the Indian Drug Controller (DCGI) to don the mantle of a “patent policing” authority by ensuring that regulatory applications submitted by generic manufacturers do not violate patent rights of originator companies.

Readers may recollect an earlier post, which warned against burdening the drug controller with such a patent policing garb. And this precisely is what the Delhi High Court has done. In fact, in many ways, the order also virtually introduces data exclusivity (a non patent form of exclusivity where generic applications cannot be processed/approved by the drug controller for a certain period of time) in India.

But before we dwell on the far reaching and rather problematic implications of this order, lets take a brief look at the facts of the case.

About a week or so back, Bristol Myers Squibb (BMS), a multinational pharmaceutical company filed a suit against Hetero Drugs, an Indian generic manufacturer, asking that they be restrained from manufacturing, selling, or offering to sell “Dasatinib”, a drug patented by BMS and used by Chronic Myloeid Leukemia (CML) patients. Readers may recollect that CML featured in the Novartis patent dispute as well, where the key issue was whether or not Novartis’ application covering Gleevec, a drug for CML, was patentable or not.

It is important to note that Hetero’s version of the patented drug is not yet being sold in the market. In fact, it cannot sell the drug unless its pending regulatory application (demonstrating bio-equivalence with BMS’s version of the drug) is cleared by the office of Drug Controller of India (DCGI).

While granting an ex parte (“without hearing”) restraining order in favour of BMS on grounds of patent infringement, the Delhi High Court noted that:

“The plaintiffs have made out a prima facie case for grant of an ex parte ad interim order. The defendants are restrained from manufacturing, selling, distributing, advertising, exporting, offering for sale or in any manner dealing directly or indirectly in any product infringing the plaintiffs patent subject matter of the suit bearing No: 203937.”

So far so good (with the caveat that the prohibition against “dealing indirectly in any infringing product” seems a tad too broad). However, what is deeply troubling is that the injunction order creates a linkage between patents and the drug regulatory process and directs the DCGI to desist from granting approval if the application implicates the patent rights of BMS. I reproduce key parts of the order in this regard:

“The plaintiffs have also sought ex parte relief of restraining the defendants from pursuing their application before the DCGI. It expected that the DCGI while performing statutory functions will not allow any party to infringe any laws and if the drug for which approval has been sought by the defendants is in breach of the patent of the plaintiffs, the approval ought not to be granted to the Defendant.

The plaintiffs to within one week make a representation to the Drug Controller General of India making out a case for the drug for which approval has been sought by the defendants being in breach/violation of the patent of the plaintiff.”

The problems with the above order are myriad. Let me try and quickly highlight some of them and I’ll look forward to hearing from our readers on other issues that I’ve missed out on:

i) The order places the onus of “patent policing” on the DCGI (Drug Controller General of India) i.e. ensuring that none of the generic drug applications submitted for approval violate the patent rights of any originator drug company. Given that the DCGI already struggles with its primary responsibility of ensuring that drugs approved for the market are both safe and effective, burdening this office (with no special patent expertise) with the additional duty of policing patent rights is downright imprudent. In an earlier Mint editorial, I warned against introducing such a system of drug “patent linkage” in India, noting that:

“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.”

Of course, since the DCGI is not a party to the law suit between BMS and Hetero, one might argue that he is not “technically” bound by the Delhi High Court order. However, going by a Mint news item, where the DCGI demonstrated a keenness in policing patents, one might expect the Delhi High court order to have some persuasive impact on him.

ii) Although the order itself does not restrain the defendant (Hetero Drugs) from pursuing its regulatory application with the office of the DCGI, it is important to note that the plaintiffs had sought such a relief from the court.

Had the order been granted in this form, it would have resulted in a clear contravention of Section 107A (a) of the Indian Patents Act which encapsulates what is commonly termed as the “Bolar” defence. Under this provision, any act of making or selling a patented invention solely for uses reasonable related to the development and submission of information required under any law for the time being in force shall not amount to a patent infringement. In other words, all of Hetero’s actions (manufacturing, using the patented drug etc) that were designed to generate such regulatory data would be exempt from patent infringement. In fact, the mere act of submitting regulatory information by Hetero or of processing such application by the DCGI, cannot by itself, amount to a patent infringement in the first place.

iii) Lastly, although this point has been made several times on SpicyIP, it bears reiteration that the Delhi courts have gone bit too far with their propensity to grant ex parte interim injunctions at the drop of a hat. While such injunctions may make sense in limited copyright/trademark cases, where a prima facie determination of infringement is far easier to undertake and the threat of disappearance of fake/pirated goods more severe, one fails to understand how such injunctions can be granted in complex patent cases. The various issues around the Roche vs Cipla (Tarceva) case amply demonstrate the sheer complexity of patent cases, where the validity of the patent is often challenged and an alleged infringer may also contend that his/her drug does not fall within the scope of the patentee’s claims.

Notwithstanding the above, folks sympathetic to BMS might argue that they were merely seeking to avoid a Roche vs Cipla kind of situation, where Cipla’s drugs were approved by the DCGI and even sold in the market prior to a suit being filed. And it was these prior sales that gave Justice Bhat the leeway to import a “pricing” and “public interest” calculus into India’s injunction jurisprudence.

Presumably, BMS filed this suit at an early stage (before the drug was even introduced in the market) to nip any potential “pricing” and public interest concerns in the bud. And to this extent, the first part of the Delhi High Court order (an injunction restraining the sale or offer to sell or distribute or advertise the drug) appears reasonable (barring the fact that it was granted ex parte i.e without even hearing the other party). However, the second part of the order is not only unnecessary, but more importantly, clearly contravenes existing Indian law/regulations. There are other ways to assauge the concerns of an aggrieved patent owner and in this Mint editorial, I had proposed a “public database of drug applications” as one such solutiuon, noting that:

“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.”

Perhaps the time is now ripe to implement such a “database” centric solution.

Conclusion

To conclude, it bears reiteration that the drug application process is quite distinct from the patent process. And given the Indian context, where the DCGI lacks any patent expertise and is understaffed and crunched for resources, the two should continue to remain separate. Presently, neither the court nor the drug controller has any authority to mandate drug patent linkage.

From a policy perspective too, any such linkage is hugely problematic. Apart from issues of institutional competence, such linkage contravenes the very essence of the Bolar provision, a patent defence that permits generic companies to safely generate regulatory data while the patent is in force and pursue their drug regulatory application process, so that no time is lost between the expiry of a patent and the entry of a generic product in the market. Such linkage also virtually results in the introduction of a “data exclusivity” like norm, a norm that a government committee (Satwant Reddy Committee) suggested, ought not to be introduced into India at this stage.

On a lighter note, let me end with an interesting “brand” related information for you: The drug “Dasatinib” is named after the inventor chemist, Jagabandhu Das, who codiscovered it while working at Bristol Myers Squibb.

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof. Amartya Sen. Professional History: After graduating from the NLS, Bangalore Prof. Basheer joined Anand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

3 comments.

  1. Abhijit

    For some reasons, pharma patents have been the most controversial and litigation intensive, atleast in the media.

    Many a times the Big pharma has been accused of misusing patents to extend their monopoly. And then there is the perennial war between the NGOs and Big Pharma on the matter of patented blockbuster drugs.

    Probably its a time to define more clearly the terms Invention, Discovery and Innovation. And then it is more critical that judges who deal with patent cases be adequately trained or maybe set the appointment criteria for such judges as having a sufficient background in managing patents etc.

    Meanwhile I discovered that there is come free course available on IGNOU about understanding IPRs.

    Reply
  2. Shamnad Basheer

    A friend whose grasp of patent law is truly phenomenal and whom I have the highest regard for, writes:

    Dear Shamnad

    I read your post on dasatinib PI. Very, very good and a great scoop. Here is what I think:

    The order is a laughable one–in fact, I would like to think it as a kind of an April Fool’s day joke.
    While granting an ex-parte ad interim order restraining Hetero, the Delhi High Court (DHC) has gone way beyond existing law in creating a link between drug regulatory approval process and patent law. It is a bizarre order, to say the least.

    Based on a dubious contention by BMS (I am sorry it is your guru, the much respected Praveen Anand, but he was only doing what was best for his client) that it has been unable to petition the Drug Controller General of India (DCGI) asking it not to approve Hetero’s product because there is no such legal provision, the Honorable Court has gone ahead and legislated from the bench and created such a link.

    The Honorable Court has held that “[I]t is expected that the Drug Controller General of India while performing statutory functions will not allow any party to infringe any laws and if the drug for which approval has been sought by the defendants is in breach of the patent of the plaintiffs, the approval ought not be granted to the defendants.

    The plaintiffs to within one week make a representation to the Drug Controller General of India making out a case for the drug for which approval has been sought by the defendants being in breach/violation of the patent of the plaintiff.” Thus, DHCt has, in effect, made the DCGI the arbiter on pharma patent infringement cases. Indian Patent Law does not envisage this. Under Indian Law the DCGI has no authority to determine patent infringement. In fact, not even in the Patent Office or the Intellectual Property Appellate Board have that authority. The judiciary is the sole authority in patent infringement cases.

    Now let us look at some ridiculous consequences if this order is allowed to stand and implemented in letter and spirit.

    · If we take the DHC’s holding that “”[I]t is expected that the Drug Controller General of India while performing statutory functions will not allow any party to infringe any laws…” literally, the logical extension of what the Honorable Court has said would to be make DCGI the arbiter on any legal issue, not just patent issues. For example, trade mark, copyright, may be income-tax issues, could be used to hold up approval.

    · Another aspect is, if the DCGI has to ensure the no party will infringe any law, determination of infringement cannot only be restricted to the patents owned by sponsor of reference drug under review.

    · If there are patents on the same drug owned by other parties, the DCGI will need ensure that they too are not infringed. And, logically, DCGI must also ensure that the innovator (seeking approval for the first time) does not infringe any third party patent.

    · Such determination must not be limited to just compound patents, but to any and every patent – including process patents – that is related to the drug under consideration.

    If all this seems absurd, they, unfortunately, are the consequences of the order of DHC, whether intended or not.

    This is a clear case where the DHC has grossly overreached and legislated from the bench. It can be clearly seen that implementing such an order would result in inordinate and unwarranted delay in the approval of generic products. And that would result in knocking down the single most important consideration that the legislators had when they amended the Indian Patent Act in 2005: ensuring continued access to affordable medicines for the common man.

    Our legislators could have enacted appropriate law has they intended to link drug regulatory approval process with patent law, if they wanted to. The fact is that they have not, at least not yet. It must also be noted that India’s obligations under the TRIPS Agreement does not require her to have any such link.

    It is a fact that several countries, like the USA, Canada and Japan have legislatively linked drug approval process to patent law. It is also a fact that many countries, including the European Union and most developing countries have chose not to do so. However, no country has made the drug regulator responsible for determining patent infringement. It remains judiciary’s domain.

    One other question that would come up if this order is allowed to stand is this: if the DCGI determines a product does not infringe any patent and approves that product, would that be the end of story or can the patent holder still separately sue for infringement (apart from appealing the DCGI decision) in a court? If he can do so, then would it not be a case of double jeopardy and if he cannot aren’t patent infringement cases being taken out of the ambit of the judicial system altogether? That will be one great way to solve the patent case workload explosion everyone has been predicting!
    In summary, I believe that the Honorable Court’s order has very serious consequences that could play havoc with the pharma industry as a whole. That portion of the order that deals with linking regulatory approval with patent law must be rescinded forthwith.

    Even the ad interim injunction is dubious. Ex-parte injunctions must not be granted except in the rarest of occasions, only when irreparable harm is inevitable but for the injunction. In this case, that certainly is not the case. Hetero seems to have taken BMS’ notices casually and that has contributed to this disproportionate reaction from the cleared ired Judge.

    Would love your comments,

    Reply
  3. Anonymous

    What is so “breaking” about it?
    The point of linkage is already pending before the Hon’ble High Court-Delhi in the matter Bayer Vs Drug Controller General of India and Cipla wherein the Hon’ble Court was pleased to direct ex-parte that the Drug Controller General will not grant marketing approval to Cipla for a product (“Sorafenib tosylate”) claimed to be a spurious version of Bayer’s patented product. The order still continues.

    Reply

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