Monday, January 19, 2009

From the Desk of Patent Circle: Delhi HC Dasatinib Order

A patent has no value if it cannot be monitored and enforced under the law and Indian patent is no exception to it. Though the Indian Patent Office (IPO) has started granting patents for drug compounds but industry runs serious concerns about their enforceability. Enforcement is not possible without proper and regulated monitoring which is already a major problem in fragmented Indian drug industry and the gravity of which can be gauged by the fact that about 20 percent drugs marketed in India are spurious drugs despite having both Central and State drug regulatory agencies. Both domestic and foreign companies are constantly struggling to tackle and raid counterfeit and spurious drugs in India. Even the government has shown serious concern over spurious drugs and has brought the Drugs and Cosmetic (Amendment) Bill, 2008 which is already been passed by both the Houses of Parliament and lately got approval of the President. However, the issue of spurious drug is not our main concern of discussion here it is just to give an idea about what extreme damage lack of proper monitoring policies can bring to Indian drug industry and consumer. Our focus of discussion is a recent order of the Delhi High Court (HC) restraining generic Dasatinib. Albeit we are bit late in reporting on this but still personally believe that the Delhi HC order got invariably distorted in the news media. So we thought running a post on the Delhi HC Dasatinib Order.

Dasatinib is an anti-cancer drug belonging to the class of tyrosine kinase inhibitors first approved in the United States on June 28, 2006 and marketed by Bristol-Myer Squibb (BMS) under the brand name Sprycel. BMS has a granted Indian patent (IN203937) for drug compound dasatinib conferring BMS the exclusive right under Sec. 48 of the Patents Act, 1970 to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing dasatinib in India. Regardless of patent protection, Hyderabad-based generic manufacturer Hetero Drugs submitted an application with the Drug Controller General of India (DCGI) for a grant of license to manufacture and distribute generic dasatinib tablets in India. Although BMS said to inform Hetero about the dasatinib patent but Hetero kept unanswered to BMS and continued to pursue its application before the DCGI. Clearly, the DCGI approval of license for generic dasatinib would have been a blatant violation of BMS right under Sec. 48 of the Patents Act, 1970. What is important to note that patent is a statutory right created by the legislature and it is duty of the executive (government) to enforce the right of the patentee. Also, it would be a complete mockery of jurisprudential aspect of ‘right’ if one government body (Indian Patent Office) confers BMS the exclusive right to prevent third parties from the act of making, using or selling dasatinib in India and the other government body (DCGI) dilutes, in fact, ignores the same right by issuing license to third party for making and selling dasatinib in India.

In law, there is a well-established legal maxim that says “ubi jus ibi remedium”: where there is a right, there is a remedy. Now in absence of any legal provision which would have prevented Hetero from pursuing application before the DCGI or would have authorized the DCGI to stop regulatory approval for generic version of patented drug, BMS had valid grounds and reason for approaching the judiciary for remedy against its right under Sec. 48 of the Patents Act, 1970. To make an appropriate case, BMS sought a legal recourse under Sec. 151 of the Code of Civil Procedure (CPC) from the Court to pass an ex parte ad interim order to restrain Hetero from manufacturing, selling, distributing, advertising, exporting or offering for sale generic dasatinib, and also an ex parte relief to restrain Hetero from pursuing their application before the DCGI. Sec. 151 of CPC triggers inherent powers of Court particularly in cases where there is no specific provision provided under the law. The Court is open to pass an appropriate consequential order under Sec. 151 of CPC as may as necessary for ends of justice.

After hearing BMS counsel and considering a prima facie case for grant of ex parte ad interim order, the Court restrained Hetero from manufacturing, selling, distributing, advertising, exporting or offering for sale generic Dasatinib. While referring BMS ex parte relief of restraining Hetero from pursuing their application before the DCGI, the Court added that it is 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 defendants (Hetero) is in breach of the patents of plaintiffs (BMS), the approval ought not to be granted to the defendants (Hetero). The Court further instructed BMS to make a representation to the DCGI within one week making out a case that Hetero generic drug for which approval has been sought being in breach of the patent granted to BMS.

Important to note that the learned Judge knowing that there is no legal provision to restrain the DCGI from approving the application for generic Dasatinib, has diligently and aptly used the word ‘ought’ while referring BMS ex parte relief of restraining Hetero from pursuing application before the DCGI. In fact, the Delhi HC order finds reasonable support in Sec. 2 of the Drugs & Cosmetic Act, 1940 (DCA) which states that the provisions under DCA shall be in addition to and not in derogation of any other law for the time being in force. Further it is important to note that this is just a temporary order which is passed to stop Hetero generic dasatinib during the pendency of the trial and also the order is restrictively limited to Hetero case. Till here, both the Delhi HC and BMS acted within the periphery of the law. The order nowhere creates any ‘patent-drug regulatory’ linkage or authorizes the DCGI to monitor drug patents and framing such an opinion at this moment when the Delhi HC has not even started hearing on the issue (just made a temporary order) and judgment still awaited is completely irrational. The issue is been unnecessarily sensationalized by the newspaper media, further creating more confusion and chaos among the domestic pharma companies and patent practitioners, however, the whole dasatinib episode has surely left us with few questions that now need utmost attention.

(1) Whether approval of generic version of a patented drug violates the exclusive right of the patentee under Sec. 48 of the Patents Act, 1970?

(2) Is there a need to formulate substantive and procedural laws under Drugs & Cosmetic Act, 1940 regarding approval of generic version of a patented drug?

(3) How enforcement of drug patents feasible in India?

(4) Is ‘patent-drug regulatory’ linkage a necessity?

(5) Importantly is India really serious about drug patents or possibly we are moving toward creating more chaos?

The Delhi HC order has surely opened a wide platform for policy discussions, particularly related to ‘patent-drug regulatory’ linkage and enforcement of patent right.

8 comments:

  1. Aliasgar Dholkawala4:55 PM

    Dear Varun,

    I would refer to section 107 A of the patent act which says that an act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to development and submission of information required under any law in India, or in other country, that regulates the manufacture, construction, use, sale or import of any product; is not considered as infringement.

    If my understanding is correct, the Indian patent law allows for manufacture of patented product for the purpose of submission of data for regulatory approval be it in India or any other country.

    It would be completely incorrect to say that there is no remedy available to the patentee. Even after a generic player gets regulatory approval, he can be sued by the patentee if he happens contravenes the right of a patentee under section 48 (makes, uses, sells, offers to sell, exports or imports the patented product). Merely getting a Marketing Approval from DCGI is no ground for defense in a suit for infringement.

    Section 107 A causes inconvinience to the patentee since the only option remaining for him to enforce his rights would be through litigation. However on the other hand, it provides and opportunity to the generic player to come and challenge the patent by willfully infringing patentees rights (Cipla Vs Roche case). Its eventually just another system created to flush out patents which are not considered as invention by the act.

    The US also has a similar system whereby a generic drug maker can challenge the innovator while seeking regulatory approval, however the US system provides a far better approach in the form of para IV declarations. It would be a great step ahead if patent-drug regulatory linkage is indeed established in a similar manner in India too. It will streamline the system to a large extent and also help create IP awareness among Indian masses.

    Regards,
    Aliasgar Dholkawala

    ReplyDelete
  2. Varun Chhonkar8:16 PM

    Dear Aliasgar,

    Thanks for your comments and your views are completely appreciated. Frankly, I was expecting comments on this and was also expecting readers bringing my attention to Sec. 107A (1). Believe me while writing on such serious issue I will never overlook Sec. 107A (1). I have intentionally kept Sec. 107A (1) out of picture as my continuing post will be dealing bolar-provision.

    However, in this post I just tried touching jurisprudential aspect of ‘right’ to explain that a right granted by one government body cannot be contradicted/violated by other government body. You are completely correct in your argument that merely getting a marketing approval from the DCGI is no ground for infringement defense but my friend in India there is no concept of mere marketing approval (tentative) it is always final approval after which the generic is free to go in the market (without any further interference from the DCGI). In such case, the DCGI itself is a party to infringement because the DCGI granted the license to make and sell which, in fact, violate the exclusive right under Sec. 48.

    Please note we do not have any provision for tentative approval in India. So filing an application with the DCGI is not mere apprehension it is a valid ground that patent will be infringed.

    Kind Regards,
    ---
    VC

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  3. Aliasgar Dholkawala11:57 AM

    Hi Varun,

    Thank you for your reply but i dont agree with your statement that "right granted by one government body cannot be contradicted/violated by other government body" When i say its a marketing approval, i didnt differentiate between a tentative and a final approval. There is only one approval which allows the generic player to launch his product in the market. However, the point i was trying to make is, even if the generic does recieve a marketing approval from DCGI, he will still be infringing the patent if he goes ahead and launches the product in the market. The approval of DCGI does not give him an immunity from patent infringement. The remedies of a patentee are not exhausted by the mere fact that DCGI has given an approval. It will only inconvinice him because now he will have to go through lenghty court litigation to defend his patent which other wise wouldnt not have happend had the generic not recieved the approval in the first place. This is exactly what has happened in the cipla vs roche case.

    Compare this scenario with US where a generic can manufacture and use the patented product one year before the patent term expires in order to submit data to get regulatory approval. A generic player can also file for a para IV decleration and risk being involved in court battle over validity of the patent. What cipla did was a crude version of this system. They got the reg approval from DCGI since the law does not prevent DCGI from granting approavl. The law (Section 107 -A) also does not prevent any person from seeking approval for a patented drug. You may get an approval toady and decide to launch your product after 6 months once you know the patent has expired or you can risk litigation by launching it right away in the hope of invalidating the patent.

    Since section 107-A specifically excludes from infringement, acts of making, using, selling or importing a patented article for the purpose of submission of data to the goverment regulatory bodies, how can the grant of liscence or approval by DCGI based on the data submitted, be in violation of the rights of the patentee?

    Getting a regulatory approval and launchig you product in market are two different acts. The law excludes the former explicitly while it punishes you for the later one!

    On the jurispredence front, under civil law to claim damages you have to estblish that your rights were indeed violated (by making, selling, offering to sell, using, importing or exporting the patented product). The mere proof that the other party intended to violate your rights (by seeking goverment approval) is not sufficient to claim damages under civil law.

    Regards,

    Aliasgar Dholkawala

    ReplyDelete
  4. Anonymous10:34 AM

    Dear Aliasgar Dholkawala
    I am very much agree with VC comments especially if you look this case n view of Bolar provision (Section 107 a) yoiu also laible to infringement if you are going to manufacture /sell the product paryticularly dasatinib.
    Bolar provison give you remady for research purpose not for marketing

    Infact during dossier submission to DCGI applicant ( here Hetero ) may have mentioned about unawareness of any patent/ application related to Dasatinib. if he do so in my view my doing so he wants to provide innocent infringment in later but this case is also not applicble here because particular application are timely published and give enough time to hetero to oppose the grant.

    Thanks VC for your valuable post . If it is possible to you put court order of this case

    I have one more question to VC
    is fact as come up in this case is applicable to any patent other that product patent?

    Thanks& regards
    Anon-I

    ReplyDelete
  5. Varun Chhonkar12:59 PM

    Dear Aliasgar,

    You may be correct in your view but for me if the Indian Patent Office (IPO) grants patentee the exclusive right to prevent third parties from manufacturing and/or selling patented product then the grant of license by the DGCI to a third party to manufacture and sell patented product is in complete contravention of patentee’s right.

    It is some kind of joke that the government first gives patentee the exclusive right to stop others from manufacturing and selling the patented product and later gives third party a license to manufacture and sell the same patented product. Anyhow it is not surprising such contradiction is always possible in India.

    Kind Regards,
    ---
    VC

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  6. Varun Chhonkar1:16 PM

    Dear Anon-I,

    Thanks for your comments. I have already provided the link to the Court order in the post.

    Further the likelihood of innocent infringement seems to be not applicable in this case considering that BMS has already informed Hetero about the product patent.

    This order is specifically applicable to product patent only. Just to add further BMS only brought product patent to stop Hetero from getting marketing approval but there may always a possibility that there can be other patents (may be process, formulation or composition patent) that BMS may used later against Hetero (if Hetero manage to enter market).

    Kind Regards,
    ---
    VC

    ReplyDelete
  7. Anonymous7:21 PM

    Dear VC
    Thanks for valuable input
    But My question is not specific for BMS here I am talking about general concept
    if no product patent avaliable in India then innovator can file such court cases ?
    if yes on what basis ?
    if he cannot file court case then can DCGI allow such product without any fear

    Do you any information regarding that is there definition of Drug according to DCGI , if it is there according to DCGI what type of product may fall in this category ( here I am talking about polymorph ,isomers etc.)

    Thanks for link

    If it is possible to get the court order of BMS VS cipla

    Thnaks once again for valuable input
    Regards
    Anon-I

    ReplyDelete
  8. Varun Chhonkar6:54 PM

    Hi Anon-I,

    In absence of any provisions similar to Hatch-Waxman act in India, filing such court cases should only be limited to compound patent because it is well-known fact that compound patent cannot be circumvented (design-around). The only way is to challenge the validity of compound patent.

    In cases of other patents covering composition, process, polymorph or formulation the innovator should not be allowed to file such court cases and the DCGI should be allowed to approve generic dossier because such patents can always be circumvented (design-around). In such cases, it should reasonably left to court to decide whether patent is infringed or not.

    If you can send me your email ID I can send you the copy of Bayer-Cipla order.

    Kind Regards,
    ---
    VC

    ReplyDelete