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Time and again, we have on this blog highlighted the dangers of ex-parte interim injunctions in cases of pharmaceutical patent litigation. For its part the Delhi High Court has been relatively restrained in granting such ex-parte injunction in pharmaceutical patent litigation. However, there have been occasions on which some judges of the High Court do grant such orders, with little adherence to Supreme Court precedents on the point.
In the present case of Issar Pharmaceuticals v. Vinod Dua (According to LinkedIN he is a Director at Ind-Swift, a generic pharmaceutical company), the Plaintiff sued for the infringement of three of its patents: 186437, 185703 & 185613. Ind-Swfit’s product, MELSWIFT, was allegedly infringing all three patents.
Justice Manmohan Singh who was at the time hearing this case, granted an ex-parte interim injunction on the very first day hearing of the case. The order can be accessed here. To be fair to Justice Singh, the plaintiffs had also alleged copyright & trademark infringement along with trade-secret misappropriation by the Defendants and some of these aspects may have warranted an interim injunction but the extension of the injunction to even potential violation of the patents in questions, was absolutely unwarranted.
For reasons I just cannot understand, some of the judges in the Delhi High Court do not understand that the process in the patent office has always been quite flawed, save for the drastic improvements that we have seen in the last few years. All of this just means that the patents issued, especially the old ones, are usually flawed for a number of reasons, both substantial and procedural. The Delhi High Court has itself dealt with several such cases of irregularities in the patent office and therefore it is even more disappointing when you see judges from the very same court granting ex-parte interim injunctions in such cases.
Getting down to the details of this present case of the three patents, for some reason best known to the patent office, I cannot even access, on the patent office website, details of two of the patents: 185703 & 185613.
The third patent, 186437, however is accessible and the file-wrapper prima faice raises several questions as to how and why the patent was even granted.
As per the Form 1 (available over here), the application (537/DEL/1997) was a divisional from another patent application (1051/DEL96), which was filed on 20th May, 1996.
The patent specification for the ‘537 patent (available over here) should be able to bag an award for being the shortest ever specification in the history of pharmaceutical patents – stretching a little over a grand total of 3 pages. There is no description in the specification of any prior art and how the impugned patent was smarter than anything known in prior art. The invention claimed in this patent, and described in the specification was a pharmaceutical composition, which could be used as a ‘vehicle for active agents for use in applications other than tanning of a skin surface’.
Since this patent application was filed prior to 2005, the patent office appears to have objected in the FER under the erstwhile Section 5 of the Patent Act which denied product patents for food, medicines and chemicals. This prohibition was done away with only in 2005 when the Indian patent legislation was amended for compliance with TRIPs. However, in reply to the FER (available over here) issued by the Patent Office, the patentee’s agent informs the patent office that the claimed invention “cannot be used as a drug by itself” and that “the product of this invention is used for the administering of the drug to the patient”. Concluding the argument, the patent agents state “Therefore we submit that the vehicle/product of this invention does not fall within the scope of Section 5(a) of the Patent Act.”
To me, the above arguments should have been rejected outright by the patent office as the definition of ‘food & medicine’ in the erstwhile legislation would have easily covered the impugned invention, which according to the Patentee, was supposed to be used in a pharmaceutical product. Further, Section 5 is quite clear that it prohibits all patents for chemical products and the impugned invention should have been barred outright under that provision. However, the patent office, in a letter dated 23rd January, 2001 (available over here) informed the applicant that the application had been accepted by the patent office and that the same would be advertised and notified as was necessary under the pre-2005 law. The patent certificate was issued on 10th June, 2002,
There is a very little probability of the IPAB or the High Court sustaining this patent after a determined trial for its revocation. Yet our judges, go ahead and grant ex-parte interim injunctions in such cases.
Things go further downhill from here. Usually, after the patent certificate was issued the patent is considered issued. However according to the patent office website the patent application was published under Section 11A on 12th September, 2008 and then the grant of patent was published on 11th March, 2011. If the patent certificate was issued in 2002, why were Section 11A and Section 43(2) publications taking place 6 and 9 years later?
The problems with this patent do not end with the above issues. The ‘e-register’ of the patent application indicates that the patent had lapsed and that the patentee had filed a application to restore it on 4th December, 2008, which application was allowed on the 20th April, 2010 – the final order of the Controller however is unavailable on the patent office website. In my experience, these restoration applications are usually nefarious affairs and any final conclusion on the legitimacy of the restoration will depend on the order of the Controller.
Therefore, when it is amply clear that at least one patent is not prima facie valid, why would a judge grant an ex-parte interim injunction and shut down a legitimate business? What’s the hurry? Why not wait for a trial and evidence?
Justice Manmohan Singh is more or less a pro plaintiff. He would perhaps not gone into the details of the patent. The fact is that the plaintiff is having the patent, must have been sufficient for him. When one would cite judgments before him, he would not allow to read the judgment, saying that he has read the same. Yes, he would have definitely read it and may be more than one times, but it should not stop the counsel arguing a matter to read that judgment and point out what he/she wants to say. We read judgments and sections many a times. Even arguing, we read sections more than one times at the same time to understand its import properly in the context of the particular case being argued.
HOWEVER, I am sure that having brought to the notice of the judge, the points raised by you with respect to the one patent, Justice Manmohan Singh would have definitely modified the ex parte interim injunction.
You have done a good job in pointing out the flaws in the patent.
anonymous said,
The value of the patent does not lie how many pages the specification contain as observed on the patent 186437.One must see that US patent office gave 2 patents on similar formulation one for administration of steroids and other for something else while the Indian patent office issued for similar formulation to adminster a peptide.Will you also dismiss the other US patents?.The formulation is not a drug as any one can see and therefore did not break the then existing Indian patent rules.
The plaintiff has patents and established that the defendant used in his product the same formulation and API.This is sufficient ffor Justice Manmohan Singh to issue ex-parte stay order.The author of the present article on the other hand questions the wisdom of the IPO in granting the above patents.Such devious arguments are responsible for the international community to brand India as not safe place for IPRS.