Patent Infringement Cannot Be Presumed

Bayer Corporation Vs. Union of India 162(2009) DLT 371

Bayer Corporation, instead of filing a suit for infringement, filed an inventive writ petition in the Delhi High Court desiring that since the applications of Cipla “SORANIB” allegedly infringed its patent, its (Cipla’s) marketing approval application under the Drugs Act should not even be processed or entertained. It is for the first time that an attempt is made to link drug approval to patent infringement in India. However, the Delhi High Court, denying the injunction, imposed a substantial cost of Rs. 6.75 Lakh to deter any such future attempts.

Bayer relied on the argument that a combined reading of Section 2 of the Drugs and Cosmetic Act along with Section 48 of the (Indian) Patent Act, 1970 establishes a Patent Linkage Mechanism under which no market approval for a drug can be granted if there a patent subsisting over that drug. It also claimed that CIPLA’s “SORANIB” is a “Spurious Drug” as defined under the Drugs Act, for which market approval cannot be granted.

The Hon’ble High Court of Delhi held that there is no Drug- Patent Linkage mechanism in India as both the Acts have different objectives and the authority to determine patent standards, is within the exclusive domain of the Controller of Patents. Moreover, the patent linkage will have undesirable effect on the India’s Policy of Public Health. It further held that the market approval of a drug does not amount to infringement of patent. Therefore, the patent infringement cannot be presumed, it has to be established in a court of law. Such adjudication is beyond the jurisdiction of Drug Authorities.

On the issue of “SORANIB” being a spurious drug, the court held that CIPLA’s “SORANIB” cannot come under the category of spurious goods as there is no element of passing off like deception or imitation present in CIPLA’s drug”.

Defending India’s IPR

It is ten years since India amended the Indian Patents Act, 1970 to bring its laws in line with the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The most important of those amendments related to the introduction of product patents for 20 years, including for pharmaceutical products. Significant safeguards were built into the legislation. These included debarring of ever greening patents, a process by which the patent holder seeks to extend the life of patents by some minor tinkering with the products. The amended legislation also expanded the scope of compulsory licensing and introduced for the first time post grant opposition to patents (Provisions relating to pre-grant opposition were retained).The legislation raised the bar for what constitutes an invention and what cannot be patented in India.

The above provisions served Indian consumers well by keeping the price of some important drugs dealing with critical illnesses such as cancer under check. The Patent office’s rulings have by and large been upheld by the highest courts. Inevitably big pharma have lobbied with their governments to force India to dilute the provisions.

The new government under pressure

The NDA government’s approach to the IPR issues has been a subject of intense discussion, especially in the context of repeated attempts by the US Trade Representative (USTR) to put India and some other countries on the mat over the alleged weaknesses in their IPR regime. The Office of the USTR is part of the executive office of the American President and apart from being the chief trade negotiator of the U.S. government has enormous clout over the conduct of trade across the world.

On April 30, the office of the USTR named India and China among 13 countries, which were placed on a priority list, requiring close scrutiny for their alleged IPR weaknesses in diverse areas including pharma, IT and publishing.

The report called upon these governments to plug what it thinks are the lacunae in their IPR regimes so as to align them with global standards. For India the USTR action has been a persistent thorn. As soon as the NDA government took office it had to face a similar report. In fact out of last year’s inclusion in the priority list, India faced a mid-term appraisal.

However, the U.S. authorities noted some improvement — a conclusion no doubt arising out of improving relations between the two countries at the highest levels.

There has been one saving grace on both occasions: India while being on the priority list was not designated a priority watch country, which might have led to penal action against India. In practical terms that means being able to stand up to influential lobbies such as seen spectacularly in pharma. The consolation prize of avoiding punitive action by the developed countries is simply not enough.

Draft of a new policy

India needs to fashion a policy that will be in tune with global standards and at the same time protect special Indian strengths. Prime Minister Narendra Modi has said as much: “India should align its IPR laws with global standards.” Commerce Minister Nirmala Sitharaman remarked earlier that “We need an integrated policy,” While nothing significant can be inferred from these statements the government has done well to release a draft IPR policy in the public domain. Taking a balanced approach, it says that existing laws — that seek to protect the rights and incentives of innovators on the one hand and public interest on the other — would remain. However it also calls for legislative changes to keep pace with economic and technological developments.

A challenging task

It is going to be an extremely challenging task to stick to that position. Of special concern have been the developments in the pharma industry where India is facing maximum pressures from extremely well funded lobbies set up by big pharma from the U.S. and other developed countries (although it must be reiterated that pharma is not the only area).

IPR challenges have to be met increasingly through political action and diplomacy. The government needs to strengthen its decision-making process and boost the skills of its negotiators. In this connection an important initiative of the NDA government has been the setting up of an IPR think tank which among other tasks, will help in the formulation of a National Intellectual Property Rights policy for the first. The draft paper is the first step. The government has called for feedbacks before it finalises a new IPR policy.

The domestic constituency of the NDA government also cannot obviously be ignored. Already there have been rumblings over the composition of the technical committee that will advise the government.

To reiterate, the main challenge is to eradicate even the faintest of suspicions that the government is acting under external pressure. India does not have an IPR policy but it has a strong legal foundation. Important precedents have been set especially in pharma-related matters. Besides, there is a well functioning Patents office with sufficient experience to grant patents and uphold consumer interests. From here a new, well balanced policy should not be too difficult. Resisting the big lobbies which have the support of the political establishments of developed countries is an entirely different matter.

(This article first appeared in The Hindu dated May 18, 2015)

Delhi High court grants interim injunction; restrains Glenmark from selling generic version of anti-diabetic drug Januvia (Sitagliptin)

On April 2013, Glenmark launched the generic version of Merck’s popular antidiabetic drug Januvia (Sitagliptin) and Janumet (combination of sitagliptin and Metformin). Subsequently Merck filed a suit against Glenmark seeking interim relief. The Delhi HC (Justice Rajiv Sahai Endlaw) denied interim relief to Merck. After denial of interim relief, Merck was also briefly engaged in mediation with Glenmark over the Januvia patent. Readers may recall that we had blogged about it here here and here. Aggrieved by the denial of interim relief Merck also filed an appeal, seeking injunction.The Delhi High court division bench granted the interim injunction. This post aims to analyze the interim injunction order. IN209816 (product patent claiming Sitagliptin) is the subject of the present suit.(Long post warning*)

Merck’s arguments:

Merck contended that Sitagliptin Phosphate Monohydrate cannot be prepared without manufacturing the active ingredient, the Sitagliptin molecule. Merck also alleged that Glenmark willfully infringed the suit patent.

Glenmark’s arguments

Glenmark alleges that the patent is invalid under Section 64(1) of the Indian patents act:

The patent is lacks inventive step over prior art, patent. Glenmark further alleged that the suit patent is a “cut and paste job” from these two patents, specifically European Patent 1406622 and WO2001034594 A1.

The complete specification of the patent does not sufficiently and fairly describe the invention and the method by which it is to be performed, since the patent does not describe the preparation of the Sitagliptin free base or Sitagliptin phosphate monohydrate, but only its hydrochloride salt

Strangely enough, Glenmark also contended that the suit patent is not useful and lacksindustrial applicability because Sitagliptin free base is itself unstable. Glenmark also stated that the Sitagliptin phosphate monohydrate was the molecule used in the clinical trial, and not Sitagliptin Free Base.

The claim goes much beyond the limited disclosures in the specification, and thus the claim is over-broad or an impermissible Markush claim that creates a false monopoly.

Glenmark alleges that Merck did not comply with its obligation under Section 8 of the act to disclose patent applications made for the “same or substantially the same invention”. It was alleged that Merck did not disclose 5948/DELNP/2005 (for Sitagliptin Phosphate Monohydrate), 1130/DELNP/2006 (Sitagliptin Phosphate Anhydrate), 2710/DELNP/2008 (Sitagliptin plus Metformin) or subsequent international applications for these compounds either.

I wonder; where does one draw the line for Section 8 disclosure? What amounts to “disclosure of same or substantially same inventions” is a grey area! In my opinion 5948/DELNP/2005, 2710/DELNP/2008,1130/DELNP/2006 and their foreign equivalents are subject matters of separate patents and are not divisionals and do not claim priority from the original product patent IN209816.If section 8 requires one to disclose all related applications in the relevant arena – this is a separate patent landscape project in itself.

Curiously, Glenmark also argues that Sitagliptin phosphate monohydrate is qualitatively different from the Sitagliptin free base – it has enhanced pharmaceutical qualities (the reverse Section 3(d) argument so to speak!).This, according to Glenmark, means that the manufacture of Sitagliptin phosphate monohydrate does not violate a patent for the Sitagliptin free base simpliciter.

Courts observations:

In an exceedingly well reasoned judgement the Division bench (Justice Ravindra Bhat and Justice Najwi Wazir) of the Delhi High court made the following observations:

Regarding prior art the court notes that irrespective of whether the two patents are similar or not, EP 1406622 was published on after the priority date for the suit patent, and therefore does not qualify as prior art.

Regarding sufficiency of disclosure in the complete specification, the court observed that the patent sufficiently discloses the Sitagliptin free base, which in itself is clear, precise. The question whether the suit patent sufficiently discloses Sitagliptin phosphate monohydrate was left open.

Regarding industrial applicability, the court rightly observed that while the patent claims disclose the Sitagliptin free base, the description relating to the issue of industrial applicability recognizes that the Sitagliptin free base will be attached to some carrier (salt form). That carrier, however, is NOT the crux of the invention but only an inert component that does not add value to the therapeutic or medical value, which is the true core of the invention. It would be a far cry to hold that Sitagliptin is useless for any known purpose. The Court also noted that Sitagliptin was not known before, and its introduction allows for the inhibition of the DPP IV enzyme in such a manner as previously unknown, whether through one inert carrier or another.

Regarding Markush claims, , for the limited issue in these interim hearings the Court notes that the Markush formula and all combinations “share a common use or property” and “ share common structure factors relevant to determine the validity of a Markush patent, as per the Draft Guidelines of Indian patent office. The court opined that whilst it may be appealing at first blush to limit a pharmaceutical patent only to the exact and precise compounds and chemical structures disclosed, that may render genuine medical inventions to naught.

Regarding Section 8 (foreign filing disclosures) the court observed that Merck in the modified Form 3, disclosed foreign filings for patent related to combinations of Sitagliptin and metformin. The Court further stated that Section 8 only mandates the disclosure of patent applications outside India and not within. This is clear from the wording of Section 8 itself.

Conclusion:

The court also frowned upon Glenmark’s at risk launch and observed that the fact that Glenmark did not utilize the opposition mechanisms weighed in favour of grant of interim injunction.

The court carefully and meticulously evaluated the three factors involved in grant of interim injunctions.

Prima facie case: The court succinctly captured the crux of the case and noted that Merck had established a strong prima facie case on the merits of the suit claim. It is established that Glenmark uses Sitagliptin free base as the active component in its chemical formulation. The court was totally unimpressed with the unsubstantiated argument advanced by Glenmark that their generic version uses Sitagliptin Phosphate monohydrate, which is manufactured directly without using the Sitagliptin free base. The court further stated that the fact that Merck unsuccessfully pursued a separate patent for Sitagliptin Phosphate is irrelevant .Thus; prima facie infringement of Merck’s patent is established, in the opinion of this Court.

Irreparable injury: Whether the claimant would suffer irreparable injury in the absence of interim injunction?- It may be argued that no injunction should be granted since all damages from loss of sales can be compensated monetarily ultimately. For this argument – the court countered that, prices may not recover after the patentee ultimately prevails, even if it is able to survive the financial setback (or “hit”) during the interim, which may take some time. The victory for the patentee therefore should not be pyrrhic but real.

Balance of convenience: The court must look at the public interest in granting an injunction, as access to drugs, is an important factor especially in case of a condition as prevalent as diabetes. Here, the price difference between the commercial products sold by Glenmark and MSD is not so startling as to compel the court to infer that allowing Glenmark to sell the drug, at lower prices would result in increased access. The court observed In the Hoffman la Roche case the price differential was about 300% and therefore in that case, held that balance of convenience did not lie in favour of grant of injunction as the possibility of several thousand being denied access to the generic drug was real.

Delhi High Court Order:

http://lobis.nic.in/dhc/SRB/judgement/20-03-2015/SRB20032015FAOOS1902013.pdf  

http://spicyip.com/2015/03/delhi-high-court-grants-interim-injunction-restrains-glenmark-from-selling-generic-version-of-anti-diabetic-drug-januvia-sitagliptin.html