About 30 months back, the US drug multinational Merck Sharp Dohme (MSD) had petitioned the Delhi High Court [DHC] to restrain an Indian firm Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs viz., Zita and Zita-Met which violated its patents in India. The drugs contain ‘Sitagliptin’ salt for which MSD has a patent in India. Then, the court had rejected the stance of MSD.
However, in a landmark judgement delivered on October 7, 2015, reversing the earlier stance, a bench of DHC has “restrained Glenmark by decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin phosphate monohydrate or any other salt of Sitagliptin in any form, alone or in combination with any other drug thereby infringing on the patent of MSD.”
In its submission, Glenmark claimed that it had used ‘Sitagliptin phosphate’ in its drugs on which MSD had no patent. But, what it forgot to recognize [deliberate or otherwise] is that Sitagliptin on which MSD has a patent is the molecule or key ingredient used in making of ‘Sitagliptin phosphate’. The court saw through the game plan of Indian company to portray the two as fundamentally distinct [which they are not] and concluded that patent rights of MSD were indeed infringed.
That the bench did not buy this ‘trivialization’ of a very serious R&D affair is abundantly clear from its very precise and meticulously worded order. By clearing mentioning “ — or any other salt of Sitagliptin in any form, alone or in combination with any other drug”, the court not only punctured Glenmark’s skulduggery in instant case but also nipped in the bud similar attempts to circumvent patent in the future as well.
Coming at a time when Modi – during recent meetings with top brass of political establishment in USA and Germany [where HQs of several pharmaceutical and agrochemical MNCs are located] – has reiterated government’s commitment to ensure effective enforcement of intellectual property rights [IPR] and creation of an environment conducive to innovation, the DHC order will certainly boost India’s credentials. But, is that enough?
Seeking enforcement of patent rights through courts is a long drawn process even as the outcome is highly uncertain and circumscribed by the perception and interpretation of individual judges. Moreover, considering that the option of going to higher court is always available [in the instant case, inevitably Glenmark is bound to challenge decision of DHC in the Supreme Court], the wait only gets longer.
In India where “safety” and “efficacy” of pharmaceutical, agrochemical or biological product is a major concern [that indeed is true for any national jurisdiction], anyone wanting to manufacture/import, sell, use or export a drug must take prior approval from the national regulator viz., Drug Controller General of India [DCGI] under the relevant provisions of the Drugs & Cosmetics Act [1940] [DCA].
Under DCA [1940] and Rules made therein, DCGI while considering applications for registration is not required to take cognizance of the existence of patent – suo motu or even when patent holder brings it to their attention. This leads to an anomalous situation whereby government itself becomes a party to patent infringement. This emboldens generic companies to freely go for setting up businesses disregarding patent and continue with alacrity using registration granted by regulator as a shield.
As regards risk of facing injunction from the court, they manage by delaying court decisions on top of exploiting several loopholes in the Patent [Amendment] Act [2005] to delay grant of patent. Moreover, unlike in USA and other developed countries, Indian courts normally do not order compensation in lieu of damages done to patent holder [in the present case, forget compensation, DHC has even allowed stock lying with distributors and retailers to be sold]. So, that is a weak remedy.
Since, the regulator/DCGI ought to know that a patent right is held by person/company over a product, why should it not ‘reject’ an application for approval/registration of such product straight-away – if it is not supported by consent letter from the patent holder? In other words, it should recognize the existence of patent – or “patent linkage” as it is known in WTO jargon – at the time of considering applications for market approval.
While, removing a maze of uncertainties and ensuring timely enforcement of patent holder’s rights, this will also reduce load on the courts who can use their time for more productive work. An additional spin-off is that it would spare employees/workers, vendors and all others connected with making and selling of infringed product the agony of losing their jobs/income when court orders closure of the business.
Even more crucially, patients will also be spared the nightmare of sudden disappearance of cheaper drug [invariably, the generic company sells its drugs at a fraction of the price at which innovator company would sell as it incurs no cost towards investment in R&D and “stewardship”] from the market and then, having to pay a much higher price for the same salt made available by inventor/company.
Once “patent linkage” gets embedded in our law, cheaper version of drug won’t get market entry in the very first place. This will help in getting patients/buyers acclimatized to the harsh reality that bringing a new/invented medicine costs money and therefore, it is necessarily priced high. For making it affordable to the poor, government can go for centralized procurement and making it available through its hospitals/health care centres at subsidized rates. But, it would be unfair and illogical to expect inventor to bear its cost which unfortunately, is happening under the existing dispensation.
A widespread perception that “patent linkage” will tantamount to going beyond India’s obligation under TRIPs [trade related intellectual property rights] agreement or “TRIPs plus” is a myth. This is a logical and inevitable step that government must take to fully protect rights of patent holder and hence, fully consistent with our commitments under the WTO.
Apart from reinforcing India’s credentials as a country that is serious about protecting intellectual property, its adoption will rein in the cult of generic companies making a quick buck – riding piggy back on efforts of innovator – and instead promote a culture of indigenous R&D to churn out new molecules [currently, this is completely missing].
A self-propelled R&D driven domestic pharmaceuticals and agrochemical industry will be much better equipped to deliver what Indian patients and farmers want and that too at a substantially lower price by leveraging our abundant scientific talent. Will Modi crack the whip by amending laws to provide for patent linkage?