Though TRIPS allows patent laws to take care of public interest, this should not be pushed to a point whereby the very incentive to innovate is stifled
The Supreme Court verdict in the Glivec case – the cancer treatment drug for which the Swiss major Novartis had sought a patent – has generated an air of exuberance amongst the ‘generic’ producers.
It is good news for lakhs of patients who will have access to this drug at a fraction of the treatment cost offered by Novartis (already some generic companies are offering at one-tenth; this will go down further).
Millions of patients in other parts of the developing world, especially Africa, also have reasons to rejoice even as Indian companies get ready to service those markets at ‘affordable’ prices.
For the health activists who have put up a sustained fight championing the cause of ‘poor’ patients have added reason to feel pleased as their efforts have borne fruit.
However, Novartis and other MNCs may have reason to feel discomfort. Indeed, they have made this known and hinted at taking a re-look at India as being a ‘credible IP protector’. A perception has been created that India does not protect ‘incremental innovations’; that only discovery of new molecules, which are very rare and far in between, would get patent protection.
Indeed, seeds of suspicion were sown when section 3(d) was incorporated in an amendment to Indian Patent Act in 2005. Global R&D companies had perceived this as a move to deny patents even as section 5 was deleted to make way for product patent to comply with TRIPS.
However, Indian lawmakers justified this as a carefully-crafted step to rein in tendencies to seek ‘frivolous’ patents on some minor modifications to an existing substance. The section bars grant of patents to new forms of known substances, unless the new form results in significant enhancement in efficacy over the known substance. Thus, apart from satisfying tests of invention as laid down under section 2(1) (clauses (j) & (ja), the applicant should demonstrate that the ‘new form’ gives substantially higher ‘efficacy’ over a previously known compound as prescribed under 3(d).
Novartis had not only appealed against rejection of its request for patent by patent controller in 2006 (later upheld by IPAB in 2009) but also challenged the constitutional validity of 3(d). Following the Supreme Court’s pronouncement, not only section 3(d) stays, it has also shown the way ‘how to read and implement’. However, a key question still remains. Does the section come in the way of ‘incremental’ inventions?
The apex court may have put to rest any doubt in this regard by emphatically stating that ‘the section did not bar all incremental inventions of chemicals and pharmaceutical substances’. But, the field remains wide open for all sorts of interpretations leaving a lot of discretion with patent controllers. How do they (or even courts) decide whether the new form is more efficacious? Certain biases are bound to creep in all the more so when the ramifications of a decision either way are wide and manifold, transcending even national boundaries.
The manner of determination by the Supreme Court in the Glivec case (the test of efficacy can only be ‘therapeutic efficacy’) may orientate patent controllers generally on to a track that results in patent grant ‘very rarely’. A sole preoccupation with this criteria would prompt examiners remain focused on ‘pharmacological/chemical properties’ of patent product to the neglect of innovations in a host of other categories.
Most of the incremental innovations are in the area of ‘new dosage form’, ‘new delivery systems’, etc. The value of these to the patients in terms of ‘quality’ and ‘speed’ of treatment could be even more than what is offered by a better compound per se. Yet the precedent set by the judgment would almost completely eliminate the possibility of applicant getting a patent on all such innovations. And that, in turn, will be a huge setback to continued R&D.
The scope for research and innovation in these areas is phenomenal. Indian companies are already taking patents in favourable jurisdictions abroad. Why should they be denied such opportunities on the home turf?
Very often a trigger against patenting of incremental innovations is the perception that the inventor (read MNC) uses this to perpetuate his monopoly over the compound. This is a misnomer.
The patent protection is confined only to the ‘new form’ of the ‘known’ substance. The latter on completion of its patent term is already available to the ‘generic’ player for manufacture and marketing. Moreover, nothing prevents any company other than the inventor of the ‘known’ compound to work on it, come up with a ‘new form’ or a ‘new dosage’ or ‘delivery system’ and take patent cover.
True, TRIPS agreement allows member governments ‘flexibilities’ to draft their patent laws in a manner that the overriding objective of making medicines ‘affordable’ to public is not compromised. However, this should not be pushed to a point whereby the very incentive to innovate is stifled. When new medicines and newer forms are not available, the talk of making these affordable is redundant!
The unusually high price of the patented drug is, no doubt, a matter of concern. However, to hammer at the very foundation of patent grant is not the way to address it. That will tantamount to ‘killing the goose that lays the golden egg’!
There are other potent ways of handling this. The government has expanded the National List of Essential Medicines to 348. The new drug pricing policy has already been approved. A committee is set up specifically to look at pricing of patented drugs.
The Patent Act also has a provision for ‘compulsory licence (CL)’. This is to deal with situations where patentee has not taken steps to make the product available or the price is ‘unaffordable’. However, CL should be used only sparingly to deal with extraordinary/emergency situations. It should not be a matter of routine or else this will have the same effect as not granting a patent!
With the Supreme Court itself clarifying that intent of section 3(d) is not to deny patent on incremental innovation to all and sundry, the ball is now in the court of the controller of patent/government to navigate the ship carefully.
Published at http://www.financialexpress.com/news/don-t-kill-the-goose-that-lays-golden-eggs/1099510/0