NDDS or Evergreening of Patents? 

The Draft Pharmaceutical Policy - 2017

(Article-5)

The Department of Pharmaceuticals (DoP) under the Ministry of Chemicals & Fertilizers recently released the 18 page Draft Pharmaceutical Policy – 2017 which has been circulated among various stake-holders of the pharmaceutical industry and civil society. 

In an attempt to understand the draft, I have decided to present a series of articles portraying my own interpretations on this draft policy. The fifth article is here.

Acceptance of Novel Drug Delivery Systems (NDDS) as “New Drug” violates the Laws of the Land

The Draft Pharmaceutical Policy – 2017 notes: “There is disproportionate focus on generic formulations to the point of exclusion of lack of adequate R&D. Whatever R&D is there is also limited to new processes for the same product (Novel Drug Delivery System – NDDS). For a long-long time there has been no molecule discovery by indigenous manufacturers.” [Para:3.4; Page:7 of the draft].

The above observation is biased and paradoxical. Focus on generic formulations for their adequate production by the indigenous manufacturers has actually helped the nation to attain self-sufficiency for the supply of medicines. How that could be the reason for lack of adequate R&D? Manufacturing of medicine in sufficient quantity cannot contravene the research and development work for invention of newer drugs. Rather, both should be concomitant. However, based on the above observation, the draft policy suggests, “All Novel Drug Delivery Systems should be considered as ‘new drugs’, unless certified otherwise by the licensing authority. This will also encourage innovations.” [Para:5.17; Page:15 of the draft].

Such “policy initiative” adopted by the government at the centre raises serious doubts about its intentions. World-wide the research pipeline for drugs and pharmaceuticals has become virtually dried up. The healthcare and pharmaceutical industry changed radically once the era of patent protection gradually started winding down. The patent cliff era began in earnest in 2011 and crescendoed in 2012. Some major well-known drugs—like Lipitor (atorvastatin), Plavix (clopidogrel), and Singulair (montelukast)—faced patent expirations and increased competition in the United States. According to estimates by Evaluate Pharma, a whopping $120 billion in sales was lost to patent expirations between 2009 and 2014. Evaluate Pharma also forecasts that $215 billion in sales will be at risk due to patent expirations between 2015 and 2020. [Source: Drug Patent Expirations: $190 Billion Is Up for Grabs; by VanEck]. This trend will pressure the sales and earnings of some of the major multinational drug firms. Under these circumstances, the multinationals are desperate to maintain their high profits by various ways and means. One such method is obviously the evergreening patent rights of their products under the WTO regime.

Fortunately, India could protect its interest against such multinational hegemony in drugs and pharmaceuticals through the Section 3(d) of the Indian Patent Act 1970 (as amended in 2005) which does not allow patent to be granted to inventions involving new forms of a known substance unless it differs significantly in properties with regard to efficacy.  According to the Section (3d), such invention or discovery is “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” [Source: indiakanoon.org]. Such legal provision defended the country’s interest in the court of law when multinational drug firms like Novartis and Bayer were challenged against over-pricing their anti-cancer drugs.

The Supreme Court of India rendered judgment on an appeal by Novartis against rejection by the India Patent Office of a product patent application for a specific compound, the beta crystalline form of imatinib mesylate. Imatinib mesylate is used to treat chronic myeloid leukemia and is marketed by Novartis as “Glivec” or “Gleevec”. Affirming the rejection, the Supreme Court confirmed that the beta crystalline form of imatinib mesylate failed the test of Section 3(d). The Court clarified that efficacy as contemplated under Section 3(d) is therapeutic efficacy. [Source: The Judgment In Novartis v. India: What The Supreme Court Of India Said; Intellectual Property Watch].

The US drug lobby never appreciated Section 3(D). Minister of State (Independent Charge) in the Ministry of Commerce & Industry Smt. Nirmala Sitharaman, in a written reply informed Rajya Sabha on 30 July, 2014 that “the Indian Patent Act does not allow evergreening of patents. This is a cause of concern to the US pharma companies.” [Source: Press Information Bureau, Government of India, Ministry of Commerce & Industry]. Therefore, it was necessary for the corporate serving government to dilute the very existence of Section 3(d) in the pharmaceutical scenario of India to please their masters particularly those who are in abroad. The acceptance of NDDS as “new drug” is a major step towards that. It is important to note that, “making small changes to a drug, often about to come off patent, in order to gain a new patent that extends its manufacturer's control over it is a way of cheating on the implicit bargain of patents: that a government-backed monopoly is granted in exchange for the invention entering the public domain at the end of the patent's lifetime.” [Source: Indian Supreme Court Rejects Trivial 'Evergreening' Of Pharma Patents; techdirt]

Now, for any existing drugs if NDDS is developed and the same is considered as “new drug”, patent protection would be extended in that case and that “new drug” will be kept outside the purview of price control. In this regard, the draft policy mentions: “DPCO will include only ‘off-patent’ medicines in its schedule. ‘In-Patent’ medicines will not be subjected to price ceiling by NPPA.” [Para:5.18 j ii; Page:17 of the draft] Therefore, such provisions in the draft policy, if finalized, would result in increasing medicine prices while ensuring the endless monopoly for few drug majors mostly the multinationals. During the post-patent regime, when the monopoly of multinationals is at stake, this would perhaps be the most priceless gift for them from the Modi-government!

(To be continued....)

@pradipsinterpretations