The Chapter IV A of the Patents Act, 1970 (Sec.24-A to 24-F) had outlived its purpose when the transition period extending from 1995 to 2005 was over once the 3rd Amendment to the Patents Act, 1970 came into effect from 1. 1. 2005. Similarly Section 5 was omitted once product patent regime came into effect. Over and above these provisions which got omitted having outlived their purpose, there are interesting scenario, where there are provisions under Indian Patent Law, Patents Act, 1970, which declared itself irrelevant and virtually extinguished itself, even though, they continue in the Act, historically. One such provision is Section 11A(7) proviso which read as follows:
Provided also that after a patent is granted in respect of applications made under sub-Section (2) of Section 5, the patent-holder shall only be entitled to receive reasonable royalty from such enterprises which have made significant investment and were producing and marketing the concerned product prior to the 1st day of January, 2005 and which continue to manufacture the product covered by the patent on the date of grant of the patent and no infringement proceedings shall be instituted against such enterprises.
This provision has outlived its purpose, since 1) Sec. 5 and Sub-section (2) of Sec. 5 omitted. 2) 1st January 2005 and prior period has now only historical context (more than 10 years passed). 3) No new launches prior to 01. 01. 2005 are likely to be sued, hereafter.
TRIPs Article 27(3)(b) states as follows in the last para “The provisions of this sub-paragraph shall be reviewed four years after the date of entry into force of the WTO Agreement. This provision has become redundant having not reviewed ever after 20 years.
Section 3(d) and other provisions of the post-WTO/TRIPs amended Patents Act, 1970
Section 3(d) was as follows prior to the third amendment: 3(d): 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;
Section 3(d) reads as follows after the third amendment: 3(d): the 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.
Explanation - For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;
The amendment of Section 3(d) was proposed on the floor of the Parliament by the combined opposition and was accepted unanimously to enable passing the Third Amendment to comply with the deadline of 01. 01. 2005. The Bill with the amendment was passed on 23rd March 2005 with retrospective effect from 01. 01. 2005.
The intention of inserting the explanation to Section 3(d) and the link to “enhanced efficacy” was clearly (later proved successfully) to prevent and extinguish attempts at “evergreening”, which means extending the life of a patent (mostly block busters) beyond the 20 years, often most extending the life of a patent for ever, by tweaking the molecule marginally, such as polymorph, crystalline, micronized etc. Even though, it may not be admitted that the immediate purpose was to reject the pending patent application for a beta crystalline form of Ematinib Mesylaten (gleevec), the general objective of preventing and discouraging evergreening succeeded, especially for contentious blockbuster molecules. It need to be mentioned here, that irrespective of the stringent Section 3(d) bar, a large number of polymorphic and crystalline patent applications for known substances have been granted post-2005 till recently, when a uniform guideline for grant of pharmaceutical patents was notified on the official website of the (Indian) Patent Office.
Overall, Section 3(d) has commendably restricted “evergreening” in India, post-2005 in the new product patent regime. In most patent office decisions both in pre-grant as well as post-grant as well as revocation proceedings in the Intellectual Property Appellate Board (IPAB) and High Courts (in counter claims), Section 3(d) grounds for opposition or revocation has been often overlapping with “obviousness” grounds. Even overseas judgements were rejecting the “obvious to crystalline” approach, even in the absence of Section 3(d). In the meantime, patent laws of many developing countries, such as Philippines, incorporated sections similar to Section 3(d) of (Indian) Patents Act, 1970, by amending their domestic patent law provisions. This adding “insult to injury” caused additional grounds for complaint from USTR and other developed countries. Section 3(d) has stood the test of times and has served India and Indian Pharma very well for last 10 years. Section 3(d) also stood the test of legal and constitutional challenge in the High Court of Madras as well as in the Supreme Court.
Having said that, Section 3(d) was intended to block incrementally but physically “tweaked” molecules getting patent protection in India, which were otherwise not patentable in India, having been in public domain (prior art) prior to 1995. The transition period of 1995 to 2015 (more particularly 2005 to 2015) needed Section 3(d). This transition time is now getting over. More and more Indian pharmaceutical companies are coming up with new crystalline forms with unique and novel XRD data and also destructive polymorphic forms as well as beneficial salts and esters. Increasing number of patent applications are coming up from domestic pharma companies, for “new use” “new indications” of known active pharma molecules and their incrementally modified forms, formulations and combinations.
In the meantime, USTR (Section 301), under pressure from PhRMA (MNC pharma lobby of USA) is attacking Section 3(d) intensively. It would be worth debating in public, if Sec.3(d) having done its job, is now outliving its utility (not with retrospective effect) prospectively. It may not be a bad idea to open up the debate and even propose a review of Section 3(d), fully admitting that no bill gets passed in Parliament till 2018 or thereafter.
This public debate on continued utility of Section 3(d) may help reduce IP related tensions in Indo-US relations, especially in light of US Congress asking for more stringent regulatory controls and barriers against Indian generic pharma manufacturers and exporters to USA.
In this context, it is pertinent to discuss Indian patent litigations involving Section 3(d). Constitutional validity of Section 3(d), as stated earlier, has been upheld by the Madras High Court in the writ petition relating to Betacrystalline salt of Imatinib Mesylate. The rejection of this patent application of Novartis by the Chennai Patent Office on various grounds including Section 3(d) was eventually (after multiple appeals and writ petitions) upheld by the Supreme Court in an eminently elaborate order in April, 2013. The more recent orders by the Division Bench of Delhi High Court and the Supreme Court as described herein below indicates the diminishing utility of Section 3(d) when a patent is already granted in India.
Erlotinib
Vide judgement dated 27th November, 2015, the Division Bench of Delhi High Court held that “This is a sufficiently broad claim that is clearly not limited to any polymorphic version of Erlotinib hydrochloride, but to Erlotinib hydrochloride itself. This compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent”.
While the honourable High Court did not grant interim injunction in favour of Roche, it decreed that Cipla would be liable to render accounts concerning manufacture and sale of Erlocip,
Late January, 2016 Supreme Court admitted the SLP filed by Cipla against Delhi High Court decision against the order of the Delhi High Court. The SLP also included a plea seeking the appointment of a scientific expert.
Sitagliptin
Suit patent no IN209816: Sitagliptin Abandoned Patent Application 5948/DELNP/2005: Sitagliptin phosphate monohydrate
Glenmark had introduced a third brand, Zita and Zitamet, in India after preliminary injunction was refused to Merck/Sun by the Hon’ble Single Bench of Delhi High Court. Matter was thereafter appealed by Merck to the Hon’ble Division Bench of the Delhi High Court, who injuncted Glenmark from selling and distributing Zita and Zitamet in the market. However, Glenmark was permitted to sell their products which were already in the market.
Subsequently, Glenmark appealed to the Hon’ble Supreme Court of India. On 15th May, 2015 Hon’ble Supreme Court injuncted Glenmark from manufacturing the unfinished formulation of Sitagliptin Phosphate Monohydrate (SPM) until 22nd July, 2015 (which was the next date of hearing). However, the existing stock of Zita and Zitamet were allowed to be sold in the market by the Hon’ble Supreme Court. Subsequently, on 4th August, 2015 the Hon’ble Supreme Court refused Glenmark’s prayer for commencing processing of unfinished formulation of Sitagliptin Phosphate Monohydrate (SPM) API, currently lying in the Glenmark’s factories into Zita and Zitamet, respectively.
On 7th October, 2015, the Hon’ble Delhi High Court passed a 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 one or more other drugs thereby infringing the suit patent number 209816 of Merck.
In this case also, the validity of a parent patent to cover all forms or salts of the product, even when a subsequent patent for a salt form which covers the product as marketed, is registered, has been upheld in India, for grant of an injunction (stay order).
In favour of saving lives
To be fair to the poor patients and the cause of affordable access for essential life-saving medicines, attention is drawn to the excellent and well-researched publication titled “Patent Protection and Innovation – Section 3(d) of the Patents Act and Indian Pharmaceutical Industry” by T. C. James, Director, NIPO (National Intellectual Property Organization). The judgement of the US Supreme Court in KSR vs. Teleflex is referred to by T. C. James. An excerpt from this globally famous judgement, quoted in this publication, states:
“…. the results of ordinary innovation are not the subject of exclusive rights under the patent laws. Were it otherwise, patents might stifle, rather than promote, the progress of useful arts”. The late justice V. R. Krishna Iyer, while creatively drafting the time tested, globally acclaimed Section 3(d) amendment to the Patents Act, 1970 in early 2005, had intended more than what the US Supreme Court said in their judgement. He had the poor suffering millions of patients and their right to access affordable treatment in his mind.
The most appropriate and admirable option in support of Obamacare as well as affordable access of critical lifesaving medicines to poor patients globally, would be for USTR to drop the attack on India’s (Patents Act, 1970) Section 3(d), drop India from Super 301 watch list and continue to let poor and ageing population globally, including in USA to access affordably priced high quality generic medicines.
(The author is CEO, Gopakumar Nair Associates)