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Big pharma’s blockade assisted by amended Section 25

Narendra B Zaveri
Wednesday, August 10, 2022, 08:00 Hrs  [IST]

Indian drug industry’s capability to produce and market drug of same quality standards as Big Pharma’s, most economically has been a matter of serious concern for the Big Pharma. They, therefore, use the patent system to block Indian drug industry’s progress by acquiring patents for repetitive, frivolous and even fraudulent claims. They also use the provisions of amended Section 25 to block production and sales by Indian pharma companies.

Since 2005, when product patent system was introduced in India, they have acquired and hold more than 7000 patents for drugs and pharma products (about 80 per cent of the pharma patents issued by Indian Patent Office) covering about 7000-8000 drugs and lakhs of chemical compounds and even trillions of Markush Type – unnamed, unknown and unidentified chemical compounds. However, they market only about 50 product covered by such patents and use the patent only to block production, etc. in respect of the others. In their attempt to block the Indian drug industry, they have also blocked availability of such patented drugs to millions of citizens requiring such drugs.

In view of the said inquiry report of US Committee in part I, it will not be surprising if, it is found that these 7000 patents were mere repetitious and fraudulent claims of in respect of only about 200-300 effective drugs. Such patents do not satisfy statutory requirements of 2 (1) (j) and (ja) and Section 3(d) of Patent Act 1970. The 2005 amendments to PA 1970 have helped Big Pharma in securing such patents.

The patent system is thus used by Big Pharma only to block production and availability of all recently developed drugs, and as a direct result thereof, deny access to vital life saving drugs to millions of Indian citizens, leaving them to suffer/die untreated.

Such patents have blocked production, importation and marketing of such life saving drugs, leaving millions of Indian citizens to suffer/die untreated, even while the law and the government extending full patent protection to such patents. There is urgent need for India to review relevant provisions of Patent Act 1970 and take urgent corrective measures to stop further damage.

A recent judgement of Supreme Court of India in case Novartis’ claim for patent is instructive and offers valuable guidance, particularly for rejection of frivolous patent claims.

India has been under constant pressure from Big Pharma and USTR to relax patenting standards and to delete Section 3(d) of Patent Act 1970 (PA’70). The matter has been conclusively established by the judgement of the Supreme Court in the Novartis’ case in 2013.

Para 90: “On a combined reading of causes (j), (ac) and (ja) of Section 2(1), in order to qualify as invention, a product must, therefore, satisfy the following tests:
i)   It must be new;
ii)  It must be capable of being made or used in an industry
iii) It must come into being as a result of an invention which has a feature that:
a)  Entails technical advance over existing knowledge;  or
b) Has an economic significance and
c) Makes the invention not obvious to a person skilled in the art.”

Para 104: “We have so far seen Section 3(d) as representing patentability, a concept distinct and separate from invention. But if clause (d) is isolated from the rest of Section 3, and the legislative history behind the incorporation of Chapter II in the Patents act, 1970, is disregarded, then it is possible to see Section 3(d) as an extension of the definition of invention and to link Section 3(d) with clauses (j) and (ja) of Section 2(1). In that case, on reading clauses (j) and (ja) of Section 2(1) with Section 3(d) it would appear that the Act sets different standards for qualifying as inventions things belonging to different classes, and for medicines and drugs and other chemical substances, the Act sets the invention threshold further higher, by virtue of the amendments made in Section 3(d) in the year 2005.”

At Para 86 the Court has recommended PA’70: Thus, after deliberations that took place for just four days, the Patents Act, 1970, came in a completely new avatar. The haste with which the Government was constrained to rush the Bill through Parliament to make the law compatible with the TRIPS Agreement perhaps explains the somewhat unclear drafting of some very important provisions, which called for much greater clarity; the presence of some terms and expressions in the definition section1 that are nowhere used in the Act; and a few loose ends that could have been properly tied up if more time and attention was given to the drafting.”

Apparently unconstitutional provisions of Section 25 (2)
The most damaging amendment introduced by 2005 amendment is of deleting of Section 23 and amending Section 25. Section 23 providing for advertisement of acceptance of the complete specification by the controller should be restored.

The unamended Section 25 providing for pre grant opposition by third parties should be restored. Section 25 (2) was amended by 2005 act providing for opposition  after the grant of patent. This amendment enabled the patentee to enjoy full patent rights, denying to the opponent and all others, right of access to the patented drugs for production, marketing or using, and drag the matter even up to Supreme Court, even if not patentable as per Section 25 (2) as grounds set out in clause a - k.

The gravity of the problem arises because this directly results in denial of access to the patented drug to millions of citizens requiring it, leaving them to suffer/die untreated - even if subsequently the patent is held to be invalid. What is involved is threat to lives of millions of citizens and direct denial and violation of fundamental rights of citizens guaranteed by Article 19 (1) (g) and 21 of the constitution, even if the patent grant is subsequently held to be void.

These amendments have enabled the patentee:

    • To enjoy patent rights even if they do not satisfy the requirements of Sections 2(1) (j) and (ja) and Section 3(d) of PA70;
    • To oppose grant of patents to other manufacturers and to prevent them from producing and marketing the drug, even if patent grant is disputed and opposition proceedings are pending;
    • The patentee is able to enjoy the rights and protection of law, even if it has no intention to produce, import or market the drug in India and in fact does not do so.
    • The absurdity and the most damaging aspect, of the amended Section 25 is that millions of other citizens requiring the drugs are denied access to the drug and are left to suffer/die untreated.

Section 25 (2) in direct violation of the constitution
The amendment of Section 25 (2), even while protecting and enforcing a disputed patent right directly results in denial of fundamental Constitutional Rights of other citizens. Other manufacturers desiring to produce and market the patented drug are prevented from doing so in violation of their fundamental right under Article 19(1) (g). On the other hand, millions of citizens requiring the patented drug for treatment of their ailments and diseases are denied access to and are left to suffer/die untreated in direct violation of their fundamental right guaranteed by Article 21.

Thus, as a direct result of the amended Section 25, the patentee is enabled to enjoy a patent right which is questionable and disputed, while the existing and more fundamental rights guaranteed to other citizens by the Constitution are irreparably defeated. Section 25 as amended is in direct violation of the Constitution and has to be deleted and replaced by the pre-existing provisions of Section 23 and 25.

The amendment is therefore unconstitutional and has to be reversed. In effect, the amendment provides full right and protection for a patent claim - subject to objection - and at the risk of fundamental right to life of millions of citizens and also denial of right to produce, market the drug while the patent right continues.  

The amended Section 25 provision are used by Big Pharma only to block production and availability of such drugs to millions of Indian citizens and to block the development of Indian drug industry.

On consideration of lives and health of millions of citizens, and the urgent need to ensure constitutional compliance, issue of an ordinance to amend Section 25(2) and the other provisions, is fully justified.

For convenience of reference the provisions of Sections 23 {as it existed before 2005 amendment} has been reproduced below.

“Advertisement of acceptance of complete specification: On the acceptance of a complete specification, the Controller shall give notice thereof to the applicant and shall advertise in the Official Gazette the fact that the specification has been accepted, and thereupon the application and the specification with the drawings (if any) as accepted by the Controller along with other documents filed by the applicant in pursuance thereof shall be open to public inspection.”

The unamended Section 25 was substantially same as the amended Section 25(1), and is therefore not reproduced.

(Author is an advocate based in Mumbai)


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