A recently published report “Pharmaceutical Patent Grants in India: How our safeguards against evergreening have failed and why the system must be reformed“, by Dr. Feroz Ali, Dr. Sudarsan Rajagopal, Dr. Venkata S. Raman and Roshan John, identifies pharmaceutical drug patents granted in likely contravention of anti-evergreening provisions under Section 3 of the Indian Patents Act, from a cohort of 2,293 patents granted between 2009 and 2016. An estimate of the rate at which the Indian Patent Office (IPO) erroneously grants such patents, as well as the rationale for grants, was reached at by analyzing the prosecution history of some grants and the claim language of all granted patents.
The report highlights that the majority (72 percent) of granted patents for pharmaceuticals are secondary patents, granted for marginal improvements over previously known drugs for which primary patents exist. Among them, only a small fraction (15 percent) of granted secondary patents was subjected to elaborate scrutiny, accompanied by a detailed written order of the Controller under Section 15 or 21. In most cases, the relevant exception to patentability has not been appropriately cited in the final written order which inherently points towards a patent application that has not been subjected to detailed scrutiny.
The Indian Patents Act,1970, incorporates the anti-evergreening provisions—sections 3(d), 3(e) and 3(i) of the Patents Act, 1970—restricts the patentability of a host of secondary patents, i.e., new forms of known substances, new property or new use of known substances, use of known processes, admixtures without synergistic effect and methods of treatment. The legal standing questioned before the IPAB and the SC was upheld and laid down certain principles to overcome objections under Section 3(d). The principles were listed out in the report as follows:
- Identifying the new form of the known substance and its pharmacological properties such as efficacy (Paras. 157; 160; 161);
- Comparing the pharmacological properties of the known substance with the new form of the known substance (Para. 163);
- Providing comparative material on enhanced efficacy in the patent application or by affidavits (Para. 171);
- Excluding physicochemical properties like “more beneficial flow properties”, “better thermodynamic stability”, and “lower hygroscopicity” for considering therapeutic efficacy (Paras. 173, 187);
- In the case of medicines, the test of efficacy can only be therapeutic efficacy which should be judged strictly and narrowly (Para. 180);
- The applicant has to specifically claim and establish by research data correlating bioavailability to enhanced therapeutic efficacy (Para. 189); and
- For patents involving new forms of known substances in chemicals and pharmaceuticals, the test of enhanced efficacy should be proved in addition to the fact that the patent application is an “invention” and involves an “inventive step”(Para. 192).
Compliance with the above standards would require:
(a) Demonstration on the part of the applicant to include efficacy data either in the specification/affidavit;
(b) Determination and recording the reasons in a written order by the Controller.
These principles remain a gold standard in overcoming objections under section 3(d). The IPO should mandatorily follow these standards while granting pharmaceutical patents. However, on close analysis of the prosecution history of the 50 cases, the report found that none of these cases met the standards set out in the Novartis decision.
In the 50 cases involving detailed scrutiny, applicants could have demonstrated improved therapeutic efficacy and synergism to overcome the safeguards set to patentability under sections 3(d) and 3(e), respectively. But none of the 50 cases studied in the report complied with the high standards set earlier by the IPO, but still managed to bypass these safeguards and got granted.
The report observed that applicants often bypassed stringent requirements under Section 3(d) by disguising secondary patents as formulations and/or combinations. This helped to steer the argument away from a Section 3(d) citation and towards Section 3(e), since demonstrating synergy under Section 3(e) is relatively an easier exercise compared to the requirements of efficacy data under Section 3(d).
No applicant made relevant submissions of clinical data to demonstrate therapeutic efficacy, as stipulated by the Supreme Court’s decision in 2013 relating to Novartis’secondary patent on Imatinib Mesylate.
Error Rate at the IPO. Inconsistencies in practice exist at the IPO, even while dealing with different secondary patents for the same drug. The study demonstrated several instances where the IPO granted some secondary patents for a drug while rejecting others. Differing standards may impact the access to medicines for a variety of diseases.
Seven out of 10 patents granted by the IPO are likely granted in error. Therefore, the study shows extremely high error rate (high as 72 percent of secondary patents).
Since no secondary patent made an appropriate and valid submission, all of them contravene anti- evergreening provisions under Indian patent law.
The report also identified seven individual drugs which show differing standards in examining similar patent applications were both rejected and granted by the IPO. The report showed that there were 41 secondary patent applications associated with these seven drugs of which 30 were granted and 11 were rejected by the IPO. The report highlights the concern of the differing standards in examining patent applications pertaining to similar drug filed by the same applicant, as the grant of even a single patent on these applications can lead to evergreen practices, impacting equitable access to medicines.
The report makes the following recommendations:
- To identify secondary patents at the application stage and ensure that suspect patents are not granted. It recommends updating of guidelines for examining pharmaceutical patents and it should lay down the standards explained by the Supreme Court in Novartis case (referred as ‘Novartis Standard’ in the report). The Novartis Standard must be included as a part of the guidelines in examining pharmaceutical applications and the IPO should strictly adhere to it while deciding an objection under Section 3(d).
- Implementing anti-evergreening checklist for examiners which ought to be included along with the First Examination Report (FER) when the patent application falls within any one of the IPC codes allocated to pharmaceutical inventions i.e., A61K, A61P, C07C, and
- Finally, it proposes amendments in Indian Patent Law to remove conditions for certain exclusions under Section 3(d) and Section 3(e) to include all kinds of secondary patents, so that there will be a complete bar on secondary patents. As the study rightly identifies that in most cases, secondary patents escape the stringent provisions on evergreening resulting in the grant of bad patents. Therefore impending public policy objectives of anti-evergreening provisions and restricting access to medicines.
The secondary patents (72 percent of 2,293 patents granted between 2009 and 2016) including the list of wrongfully granted 50 patents, pointed out in the study, apparently failed to meet the Novartis standard set by the apex court and also successfully bypassed the stringent anti-evergreening provisions of section 3 of the Patents Act, therefore clearly showing the mischief in obtaining it. Since these patents go prima facie against law and policy, they are to be revoked by the government under Section 66 of the Patents Acts. Section 66 states:
“Revocation of patent in public interest: Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.”
This correctional provision has been invoked twice to revoke patents in public interest. The first instance was in the year 1994 and the second one happened way later in 2012.
Revocation of Agracerus’s patent (1994), a U.S. company, for genetically engineered cotton cell lines. The government realized the implications of granting such a patent is prejudicial to farmers’ rights and cotton is an important crop essential to the national economy and should not be the subject matter of patents. The patent was eventually revoked in public interest after it came to notice that this patent should not have been granted under Section 3 of the Patents Act.
Revocation of Avasthagen’s patent (2012), “a synergistic ayurvedic/ functional food bioactive composition” was revoked as the claimed subject matter was already disclosed and known in public domain through the traditional knowledge of India.
On the similar lines, the implications of these wrongful pharma patents will be two-fold; one, these secondary patents goes against the law as they mischievously surpassed the stringent anti-evergreening provisions like Section 3(d) of the Patents Act. Two, the continuation of such patents will set a bad precedent for the future applications following the same mischievous route which can eventually defeat the purpose of Section 3(d) to prevent the evergreening of pharmaceuticals which will have an adverse effect of accessibility to affordable healthcare in India. This threatens affordable healthcare and medicines and also potentially compromise the right to health under Article 21 of the Constitution. Therefore, to deal with the present situation, the government should take suo moto action under Section 66 to revoke pharma patents in conflict with provisions of the Patents Act, especially Section 3 (d). This is required to ensure that the mischievously obtained private interest should not override public interest at large.
Shirin Syed is an IP Researcher at North Maharashtra University (NMU).
[The opinions expressed in this article are the personal opinions of the author. The facts and opinions appearing in the article do not reflect the views of LiveLaw and LiveLaw does not assume any responsibility or liability for the same]