The Efficacy Standard - India's New Patentability Criteria

Nigel D’Souza is a JD Candidate at Osgoode Hall Law School.

I have been researching at Human Rights Law Network for over a month now and my findings are quite concerning. In terms of patent law, a skeleton based on international standards is in place but clarity is lacking. As mentioned in my previous post, there were numerous amendments made to the 1970 Patent Act to become compliant with TRIPS and WTO standards. One outcome is the inability to simply reverse engineer drug products and provide generic versions at cheaper prices. Another outcome, as of now, is the higher threshold that needs to be satisfied to achieve patentability. This disallows simple modifications or combinations of existing drugs. However, many NGO’s fear this threshold will not remain stagnant and will likely lower since many pharmaceutical multinationals oppose it. With their resources and legal teams, they will likely explore all options to lower this standard. To understand the “efficacy standard” that was inserted into the reformed Patent Act and its implications, it is vital to decompose s.3(d). Precedents established dealing with this provision will ascertain the patentability threshold for future applications. For the remainder of my tenure at HRLN, case law primarily encompassing s.3(d) will definitely be incorporated into my research.

Patent Act (2005) – The Efficacy Standard

A prime example of this standard being used is in a recent case dealing with the drug Nevirapine, an ARV medication for the treatment of HIV/AIDS. The patent applicant was able to produce the drug in liquid form allowing it to be administered in a pediatric capacity. One would initially assume this could be ideal since many children lack the capacity to swallow pills. However, they were denied patentability and production of this drug since it was not a substantial modification in a therapeutic capacity. This denial was prompted by action undertaken by many NGO’s since they feared the granting of a patent would provide them the opportunity to monopolize this form of medication. This would result in the medication being expensive and limit access to young couples who often have children in need of the medication. This case reflects the need for reform towards patent law to allow accessibility for impoverished groups but also induce further research by providing patent protection.

It is vital to know the exact wording of s.3(d), which states a patent will be denied if there is a “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.” To further elaborate this provision, an explanation is also provided to outline what is not considered a new efficacy. Within the Patent Act of 2005, it states that “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.” (Patent Act 2005) This provision lacks clarity if benchmarked against reputable international patent law.

Pre-Grant Patent Opposition

One of the primary purposes of the booklet I will be composing at HRLN will be to inform lawyers on how to file a pre-grant opposition. As mentioned in my previous post, through attendance at conferences and field research, it was becoming apparent that filing public interest litigation cases is not achieving desired goals. A benefit of the 2005 amendments is the inclusion of s.25 within the Patent Act. This provision allows outside organizations, including NGO’s, the opportunity to file pre-grant oppositions. This gives them the chance to review a patent application before patentability is granted. If they find problems with the application, they are provided the ability to bring it to the attention of the patent office of India. This will likely delay the patent process and may result in the denial of patentability. This is a useful legal avenue to undertake but many lawyers within India are not knowledgeable on how to utilize it. Within my booklet, I will provide background knowledge regarding patent law. Once this foundation is established, it will be easier for lawyers to abide with the necessary steps to file the pre-grant oppositions, which will also be outlined in the booklet.

Pre-Grant Opposition Cases

Through their recent ruling, it was demonstrated that the Madras High Court strongly supports pre-grant opposition procedures undertaken by the patent office. The patent for the drug Valganciclovir was given without due consideration to pre-grant oppositions which was filed by civil society organizations. The high court in Madras ruled that improper consideration given to these oppositions should result in the annulment of the granted patent. To truly obtain patentability, the office must hear the oppositions and then make a ruling whether to grant a patent. The reason why this ruling is significant becomes apparent when prices are investigated. If Roche had attained patentability, they would likely charge $10000US for a four month treatment. On the other hand, MSF approached Roche in 2006 to discuss a price to offer the drug to less developed countries and they agreed to sell the drug for $1900US. There is a substantial price difference between the cost quoted to MSF and the one given for the general public. Reducing the cost of drugs is a factor that should be kept at the forefront (along with effects on the incentives to innovate) during considerations involving life saving drugs.

Novartis Case: One of the First Patent Applications and Refined Efficacy Standard

Once the Patent Act amendments came into force in 2005, the drug Glivec produced by Novartis, was one of the first considered for patentability. The patent application by Novartis was rejected since it was considered a simple modification of an existing drug. This was deemed an important rejection, setting a vital precedent since it was the one of the first drugs considered following the WTO compliant amendments. This prompted Novartis to initiate a legal case where they argue that the 2005 amendments to patent law actually do not comply with TRIPS. They are calling into question the “inventive step” which is required by patent law. This definition was amended and inserted into section 2, provision JA within the Patent Act. The filing of this case sparked numerous protests, outrage and concern. Many NGO’s were concerned of the resulting implications if Novartis were to win the case. Since their patent was the initial rejection within the Patent Office, the outcome of their case within the court system would likely establish a leading precedent. If they had succeeded in court, it would have lowered the patentability threshold in India and possibly allowed simple modifications to existing drugs to achieve patentability. These mild modifications to existing drugs and the ability to attain a patent would disallow established GP’s from producing low cost drugs and decrease access to those who are impoverished. The ramifications would be both domestic and international. Novartis did not not win their case, which resulted in many NGO’s applauding the courts. However, one must remain cognizant that this was a precedent establishing case and the ruling is not law. This results in the allowance of variances from one case to the next. Another important implication is that the case does not eliminate evergreening. If a company were able to provide a combination or modification which maintains a higher level in terms of efficacy, then they could achieve patentability. This reflects the need for government to establish law which is clear and then guided by precedents.

I am looking forward to researching more, conducting interviews and reviewing steps involved in filing a pre-grant opposition. I will keep you all updated.

One Comment
  1. The provision s. 3(d) in the 2005 Act has been taken from a European Directive Article 10(2)(b) of Directive 2004/27/EC

    If the term ‘efficacy’ were to be construed in a liberal manner to include even a general hint of an added advantage in using the new form, it is possible that a good number of formulations would qualify as new substances upon the showing of an increased efficacy.

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