The elephant in the Patent Office

The elephant in the Patent Office

Context

Patents for trivial improvements on drugs, though statutorily barred, are routinely granted

What has happened?

India hit the headlines when it incorporated certain anti-evergreening provisions such as Sections 3(d), 3(e) and 3(i) into the Patents Act to restrict patentability of a host of secondary patents — essentially alternative forms of already existing patented drugs aimed at further extending their term of protection

The issue

• Analysis of pharmaceutical patent applications suggests that the IPO is operating at an error rate as high as 72%, which corresponds to all secondary patents granted by the IPO
• Meaning seven out of 10 patents granted by the IPO are likely granted in error.

Combine and confuse

In the last two decades, the IPO has granted 1,654 secondary patents, of which 91% were directed to formulations, compositions and combinations.

• Section 3(d): Covers “combinations and other derivatives of known substance”
• Section 3(e): Covers “substance obtained by a mere admixture resulting only in the aggregation of the properties of the components or a process for producing such substance”
• If objection is raised

Whenever an objection is raised under these sections, the law requires the applicant to submit efficacy data for the former and demonstrate synergism for the later

• The key point here

The applicants bypass the stringent requirements under Section 3(d) by presenting their inventions as a composition or combination of known substances and steering away the objection from Section 3(d) to Section 3(e)

• Why applicants do this?
  • Demonstrating synergy under Section 3(e) is a relatively easier exercise compared to the requirements of efficacy data under Section 3(d), as mandated by the Supreme Court in the Novartis case
  • Section 3(d) is being interpreted narrowly by the courts and the IPO to apply only to a new form of a known substance, and not to combinations and compositions involving known substances.
• Ajanta Pharma Ltd v. Allergan Inc
  • To remove the applicability of Section 3(d) in cases where combinations are involved, patent applicants rely on the decision of the Intellectual Property Appellate Board (IPAB) in Ajanta Pharma Ltd v. Allergan Inc , which also finds mention in the 2014 IPO guidelines for examination of pharmaceutical patent applications
  • A mere passing observation made by the IPAB cannot be considered as a binding authority as such a narrow interpretation of Section 3(d) would defeat the objective of the section.
• What is needed?

Keeping in mind the widespread practice in the pharmaceutical industry of creating new compositions/combinations, it should be given an expansive meaning to cover combinations with other substances.

Method of treatment

A category that is statutorily barred

• Section 3(i) of the Act categorically excludes methods of treatments from the purview of patent protection
• However, though statutorily barred, such patents were granted by clever drafting and legal argument e.g. by merely removing the words “method of treating”

Call for action

• Recommended a standardised mechanism for examination of patent application
• As the grant of patents create property-like rights in intangibles, the IPO should steer its focus towards grant of quality patents than on the quantity.