Patent

IPO issues revised draft guidelines for examination of pharmaceutical patents: A perspective


After finalizing guidelines for examining computer related, biotechnological and traditional knowledge patent applications, the Indian patent office released guidelines for examination of pharmaceutical patent applications.

The pharmaceutical sector has always enjoyed an unusual prominence in debates about IP policy, and has always been the subject of national and international controversies.

The original pharma patent examination guidelines (which can be accessed here) was open for public comments. Stakeholders met and discussed the guidelines extensively. Here stakeholders refer to a person interested or concerned in the business and includes a wide variety of groups, like  policy makers,law firms,pharma lobby groups,patent agents,pharmaceutical companies, NGO’s and so forth.

StakeholderMeet_2_01August2014

Stakeholders meet discussing the pharma guidelines

The stakeholder’s comments pointed out several inaccuracies in the original draft, which led the Indian patent office to issue a revised set of guidelines. While the traditional knowledge patent examination guidelines sparked a heated debate too, there were no revisions made.

This post aims to compare the original and revised draft pharma patent examination guidelines and also outline the salient features.

INN name:

The original draft guidelines require that the applicant is required to provide information on INN name of the drug. An INN is the generic name of a pharmaceutical drug assigned to it by the WHO. In the patent specification a product patent claims a drug by its chemical (IUPAC)  name or Markush structure. For example for Glivec( brand name of anticancer drug)  the IUPAC name is 4-[(4-methylpiperazin-1-yl)methyl]-N-(4-methyl-3-{[4-(pyridin-3-yl)pyrimidin-2-yl]amino}phenyl)benzamide and generic name is imatinib.If the INN name is mentioned in the patent specification then non-specialists can easily identify and  file oppositions against patents. We have discussed the INN proposal in detail over here.

It’s expensive to apply for an INN name and also a markush structure may encompass several compounds so it is difficult to disclose all the INN’s. INN’s may not available at the time of patent applications and may be issued after the patent has been examined and granted. Also a proposal like this in the guidelines is beyond the mandate of the law (S.159).

The stakeholder’s strongly objected to the proposal and now the revised guidelines do not mandate or require the applicant to disclose the INN name.

Novelty:

The original guidelines state that the claimed subject matter lacks novelty if the prior art document implicitly discloses or inherently anticipates the subject matter of the invention.

The stakeholders contended that the concepts of implicit disclosure and inherent anticipation come under the purview of doctrine of obviousness and do not concern novelty. The revised guidelines remain unchanged in this regard and list implicit disclosure and inherent anticipation under novelty.

I think that the concepts of implicit disclosure and inherent anticipation come under the ambit of doctrine of novelty. This is especially true in case of inventions claiming ranges, parameters. Specific disclosure can destroy novelty of generic disclosure (the disclosure of chloride salts can anticipate halide salts). However while referring to implicit disclosure and inherent anticipation it is important to specify that the disclosure should be derivable directly and unambiguously from the document to avoid inconsistencies in novelty assessment.

Inventive step:

For inventive step, the original guidelines in illustrative examples refer PEGylated interferon (Pegasys) which was invalidated by the IPAB for obviousness. We had discussed the case here.

The stakeholders strongly objected to the example in the guidelines and stated that the Pegasys IPAB order had been stayed and should not be referred to while evaluating inventive step.

There is no reference to the Pegasys case in the revised guidelines.

Industrial applicability/Utility

The original guidelines state that the patent specification must disclose a practical application and industrial use for the claimed invention wherein a concrete benefit must be derivable directly from the description coupled with common general knowledge. Mere speculative use or vague and speculative indication of possible objective will not suffice.

The stakeholders objected to the original guidelines and stated that the Illustrative examples are not clear, no case law provided to adjudge whether the use is “merely speculative” and the Act only requires to have an “industrial application” and doesn’t any require commercial viability.

Enablement/Insufficiency of disclosure

The original draft guidelines stipulate that complete specification should disclose and test every possible embodiment claimed in the markush structure.

The stakeholders argued that a test for every possible embodiment of the claimed Markush was beyond the mandate of the patent act.Thankfully the revised guidelines only representative compounds mentioned in the embodiments need to be tested.

Patentability issues: Section 3(p)

For issues related to patentability of traditional knowledge the guidelines link to traditional knowledge guidelines which were published by the patent office previously. In our previous posts we had critiqued the guidelines and had mentioned that the guidelines go beyond the scope of the law. However amendments to the Traditional Knowledge guidelines weren’t introduced.

Conclusion

Various media outlets inaccurately referred to the pharma patent examination guidelines as revision or amendments in patent law. The scope of the guidelines as presented in page 5 clearly states that “The present guidelines are prepared with the objective that the Guidelines will help the Examiners and the Controllers of the Patent Office in achieving consistently uniform standards of patent examination and grant. The guidelines set out below contain, where feasible, certain illustrations. These illustrations are not intended to exhaust the manner in which the relevant guidelines are to be applied in practice. Examiners are requested to examine applications on a case-to-case basis, without being prejudiced by the specific illustrations being provided herein. In case of any conflict between these Guidelines and the Patents Act, 1970 and the Rules made thereunder, the provisions of the Act and Rules will prevail.

Over to you readers! Readers please do chime in with your comments and thoughts on the revised guidelines. September 2,2014 is the last date for sending in comments and suggestions on the revised guidelines to the patent office .

Madhulika Vishwanathan

Madhulika Vishwanathan

Madhulika is a registered Indian patent agent and has completed her Master’s in Pharmacology from the Institute of Chemical Technology (ICT), Mumbai. Her interests include issues involving pharmaceutical and biotechnology patent law, regulatory aspects like Hatch Waxman litigation and antitrust law.She is currently working at law firm based out of Memphis, TN.

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