Revised Draft Guidelines for Examination of Pharma Patent Applications

We have earlier reported the release of Draft Guidelines for Examination of Pharma Patent Applications. The Patent office has now released revised draft guidelines and in continuation of our earlier article here, we explain herein what those revisions are and impact of the guidelines in general. The revised guidelines are available here.

The revised guidelines of 12th August 2014 are not much different from the earlier guidelines of 28th February 2014 with only some clarity provided at certain places. For example, the scope of the guidelines is clarified by inserting that “Examiners are requested to examine applications on a case-to-case basis, without being prejudiced by the specific illustrations being provided herein.”  Some other clarifications/changes include:

  1. On carrying out a prior art search for pharmaceutical products, if the applicant does not inform the INN even on the request, the examiner should try to find out the INN and use the same in the search strategy.
  2. Further clarity on identification of prior art documents pertaining to Markush formula is provided wherein it is emphasized that “If a markush formula covers innumerable compounds and certain other compounds fall within another prior art, in such cases all these prior art documents are to be cited. A generic disclosure in the prior art may not necessarily take away the novelty of a specific disclosure. A specific disclosure in the prior art takes away the novelty of a generic disclosure”
  3. On the discussion of “skilled person” in section 8.6, the revised guidelines add new IPAB order on Enercon vs alloys Wobbens, ‘We do not intend to visualize a person who has super skills, but we do not think we should make this person skilled in the art to be incapable of carrying out anything but basic instructions”.
  4. On sufficiency of disclosure requirements pertaining to biological materials, the new guidelines add disclosure requirements pertaining to depositing the material to an International Depository Authority (IDA) under the Budapest Treaty.

There are some other minor changes for clarity purposes for example:

  1. Deletion of the following examples: “2) Use of compound A in the process of preparing B. and 3) Use of compound A in the composition of ————– ” from illustrations depicting use claims (non-product and non-process claims)
  2. Deletion of the following one illustration on implicit disclosure: “For example, the invention claims halide salts of a compound whereas the prior art teaches the chloride salts of the same compound but does not explicitly disclose the other halide salts. However, it may be noted that the question of implicit disclosure is often a mixed issue of novelty and inventive step.
  3. Deletion of a following sentence from “8.8 Reasonable expectation of success”:In other words enhanced effects cannot be adduced as evidence of inventive step if they emerge from obvious tests.
  4. Addition of a new illustrative example for section 3(j).
  5. Deletion of one paragraph (para 11.15 in earlier version) on sufficiency of description
  6. Addition of Structures for clarity in the illustrative example for Unity of invention in para 12.13

These guidelines are released with an objective to provide clarity and understanding on various patentability criteria to the Examiners/Controllers so that a uniform standard of examination can be achieved in pharmaceutical inventions. There have been several instances where certain type of claims are allowed by one examiner and rejected by others. For example, even though it is statutorily mentioned that method of treatment claims are not patentable under section 3(i) but still such claims are sometimes filed as use claims for example as “use of compound X in treatment of disease Y…” or compound claims for example as “compound X for use in treatment of disease Y..” which claims have been allowed by some Examiners in the past. These guidelines now clarify that only products or processes will be patentable and no such use claims will be patentable. This strives to provide much needed uniformity in examination standards. Another highlight of the guidelines is that these include recent IPAB and court decisions for providing further clarity. For example, section 3d has been well explained w.r.t Supreme Court’s Novartis decision. Obviousness criteria is well explained giving various illustrations, particularly defining “skilled person”, “reasonable expectation of success” “motivation” w.r.t various IPAB/court decisions. Product by process claims are clearly defined explaining that they are patentable only when the product is novel and non-obvious. Claims containing Markush structures are specifically well-explained w.r.t various patentability criteria. Since all these explanations available in these guidelines on various types of pharmaceutical claims are not explicitly present in the Patent Act, so releasing these guidelines should prove to be a boon to Examiners/Controllers especially in view of inconsistent examination standards seen in the past.

In sum, these guidelines will help Examiners establishing patentability of pharmaceutical inventions with much ease and clarity now avoiding inconsistency in examination standards.

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