Brain League IP Counsels

Page 5 Section 8.2: A claim to a polynucleotide sequence that was available, e.g. as part of a library before the priority date, lacks novelty, even if the sequence of the polynucleotide has not been previously determined. Such a guideline would contribute to impede sequencing and characterization of specific genes within a library. In this case, since the sequence has not been determined and the invention has not be disclosed in concrete terms, it is suggested that such a library not be considered to destroy novelty. This example illustrates increased potency as the unexpected property of the analogue which contributes to inventive step. However, a property of the compound wherein it behaves differently, and not necessarily efficacious, as compared to its analogue should also be considered to as unexpected property. It is suggested that illustrations to provide clarity on the admissible limits of unexpected property be provided. This section broadly provides the use of human embryo for commercial exploitation as immoral. It does not clearly explain if stem cell based inventions are within the ambit of inventions contrary to mortality. By including such a guideline it is construed that the patent office is intending to restrict the possible, maybe in-vitro, production and destruction of human embryos for which may occur for the generation of stem cells. Such broad generalization might impede research in the field of Stem cell Technology. It is suggested that a clear distinction between human embryo exploitation and stem cell based inventions be drawn. However, if the office intends to label stem cell based inventions as immoral, it is suggested that more explanation on why the office considers stem cell based inventions as immoral be provided. This analysis provided in this example directly concludes that a method using human embryonic stem cells is against morality without providing appropriate reasoning. Detailed Page 1

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Section 9; Illustrative Example 2:

The claimed human interferon 2 is structurally close to the prior arts human interferon 1. However, the alleged invention can be held non-obvious, because of the fact that the claimed human interferon is thirty times more potent in its antiviral activity than its prior art analogue.

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Section 10:

A few non limiting examples may further clarify the issues: (a) a process for cloning human beings or animals; (b) a process for modifying the germ line of human beings; (c) a process for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such process; (d) a process for preparing seeds or other genetic materials comprising elements which might cause adverse environmental impact, like terminator gene technology; (e) uses of human embryos for commercial exploitation.

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Illustrative Example:

Analysis: The subject-matter falls within the scope of Section 3 (b) of the Act, as being directed to a method in which human embryonic stem cells

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Brain League IP Counsels

are commercially exploited for determining the embryotoxicity of the compound, which is against morality. Hence, it is not patentable. The inventions relating to threedimensional or crystal structure of a polypeptide attracts the provision of Section 3 (d) of the Act unless it is proved that such polypeptide differs significantly in the properties with regards to therapeutic efficacy. reasoning and analysis on such conclusion would be helpful.

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Section 12:

Explanation on why the office has concluded efficacy (provided in Section 3(d)) to be synonymous to therapeutic efficacy would be helpful.

Note: It is observed that in many instances the analysis provided in examples is conclusive and do not provide appropriate reasoning on such conclusions. Providing detailed analysis in such instances would be helpful. Also, most of the examples illustrate situations wherein the claims are nonpatentable. Inclusion of more examples demonstrating situations wherein claims are patentable would provide more clarity in assessing patentability. Further, it is noticed that a few cases cited in the guidelines, used for analysis, are in the field of chemistry and not biotechnology. In light of the variations and the level of unpredictability in Biotechnology, i.e. expected considering the age/newness of the field, as compared to Chemistry, it is suggested that such generality between the fields be avoided.

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