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Brain League IP Counsels

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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 beenpreviously 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 bedisclosed in concrete terms, it is

suggested that such a library not be

considered to destroy novelty.

Page 9 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 itsantiviral activity than its prior

art analogue.

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 consideredto as unexpected property. It is

suggested that illustrations to

provide clarity on the admissible

limits of unexpected property be

provided.

Page 11 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 formodifying 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.

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. Byincluding 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 exploitationand 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.

Page 12 Illustrative

Example:

Analysis: The subject-matter

falls within the scope of Section

3 (b) of the Act, as being

directed to a method in whichhuman embryonic stem cells

This analysis provided in this example

directly concludes that a method

using human embryonic stem cells is

against morality without providingappropriate reasoning. Detailed

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Brain League IP Counsels

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are commercially exploited for

determining the embryotoxicity

of the compound, which is

against morality. Hence, it is not

patentable.

reasoning and analysis on such

conclusion would be helpful.

Page 13 Section 12: The inventions relating to three-dimensional 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.

Explanation on why the office hasconcluded 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 instanceswould be helpful. Also, most of the examples illustrate situations wherein the claims are non-

patentable. 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.