Starbucks vs. SardarBuksh

PATENTABILITY OF NUCLEIC ACID MOLECULE RELATED INVENTIONS WHOSE

FUNCTIONS ARE INFERRED BASED ON HOMOLOGY SEARCH: PROBLEMS AND

PERSPECTIVES

Patenting of genes often incites a widespread controversy since it seems odd to patent the universal entity like a gene. According to Section 3(c) of the Indian Patents Act, 1970, mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature is not a patentable invention.

Manual of Patent Practice and Procedure briefly talks about gene patents with an example under the head of unity of an invention-

When a genetically modified Gene Sequence/ Amino Acid Sequence is novel, involves an inventive step and has industrial application, the following can be claimed.

a) Gene sequence / Amino Acid sequence

b) A method of expressing above sequence

c) An antibody against that protein / sequence

d) A kit made from the antibody / sequence

Above example gives an indication that a gene is patentable only when it is recombinant and has inventive step and industrial application. However, the meaning of the term ‘genetically modified gene’ has not been elaborated and therefore subject to interpretation. 

Indian Patent Office (IPO) has granted gene patents, details of some of them are given below:

Guidelines for examination of Biotechnology applications for patent state that-

Products such as microorganisms, nucleic acid sequences, proteins, enzymes, compounds, etc., which are directly isolated from nature, are not patentable subject-matter. 

Processes of isolation of above mentioned products can be eligible subject matter contingent to the

requirements of Section 2(1)(j) of the Act.

Having said this, what happens to the previous patents granted that do cover isolated nucleic acid sequences?

Whether Section 3(c) embraces every discovery?

The ambiguous wording of the guideline has an alternative explanation in paragraph 9 of Guidelines for examination of Biotechnology applications (Industrial Application) which states that- 

“In the context of the gene sequences, it may be said that whatever ingenuity is involved in discovering a gene sequence, one cannot have a patent for it or a protein encoded by it unless it is disclosed how it can be used. It is therefore necessary to consider whether the invention claimed has a useful purpose and whether the specification identifies any practical way of using it”.

The requirement of industrial applicability is met as long as the claimed invention can be made in industry without taking into account the use of the invention. However, above elucidation articulates that the “usefulness” of the claimed invention is pertinent for the determination of the industrial applicability. This suggests that it is the industrial application which converts the discovery into an invention. 

In spite of this, there is another ambiguity in the meaning of the function or the utility of a gene or the protein(s) it codes for. Paragraph 9 of the Guideline provides further clarification on this point that –

“The use of claimed subject-matter (e.g. a gene or a protein) disclosed in the specification should not be merely speculative, rather the said use should be specific, substantial and credible for establishing industrial applicability of the claimed subject-matter”.

USPTO clarified what amounts to specific, substantial and credible in Trilateral Project B3b2 as-

{Tilateral Project B3b, “Comparative study on biotechnology patent practices”. Available at:

http://www.trilateral.net/projects/biotechnology/mutual.pdf}

A utility is considered to be specific when it is particular to the subject matter disclosed, in contrast to a general utility that would be applicable to the broad class of the invention.

A utility is considered to be substantial when it defines a "real world" use. However, disclosed utilities that require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use are not substantial utilities.

An assertion of a specific and substantial utility is considered to be credible unless the logic underlying the assertion is seriously flawed (e.g., the assertion is based on theories that are contradictory to well-established principles, such as the first law of thermodynamics or the conservation of momentum), or the facts upon which the assertion is based are inconsistent with the logic underlying the assertion. Credibility as used in this context refers to the reliability of the statement based on the logic and facts that are offered by the applicant to support the assertion of utility. A credible utility is assessed from the standpoint of whether a person of ordinary skill in the art would accept that the recited or disclosed invention is currently available for such use.

What Bioinformatics provides is an idea of the class of protein to which the gene belongs. Its actual use by the organism is still a different matter and its elucidation can involve years of research. In such circumstances, actual technical application is even more remote. It is debatable how much information on the industrial application of an invention is required under the Indian law. 

A recent ruling by the UK Supreme Court [Human Genome Sciences v. Eli Lilly, [2011] UKSC 51, [2012] RPC 6 (UK Supreme Court)] persuasive authority for guidance on how to deal with applications that apparently lack industrial application.

Eli Lilly v. Human Genome Sciences {[2010] EWCA Civ 33 (Court of Appeal)} was the first case to be heard before the UK Courts where a gene, neutrokine-β, had been found by data mining techniques, and a function assigned to it based upon its homology to other members of the TNF ligand superfamily, but without any data obtained from in vivo or in vitro studies. 

In the Patents Court, Kitchin J applied nine principles for industrial application and rejected the patent application on the grounds that it lacked industrial applicability. In contrast, and after detailed consideration of UK case law and European jurisprudence together, the submissions from the BioIndustry Association (“the BIA”) relating to the policy issues surrounding Industrial Applicability in the area of biotechnology, the UK Supreme Court overturned the decision of the Patents Court (previously upheld at appeal), thus coming to the same decision of the European Board of Appeal in T 0018/09. Lord Neuberger summarized his ruling using what he referred to as ‘the essence of the Board’s approach in relation to the requirements of Article 57 in relation to biological material’ in the following points:

(i) The patent must disclose “a practical application” and “some profitable use” for the claimed substance, so that the ensuing monopoly “can be expected [to lead to] some…commercial benefit” (T 0870/04, para 4, T 0898/05, paras 2 and 4);

(ii) A “concrete benefit”, namely the invention’s “use … in industrial practice” must be “derivable directly from the description”, coupled with common general knowledge (T0898/05, para 6, T 0604/04, para 15);

(iii) A merely “speculative” use will not suffice, so “a vague and speculative indication of possible objectives that might or might not be achievable” will not do (T 0870/04, para 21 and T 0898/05, paras 6 and 21);

(iv) The patent and common general knowledge must enable the skilled person “to reproduce” or “exploit” the claimed invention without “undue burden”, or having to carry out “a research programme” (T 0604/04, para 22, T 0898/05, para 6);Where a patent discloses a new protein and its encoding gene;

(v) The patent, when taken with common general knowledge, must demonstrate “a real as opposed to a purely theoretical possibility of exploitation” (T 0604/04, para 15, T0898/05, paras 6, 22 and 31);

(vi) Merely identifying the structure of a protein, without attributing to it a “clear role”, or “suggest[ing]” any “practical use” for it, or suggesting “a vague and speculative indication of possible objectives that might be achieved”, is not enough (T 0870/04, paras 6-7, 11, and 21; T 0898/05, paras 7, 10 and 31);

(vii) The absence of any experimental or wet lab evidence of activity of the claimed protein is not fatal (T 0898/05, paras 21 and 31, T 1452/06, para 5);

(viii) A “plausible” or “reasonably credible” claimed use, or an “educated guess”, can suffice (T 1329/04, paras 6 and 11, T 0640/04, para 6, T 0898/05, paras 8, 21, 27 and 31, T 1452/06, para 6, T 1165/06 para 25);

(ix) Such plausibility can be assisted by being confirmed by “later evidence”, although later evidence on its own will not do (T 1329/04, para 12, T 0898/05, para 24, T 1452/06, para 6, T 1165/06, para 25);

(x) The requirements of a plausible and specific possibility of exploitation can be at the biochemical, the cellular or the biological level (T 0898/05, paras 29-30); Where the protein is said to be a family or superfamily member:

(xi) If all known members have a “role in the proliferation, differentiation and/or activation of immune cells” or “function in controlling physiology, development and differentiation of mammalian cells”, assigning a similar role to the protein may suffice (T 1329/04, para 13, T 0898/05, para 21, T 1165/06, paras 14 and 16, and T 0870/04,para 12);

(xii) So “the problem to be solved” in such a case can be “isolating a further member of the [family]” (T 1329/04, para 4, T 0604/04, para 22, T 1165/06, paras 14 and 16);

(xiii) If the disclosure is “important to the pharmaceutical industry”, the disclosure of the sequences of the protein and its gene may suffice, even though its role has not “been clearly defined” (T 0604/04, para 18);

(xiv) The position may be different if there is evidence, either in the patent or elsewhere, which calls the claimed role or membership of the family into question (T 0898/05 para 24, T 1452/06, para 5);

(xv) The position may also be different if the known members have different activities, although they need not always be “precisely interchangeable in terms of their biological action”, and it may be acceptable if “most” of them have a common role (T 0870/04, para 12, T 0604/04, para 16, T 0898/05, para 27).

Question arises:

If the substance can be properly characterized either by its structure, by the process by which it is obtained or by other parameters and is “new” in the absolute sense of having no previously recognised existence, then whether the substance per se can be considered to be patentable.

Take for an example, A Claim covers a genomic DNA sequence identified by Seq. ID No.1(It is new in the absolute sense and has no previously recognized existence) which encodes a particular protein. Let’s say the claims do not cover any variations of this genomic DNA which restricts the scope of the claim and others are not foreclosed from using the claimed genomic DNA for other purposes.

In view of Section 3(c) of the Indian Patents Act, Guidelines for Examination of Biotechnology Applications for Patent and recent decisions of US Supreme Court including Myriad case {Association for Molecular Pathology v. Myriad Genetics Inc., 106 USPQ2d 1972 (2013)} and Mayo Case {Mayo Collaborative Services v. Prometheus Laboratories, Inc., 101 USPQ2d 1961 (2012)}, genomic DNA amounts to mere discovery.

{P.S. Information is a bit old..forms part of my work. Updates shall follow soon}

--keep striving--

until next time..

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