India: Non-Obviousness/Inventive-Step –The Essential Requirement For Biotechnology Patent Prosecution

INTRODUCTION:

Patent protection plays a crucial role on which the biotechnology industry's tremendous investment in research and development as well as its growth rests. The biotechnological inventions majorly includes products and/or processes of gene engineering technologies, methods of isolation of micro-organisms from culture medium, methods of mutation, cultures, mutants, transformants, plasmids, processes for making monoclonal antibodies, etc.,1 Often, the focus is laid on controversial issues surrounding biotechnology patenting such as criteria for patenting plants and animals, the patenting of gene sequences and related morality issues. Contrary to the aforesaid issues, majority of biotechnology patent applications will be decided on serious issues of patent system such as novelty, inventive step and industrial application as well as the sufficiency of disclosure and support of the description to the claims.

Obviousness, or lack of inventive development, is a ground for rejecting a claim during patent prosecution or for invalidating the claim in patent infringement litigation. An invention is unpatentable because the differences between the claim and the prior art should have been obvious at the time of invention to a person of ordinary skill in the realm of that art.

PROVISION OF INDIAN PATENTS ACT 1970

Section 2(1)(ja) : "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.

Inventive step is defined as the step that makes an invention new and unique. However, there is always a never-ending debate on what exactly comprises an inventive step.

Consider the case of an isolated purified form of a protein which is not obvious if it is otherwise identical to the naturally occurring protein that is already known. The courts resorted to the traditional approach of comparing what is claimed with the prior art. In another example, if a protein is already known, but what is claimed in an invention is a gene and the gene has been isolated and purified. Such a gene clears novelty but it is difficult to assess the obviousness/inventivestep owing to the fact that a particular gene having a particular nucleotide sequence exists in principle but whether it would be obvious to one skilled in the art to identify and isolate the aforesaid gene is another hurdle.

It was held in In re Bell case that "it may be true that knowing the structure of the protein, one can use the genetic code to hypothesize possible structures for the corresponding gene and that one has the potential for obtaining that gene"2, nevertheless the degeneracy of the genetic code is such that there are more than 1036 different possible nucleotide sequences in a gene that might code for a protein. Therefore, unless there is something in prior art that would suggest a researcher a particular gene in question, isolation and purification of nucleotide sequences are not obvious and may be patented as opposed to the mere hypothesis of existence of numerous nucleotide sequences that might possible encode the particular protein. Though the process for looking for the right nucleotide sequence might be known, it is not obvious to choose the right sequence from the entire human genome.

The draft guidelines issued by the Indian Patent Office, mandates to the examiner to design a comprehensive search strategy by combining various search parameters including key words, IPC, sequences etc and thorough search should be carried out in patent as well as non patent literature. The following are some of the illustrative examples mentioned in the aforesaid guidelines for assessing non-obviousness/inventive criteria of biotechnology based inventions.

PRIOR ART SEARCH FOR ESTABLISHING NON-OBVIOUSNESS OF BIOTECHNOLOGICAL INVENTIONS

It is noteworthy to analyze few examples in order to establish non-obviousness of biotechnological inventions through prior art.

Let us consider the claim of an invention as follows as an example:

"An isolated DNA sequence encoding a mature human IL-3 protein having a proline residue at position 8 of the mature polypeptide, said protein processing bone proliferation-inducing activity in a human bone marrow proliferation assay. It was mentioned that the difference with prior art is that the claimed compound at position 8, there was a proline moiety whereas in the prior art compound in the same position there was a serine molecule. When analyzed by the Controller it was found that the single variation in the amino acid sequence does not normally change the activity and function of the protein unless such change is in a critical region of the protein. Since the Applicant could not provide any evidence that the protein coded by the claimed DNA was different from that of the prior art in its chemical properties inventive step was not acknowledged.

OBVIOUSNESS/INVENTIVE-STEP IN VIEW OF SINGLE PRIOR ART OR COMBINATION OF RELEVANT PRIOR ART DOCUMENTS

Let us consider the claim of an invention as follows as an example,

"An improved process for the production of galactooligosaccharides (GOS) of high yield and purity comprising the steps of: (i) isolating Bullera singularis and Saccharomyces sp. (ii) immobilizing the B. Singularis and Saccharomyces sp; (iii) hydrolysis of lactose by the immobilized microbial cells, said reaction being carried out until galactose content being at least 65 % and (iv) optionally concentrating the galactooligosaccharides solution. "

The prior art document D1 disclosed a process for the production of galactic-oligosaccharides from lactose using immobilized B.Singularis cells. D2 disclosed the use of Saccharomyces sp. for the production of galactooligosaccharides from lactose. It further disclosed that Saccharomyces sp. uses lactose as a carbon source & approximately it removes 92% of glucose from the GOS mixture by fermentation without losing the GOS content. It was analyzed by the Controller that since it is evident from D2 that Saccharomyces sp. consume glucose, one of ordinary person skilled in the art would be motivated to use Saccharomyces sp. in combination with B. singularis to solve the problem of separation of saccharides and also, reducing the competitive inhibition of beta-galactosidase enzyme by glucose, which leading to high yield & purity of GOS. Thus, the claimed subject-matter lacks inventive step.

MUTATIONS IN POLYNUCLEOTIDE/ POLYPEPTIDE CHAIN

It was mentioned in the guidelines that if the claimed invention relates to a polynucleotide/polypeptide having mutation(s) in a known sequence of polynucleotide/ polypeptide, which does not result in an unexpected property whatsoever, then the claimed subject-matter lacks inventive step.

In another invention it was claimed for "Pro-insulin having a C-peptide encompassing only two amino acids selected from Arg-Lys, Lys-Lys and Lys-Arg*". It is known that Human Pro-insulin is comprised of three chains, A, B and C, in the insulin the two chains are combined eliminating the third chain, i.e. the C–chain consisting of thirty amino acids). Further the Prior art discloses natural Pro-insulin having 30 amino acids C-peptide, Pro-insulin with C-peptide as short as two amino acids (Arg-Arg)

It was held by the Controller that the claim was prima facie obvious. Though the applicant argued that the yield of claimed Pro-insulin having a C-peptide expressed in yeast is 1.6 to 2.0 mmol/l whereas the yield of the prior art Pro-insulin with a C-chain of Arg- Arg is only 1.0 mmol/l such a difference in change did not constitute 'unexpected property' and hence, the subject-matter was held to be obvious.

In another example of an invention, it was claimed for 'A recombinant DNA sequence of SEQ ID NO: X encoding human interferon α2 polypeptide'. It is known from prior art the existence of a nucleic acid sequence of SEQ ID NO: X1 encoding human interferon α1 polypeptide. After thorough analysis it was held by the controller that although the claimed human interferon α2 is structurally close to the prior art's human interferon α1, the alleged invention was non-obvious as the claimed human interferon is thirty times more potent in its antiviral activity than its prior art analogue.

CONCLUSION

From the above analyzed examples, two things are obvious,

  • that Indian Patent office deals with a great number of patent applications in order to determine whether or not an inventive step exists or not.
  • that there are number of different factors involved in deciding whether or not an invention is obvious.

The amount of clarity we achieve in this issue plays a vital role in determining whether a patent application will proceed to grant or whether a patent application will be rejected or a patent in suit will be declared invalid.

Footnotes

1. Guidelines For Examination of Biotechnology Applications For Patent, Office of The Controller General of Patents, Designs and Trade Marks, March 2013; available from http://www.ipindia.nic.in/whats_new/biotech_Guidelines_25March2013.pdf   ,

2. http://nopr.niscair.res.in/bitstream/123456789/4886/1/JIPR%209%285%29%20471-480.pdf

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