IPOPHL Issues Biotechnological Patent Application Examination Guidelines
Ma. Sophia Editha C. Cruz-Abrenica, Villaraza and Angangco Law Firm (Philippines)
On October 2022, the IPOPHL issued Guidelines on the Examination of Biotechnological Applications (“Guidelines”). The Guidelines cover inventions pertaining to Microorganisms, Nucleic Acid and Polypeptides, Antibodies, Stem Cells and Plants and Animals. For patentability of biological materials, it is important that human intervention was an indispensable aspect, and not merely an aid to isolation of the biological material or the performance of a biological process.[i] Salient aspects of the Guidelines are as follows:
A. Patentability of Microorganisms. Mere discovery of a microorganism occurring freely in nature is not patentable.[ii] Isolation of a microorganism from its natural environment, or use of a microbiological process may be the subject of an invention even if the said microorganism is naturally-occurring. As such, the specifications should indicate the technical features characterizing the said organism.[iii] A microorganism in technically-isolated form will be considered as novel over a previously-known mixture of said microorganism with other microorganisms.[iv] If a microorganism possesses characteristics substantially different from the known species and which have advantageous effects, the requirement for inventive step is satisfied.[v]
B. Patentability of Nucleic Acids and Peptides. Nucleic acids and genes, or polypeptides and proteins that have been isolated from their natural environment may be eligible for patent protection.[vi] A complementary DNA (cDNA) which comprises introns but lacks introns may be patentable.[vii]
- Nucleid Acid Sequences. Nucleic acid sequences per se that replicate the genetic information in the genome of humans or other organisms are ineligible for patenting.[viii] Mere isolation and identification of a gene or DNA in a form that occurs naturally is also ineligible for patent protection.[ix] However, genetic material isolated with human intervention, has industrial effectivity and with technical effect may be patented.[x]
- Vectors. A vector that comprises a novel gene and its promoter/regulatory region or other vector component, such as the origin of replication or a restriction enzyme site, which has never been described in any prior art, satisfies the novelty requirement.[xi] A claim to a vector may be considered as inventive if any of the elements, as enumerated in the Guidelines, is not found in prior art.[xii] Unexpected results involving the use of the said vector may further support inventive step.[xiii]
- Polypeptides/Proteins vis-à-vis Nucleotides/Genes. If a claim to a polypeptide is considered as novel and inventive, the claim to the corresponding gene encoding said polypeptide may be considered as inventive as well.[xiv] However, if the polypeptide is not novel, the corresponding gene is no longer eligible for patent protection.[xv]
- If a claim pertains to a gene having a definite nucleotide sequence which exhibit advantageous effects in comparison with other genes encoding a protein, and the nucleotide sequence cannot be predicted by a person skilled in the art, said invention may be considered as having an inventive step.[xvi]
- Probes. Probes defined by nucleotide sequences and exhibit surprising advantageous effects may be considered as inventive.[xvii] The DNA sequence against which it serves as a probe must be properly disclosed with respect to function and biological activity.[xviii] Note that if the gene for which a probe is used for detection is not considered as inventive, the probe itself will also generally not be considered as inventive.[xix]
C. Patentability of Antibodies. Antibodies removed or isolated through technical means from the natural biological environment are eligible for patent, since they do not naturally occur in isolated form in nature.[xx] Antibodies are usually described in terms of the antigen to which they bind.[xxi] If the antigen is novel, then the antibody is usually considered to be novel as well.[xxii] If prior art discloses antibodies that bind with a close structural relative of the new antigen, then a claim to an antibody reactive with such new antigen will no longer be patentable for being anticipated.[xxiii] For a new antibody corresponding to a known antigen to be considered as novel, it should be defined by other structural and functional features that give a particular advantageous technical effect when compared to prior art.[xxiv]
D. Patentability of Stem Cells. The Guidelines discuss what stem cells are eligible for patenting and which are not patentable. The Guidelines indicate that the primary consideration for evaluation of eligibility for patenting of stem cells is their source and how they were obtained, taking into account whether use of embryo as base material involves destruction of the same.[xxv] Direct destruction includes isolation of said embryo such that it will no longer develop into a viable organism.[xxvi] In such a case, patentability of stem cells, products and methods of obtaining them may be questioned based on Section 22.6 of the Intellectual Property Code of the Philippines which excludes matter contrary to public order and morality.[xxvii]
The Guidelines enumerate the embryonic stem cells excluded from patentability.[xxviii] Totipotent stem cells, defined under the Guidelines as “[c]ells that have the capacity to self-renew by dividing and to develop into the three primary germ cell layers of the early embryo and into extra-embryonic tissues such as the placenta”[xxix], are excluded from patent protection.[xxx]
E. Patentability of Plants and Animals. Inventions that are not confined to a single animal breed or plant variety are considered as patentable.[xxxi] Otherwise, protection other than those in the IP Code of the Philippines may apply.[xxxii] Plant varieties may be protected under Republic Act No. 9168, the Philippine Plant Variety Protection Act.[xxxiii] If a specific animal breed is not identified in the claim, it is not considered as being directed to such breed and hence, since it does not pertain to a single animal breed, it may still be patentable.[xxxiv]
Biological processes for the production of plants and animals are not patentable and the products of said biological processes are not patentable.[xxxv] Additional technical steps, performed before or after crossing and selection, which merely assist or enable crossing and selection, are also not patentable.[xxxvi] However, if the processes contain an additional technical step that by itself introduces or modifies a genomic trait of the plant or animal and which is not the result of mixing of genes or gametes, then said process may be patented.[xxxvii] If human technical intervention plays a significant role in determining or controlling the desired result, a process for the production of plants that is not based on the sexual crossing of whole genomes or through asexual propagation of plants may be considered as patentable.[xxxviii] However, if a known method for gene modification is used on a plant or animal and said gene has been previously disclosed, the resulting plant or animal is not patentable.[xxxix]
Illustrative Examples and Analyses, Supplementary Discussions and Annexes. The Guidelines are replete with Illustrative Examples and Analysis, and further contain supplementary discussions touching on Unity of Inventions[xl], Sequence Claims[xli], Animal Suffering[xlii] and Organs and Tissues[xliii]. Annexes on Claim Construction[xliv], The Budapest Treaty[xlv], Suggested Readings[xlvi] and References[xlvii] were also provided in the Biotech Guidelines.
[i] Guidelines, p. 24.
[ii] Guidelines, p. 25.
[iv] Guidelines, p. 26.
[vi] Guidelines, p. 36.
[vii] Guidelines, p. 36-37.
[viii] Guidelines, p. 40.
[xi] Guidelines, p. 42.
[xii] Guidelines, p. 46-47.
[xiii] Guidelines, p. 47.
[xiv] Guidelines, p. 42.
[xvii] Guidelines, p. 47.
[xx] Guidelines, p. 53.
[xxiv] Guidelines, p. 55.
[xxv] Guidelines, p. 66.
[xxix] Guidelines, p. 17.
[xxx] Guidelines, p. 67.
[xxxi] Guidelines, p. 79.
[xxxiv] Guidelines, p. 80.
[xxxv] Guidelines, p. 82.
[xxxvi] Guidelines, p. 83.
[xxxvii] Guidelines, p. 84.
[xxxviii] Guidelines, p. 85.
[xxxix] Guidelines, p. 86.
[xl] Guidelines, p. 92-99.
[xli] Guidelines, p. 99-100.
[xlii] Guidelines, p. 100.
[xliv] Guidelines, p. 102-104.
[xlv] Guidelines, p. 105-106.
[xlvi] Guidelines, p. 107-111.
[xlvii] Guidelines, p. 112-118.