The Madras High Court in a recent ruling dated March 06, 2024, vindicated an appeal filed by Imclone LLC against the refusal order issued by the Assistant Controller of Patents and Designs in Indian patent application No.5808/CHENP/2007.
Facts
The patent application titled “Receptor Antagonists for Treatment of Metastatic Bone Cancer” was filed by the Appellant in India on December 17, 2007, as a national phase application derived from PCT application No. PCT/US2006/023856. The Application claimed a monoclonal antibody produced by the use of hybridoma technology.
The Patent Office (the Respondent) issued a first examination report (FER) on 10 March 2014, asserting that the claimed invention is non-patentable under Section 3(i), Section 3(c) and Section 3(j) of the Patents Act, 1970.
In the response dated February 13, 2015, the Appellant overcame the objections under Section 3(i), and Section 3(j) by amending the claims but refuted the objection under Section 3 (c) by contending that the claimed antibody was generated by immunising transgenic mice and was not isolated from nature.
Subsequently, a hearing notice was issued by the Respondent on November 20, 2017, maintaining most of the objections of the FER. The Appellant responded by asserting that the amended claims are in respect of a recombinant antibody or antibody fragment specific for Human PDGFR alpha necessarily engineered by Immunisation, Somatic recombination and Selection techniques. The Appellant further asserted that engineered porcine aortic endothelial (PAE) cells expressing human platelet- derived growth factor receptor alpha (PDGFR alpha) and recombinant PDGFR alpha extracellular domain (ECD) that were used as antigens during immunisation of the mice do not normally exist in nature. Furthermore, the Appellant submitted that the claimed antibody also does not freely occur in nature, nor is it isolated from a human being because PDGFR alpha is necessary for embryonic development and, consequently, the natural production of an antibody by the human body to the PGDFR alpha would impede and arrest embryonic development.
Post the conclusion of the hearing, the Respondent issued the impugned order refusing the application under section 3(c) of the Patents Act, on the grounds that the antibody claimed in Claims 1 to 4 (as amended) is the discovery of a naturally existing molecule/substance and, therefore, not patent eligible. The order further cited that the addition of the word ‘Recombinant’ in Appellant’s response is not supported by the specification. The Respondent while issuing the impugned order also relied on the fact that the description of the organism in the sequence listing, submitted by the Appellant, is Homo sapiens.
Court’s Analysis
The Court first determined the issue that pertained to the interpretation of clause (c) of Section 3 of the Patents Act, that reads as follows:
“the 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”.
Comparing the provision of section 3 (c) with its pre-amended text, that reads as, “the mere discovery of a scientific principle or the formulation of an abstract theory”, the Court observed that this provision was originally limited to the mere discovery of scientific principles or the formulation of abstract theories. Further, the Court noticed that the qualifier “mere”, which is an adjective, was added before the noun “discovery” in the first limb to underscore that something more than a discovery of a scientific principle, such as the production of a novel device that operates on such scientific principle, may fall outside the scope of patent exclusion. The Court also noticed that if said qualifier was intended to apply on the third limb i.e; “discovery of any living thing or non-living substance occurring in nature” of the provision, then it was likely that the word “mere” would have found a place before the word “discovery” in the third limb as well, as noticed in clause (d) of Section 3, wherein the qualifier “mere” is used in each limb of the provision. Therefore, the Court deviated from the interpretation laid by Delhi High Court in Diamond Star Global Sdn. Bhd. V. Joint Controller of Patents and Designs, 2023, by observing that the text when interpreted as per the ordinary rules of grammar, the immediate statutory context, and the legislative history of amended clause (c) of section 3 point to the same conclusion that the qualifier “mere” is confined to the nearest reasonable referent “discovery of a scientific principle” and does not extend to “the discovery of any living thing or non-living substance occurring in nature.”
The Court while analysing the amendments to Indian Patent Law said,
“………… The Patents Act was enacted pursuant to a report of the Iyyangar Committee. In the said report, at paragraph 328 thereof, the Committee was of the view that discoveries are universally not patentable. The rationale appears to be that a discovery is a process by which something already in existence is found, whereas an invention is the creation of something that was not in existence previously. Given that the Patents Act was intended to foster inventiveness and not to reward discovery of things that already exist, the basis for the exclusion is clearly discernible.”
While observing the statutory prescription “discovery of any … non-living substance occurring in nature”, the Court pointed out that the noun “discovery” in Section 3 (c) is intended to apply both to living things and non-living substances occurring in nature and said noun implies finding something which already exists and not producing, engineering or making something. Further, emphasizing on the impact of the phrase “occurring in nature” in Section 3 (c), the Court observed that the use of the present continuous form of said phrase indicates that the exclusion will only apply to the process of finding a hitherto undiscovered non-living substance by identifying and isolating it from nature.
The Court while interpreting Section 3 (c) of the Indian Patent Law said,
“………….as noticed earlier, Section 3(c) uses the expression “occurring in nature” to qualify “discovery of a non-living substance.” While it could be argued that this qualifier is only intended to underscore that the exclusion would not apply to a non-living substance that is man-made, in my view, said explanation does not withstand close scrutiny because such non-living substance, if man-made and novel, would not be discovered; it would be created or invented. If man-made but not novel, it would be produced and not discovered. It would also not surmount the Section 2(1)(j) hurdle and the Section 3(c) exclusion is clearly not intended for such non-living substances. What is the sequitur of the use of the expression “occurring in nature”: would a synthetic version of a substance that rarely occurs in nature but is required to be produced in large quantities for the treatment of serious illnesses qualify for or be excluded from patent protection? Should a patent applicant establish that such non-living substance never occurs in nature? The text of clause (c) of Section 3 contains guidance.”
“The statutory prescription is “discovery of any … non-living substance occurring in nature”. Both the use of the noun “discovery”- which implies finding something which already exists and not producing, engineering or making something – and the use of the present continuous form “occurring in nature” indicate that the exclusion will only apply to the process of finding a hitherto undiscovered non-living substance by identifying and isolating it from nature. While reaching this conclusion, I take on board the presumption in statutory construction that redundancy should not be imputed to Parliament, and that the expression “occurring in nature” should not be robbed off of all meaning and purpose. Ultimately, it should not be lost sight of that Section 3(c) is confined to patent exclusions or ineligibility and passing through such filter does not guarantee the grant of patent.”
The Court further observed that the real challenge with regard to a patent application in respect of a synthesized non-living substance, especially a monoclonal antibody, is establishing novelty, technical advancement and not patent eligibility. For such purpose, the Court said that the sequence of the antibody, especially the CDRs, may need to be compared with known antibody sequences to establish that said application does not fall with other exclusions of Section 3 (such as sub-section (d) thereof), and further satisfy the inventive step requirements of Section 2(1)(j) of the Patents Act.
On examining the sequence listing, the Court found that the Respondent’s contention that the organism of origin was listed as Homo sapiens is true with regard to the majority of the 63 SEQ ID’s in the sequence listing, including the SEQ IDs in respect of which claims were made by the Appellant. However, the same was not true with regard to SEQ IDs 17 to 29, specifying that the organism is “unidentified” or “artificial”.
Further, evaluating the disclosures in the complete specification, the Court concluded that the antibody was generated by deleting murine genetic material from mice and replacing the same with human genetic material in the mice and, thereafter, injecting an engineered antigen into the mice. After doing so, material extracted from the spleen of the mice was fused with myeloma cells by the hybridoma process resulting in the claimed antibody. Therefore, the conclusion of the Respondent that the antibodies claimed in the Appellant’s invention occur in nature was strongly refuted on the basis that the antibody was undoubtedly not isolated from a human being, but was engineered by an elaborate process in a manner described in the complete specification. The disclosure in the complete specification is set out below:
“[00153] Isolation of human anti-PDGFR alpha antibodies. Human anti-PDGFR alpha monoclonal antibodies were generated by a standard hybridoma technology (Harlow and Lane, ed., Antibodies: a Laboratory Manual, Cold Spring Harbor, 211-213 (1998), which is incorporated by reference herein) using transgenic mice (Medarex Inc., Sunnyvale, CA) that express human gamma heavy and kappa light immunoglobulin chains. Human PDGFR alpha extracellular domain (ECD) was purchased from R&D Systems (Minneapolis, MN). KM mice were immunised subcutaneously (s.c.) with 3 * 10 porcine aortic endothelial cells stably expressing PDGF are alpha (PAE Ra). After four weeks, mice were boosted s.c. with 50 ug PGDFR alpha ECD in complete Freund’s adjuvant plus 3 * 10 PAE Ra cells given i.p. Mice were boosted two more times, 3 weeks apart, with 25 ug PDGFR alpha ECD in incomplete Freund’s adjuvant.
[00154] splenocytes from mice with high serum binding and blocking titres were isolated and fused with myeloma cells. Hybridoma cultures displaying blocking activity versus a cloned and antibodies from the hybridoma were purified by protein G chromatography.”
Conclusion
The Court cumulatively considering all these facts, circumstances, and the context of Court’s conclusions on the scope and ambit of Section 3(c) of the Patents Act, concluded that the claimed invention is not excluded from patent protection under clause (c) of section 3. Consequently, the impugned order was set aside.
Finally, the Court issued an order with a directive to grant the claimed invention on the basis of the current claims as submitted in the course of the hearing before the Respondent.
The granted claims are set out below:
“We claim:
- The recombinant antibody or antibody fragment specific for human PDGFR alpha comprising CDR H1 of the sequence SSSYY (SEQ ID No.2); CDRH2 of the sequence SFFYTGSTYYNPSLRS (SEQ ID No.4);
CDRH3 of the sequence QSTYYYGSGNYYGWFDR (SEQ ID No.6) in the heavy chain variable region; CDRLR1 of the sequence RASQSSYLA (SEQ ID No.10); CDRL2 of the sequence DASNRAT (SEQ ID No.12); and CDRL3 of the sequence QQRSNWPPA(SEQ ID No. 14) in the light chain variable region.
- The recombinant antibody or antibody fragment of Claim 1, which comprises a heavy chain variable region having SEQ ID No.8 or a light chain variable region having SEQ ID No.16.
- The recombinant antibody or antibody fragment of Claim 1, which comprises a heavy chain variable region having SEQ ID No.8 and a light chain variable region having SEQ ID No.16.
- The antibody or antibody fragment of any one of claims 1 to 3, which inhibits binding of PDGFR alpha to a ligand of PDGFR alpha or which neutralises PDGFR alpha”
Citation: Imclone LLC vs Assistant Controller of Patents and Designs, Madras High Court, 06th March, 2024, (T) CMA (PT) No.126 of 2023 (OA/08/2019/PT/CHN)
Authored by Ms. Rukaya Amin Chowdery, Patent Team, BananaIP Counsels.
Reviewed and confirmed by Ms. Neetha Mohan, Patent Team, BananaIP Counsels.
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