The recent Federal Court of Australia decision of Boehringer Ingelheim Animal Health USA Inc v Zoetis Services LLC1 has (on one aspect) highlighted the ongoing attention given by the Federal Court of Australia upon the construction of the word “comprising” in the main claims of patents.
The Court’s construction of the word “comprising” in the main claim is critical to determine the scope of a claimed invention. Such construction would then have the consequence of determining whether the construed claims have “sufficiency” (under sub-section 40(2)(a) Patents Act 1990 (Cth)) and “support” (under sub-section 40(3)) Patents Act 1990 (Cth).2
The case was an appeal against the opposition to the grant of three (3) patent applications by Zoetis Services LLC which were essentially directed to immunogenic compositions for veterinary use. Our comments are limited to the 535 Patent Application (AU 2013243535) only.
Claim 1 of the 535 Patent Application was construed by the Court and which recites the invention as follows:
An immunogenic composition comprising the supernatant of a Mycoplasma hyopneumoniae (M. hyo) culture, wherein the supernatant of the M. hyo culture has been separated from insoluble cellular material by centrifugation, filtration, or precipitation and is substantially free of both (i) IgG and (ii) immunocomplexes comprised of antigen bound to immunoglobulin.
The Federal Court of Australia reviewed the Australian legal authorities to hold that a definition of “comprise” in a patent specification cannot give the word “comprise” and its variants (and therefore “comprising”) an “unbridled operation” to contort a claimed invention into a substantially different invention to that described in the specification.3 Whether a definition of “comprise”’ may need to yield to the context of the description of the invention in the specification will be specific to the particular specification in each case.4
The Court construed that claim 1 of the 535 Patent Application is not limited to one M. hyo protein antigen, but it is limited to M. hyo antigens, found in the M. hyo supernatant.5 The scope of claim 1 of the 535 Patent Application did not include the universe of antigens not mentioned in the specification.6
The Court further held that the use of the term “comprising” does not extend the scope of claim 1 to include antigens directed to other diseases not limited to those listed in claim 3 nor to a universe of antigens beyond those.7 The Court held that a “common sense result” is a construction that the invention is limited by what is listed in the specification and not the universe of other possible antigens that could be included with the M. hyo composition.8
Further, the inclusive definition of “comprising” ensures that the immunological composition of claim 1, is not limited to only the essential integers listed in claim 1, but also includes non-essential elements which the skilled person would understand to be required for an immunological composition, such as adjuvants and excipients.9
The Court then turned to claim 3 and construed that the scope of claim 3 included the M. hyo antigens found in the M. hyo supernatant of claim 1 plus “at least one additional antigen” selected from a list of additional antigens expressed in claim 3, which is protective against microorganisms other than M. hyo, such as viruses and Brachyspira.10
Having regard to the claim scope then construed, the Court held that whilst claim 1 was enabled under sub-section 40(2)(a)11 and supported under sub-section 40(3),12 claim 3 was not supported by matter in the specification under subsection 40(3) as there was no technical contribution to the art in the specification to make the immunogenic composition consisting of the M. hyo platform and antigens other than M. hyo listed in claim 3.13
Further, the Court held that it would not be plausible to work the invention across the full scope of claim 3 on the basis of the disclosure in the specification without undue burden. A research project would be required. Claim 3 therefore lacked enablement under sub-section 40(2)(a).14
Conclusion
If a patentee wishes to claim a plurality of antigens in an immunogenic composition for veterinary use that are not expressly listed in claim 1, such antigens would need to be claimed in the dependant claims and further exhaustively listed or clearly disclosed in the specification. Any use of the term “comprising” in claim 1, requires an inclusive definition in the description, as well as a clear technical contribution to the art of those claimed antigens listed in the description to satisfy support under sub-section 40(3). The claimed antigens would also need to be clearly disclosed in the description across the full scope of the claim, in order for the claim to be enabled under sub-section 40(2)(a).