First published as part of Miriam Zanker, Suzy Roessel, Elizabeth Godfrey and Linda Xu, 'Current Developments - Australia: "Comprising": A double-edged sword - Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)  FCA 1477 (14 October 2020) and Not so sweet victory for wicked business: PDP Capital Pty Ltd v Grasshopper Ventures Pty LTd  FCA 1078 (30 July 2020)' (2020) 122 Intellectual Property Forum 91.
In the recent Federal Court of Australia decision in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)  FCA 1477, Justice Burley held that the proposed importation and sale of MSD's 15-valent pneumococcal vaccine would infringe certain claims of three of Wyeth's patents relating to Wyeth's 13-valent pneumococcal vaccine. However, following findings that the asserted claims of one patent were invalid for lack of support under s.40(3) of the post-"Raising the Bar" amendments Patents Act 1990 (Cth) (the "Post-RTB Act"), and the asserted claims of another lacked an inventive step, the infringement action only succeeded in relation to the asserted claims of the remaining patent, which were held to be valid and infringed.
Wyeth LLC ("Wyeth") is the patentee of the following Australian patents:
- Patent No 2006235013 ("013 patent") and Patent No 2013206844 ("844 patent") each entitled "Multivalent pneumococcal polysaccharide-protein conjugate composition" and concerning a 13-valent pneumococcal vaccine (together, the "composition patents"); and
- Patent No 2012216628 ("628 patent") entitled "Novel Formulations which Stabilize and Inhibit Precipitation of Immunogenic Compositions" and concerns a siliconized container means whereby polysaccharide-protein conjugates may be stabilized (referred to as the "container patent").
In August 2017, Merck Sharp & Dohme Corporation ("MSD") commenced proceedings against Wyeth alleging that certain claims of Wyeth's composition patents and container patent were invalid. Wyeth denied the invalidity claims and, in light of MSD's intended launch of a 15-valent pneumococcal vaccine in Australia, alleged infringement of particular claims of each of the patents.
Notably, the law as it stood prior to the "Raising the Bar" ("RTB") amendments to the Patents Act 1990 (Cth) applied to the claims of the 013 patent, whereas the RTB amendments applied to the 844 patent. This distinction led to different findings on MSD's unsuccessful "lack of fair basis" allegation in relation to the asserted 013 patent claims, and its corresponding - and successful - "lack of support" allegation in relation to the asserted 844 patent claims. The "support" requirement replaced "fair basis" for patents subject to the post-RTB Act.
Wyeth's Composition Patents
Construction of "comprising"
The question of whether the asserted claims of each of the composition patents and the container patent would be infringed by MSD's threatened importation and sale of the vaccine turned on the meaning of the word "comprising", which was defined in each of the patents to be understood to "imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps."
In determining whether the sale and importation of MSD's15-valent pneumococcal vaccine would infringe Wyeth's composition patents, the Court had to consider whether, as a matter of construction, MSD's 15-valent pneumococcal vaccine fell within the scope of the composition patents' claims. The primary construction issue presented to the Court was use of the term "comprising" in the claims, in particular where the claim identified 13 nominated serotypes (whereas MSD's alleged infringing product included 13 nominated serotypes plus two more). 1
Justice Burley held "the words "comprising" and "comprises" are clearly defined in the specification in an inclusive sense, or in other words, "including and "includes"." 2 Burley J also turned to the patent specifications to ascertain whether a different interpretation of "comprising" was mandated.
Ultimately, Burley J favoured Wyeth's construction of "comprising" and as a result, held that MSD's proposed importation and sale of its15-valent pneumococcal vaccine into Australia would infringe the asserted claims of the composition patents.3
MSD contended that the asserted claims of each of the composition patents were invalid under a number of grounds including, relevantly, lack of fair basis with respect to the 013 patent, and lack of support with respect to the 844 patent.
The 013 patent: Lack of fair basis
MSD submitted that the disclosure in the 013 specification is of a composition with the 13 specified serotypes and no more, and that there was no real and reasonably clear disclosure of an immunogenic composition with more than 13 serotypes. Wyeth submitted that a composition with more than 13 serotypes can, on a correct construction of the word "comprises", fall within the scope of the claims, but that does not mean that Wyeth claims all of the serotypes in such a composition.
His Honour, in finding that the claims were fairly based, observed that MSD's argument:
distracts from the real inquiry, which is not whether the infringing article is disclosed in the specification . but whether the invention claimed is disclosed.4
The 844 patent: Lack of support
Interestingly, at trial, the lack of support case was confined to brief closing submissions and, following the United Kingdom decision in Regeneron Pharmaceuticals Inc (Respondent) v Kymab Ltd (Applicant)  UKSC 27 ("Regeneron") handed down in June this year, his Honour invited the parties to supply further written submissions concerning the applicability of that decision in Australia.
MSD submitted that to satisfy the support obligation, the scope of the claims "should correspond to the technical contribution to the art" provided in the specification.5
Wyeth argued that MSD's approach would mean that any product claim, particularly one that uses "comprising" or "including", is liable to be revoked for lack of support on the basis that the claimed product could be produced with an additional integer not mentioned in the specification.
His Honour conducted a detailed review of the RTB amendments to the Act and secondary materials to discern the intention of replacing "fair basis" for the "support" obligation for post-RTB patents, finding that the change was intended to align Australian requirements with those of overseas jurisdictions, such as the United Kingdom, and that it was therefore plainly appropriate that Australian courts should take guidance from the law in the European Union and the United Kingdom when considering the scope of the "support" requirement.
His Honour, citing Biogen Inc v Medeva Plc  10 WLUK 486;  RPC 1, 50-1, found that the asserted claims of the 844 patent (claims 1-9, 16-18 and 20-23) were invalid for lack of support. In particular, his Honour stated at :
[Wyeth] has established in its specification that it has hit upon a new product which has a beneficial effect, but it has claimed a monopoly that includes compositions that are not the product of the technical contribution to the art provided by the specification. The inclusively worded claims do not correspond to the technical contribution to the art. The claims cover products that the specification does not enable, and the specification discloses no principle that would enable others to be made.
Composition patents: Conclusion
All of MSD's invalidity allegations with respect to the asserted claims of the 013 patent failed. It follows that his Honour found that the asserted claims of Wyeth's 013 patent were valid and would be infringed by the sale and importation into Australia of MSD's 15-valent pneumococcal vaccine.
The asserted claims of Wyeth's 844 patent were found to be invalid for lack of support and therefore could not be considered to have been infringed by the threatened sale and importation into Australia of MSD's vaccine.
Wyeth's Container Patent
MSD contended that the asserted claims of the container patent were invalid on a range of grounds, including inventive step.
The inventive step challenge to claims 1 and 9, and claim 18 (when considered together with the combination of claim 1 or claim 9) of the container patent succeeded, leading to a finding that the claims of the container patent are invalid. Accordingly, the importation and sale of MSD's 15-valent pneumococcal vaccine would not infringe the asserted claims of the container patent.
This case provides guidance on how Australian courts will apply the post-RTB "support" requirement, and makes clear that the approach taken in the European Union and the United Kingdom is applicable when considering the scope of the requirement. The case also demonstrates that the use of inclusive wording such as "comprising" in a patent claim may, depending on the invention, be fatal for the validity of that claim.
The Court made orders inviting the parties to provide proposed orders setting out the appropriate form of orders to give effect to the decision, with any areas of disagreement marked up. Once the Court has made such orders, the clock will start running with respect to filing any appeal.
1. Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)  FCA 1477 .
2. Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)  FCA 1477 .
3. Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)  FCA 1477 .
4. Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)  FCA 1477 .
5. Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)  FCA 1477 .
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