Summary
In a recent Patent Office opposition decision, Merial Limited v Zoetis Services LLC [2016] APO 12 (“Merial v Zoetis), which issued on 7 March 2016, the delegate held that the applicant was allowed to remove a factually incorrect statement and thereby address a manner of manufacture (“obvious on the face of the specification”) ground of opposition. Although the opposition ultimately succeeded due to a lack of inventive step, it is worth noting that, if an admission in the specification can be shown to be in error, and the admission was not the sole factor the opponent relied on in deciding whether to oppose grant of the patent, the applicant can amend the specification and not be bound by earlier versions.
Background
The decision relates to Merial’s opposition to the grant of Zoetis’ Australian patent application no. 2007343130 entitled “Methods of vaccine administration”. The grounds of opposition raised by Merial were manner of manufacture, novelty and inventive step.
Manner of Manufacture
To meet the requirements of section 18(1)(a) of the Patents Act 1990 (Cth) an invention, so far as claimed in any claim must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. The threshold requirement for a patentable invention is that it must not be apparent (obvious) on the face of the specification that the claimed subject matter lacks the necessary quality of inventiveness for it to be a proper subject of letters patent under the Statute of Monopolies (NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 at [9]).
In the present case, Merial’s assertion that the claimed methods of vaccine administration were “obvious on the face of the specification” was based on a statement at page 12, paragraph 57 of the specification as originally filed, and in the accepted specification, that relevant vaccines, such as Pfizer’s VANGUARD® Plus 5 L4 vaccine, which was known and commercially available before the priority date, could be “orally administered”. Specifically, paragraph 57 read:
“The subjects suitable for vaccination would include dogs that are about four weeks of age or older. Thus, the first dose would be given to a dog at about four weeks of age, followed by subsequent doses according to the timetable given herein. Certain commercially prepared vaccines provide directions for the timing of administration and number of doses based on the potential for maternal antibody interference. For example, the product label for VANGUARD® Plus 5 L4 (Pfizer Inc) indicates that dogs receiving the first vaccine at less than 9 weeks of age should be administered a third orally administered one-ml dose at about three weeks after a second dose.”
Hence, prima facie, the statement that Pfizer’s product label indicated that a dose should be orally administered renders the oral administration of this vaccine obvious on the face of the specification.
In response, Zoetis submitted that, since the specification has been amended to remove the words “orally administered”, the manner of manufacture ground of objection is unsustainable. The delegate was (at least initially) not convinced as earlier versions of the specification containing the admission are on the public record, including the PCT specification, the accepted specification and the priority document.
Given that there is little judicial authority in Australia on this point, the delegate sought guidance from an earlier UK Court of Appeal decision, Gerber Garment Technology Inc v Lectra Systems Ltd [1995] FSR 492 at 494-5 (“Gerber”), in which the Court found that:
“… a recital [of the prior art] constituted an admission which must necessarily carry great weight, but that it did not estop the patentee or debar him from leading evidence to contradict it. … It would be contrary to all principles to hold a party to be estopped as against another party by an erroneous statement on which the other party has not relied.”
Following an analysis of the present case in light of Gerber, the delegate held that, seeing as the admission regarding oral administration of the vaccine at paragraph 57 was not the sole factor Merial relied on in deciding whether to oppose grant of the patent, Zoetis should not be stopped from disputing whether the reference to oral administration at paragraph 57 is factually correct.
Zoetis was able to provide evidence in support of that, before the priority date, the VANGUARD® Plus 5 L4 product label did not indicate that it should be “administered orally”, and Merial was unable to refute Zoetis’ evidence that the statement at paragraph 57 is factually incorrect.
Delegate’s Decision
In the end, the delegate ruled in favour of Zoetis and concluded that the single reference to orally administering the VANGUARD® Plus 5 L4 vaccine at paragraph 57 is factually incorrect and does not form part of the disclosure. Thus, the specification does not admit on its face that the claimed methods of vaccine administration were previously known and the manner of manufacture ground of opposition fails.