Intellectual Property Law Update - Boehringer Ingelheim Animal Health USA Inc v Elanco New Zealand

Intellectual Property
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Patents – s 104 amendments – allowability of amendment excluding a compound not specifically mentioned in the specification prior to amendment but generally described – whether parties bound by findings made in substantive s 59 opposition

Elanco seeks a patent for a paste to prevent mastitis in animals, the paste comprising an antiseptic formulated in an oil-based physical barrier with certain properties. This case concerns an appeal from a decision of a delegate of the Commissioner of Patents to allow an amendment to claim 1 of that patent to exclude a certain class of antiseptics from the claims.

Previously, Boehringer had successfully opposed grant of the patent on the basis that the claimed paste was not novel or inventive over a prior use of acriflavine, an acridine, being a compound that was known to have antiseptic properties.

Elanco’s predecessor in title to the patent application requested, pursuant to section 104 of the Patents Act 1990 (Cth), to amend claim 1 of the patent application to exclude acridine as an antiseptic. Plainly enough, it must have considered that doing so would address the previous finding of lack of novelty and inventive step.

Boehringer unsuccessfully opposed the amendment before the Patent Office and filed this appeal from the delegate’s adverse decision. This appeal concerns sections 102 and 40(3) of the Patents Act in force prior to the amendments made by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth). Suffice to say, the result may have been different had the post-Raising the Bar provisions applied.

The issues for determination were whether the amendment was not allowable because, as a result of the amendment: the specification would claim matter not in substance disclosed in the specification as filed (section 102(1)); a claim of the specification would not fall within the scope of the claims of the specification before amendment (section 102(2)(a)); or the specification would not comply with section 40(3) which required the claim to be clear and succinct and fairly based on matter described in the specification (section 102(2)(b)).

The specification before amendment (and as filed) included three important passages. The first identified the desirable properties of the antiseptic to be used in the invention, which properties would include some acridines. The second passage referred to a specific antiseptic, chlorhexidine, that was used in the examples. The third passage referred to four other particular antiseptics. None of them was an acridine. The third passage also referred to broad classes or properties of antiseptics that would include acridines.

Boehringer’s primary point was that there was not real or reasonably clear disclosure of an invention in the specification as filed in which acridine is excluded from use as an antiseptic and so the amended claim excluding acridine as an antiseptic was fundamentally inconsistent with the specification as filed (and prior to amendment).

A question arose as to whether the delegate’s finding on the main opposition that acriflavine had antiseptic properties was binding on Elanco. In particular, Elanco said that it was not binding on an appeal from a subsequent decision to allow an amendment, because the appeal was a hearing de novo. Besanko J gave that argument short shrift: “the finding is binding on the parties and it is not to the point that this proceeding is a rehearing before the Court. The point is that it is not an appeal from the substantive opposition decision”, in which case the finding could have been put in issue by Elanco.

Nevertheless, a considerable amount of evidence was heard regarding acridines and what about them might be considered common general knowledge. While it appears that Elanco’s assertions that acridines were a forgotten species of antiseptic, Besanko J disagreed. However, despite this set-back, Elanco won the appeal. Why? Because the point ultimately was of little, if any, relevance.

Typically, an amendment which narrows a claim to exclude a specific class of compounds is allowable where the amended claims do not travel beyond the disclosure in the body of the specification. It did not matter that there was no disclosure in the specification that, for the invention, acridines are not to be used. The point was that there was a real and reasonably clear disclosure in the body of the specification of the antiseptic compounds in fact claimed after the amendment – that is, the antiseptics other than acridines.

To meet that difficulty, Boehringer contended that, nonetheless, because acridines had all the properties of what the specification identified as preferred for the claimed antiseptic, the amendment redefined the invention so that the body of the specification (which encouraged the use of acridines) was fundamentally inconsistent with a claim that excluded acridines. As to that contention, Besanko J found that the proposition was not established because the specification “overwhelmingly indicates that the preferred antiseptic in the invention is chlorhexidine” which was not an acridine and acridines were not mentioned by name in the specification. His Honour concluded:

Even if I am wrong about the content of common general knowledge or about its relevance to the meaning of the terms “ionised antiseptics” and “QAC”, nevertheless, in my opinion, there is no positive recommendation to use acridines such that there is a fundamental inconsistency between the body of the specification and the amended claims. That is because the skilled addressee would know that there were over a thousand ionised antiseptics and QACs which are not acridines and over a thousand acridines which are not ionised antiseptics and QACs. That, to my mind, means that this case falls well short of the type of positive recommendation before the Court in AstraZeneca. That position is only made stronger if, as the respondent suggested, the skilled addressee is also armed with knowledge of the following: (1) acridines are rarely used and historical (see at [251] above); (2) it is not suggested in any of the relevant text books that acridines should be considered in veterinary medicine (see at [260] above); (3) there are numerous more commonly used safe and effective antiseptics than acridines; and (4) Albert referred to acriflavine as highly acidic and toxic and little used.

The appeal was dismissed.

Intellectual Property Law Update - Patents
Tom Cordiner Headshot

Tom Cordiner QC holds the dual qualification of barrister and registered patents and trade mark attorney

M Marcus

Melissa Marcus practises in defamation law and all aspects of intellectual property

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Marcus Fleming practises in commercial litigation, with a particular focus on intellectual property law

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