Albany Molecular Research Inc. v. Alphapharm Pty Ltd.  FCA 120
In the recent decision on two proceedings relating to infringement of Australian Patent No. 699799, Justice Jessup of the Federal Court has held that the disclosure of a compound in a prior art document without an effective method to prepare it anticipates a later claim to the compound.
The infringement allegations and invalidity claims
The judgement arises as a result of an allegation by Albany Molecular Research Inc. (AMR) that Alphapharm Pty Ltd. and others had infringed Australian patent No. 699799 ("The Patent") by the sale of products comprising fexofenadine hydrochloride. The claims at issue are directed to substantially pure piperidine derivatives per se, including fexofenadine, pharmaceutical compositions comprising such derivatives and methods of treating allergic reactions. It was AMR's position that the respondents had infringed claims 1 and 6 to 11 of The Patent. The respondents contended that The Patent is invalid on many grounds including lack of novelty, lack of inventive step, lack of clarity and succinctness and false suggestion.
Whilst the judgement dealt with a number of grounds of invalidity, the findings in relation to novelty are of particular interest. The respondents alleged that prior published patents referred to as "Carr 129" and "Carr 146" render the relevant claims of The Patent lacking in novelty because they disclose the claimed piperidine derivatives. The respondents urged that in the case of a claim directed to a compound per se, disclosure of the compound in a prior art document deprives that claim of novelty.
AMR accepted that Carr 129 and Carr 146 disclose the claimed piperidine derivatives including fexofenadine and that the disclosures extended to pure compounds. AMR's position was however that Carr 129 and Carr 146 were not novelty defeating because both documents failed to provide information to a skilled person by which the compounds could practically and effectively be brought into existence. Essentially, AMR sought to rely on the proposition that mere disclosure of a compound by name in a prior art document would not amount to anticipation unless a method of preparation was provided, or in the alternative a skilled person could readily prepare the compound as a matter of routine. Having regard to the decisions in the Lundbeck1 and Apotex2 cases his Honour stated:
"In the view I take of the law as expounded in Lundbeck and Apotex, the disclosure of a compound by exact naming in the prior art is sufficient, of itself, to constitute anticipation." [at 36]
On this basis, claims 1 and 6 to 10 of The Patent were held to lack novelty.
Did the specifications disclose an effective means of preparation?
Despite the findings on novelty, his Honour went on to consider whether Carr 129 and Carr 146 disclose effective means for preparation of substantially pure fexofenadine hydrochloride. Based on expert evidence it was found that Carr 129 did not in fact disclose effective means for preparing fexofenadine hydrochloride. As a result thereof his Honour concluded:
"It follows that, if I am wrong about the law as established in Lundbeck and Apotex, I would hold that the invention, so far as claimed in the claims which are presently relevant, was not anticipated by Carr 129. And the same conclusion must apply in the case of Carr 146."
His Honour also held that the remaining grounds of invalidity pleaded by the respondents were not made out (which, perhaps curiously, included inventive step), and hence the statement in the previous paragraph would appear to invite an appeal by AMR on the grounds that the law established in Lundbeck and Apotex was applied incorrectly in the present case.
Because claims 1 and 6 to 10 were found to lack novelty, and because no evidence was lead by AMR that claim 11 had in fact been infringed by the respondents, his Honour dismissed AMR's infringement claim.
There remains a question as to whether the entire patent is to be revoked based on the ground of false suggestion in light of submissions made by AMR's predecessor in title before the Australian Patent Office during prosecution of the patent application. It is apparent that his Honour has not yet formed a final conclusion in relation to this ground and further written submissions are expected from the parties in the near future.