Justice Jessup has handed down an important decision in Albany Molecular Research Inc v Alphapharm that clarifies the appropriate test to apply when considering the validity of a patent that claims a compound that is precisely disclosed in the prior art.
Importantly, His Honour found that where there is disclosure in the prior art of exactly what is claimed, the patent will be invalid for want of novelty. It is only where there is an integer missing from the prior disclosure, or where there is a question of whether a process “inevitably” produces the subsequently claimed compound, that questions of enablement arise.
The patent in suit claimed “substantially pure” fexofenadine, a compound used in the treatment of allergic reactions. The specification (following an amendment) provided that “substantially pure” meant purity greater than 98%. The compound, together with a process for its production, was disclosed in prior Australian and US patents (the Carr Patents), and, interestingly, the Australian patent claimed the compound in “substantially pure” form. However, it was said by the patentee that the process for producing the compound in the prior art gave, at best, 96.3% purity, and as such, did not anticipate.
Alphapharm, represented by Mallesons, argued that the patent was invalid for want of novelty, both on the basis of the disclosure of the compound in the prior art, and on the basis of experimental evidence that showed that the prior art process, with some limited variation, produced substantially pure fexofenadine. Further, it was submitted that the patent in suit was invalid for want of inventive step as the variations that were made to the prior art process were routine variations that the skilled person in the art would have made as a matter of course in the expectation of achieving substantially pure (that is, greater that 98% pure) fexofenadine. It was also submitted on behalf of Alphapharm that the patent was invalid for having been granted on the basis of a material false suggestion, and that the claims lacked clarity.
AMRI relied on Hill v Evans (1862) 1A IPR 1 as authority for the proposition that to anticipate, a document must enable a person skilled in the art to at once perceive, understand and be able to practically apply the discovery without further experimentation, such that if something remains to be ascertained that is necessary for the useful application of the discovery, there is room for another patent. Similarly, AMRI relied on the finding in Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 that an alleged anticipation will not anticipate if it does not necessarily result in the claimed invention.
Finding that the patent in suit was invalid for want of novelty, Justice Jessup applied the Full Court’s reasoning in H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 and Apotex Pty Ltd v Sanofi-Aventis (2009) 82 IPR 416 that where the prior art discloses exactly what is claimed, there is anticipation. Rejecting AMRI’s submission that the Carr Patents did not anticipate because they did not provide information as to the means by which the claimed compound (in substantially pure form) could be produced, His Honour found that it is only where the prior art discloses some but not all integers (the “missing integer cases”), or where the prior art discloses a process that may or may not lead to the subsequently claimed invention (the “inevitable result cases”), that the question of enablement arises. It is then a question of whether the person skilled in the art would add the missing information as a matter of course without the application of inventive ingenuity, or whether the prior art process inevitably produces the invention.
Having found that the patent was invalid for want of novelty, His Honour then turned to the alternative submission put by Alphapharm, that in the event it is necessary to show that the prior art is enabling, experiments carried out by Alphapharm’s expert demonstrated that the process disclosed in the Carr Patents produces substantially pure (100% pure) fexofenadine. The parties agreed that Alphapharm’s expert had produced 100% pure fexofenadine, and that there had been a departure from the process described in the Carr Patents. However, it was Alphapharm’s submission that the departures were no more than routine variations that would be applied by the ordinary person skilled in the art. That is, the variations were ordinary trial and error variations that the person skilled in the art could be expected to carry out in order to get the invention to work (from Lundbeck v Alphapharm).
While Justice Jessup found that certain variations were those that the person skilled in the art, equipped with the intellectual and practical wherewithal to perceive instructions, and prepared to exercise some expertise, perseverance and trial and error, would make (such as observing anhydrous conditions in the absence of specific instructions to do so, varying solvents and proceeding to a next step in the reaction sequence with impure material from a previous reaction), one step in the reaction that it was necessary to repeat a number of times before a successful “protocol” was derived, was found to involve more than ordinary trial and error. Consequently, it was not accepted that if it was necessary for a prior publication to be enabling, the Carr Patents would anticipate.
Justice Jessup noted that the question to ask when assessing inventive step is whether the invention would have been obvious to a person skilled in the art, such that when faced with the problem, they would have taken as a matter of routine whatever steps might have led from the prior art to the invention.
Alphapharm submitted that the person skilled in the art would have been directly led as a matter of course to try the variations that were made to the process disclosed in the Carr Patents in the expectation of producing substantially pure fexofenadine.
In the same way as discussed above in relation to the question of whether the Carr Patents were an “enabling disclosure”, Justice Jessup found that some variations that were made were those that the skilled addressee would have made as a matter of routine. However, it was not accepted that the person skilled in the art would have been directly led to try the protocol that had been developed by Alphapharm’s expert to successfully carry out one of the steps in the reaction sequence. Rather, it was found that deriving the protocol had required each of a number of possible choices to be attempted before the successful result was arrived at.
To overcome an objection based on the Carr Patents, the patentee had sent a letter to the Australian Patent Office indicating that a 96.3% pure intermediate product had been obtained, but that a final product with greater than 98% purity could not be obtained following the Carr Patents. That is, “substantially pure” products could not be obtained following the synthesis disclosed in the Carr Patents.
Accepting Alphapharm’s submission that the patent had been granted on the basis of this representation, and that the representation was false, Justice Jessup found that Alphapharm’s experimental evidence that the final two steps in the sequence produced 100% pure fexofenadine from the 96.3% pure intermediate, demonstrated that the representation that 98+% purity could not be obtained following the Carr Patents was false. Similarly, it was found that the representation was material because of the emphasis the patentee had placed on the fact that the prior art did not produce substantially pure fexofenadine.
The decision is a useful illustration of the application of the Full Federal Court decisions in Lundbeck v Alphapharm and Apotex v Sanofi to the question of enabling disclosure, and the distinction that is drawn between the precise disclosure cases (such as this one) on the one hand, and the “missing integer” and “inevitable result” cases on the other. It is only in the latter that questions of enablement, or sufficiency of the prior disclosure, will arise.