- a) mixing pharmacologically effective amounts of entacapone and levodopa, or a pharmaceutically acceptable salt or hydrate thereof, with at least one pharmaceutically acceptable excipient and a disintegrant to obtain a first mixture;
- b) granulating the first mixture to obtain a granule batch;
- c) adding a pharmacologically effective amount of carbidopa, or a pharmaceutically acceptable salt or hydrate thereof, optionally a lubricant, and optionally one or more pharmaceutically acceptable excipients to the granule batch to obtain a second mixture;
- d) formulating the second mixture into a plurality of dosage forms.
20 October, 2016
New case highlights the dangers of failing to write comprehensive patent specificationsNew case highlights the dangers of failing to write comprehensive patent specifications
[caption id="attachment_3055" align="alignright" width="150"] By Naleesha Niranjan[/caption] The success or failure of a patent in court can depend entirely on the Court’s definition of a single word in the specification. Some words of course are more common and important in patent specifications than others, and established conventions grow up through case law concerning the way that a Court should define these words. [caption id="attachment_311" align="alignright" width="150"] For more information about patent drafting in Australia, contact Dr Declan McKeveney.[/caption] However, these accepted interpretations often vary considerably from one country to another. One recent Federal Court case has highlighted a critical difference in how Australian courts define the word “comprises” compared to US practice, and has emphasised the importance of comprehensive preparation of the specification in the Australian context. Established Australian Practice It is well-established Australian patent practice to include a paragraph in a patent specification that explicitly defines the term “comprises”, and its variations, throughout the specification, as it is intended to be interpreted which is typically in an “inclusive” sense. This definition, is designed to prevent a court from applying an exhaustive interpretation of “comprises” when used in describing the various features or steps which comprise the invention – in other words to prevent the court deciding that the invention ‘comprises’ of the listed features or steps only, to the exclusion of any other possible features or steps, and therefore unduly limit the scope of the patent’s claims. This standard practice was a reaction of Australian patent attorneys to the “General Clutch” decision. In General Clutch v. Sbriggs (1997) the Federal Court of Australia, in consulting several dictionaries, decided that the term “comprising” was to be interpreted as limiting the claim in question to only having those elements explicitly recited following the word and no others. Contrast to US Practice Later, in Gambro v Fresenius (2004), the Australia Federal Court decided that the meaning and operation of “comprising” depended on the specific context in which it is used within the unique specification at hand. This is unlike US patent practice, for example, where the terms “comprising of”, “consists of” and “consisting essentially of” and variations of these terms, have well-defined and universally understood meanings. It is accepted US court practice that “comprising of” is to be interpreted as open-ended in that the claim may include additional elements to those listed. “Consists of” typically signifies a “closed-end” claim such that the claim is restricted to only those elements listed. “Consisting essentially of”, used typically in claims concerning a chemical invention, provides a middle ground between “comprising of” and “consists of” in which the claims may include other unlisted features or steps as long as they do not “materially affect the basic and novel properties of the invention”. The Case The recent Full Federal Court decision in Actavis Pty Ltd v Orion Corporation  FCAFC 121 has shed some further light on the interpretation of the term “comprising” in Australian claim construction, and highlighted the dangers of relying on the standard ‘comprises’ paragraph. Orion Corporation, the patentee, alleged that by seeking to market pharmaceutical products including entacapone, levodopa and carbidopa, as indicated for management of Parkinson’s disease, Actavis Pty Ltd was threatening to infringe claims of their Patent no. 765932. While discussing issues of claim construction the court delved into the operation of the word “comprises” in the following claim 17 of the patent in suit. Claim 17: A method for preparing an oral solid composition comprising entacapone, levodopa, and carbidopa, or a pharmaceutically acceptable salt or hydrate thereof, wherein the method comprises