WELCOME TO MY BLOGMy name is Paul Kilborn. I am a registered Australian patent attorney. I have a particular interest in the development of Australian patent law in relation to pharmaceuticals and their uses.
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Aripiprazole (Abilify™)
Generic Health Pty Ltd v Otsuka Pharmaceutical Co Ltd [2012] FCA 412 (23 April 2012)
Generic Health Pty Ltd (Generic Health) has applied for leave to appeal against an interlocutory injunction restraining its threatened supply of certain generic pharmaceutical products containing aripiprazole. The leave to appeal application has been referred to a Full Court of the Federal Court for determination.
Otsuka Pharmaceutical Co Ltd (Otsuka) and its exclusive licensee Bristol-Myers Squibb Company (who markets aripiprazole formulations through its Australian subsidiary under the name 'Abilify') argued that Generic Health's conduct threatened the infringement of two of Otsuka's patents in several respects but the primary judge was only satisfied that there was a prima facie case of infringement in respect of one patent claim, namely, claim 7 of Australian patent No 2005201772 (the 772 patent). Claim 7 is concerned with a method of treating certain kinds of patients with disorders of the central nervous system associated with the 5-HT1A receptor sub-type, specifically disorders "selected from cognitive impairment caused by [treatment-resistant, inveterate or] chronic schizophrenia" and which fail to respond to more than one of a number of specified antipsychotic drugs. The method comprises administering to the patient a therapeutically effective amount of a carbostyril compound of a particular formula which encompasses aripiprazole or a pharmaceutically acceptable salt or solvate of it.
Otsuka had originally argued that 'Swiss style' Claim 1 of the 772 patent was also infringed by Generic Health's acts. However the judge at first instance was not satisfied that Generic Health's acts, 'even if amounting to a prima facie infringement of claim 1 of the 752 patent, would be of sufficient practical significance to amount to injury of a kind that would warrant the grant of interim injunctive relief'.
Links to the two decisions of the Federal Court can be found under the 'Abilfy' button to the left.
The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 passed into law with Royal Assent given on 15 April 2012.
Most of the amendments to the Patents Act 1990 will not come into effect until 15 April 2013.
One amendment that is now in effect is section 119C, which provides infringement exemption for acts undertaken for experimental purposes:
(1) A person may, without infringing a patent for an invention, do an act that would infringe the patent apart from this subsection, if the act is done for experimental purposes relating to the subject matter of the invention.
(2) For the purposes of this section, experimental purposes relating to the subject matter of the invention include, but are not limited to, the following:
(a) determining the properties of the invention;
(b) determining the scope of a claim relating to the invention;
(c) improving or modifying the invention;
(d) determining the validity of the patent or of a claim relating to the invention;
(e) determining whether the patent for the invention would be, or has been, infringed by the doing of an act.
I have prepared a marked-up unofficial version of the Patents Act 1990 and this can be downloaded by clicking on the appropriate button on the left. Please note that while every effort has been made to ensure that the amendments have been correctly incorporated, this version should not be relied on for the purposes of giving legal advice.
Apotex has failed to limit an interlocutory injunction based on three Astrazenaca patents against its generic rosuvastatin: Apotex Pty Ltd v AstraZeneca AB (No 2) [2012] FCA 142.
Venlafaxine Hydrochloride Efexor® XR
Infringed claims of Wyeth's Efexor® XR patent held invalid by Full Federal Court
CITATION Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132
The Full Court held that the priority date of claims was not the filing date of the priority document but rather the date of filing an amendment to the claims. The Full Court also held that the infringed claims were invalid for not being fairly based the description.
The Full Court construed the specification of the patent and that of the priority document as only disclosing the preferred embodiment, despite the fact that both documents included statements by the applicant describing the invention in much broader terms. Issues relating to 'fair basis' and 'in substance disclosed' proved fatal to the validity of the claims.
SIGNIFICANCE The decision is significant in that it suggests that when determining whether a claim is 'fairly based' on the disclosure of a complete specification, a degree of conflation of the issues of insufficiency of description and inventive contribution is permissible.
It is also significant in that the Full Court appears to have construed the disclosure of the priority document as it would a complete specification under s 40(3) of the Patents Act 1990, rather than treating the claims and supporting description of the priority document as separate disclosures from each of which claims of an Australian application may claim priority (E.I. Du Pont de Nemours and Co.'s Application, (1954) 71 RPC 263).BACKGROUND There were three appellants in this matter - Sigma Pharmaceuticals (Australia) Pty Ltd (Sigma), Alphapharm Pty Limited (Alphapharm) and Generic Health Pty Ltd (Generic Health), all of whom have obtained registration on the Australian Register of Therapeutic Goods of an extended release form of Venlafaxine (Evelexa XR, Enlafax-XR and Venlafaxine Generichealth XR respectively). All three products are described in the Therapeutic Goods Register as being in the form of a modified release capsule.
At first instance, Sigma, Alphapharm and Generic Health instituted revocation action in the Federal Court against Australian Patent No 2003259586 (the Patent) in the name of Wyeth, which has claims directed to methods of providing certain therapeutic blood plasma levels of venlafaxine. Wyeth cross claimed against the three companies, asserting that they threatened to infringe the Patent. The matter was heard by Jagot J of the Federal Court. In a judgment dated 8 November 2010 (Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2010] FCA 1211). Her Honour held the claims of the Patent to be valid and that Sigma, Alphapharm and Generic Health had threatened to infringe claims 1, 4, 5, 8, 9, 10, 15, 16 and 27 of the patent and granted the injunctions sought by Wyeth.
THE 'GENERIC' FORMULATION According to expert evidence led by Alphapharm, its Enlafax-XR formulations comprise tablet(s) contained in a hard gelatin capsule shell. The excipients in the Enlafax Formulations are predominantly hypromellose i.e. a cellulose ether. This latter component performs the primary 'hydrogel' function. The formulation of Sigma and Generic Health appear to be based on similar technology.
THE LEGAL ISSUES The Full Federal Court (Bennett, Nicholas and Yates JJ) confirmed the finding at first instance that the appellants had failed to establish that the specification of the Patent did not fully describe the invention (s 40(2)(a)) or that the patent was gained by false suggestion (s 138(3(d)). Moreover, Justice Bennett held that if the relevant claims of the Patent had been valid, the Enlafax-XR formulation would infringe the Patent. However, her Honour found that claims 1 to 17 and 27 of the Patent are not fairly based on the Priority Document and further claimed matter that was in substance disclosed as a result of amendments made in 2006. Accordingly, the priority date of the Amended Patent is deferred to 20 December 2006 with the result that those claims failed for lack of novelty.
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ps I came across the following very clever infographic describing patents. While it is not rigorously correct on some matters, it provides an excellent represenation of the 'flavour' of the 'patent wars' in the US context.
Via: Business Insurance Site