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WELCOME TO MY BLOG

My name is Paul Kilborn. I am an 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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High Court finds methods of medical treatment of human beings can be the subject of patents

  Sanofi
''
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (4 December 2013)

In a majority judgment (4:1) the High Court of Australia finds that medical treatments of the human body can be patentable.

The single claim of the patent reads:

'A method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of [leflunomide].'

The issues raised by Apotex are:

1. Whether the claim of Australian Patent No. 670,491, being a claim for a method of treatment of the human body, is a patentable invention within the meaning of s 18(1)(a) of the Patents Act 1990 (Cth). In the alternative, whether the claim, being a claim for a second or subsequent medical use of a previously known product, claims a patentable invention.

2. In light of the fact that the Patent claims only the use of a compound for the treatment of psoriasis, whether the Applicant/Appellant (Apotex), when it supplies the compound and indicates its use for the treatment of a different disease, would infringe the Patent under s 117(1) of the Act. (Apotex has sought special leave for this ground of appeal)

The case information and transcipts for the hearing can be found under the 'Leflunomide' tab on the menu to the left.


BRCA1 gene
Cancer Voices Australia v Myriad Genetics Inc FCA 65 (15 February 2013)

Today Justice Nicholas of the Federal Court of Australia dismissed an application by Cancer Voices Australia seeking declarations that claims 1-3 of Australian standard patent number 686004 are invalid on the basis that none claim a manner of manufacture and, therefore, do not satisfy the requirements of s 18(1)(a) of the Patents Act 1990. Cancer Voices also sought orders revoking claims 1-3.

The claims in contention read as follows:
1. An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:l one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.
2. An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a mutant BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations set forth in Tables 12, 12A and 14.
3. An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a polymorphic BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more polymorphisms set forth in Tables 18 and 19.

His Honour concluded that the claims were directed to a manner of manufacture and therefore patentable subject matter:

'136. There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent. However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells. The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated.
137. The applicants contended that each of the disputed claims was invalid on the sole ground that it was not a claim to a manner of manufacture and therefore did not comply with the requirements of s 18(1)(a) of the Act. That contention should be rejected for the reasons previously given. In my opinion each of the claims is to a manner of manufacture as that expression should now be understood. My reasons have nothing to say about the possible invalidity of the disputed claims on any other ground.'

Justice Nicholas noted that a corresponding US patent was under appeal before the US Supreme Court, however, his Honour considered that there are two reasons for concluding that the outcome of the US appeal is unlikely to provide any assistance for either side in the Australian context. First the consitutional setting for patent law in Australia is quite different from that applying in Australia. Secondly, the evidence presented in the US was not the same as that present in the present case:

'134. On 30 November 2012, the US Supreme Court announced that it would hear an appeal in the Myriad case. The US law in relation to the patentability is therefore not likely to be settled until the Supreme Court reaches it own decision on the issue. 135. In any event, it seems to me that the Myriad decision does not provide any direct assistance to either side in the present case. I say this for two reasons. First, the law in Australia is different. I must apply the law as explained in NRDC. It must also be recognised, especially as the Myriad case heads to the US Supreme Court, that the constitutional setting in which patent legislation operates in the US is quite different to that in which patent legislation operates in this country: Grain Pool of Western Australia v Commonwealth of Australia [2000] HCA 14; (2000) 202 CLR 479 at paras [28]-[32]. Secondly, the evidence in the Myriad case was not the same as the evidence in the present cast. And at least in relation to the matter of covalent bonds, I have taken a different view of the facts to that taken by Judge Lourie.'

The decision itself can be located at http://www.austlii.edu.au/au/cases/cth/FCA/2013/65.html


     Aripiprazole (Abilify™)
Generic Health Pty Ltd v Otsuka Pharmaceutical Co Ltd [2012] FCA 412 (23 April 2012)

Generic Health Pty Ltd (Generic Health) application for leave to appeal against an interlocutory injunction restraining its threatened supply of certain generic pharmaceutical products containing aripiprazole has been refused by a Full Court of the Federal Court.

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'.

The original Federal Court decision and that of the Full Court of the Federal Court can be found under the 'Abilify' button to the left.



    Wyeth image Venlafaxine Hydrochloride Effexor® XR

Wyeth & Anor v Sigma Pharmaceuticals (Australia) Pty Limited; Wyeth & Anor v Alphapharm Pty Limited; Wyeth & Anor v Generic Health Pty Ltd [2012] HCATrans 116 (11 May 2012)

High Court refuses Wyeth special leave to appeal

The High Court has refused Wyeth special leave to appeal against a decision of the Full Federal Court which held that the infringed claims of Wyeth/Pfizer patent are invalid for lack of novelty. The Full Federal Court held that the priority date of infringed claims of the patent was the date of an amendment made to those claims that resulted in the claims claiming matter 'in substance disclosed'" as a result of the amendment (see below for more commentary) .


Intellectual Property Laws Amendment (Raising the Bar) Act 2012

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.


    Wyeth image Venlafaxine Hydrochloride Effexor® XR

Infringed claims of Wyeth's Effexor® 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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