FEDERAL COURT OF AUSTRALIA

Apotex Pty Ltd v Warner-Lambert Company LLC [2014] FCA 843

THE COURT ORDERS THAT:

1.    The applicant is to provide the further and better particulars referred to in [8] and [10] of these reasons within 7 days of today.

2.    The applicant is to reformulate para 33 of the proposed Second Further Amended Statement of Claim so as to comply with the requirements of order 7 made on 27 June 2014.

3.    Subject to compliance with orders 1 and 2, the applicant has leave to file its proposed Second Further Amended Statement of Claim within 14 days of today.

4.    The directions hearing listed on 1 September 2014 be vacated.

5.    The proceeding be listed for directions at 9:30am on 17 November 2014.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

THE COURT ORDERS THAT:

1.    The cross-claimant is to provide the further and better particulars referred to in [8] and [10] of these reasons within 7 days of today.

2.    The cross-claimant is to reformulate para 28 of the proposed Amended Particulars of Invalidity so as to comply with the requirements of order 4 made on 27 June 2014.

3.    Subject to compliance with orders 1 and 2, the cross-claimant has leave to file its proposed Amended Particulars of Invalidity within 14 days of today.

4.    The directions hearing listed on 1 September 2014 be vacated.

5.    The proceeding be listed for directions at 9:30am on 17 November 2014.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

(Revised from Transcript)

1    Before me is an application for leave to file a Second Further Amended Statement of Claim in which the applicant (Apotex) asserts the invalidity of Australian Patent No. 714980 (the Patent) entitled “Isobutylgaba and its derivatives for the treatment of pain”. The Patent relates to methods for treating pain including, but not limited to, neuropathic pain using pregabalin and related compounds (formulations of the invention).

2    Claim 1 is directed to “[a] method for treating pain” using a formulation of the invention. Claim 4 is a method for treating pain according to claim 1 “wherein the pain treated is inflammatory pain”. Each of claims 5 to 15 is for a method for treating pain using a formulation of the invention wherein the pain to be treated is:

    neuropathic pain (claim 5);

    cancer pain (claim 6);

    postoperative pain (claim 7);

    phantom limit [sic] pain (claim 8);

    burn pain (claim 9);

    gout pain (claim 10);

    osteoarthritic pain (claim 11);

    trigeminal neuralgia pain (claim 12);

    acute herpetic and postherpetic pain (claim 13);

    causalgia pain (claim 14);

    idiopathic pain (claim 15).

Claims 16 to 30 are Swiss-style claims which mirror this approach. Claims 31 and 32 are omnibus claims.

3    Apotex alleges that the (S) enantiomer is a formulation of the invention. Apotex then alleges in para 29 that the (S) enantiomer is not effective in the treatment of pain conditions that do not involve neuropathic pain or central sensitisation. The particulars to this allegation identify the following types of pain against which the (S) enantiomer is said to be an ineffective treatment:

(a)    Nociceptive pain not involving central sensitisation or neuropathic pain;

(b)    Nociceptive inflammatory pain not involving central sensitisation or neuropathic pain;

(c)    Nociceptive cancer pain not involving central sensitisation or neuropathic pain;

(d)    Nociceptive postoperative pain not involving central sensitisation or neuropathic pain;

(e)    Nociceptive burn pain not involving central sensitisation or neuropathic pain;

(f)    Nociceptive gout pain not involving central sensitisation or neuropathic pain;

(g)    Nociceptive osteoarthritic pain not involving central sensitisation or neuropathic pain;

(h)    Nociceptive acute herpetic pain not involving central sensitisation or neuropathic pain;

(i)    Nociceptive idiopathic pain not involving central sensitisation or neuropathic pain;

(j)    Inflammatory pain caused by acute tissue damage from trauma;

(k)    Cancer pain caused by a tumour mass secreting chemicals which sensitise and/or activate nociceptors and/or damage other tissues in the local area leading to forms of nociceptive pain;

(l)    Cancer pain caused by a tumour mass pushing against surrounding healthy tissues leading to a form of nociceptive pain;

(m)    Postoperative pain caused by acute inflammatory pain arising postoperatively;

(n)    Burn pain caused by first and/or second degree burns;

(o)    Acute gout pain;

(p)    Chronic gout pain not involving central sensitisation or neuropathic pain;

(q)    Acute, episodic osteoarthritic pain;

(r)    Persistent, low-level osteoarthritic pain with acute exacerbations;

(s)    Septic arthritis;

(t)    Acute pain from the obstruction of a hollow organ;

(u)    Acute pain from myocardial ischaemia or infarction; and

(v)    Pain from insect bites or envenomations.

4    Paragraph 30 then alleges that by reason of the matters pleaded in (inter alia) para 29, there are pain conditions within the scope of claims 1 to 4, 6, 7, 9 to 11, 13, 15 to 19, 21, 22, 24 to 26, 28, 30 and 31 of the Patent that the (S) enantiomer is not useful to treat. These claims are therefore said to be inutile.

5    The respondent (Pfizer) submitted that proposed paras 29 and 30 do not adequately inform Pfizer of the case it is required to meet at trial. I do not accept this submission.

6    The claims of the patent in suit do not distinguish between “neuropathic pain” or “central sensitisation” on the one hand, and “nociceptive pain” on the other, except in claim 5 and the corresponding Swiss style claim both of which refer only to neuropathic pain. Apotex’s case, which I think clearly emerges from its proposed pleading, is that the (S) enantiomer which it says is a formulation of the invention, is not effective in the treatment of nociceptive pain including nociceptive osteoarthritic pain, herpetic pain, and idiopathic pain not involving central sensitisation or neuropathic pain. Further, the allegations of inutility are supported by specific allegations of the pain associated with various conditions, including certain types of cancer-induced pain, burn pain and osteoarthritic pain which do not involve neuropathic pain or central sensitisation, for which the (S) enantiomer is said to be an ineffective treatment.

7    Pfizer also took issue with the way in which particulars (a) to (i) and (p) appended to para 29 are expressed. It was argued that they merely restate the general allegation in that paragraph. I do not agree. They identify nociceptive pain or at least nociceptive pain not involving central sensitisation or neuropathic pain as a type of pain against which the (S) enantiomer is said to be ineffective. Pfizer’s submission did not raise any specific complaint about the meaning of these terms as they would be understood by a skilled addressee.

8    There are other matters raised by Pfizer that I think Apotex should be required to address by way of the further and better particulars:

    The particulars in para 29 distinguish between acute and chronic pain. Pfizer says that the distinction between the two types of pain is imprecise and subject to a number of divergent definitions even among Apotex’s own expert witnesses. This is a matter that can and should be the subject of clarification by way of further particulars.

    Pfizer has also sought clarification as to whether it is Apotex’s case that the (S) enantiomer is ineffective to treat the pain referred to in the particulars to para 29 in all cases or in only some patient groups or individuals suffering from the described conditions. Again, I think this is a matter that can and should be clarified by way of further particulars.

9    There is another complaint made about para 33 in that it is said by Pfizer that it does not comply with order 7 dated 27 June 2014 which required Apotex’s proposed amendment to include a full and self-contained (ie. not by way of cross-reference to evidence) statement of particulars of the facts and matters relied upon in support of any allegation of inutility. The particulars to para 33 should be reformulated so as to comply with that order.

10    Finally, there is also a complaint by Pfizer in relation to proposed para 37(b) which asserts that “[t]he Racemate is … ineffective in the treatment of any pain condition except at unacceptably high doses”. Pfizer says that it is not clear what the expression “unacceptably high doses” means in this context. I agree. Further particulars of this allegation should be provided which specify what the dosages referred to are and why they are said to be unacceptable.

11    Subject to the provision of the further and better particulars to which I have referred and the reformulation of para 33, Apotex will be granted leave to file the Second Further Amended Statement of Claim in the form of the document served on 7 July 2014.

12    Orders are made accordingly in this proceeding and in the related proceeding in which leave to make similar amendments was sought by the cross-claimant (Generic Partners).

Associate:

Dated:     8 August 2014