FEDERAL COURT OF AUSTRALIA
Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2010] FCA 1211
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- Case
- [2010] FCA 1211
- Decision Date
CaseChat Overview and Summary
The primary legal issues before the court were whether the patent claims were valid, clear, and sufficiently described, and whether the applicants had infringed the patent. The court also needed to determine if the patent was obtained by false suggestion or misrepresentation and if the claimed invention was useful. The applicants argued that the patent was invalid on several grounds, including lack of inventive step, obviousness, and insufficiency of description. They also claimed that the patent was obtained by false suggestion or misrepresentation and that the invention was not useful. Wyeth argued that the patent was valid and that the applicants had infringed it.
The court found that the patent was valid, clear, and sufficiently described. The claims were not obvious and the invention was sufficiently described in the specification. The court rejected the applicants' argument that the patent was obtained by false suggestion or misrepresentation and found that the invention was useful. The court also found that the applicants had infringed the patent by marketing their products, which fell within the scope of the claims. The court dismissed the applicants' application for revocation of the patent and granted Wyeth's claims for infringement, injunctions, damages, and an account of profits.
The court ordered that the applicants be restrained from infringing the patent by importing, marketing, selling, or supplying the disputed products in Australia during the term of the patent without Wyeth's license or authority. The applicants were also ordered to destroy any infringing products in their possession and to pay Wyeth's costs of the proceeding. The court stayed certain orders pending any potential appeal to the Full Court of the Federal Court.
Orders
Orders of the court
2. The draft reasons for judgment provided to the parties on 23 September 2010 be published as the reasons for judgment, except for:
(a) the quote in [624]: 2nd paragraph last sentence, 4th paragraph after “excipients” to the end of the 4th paragraph, 5th paragraph last sentence;
(b) [628] 3rd to 6th sentences inclusive; and
(c) [629] 4th to 8th sentences inclusive
(together the confidential sentences).
3. The parties be provided with the reasons for judgment both as published and including the confidential sentences.
4. The confidential sentences be kept confidential by the parties (other than Alphapharm Pty Limited) and not be disclosed other than to their legal representatives and such other person as may be agreed to in writing by Alphapharm Pty Limited.
5. The Application be dismissed.
6. Order 1 made on 3 June 2009 be discharged and the Respondents / Cross-Claimants be released from the undertakings given by them to the Court in relation to those orders, being undertakings:
(a) to submit to such order (if any) as the Court may consider to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person, whether or not a party, adversely affected by any operation of those orders or any continuation (with or without variation) thereof; and
(b) to pay the compensation referred to in (a) to the person there referred to.
7. The Applicant / Cross-Respondent (whether by itself, its directors, servants, agents or otherwise) be restrained from infringing claims 1, 4, 5, 8, 9, 10, 15, 16 and 27 of the Patent, including, without limitation, by, in Australia, during the term of the Patent and without the licence or authority of the First Respondent / First Cross-Claimant:
(a) importing, marketing, taking orders for, selling, supplying or offering to supply the Evelexa XR Products (or any other product comprising the same generic extended release formulation of venlafaxine hydrochloride) for use by persons in need of venlafaxine;
(b) applying to list the Evelexa XR Products (or any other product comprising the same extended release formulation of venlafaxine hydrochloride) on the Schedule of Pharmaceutical Benefits;
(c) authorising any other person to do any act referred to in sub-paragraphs (a) or (b) above; or
(d) procuring or inducing or joining in a common design with any other person to do any act referred to in sub-paragraphs (a), (b) or (c) above.
8. Within 14 days of the date of these orders the Applicant / Cross-Respondent destroy any Evelexa XR Products (or any other product comprising the same generic modified release formulation of venlafaxine hydrochloride) in Australia in the possession, power or control of the Applicant / Cross-Respondent.
9. Within 14 days of the date of these orders the Applicant / Cross-Respondent file and serve an affidavit verifying compliance with order 8 of these orders.
10. The Applicant / Cross-Respondent pay the Respondents / Cross-Claimants’ costs of and incidental to the proceeding, as agreed or taxed.
THE COURT CERTIFIES THAT
11. For the purpose of section 19 of the Patents Act 1990 (Cth), the validity of claims 1 to 28 of the Patent was questioned unsuccessfully in this proceeding.
THE COURT FURTHER:
12. ORDERS that orders 8, 9 and 11 above be stayed:
(a) initially until the date which is 14 days after the making of these orders; and
(b) if a notice of appeal to the Full Court of the Federal Court is filed within that period, until the determination of that appeal.
13. ORDERS the Applicant, during the currency of the stay in order 12 above, not to move, transfer, or otherwise deal in any Evelexa XR Products.
14. NOTES the undertaking of the Respondents / Cross-Claimants to the Court that, until further order, they will not make any application to de-list Efexor-XR from the Pharmaceutical Benefits Scheme.
15. ORDERS that the notice of motion filed 27 October 2010 be dismissed with costs.
Note:
2. The draft reasons for judgment provided to the parties on 23 September 2010 be published as the reasons for judgment, except for:
(a) the quote in [624]: 2nd paragraph last sentence, 4th paragraph after “excipients” to the end of the 4th paragraph, 5th paragraph last sentence;
(b) [628] 3rd to 6th sentences inclusive; and
(c) [629] 4th to 8th sentences inclusive
(together the confidential sentences).
3. The parties be provided with the reasons for judgment both as published and including the confidential sentences.
4. The confidential sentences be kept confidential by the parties (other than Alphapharm Pty Limited) and not be disclosed other than to their legal representatives and such other person as may be agreed to in writing by Alphapharm Pty Limited.
5. The Application be dismissed.
6. Orders 1 and 2 made on 25 August 2009 be discharged and the Respondents / Cross-Claimants be released from the undertakings given by them to the Court in relation to those orders, being undertakings:
(a) to submit to such order (if any) as the Court may consider to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person, whether or not a party, adversely affected by any operation of those orders or any continuation (with or without variation) thereof; and
(b) to pay the compensation referred to in (a) to the person there referred to; and
(c) until further order, not to make any application to de-list Efexor-XR from the Pharmaceuticals Benefits Scheme.
7. The Applicant / Cross-Respondent (whether by itself, its directors, servants, agents or otherwise) be restrained from infringing claims 1, 4, 5, 8, 9, 10, 15, 16 and 27 of the Patent, including, without limitation, by, in Australia, during the term of the Patent and without the licence or authority of the First Respondent / First Cross-Claimant:
(a) importing, marketing, taking orders for, selling, supplying or offering to supply the Enlafax-XR Products (or any other product comprising the same generic modified release formulation of venlafaxine hydrochloride) for use by persons in need of venlafaxine;
(b) importing, marketing, taking orders for, selling, supplying or offering to supply the Enlafax-XR Products (or any other product comprising the same generic modified release formulation of venlafaxine hydrochloride) together with the giving of, or the publication of advertisements containing, instructions or inducements for the use of the Enlafax-XR Products by persons in need of venlafaxine;
(c) applying to list the Enlafax-XR Products (or any other product comprising the same generic modified release formulation of venlafaxine hydrochloride) on the Schedule of Pharmaceutical Benefits;
(d) authorising any other person to do any act referred to in sub-paragraphs (a), (b), or (c) above; or
(e) procuring or inducing or joining in a common design with any other person to do any act referred to in sub-paragraphs (a), (b), (c) or (d) above.
8. Within 14 days of the date of this order the Applicant / Cross-Respondent destroy any Enlafax-XR Products (or any other product comprising the same generic modified release formulation of venlafaxine hydrochloride) in Australia in the possession, power or control of the Applicant / Cross-Respondent.
9. Within 14 days of the date of this order the Applicant / Cross-Respondent file and serve an affidavit verifying compliance with order 8 of these orders.
10. The Applicant / Cross-Respondent pay the Respondents / Cross-Claimants’ costs of and incidental to the proceeding, as agreed or taxed.
THE COURT CERTIFIES THAT:
11. For the purpose of section 19 of the Patents Act 1990 (Cth), the validity of claims 1 to 28 of the Patent was questioned unsuccessfully in this proceeding.
THE COURT FURTHER:
12. ORDERS that upon the undertaking noted in paragraph 13 below, orders 8, 9 and 11 above be stayed:
(a) initially until the date which is 14 days after the making of these orders; and
(b) if a notice of appeal to the Full Court of the Federal Court is filed within that period, until the determination of that appeal.
13. NOTES that the Applicant undertakes to the Court that, during the currency of the stay in order 12 above, it will not move, transfer, or otherwise deal in any Enlafax-XR Products.
14. NOTES the undertaking of the Respondents / Cross-Claimants to the Court that, until further order, they will not make any application to de-list Efexor-XR from the Pharmaceutical Benefits Scheme.
Note:
Background
Background to the litigation
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Evidence
Evidence Before The Court
Decision
Reasons for decision
Ratio Decidendi
Legal Principle Established
Full text does not contain this section.