Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth

Link copied
Case Copied 64 min read

FEDERAL COURT OF AUSTRALIA

Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2010] FCA 1211

Citation: Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2010] FCA 1211
Parties:

SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LTD v WYETH and WYETH AUSTRALIA PTY LIMITED

ALPHAPHARM PTY LIMITED v WYETH and WYETH AUSTRALIA PTY LIMITED

GENERIC HEALTH PTY LTD v WYETH and WYETH AUSTRALIA PTY LIMITED

File numbers: VID 195 of 2009
NSD 596 of 2009
NSD 1124 of 2009
Judge: JAGOT J
Date of judgment: 8 November 2010
Catchwords:

PATENTS – validity – priority date – whether claims fairly based on matter disclosed in body of specification – whether invention sufficiently described – whether claims clear

PATENTS – validity – inventive step – obviousness – whether claims lacked an inventive step compared with prior art base – commercial success

PATENTS – revocation of patent – whether patent obtained by false suggestion or misrepresentation – entitlement – whether claimed invention is useful

PATENTS – infringement

Legislation: Patents Act 1990 (Cth)
Cases cited: Aktiebolaget Hässle v Alphapharm Pty Limited (2002) 212 CLR 411; [2002] HCA 59
Alphapharm Pty Ltd v H Lundbeck A/S (2008) 76 IPR 618; [2008] FCA 559
Alphapharm Pty Ltd v Wyeth (2009) 82 IPR 71; [2009] FCA 945
Apotex Pty Ltd (formerly GenRx Pty Ltd) v Sanofi-Aventis (2008) 78 IPR 485; [2008] FCA 1194
Apotex Pty Ltd v Sanofi-Aventis (2009) 82 IPR 416; [2009] FCAFC 134
Atlantis Corporation Pty Ltd v Schindler (1997) 39 IPR 29
BP Exploration Co (Libya) Ltd v Hunt [1980] 1 NSWLR 496
Commercial Union Assurance Company of Australia v Ferrcom Pty Ltd (1991) 22 NSWLR 389
EI Du Pont de Nemours and Company v ICI Chemicals & Polymers Ltd (2005) 66 IPR 462; [2005] FCA 892
Fresenius Medical Care Australia Pty Ltd v Gambro Pty Ltd (2005) 224 ALR 168; [2005] FCAFC 220
H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151; [2009] FCAFC 70
ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc (1999) 45 IPR 577; [1999] FCA 345
ITW AFC Pty Ltd v Loi & Tran Pty Ltd (2008) 76 IPR 129; [2008] FCA 552
JMVB Enterprises Pty Ltd (formerly known as A’Van Campers Pty Ltd) v Camoflag Pty Ltd (2005) 67 IPR 68; [2005] FCA 1474
Jones v Dunkel (1958) 101 CLR 298
Kimberly-Clark Australia Pty Limited v Arico Trading International Pty Limited (2001) 207 CLR 1; [2001] HCA 8
Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126
Lockwood Security Products Pty Limited v Doric Products Pty Limited (No 1) (2004) 217 CLR 274; [2004] HCA 58
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (2007) 235 CLR 173; [2007] HCA 21
Martin v Scribal Pty Ltd (1954) 92 CLR 17
Merck & Co Inc v Arrow Pharmaceuticals Ltd (2006) 68 IPR 511; [2006] FCAFC 91
Microsoft Corporation v PC Club Australia Pty Ltd (2005) 148 FCR 310; [2005] FCA…
CaseChat AU logo

Keep reading for free

Create a free CaseChat account to read Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth and more:

  • Read every judgment in full
  • Ask AI and get answers linked to paragraphs
  • See how each paragraph was cited in later cases
  • Download judgments as PDF or Word
Continue with Google

One click creates your free account or signs you in.

By continuing you agree to the Terms and Privacy Policy.

Details
Case
[2010] FCA 1211
Decision Date

CaseChat Overview and Summary

Sigma Pharmaceuticals (Australia) Pty Ltd and Generic Health Pty Ltd (collectively referred to as "the applicants") sought to have the patent held by Wyeth, which covers a method of administering venlafaxine hydrochloride, revoked. The applicants also sought a declaration that they had not infringed the patent and an injunction preventing Wyeth from enforcing the patent against them. Wyeth, in turn, claimed that the applicants had infringed the patent and sought an injunction preventing the applicants from continuing to infringe, as well as damages and an account of profits.

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

Full text does not contain this section.

Evidence

Evidence Before The Court

Other amendments (both by deletion and addition) were made to the specification before that part of the document describing the four examples of venlafaxine hydrochloride extended release capsules and the claims (which were also amended). C OVERVIEW OF EVIDENCE The central witnesses in the proceeding and matters dealt with in their evidence are set out below. C1 Professor Charman Professor Neil Charman graduated with a Bachelor of Pharmacy from the Victorian College of Pharmacy in 1981. He became a Doctor of Philosophy (PhD) in pharmaceutical chemistry in 1985. Between 1983 and 1985 he was a graduate research assistant at the University of Kansas. From 1986 to 1987 he was employed at the Sterling-Winthrop Research Institute, as a senior research scientist in the Department of Pharmaceutical Sciences. He was promoted to Institute Group Leader in 1988. He returned to Australia in 1989 to take up the position of senior lecturer in Pharmaceutics in the Department of Pharmaceutics, Victorian College of Pharmacy, Monash University. From 1989 to 1995 he held the positions of senior lecturer, was then appointed Personal Chair as Professor of Pharmaceuticals (June 1995 to December 2006), and Associate Dean (Research) (March 1999 to March 2002). In January 2007 he was appointed Dean of the Victorian College of Pharmacy, Monash University and Director of the Monash Institute of Pharmaceutical Sciences, Monash University. He continues to hold both positions although the Victorian College of Pharmacy has been re-named as the Faculty of Pharmacy and Pharmaceutical Sciences. According to Professor Charman the Faculty of Pharmacy and Pharmaceutical Sciences, Monash University is the “most successful, largest and most experienced pharmaceutical sciences research program in Australia”. Professor Charman’s major research areas include:(a)lead optimisation and absorption, distribution, metabolism and excretion (ADME) studies for new drug candidates including metabolic profiling, bioavailability and pharmacokinetic assessment, toxicokinetic assessment and preformulation assessment. These programs typically involve extensive collaborations between the disciplines of drug discovery, medicinal chemistry and biological scientists;(b)a multidisciplinary and collaborative approach to address major issues in drug discovery, drug delivery and the pharmaceutical sciences, especially in the field of malaria and neglected diseases. These studies typically involve the lead optimisation and compound design using a variety of structural biology, in vitro activity and in vivo animal models, pharmacokinetic and metabolic studies and early stage exploratory toxicology studies;(c)the use of lipids and lipidic excipients to enhance the oral bioavailability of poorly absorbed drugs. This includes formulation design, physiochemical approaches to enhanced absorption and the assessment of the effects of lipids and lipidic excipients on biological factors;(d)lymphatic drug transport and the major factors that can be manipulated, or exploited, to increase intestinal drug transport. This work includes assessment of the effects of post-prandial plasma lipoproteins on drug metabolism and drug clearance; and(e)the integration of interfacial and colloidal chemistry for the optimal design and evaluation of multiphase pharmaceutical formulations which include microemulsions, self-emulsifying lipid emulsions, interactive solids and a variety of colloidal-based formulations.

Decision

Reasons for decision

According to Wyeth this evidence (subject to the hydrogel argument) is sufficient to establish infringement of claims 1, 4, 5, 8, 9, 10, 15, 16 and 27 of the patent in that:Such infringement arises:(a)pursuant to s 117 of the Act, on the basis that the products are capable of only one reasonable use (s 117(2)(a)); there is reason to believe that the products, not being staple commercial products, will be used in the manner referred to (s 117(2)(b)); and because such use will be use in accordance with instructions or inducements given for the use of the products (s 117(2)(c));(b) by authorisation pursuant to s 13(1) of the Act; and (c) at common law, under the principles of joint tortfeasorship.M2 Conclusions on infringement Insofar as the applicants relied on arguments essentially of construction (150 ng/ml and therapeutic blood plasma concentration) Wyeth’s submissions must be accepted. It is clear from Professor Charman’s evidence read with the applicants’ product information that the use of the applicants’ products would infringe the claims of the patent on which Wyeth relies. The evidence supports an inference that the applicants themselves have reason to believe that a significant proportion of patients will have a Cmax of less than 150 ng/ml after administration of their product and that a therapeutic (that is, clinically effective) blood plasma concentration of venlafaxine will be achieved. In other words, and consistent with Wyeth’s case, the only defence of substance is the hydrogel argument. The difficulty for Alphapharm and Generic Health is that, assuming their products to use hydrogel tablet technology within the meaning of the patent, there is no sound basis to construe the words “a single daily dosing formulation of venlafaxine hydrochloride” as meaning “a single daily dosing formulation (not utilising hydrogel tablet technology)”. Those words of limitation cannot be read into the claims by reference to the specification. The reference in the claims to “a single daily dosing formulation of venlafaxine hydrochloride” is not unclear. The scope of those words cannot be read down by reference to the specification (Welch Perrin and Company Proprietary Limited v Worrel (1961) 106 CLR 588 at 610). In contrast to the observation in H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151; [2009] FCAFC 70 at [120] on which Alphapharm and Generic Health relied, this is not a case where the words in question have no positive meaning thereby enabling recourse to the text of the specification to ascertain the nature of the invention. If such recourse may be had, the specification construed as a whole also does not support the construction for which Alphapharm and Generic Health contend. The specification discloses that the invention is the method. The particular formulation is one embodiment of the method of the invention which, in contrast to the inventor’s attempts to use hydrogel tablet technology, proved practical for use in the method of the invention. In this context, the words “a single daily dosing formulation of venlafaxine hydrochloride” cannot be construed to mean “a single daily dosing formulation (not utilising hydrogel tablet technology)”.

Ratio Decidendi

Legal Principle Established

Full text does not contain this section.