Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) [2016] FCA 1238

Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) [2016] FCA 1238

The patent claims were valid and enforceable. The specification was sufficient to enable a person skilled in the art to perform the invention in humans without the need for further invention or undue burden. The invention was useful in that administering pregabalin or relevant compounds would offer therapeutic benefit to patients with pain, even if minimal in some pain types, and even if more effective treatments existed. No material misrepresentation or false suggestion was made to the Patent Office that materially contributed to the grant. Importation and sale in Australia of products made by the patented process overseas infringes the Swiss claims because those acts occur within the...

Parties
Applicant / Cross Respondent (nsd 763 of 2013): Apotex Pty Ltd; Respondent / First Cross Claimant (nsd 763 of 2013); First Applicant / First Cross Respondent (nsd 251 of 2014): Warner-Lambert Company LLC; Second Cross Claimant (nsd 763 of 2013); Second Applicant / Second Cross Respondent (nsd 251 of 2014): PF PRISM CV; Third Cross Claimant (nsd 763 of 2013); Third Applicant / Third Cross Respondent (nsd 251 of 2014): Pfizer Ireland Pharmaceuticals; Fourth Cross Claimant (nsd 763 of 2013); Fourth Applicant / Fourth Cross Respondent (nsd 251 of 2014): Pfizer Asia Pacific Pte Ltd; Fifth Cross Claimant (nsd 763 of 2013); Fifth Applicant / Fifth Cross Respondent (nsd 251 of 2014): Pfizer Australia Pty Ltd (ACN 008 422 348); Respondent / Cross Claimant (nsd 251 of 2014); Sixth Applicant (nsd 251 of 2014): Generic Partners Pty Ltd (ACN 132 833 777)
Jurisdiction
Australia
Judgment Date
21 October 2016
Procedural Posture
Federal Court Patent Infringement and Revocation Proceedings / Judgment After Trial: Liability, Validity and Construction
Outcome
Challenges to the validity of claims 1 to 32 rejected; Pfizer entitled to quia timet injunctive relief for threatened infringement by Apotex for claims 1-31 and by GPPL for claims 1-30; both proceedings stood over for final orders.
Legal Topics
Patent Validity, Patent Infringement, Patent Construction, Utility (usefulness), Sufficiency of Disclosure, Entitlement, False Suggestion or Misrepresentation
Intellectual Property Patents Patent Validity Patent Infringement Patent Construction Utility (usefulness) Sufficiency of Disclosure Entitlement +1 more

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Parties

Apotex Pty Ltd

Applicant / Cross Respondent (nsd 763 of 2013)

Warner-Lambert Company LLC

Respondent / First Cross Claimant (nsd 763 of 2013); First Applicant / First Cross Respondent (nsd 251 of 2014)

PF PRISM CV

Second Cross Claimant (nsd 763 of 2013); Second Applicant / Second Cross Respondent (nsd 251 of 2014)

Pfizer Ireland Pharmaceuticals

Third Cross Claimant (nsd 763 of 2013); Third Applicant / Third Cross Respondent (nsd 251 of 2014)

Pfizer Asia Pacific Pte Ltd

Fourth Cross Claimant (nsd 763 of 2013); Fourth Applicant / Fourth Cross Respondent (nsd 251 of 2014)

Pfizer Australia Pty Ltd (ACN 008 422 348)

Fifth Cross Claimant (nsd 763 of 2013); Fifth Applicant / Fifth Cross Respondent (nsd 251 of 2014)

Generic Partners Pty Ltd (ACN 132 833 777)

Respondent / Cross Claimant (nsd 251 of 2014); Sixth Applicant (nsd 251 of 2014)

Procedural Posture

Federal Court Patent Infringement and Revocation Proceedings / Judgment After Trial: Liability, Validity and Construction

Legal Issues

  1. 1 Construction of patent claims relating to methods for treating pain using certain compounds (including pregabalin)
  2. 2 Whether the patent was obtained by false suggestion or misrepresentation
  3. 3 Whether the patent specification fully describes the invention as required by statute

Ratio Decidendi

The patent claims were valid and enforceable. The specification was sufficient to enable a person skilled in the art to perform the invention in humans without the need for further invention or undue burden. The invention was useful in that administering pregabalin or relevant compounds would offer therapeutic benefit to patients with pain, even if minimal in some pain types, and even if more effective treatments existed. No material misrepresentation or false suggestion was made to the Patent Office that materially contributed to the grant. Importation and sale in Australia of products made by the patented process overseas infringes the Swiss claims because those acts occur within the...

Court Disposition

Challenges to the validity of claims 1 to 32 rejected; Pfizer entitled to quia timet injunctive relief for threatened infringement by Apotex for claims 1-31 and by GPPL for claims 1-30; both proceedings stood over for final orders.

Orders

  • The relevant parties are to file and serve a draft minute of final orders within 7 days.
  • The proceedings are stood over to a date to be fixed for making final orders.