Odette Gourley, Corrs Chambers Westgarth - New Approaches and Challenges for Pharma and Biosimilar Patent Litigation

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Odette Gourley delivered the presentation at 2014 Pharmaceutical Law Conference.

The Pharmaceutical Law Conference is the foremost meeting place and networking hub of the pharmaceutical law industry, and the only pharmaceutical law event in the Asia-Pacific region. The 2014 event highlights included pharma law reform, IP, competitive strategies, industry transparency, sustainable drug pricing and patenting life sciences and more.

For more information about the event, please visit: http://www.informa.com.au/pharmalawevent14

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Odette Gourley, Corrs Chambers Westgarth - New Approaches and Challenges for Pharma and Biosimilar Patent Litigation

  1. 1. 1 NEW APPROACHES AND CHALLENGES FOR PHARMA AND BIOSIMILAR PATENT LITIGATION May 2014 Odette Gourley Partner Corrs Chambers Westgarth odette.gourley@corrs.com.au +61 2 9210 6066
  2. 2. 22 Agenda • Urgent injunction applications for Biosimilars • Non-infringement declarations • Too much point taking in pharma patent litigation? MAY 2014
  3. 3. 33 Urgent injunction applications for biosimilars • Urgent injunction requirements are arguable case of infringement, irreparable harm and balance of convenience favouring restraint pending trial • More often than not met for small molecules • Risk of immediate irreversible reimbursed price drop and market share and profitability loss MAY 2014
  4. 4. 44 Urgent injunction applications for biosimilars • By the way, not always: Hospira v Sanofi 2010 • Docetaxol anti-cancer drug • Unexplained delay by patentee after early lawyer notice correspondence with full particulars and active follow up • Special features of cancer chemotherapy – no automatic price drop, consequences of price disclosure unclear, market share loss would not be marked given lack of competition MAY 2014
  5. 5. 55 Urgent injunction applications for biosimilars • All circumstances are relevant so what about biologic generics • Arguable case of infringement – may be less clear given complexity resulting from differences over the originator product • Market circumstances may affect likelihood of irreparable harm and balance of convenience MAY 2014
  6. 6. 66 Urgent injunction applications for biosimilars • Both products may compete side by side with limited price changes • Slower rate of conversion of market from the originator product to the biosimilar • Additional public benefit arguments because the new product is not the same (less side effects, improved compliance etc) MAY 2014
  7. 7. 77 Non-infringement declarations • A possible new approach for all generics • A generic may seek a declaration that its conduct does not or would not infringe a patent • Procedure reformed in the 2013 Raising the Bar amendments • Had previously been rarely used and not with success MAY 2014
  8. 8. 88 Non-infringement declarations • The process involves the provision of full particulars of the conduct • The generic must be prepared to pay for the patentee to get an opinion on infringement (not a big deal in the circumstances) • If the patentee refuses to make an admission of non-infringement, a declaration may be sought from the Court • Costs orders flow as is appropriate from the outcome; previously, the patentee always got its costs, win or lose MAY 2014
  9. 9. 99 Non-infringement declarations • The procedure provides an option for early testing of an infringement argument • If the declaration is granted or admission given, the generic is protected against damages/profits if infringement later established MAY 2014
  10. 10. 1010 Non-infringement declarations • Seems to be assumed, however, that patentee does not participate (because if they did and declaration granted, it is does not seem likely the declaration would often be later revoked) • More likely that the declaration prompts an infringement suit and an invalidity challenge but the tactics may vary from case to case and the ability to initiate a formal process, or threaten it, will be useful • After the reforms, no barrier to seeking a non-infringement declaration and orders for revocation of a patent in the one proceeding (Eli Lilly v Generic Health 2013) – Justice Nicholas MAY 2014
  11. 11. 1111 Non-infringement declarations • The tactics need careful consideration case by case • Eg failure to seek non-infringement declaration may be relevant to the balance of convenience • Consider Hospira v Sanofi 2010 – would the court have expected Hospira to go further than its correspondence and use the procedure? • The judges are alive to it: Eli Lilly v Generic Health 2013: the non- infringement declaration has new life MAY 2014
  12. 12. 1212 Too much point taking in pharma patent cases? • Is there a new challenge in the Court seeking to limit the parties’ freedom to run the case as they choose? • “I don’t see I should let you do this now. That’s not right I mean that is not the way to run litigation in the 21st century. It does not achieve the over arching purpose of getting to the real issues as quickly, inexpensively and as sufficiently as possible. It is, in fact, complete evasion of that obligation ... I mean, the court has only got so much time to deal with very well resourced, very rich, very knowledgeable litigants who know perfectly well what the case was about I’m just not going to let this blow out ... it’s not right ... because ... this is a real problem for litigation [in patent cases].” MAY 2014
  13. 13. 1313 Too much point taking in pharma patent cases? • Children’s Panadol case study • Nurofen for Children Australian patent for a liquid dosing apparatus comprising a bottle, a bottle neck liner and a flat nosed syringe MAY 2014
  14. 14. 1414 Too much point taking in pharma patent cases? MAY 2014
  15. 15. 1515 Too much point taking in pharma patent cases? Claim 1: A liquid dispensing apparatus comprising a bottle, a bottle neck liner and a flat- nosed syringe having a plunger and a barrel, the barrel terminating at its distal end in a generally flat face having a diameter corresponding to the diameter of the syringe barrel and being perpendicular to the longitudinal axis of the barrel, the bottle having a bottle neck in which is located the bottle neck liner having a cylindrical body sealingly engaged inside the bottle neck such that liquid cannot flow between the bottle neck liner and the bottle neck, the bottle neck liner comprising a sleeve comprising at its lower end an inward step located within the bottle neck, an aperture being defined inwardly of the inward step, wherein the cylindrical body and the sleeve are connected together with a web of material only at the upper end of the cylindrical body and of the sleeve, wherein the sleeve is formed with a flared portion at its upper end into which the distal end of the syringe barrel passes; wherein when the syringe barrel is inserted into the sleeve the inward step prevents the syringe barrel from protruding past the step and liquid cannot flow between the sleeve and the barrel, but can leave the bottle only via the aperture and thence the syringe. MAY 2014
  16. 16. 1616 Too much point taking in pharma patent cases? • New Children’s Panadol launched - March 2013 • Letter before action - 22 April 2013 • Proceedings commenced - 2 May 2013 MAY 2014
  17. 17. 1717 Too much point taking in pharma patent cases? • Interlocutory injunction hearing – 27 - 28 May 2013 • There was an arguable case on infringement, in particular, that the bottle neck liner had a flared portion with the features in the claim MAY 2014
  18. 18. 1818 Too much point taking in pharma patent cases? • Validity – arguments on novelty and entitlement weak on the present evidence • Balance of convenience – finely balanced but relatively easy to change the Children’s Panadol product • Interlocutory injunction granted - 28 May 2013 MAY 2014
  19. 19. 1919 Too much point taking in pharma patent cases? • Syringe component in the Children’s Panadol liquid dosing apparatus changed – 31 May 2013 MAY 2014
  20. 20. 2020 Too much point taking in pharma patent cases? • Second interlocutory injunction hearing – 17 July 2013 • Arguable case of infringement • The patent claim did not require that the barrel of the syringe have the same diameter all the way along and Panadol’s argument that the syringe had a tip or nozzle rather than a flat face was not the better argument, at the interlocutory stage • Children’s Panadol not permitted to add new evidence on balance of convenience • Interlocutory injunction granted – 17 July 2013 MAY 2014
  21. 21. 2121 Too much point taking in pharma patent cases? • Children’s Panadol urgent application for leave to appeal - 22 July 2013 • (Also, approach by Children’s Panadol to the trial judge to stand aside for apparent bias through pre-judgement – 9 August 2013 – see more later) • Full Court granted leave and allowed the appeal – 2 September 2013 • Children’s Panadol’s argument on the new syringe was the better argument • The Trial Judge was wrong not to allow additional balance of convenience evidence MAY 2014
  22. 22. 2222 Too much point taking in pharma patent cases? • Application to have the Judge stand aside heard - 19 September 2013 • Application heard - 26 and 27 September 2013 • Application dismissed - 27 September • Urgent application for leave to appeal and appeal – 11 October 2013 • Full Court hearing – application for leave refused - 4 December 2013 MAY 2014
  23. 23. 2323 Too much point taking in pharma patent cases? • The alleged apparent pre-judgement related to comments about an expert and about the construction of the claim • Eg “This is just nonsense isn’t it ... I mean, really, this is just a general medical use ... and, it doesn’t apply to all syringes. So how on earth can this be addressed to this particular kind of syringe.” MAY 2014
  24. 24. 2424 Too much point taking in pharma patent cases? • Full Court decision • The judge had not expressed an adverse view about the witness’s credibility • Merely an application for an interlocutory not a permanent injunction, with the primary judge deciding the point of construction at a prima facie level and on limited evidence • The debate between bench and bar revealed in the transcript was robust but readily understood by the fair-minded lay observer as part of the process of quickly coming to grips and testing arguments • Nothing suggested a judicial mind incapable of alteration or having a fixed view MAY 2014
  25. 25. 2525 Too much point taking in pharma patent cases? • Case on trial on Monday for two weeks • What are the learnings? • Do we need a new approach? • Unlikely that litigants will drive change • Will the court drive change? MAY 2014
  26. 26. 2626 Questions and comments MAY 2014
  27. 27. 2727 Thank you for attending Odette Gourley Partner Corrs Chambers Westgarth odette.gourley@corrs.com.au +61 2 9210 6066 NEW APPROACHES AND CHALLENGES FOR PHARMA AND BIOSIMILAR PATENT LITIGATION MAY 2014

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