InterPharma Pty Ltd v Hospira, Inc (No 5)

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FEDERAL COURT OF AUSTRALIA

InterPharma Pty Ltd v Hospira, Inc (No 5) [2019] FCA 960

File number: VID 885 of 2017
Judge: KENNY J
Date of judgment: 20 June 2019
Catchwords: PATENTS – dexmedetomidine in intensive care unit sedation – construction of claims – alleged invalidity of patent on grounds of lack of clarity, manner of manufacture, novelty, inventive step and fair basis – challenge to validity of patent rejected – whether proposed conduct threatened to infringe claims of patent prior to expiry – threatened infringement established
Legislation:

Evidence Act1995 (Cth) ss 69, 136

Patents Act 1990 (Cth) ss 7, 13, 18, 40, 117, 138, Sch 1

Statute of Monopolies 1623 (Imp) s 6

Therapeutic Goods Act 1989 (Cth) ss 3, 23

Cases cited:

Actavis UK Ltd v Janssen Pharmaceuticals NV [2008] EWHC 1422; FSR 35

Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444; [2009] 1 All ER 196

Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd [1998] HCA 19; 194 CLR 171

Ajinomoto Co Inc v NutraSweet Australia Pty Ltd [2008] FCAFC 34; 76 IPR 1; 166 FCR 530

Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411

Albany Molecular Research Inc v Alphapharm Pty Ltd [2011] FCA 120; 90 IPR 457

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) [2012] FCAFC 102; 96 IPR 185; 204 FCR 494

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50; 253 CLR 284

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99; 107 IPR 177; 226 FCR 324

AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30; 257 CLR 356

Austal Ships Sales Pty Ltd v Stena Rederi Aktiebolag [2008] FCAFC 121; 77 IPR 229

Beadcrete Pty Ltd v Fei Yu (t/as Jewels 4 Pools) (No 2) [2013] FCA 187; 100 IPR 188

Bristol-Myers Squibb Co v Baker Norton Pharmaceuticals Inc [1999] RPC 253

Bristol-Myers Squibb Co v F H Faulding & Co Ltd [2000] FCA 316; 97 FCR 524

Britax Childcare Pty Ltd v Infa-Secure Pty Ltd (No 4) [2015] FCA 651; 113 IPR 280

British Acoustic Films Ltd v Nettlefold Productions (1936) 53 RPC 221

British Dynamite Co v Krebs (1879) 13 RPC 190

C Van Der Lely NV v Bamfords Ltd (1962) 1A IPR 86; [1963] RPC 61

Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183

Commissioner of Patents v Emperor Sports Pty Ltd [2006] FCAFC 26; 67 IPR 488; 149 FCR 386

Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232

D’Arcy v Myriad Genetics Inc [2015] HCA 35; 258 CLR 334

Davies v Lazer Safe Pty Ltd [2018] FCA 702; 132 IPR 202

Davies v Lazer Safe Pty Ltd [2019] FCAFC 65

Electric and Musical Industries, Ltd v Lissen, Ltd [1938] 4 All ER 221; (1939) 56 RPC 23

Fei Yu t/as Jewels 4 Pools v Beadcrete Pty…

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Details
Case
[2019] FCA 960
Decision Date

CaseChat Overview and Summary

In this case, InterPharma Pty Ltd sought to challenge the validity of a patent held by Hospira, Inc, which related to the use of dexmedetomidine for sedation in intensive care units (ICU). The dispute came before the Federal Court of Australia. The central issues before the court were whether the patent was invalid on various grounds, including lack of clarity, manner of manufacture, novelty, inventive step, and fair basis. Additionally, the court needed to determine whether InterPharma's proposed conduct threatened to infringe the patent prior to its expiry.

The court first addressed the validity of the patent. It found that the claims of the patent were clearly disclosed in the specification and did not exceed the scope of the invention as described. The court rejected InterPharma's arguments that the patent lacked clarity, was not novel, did not involve an inventive step, or was not based on a fair basis. The court held that the claims of the patent were valid and sufficiently disclosed the use of dexmedetomidine for ICU sedation.

The court then turned to the issue of whether InterPharma's proposed conduct threatened to infringe the patent. The court found that InterPharma's actions indeed threatened to infringe the patent, as they involved the use of dexmedetomidine for ICU sedation, which was covered by the claims of the patent. The court held that InterPharma's threat to infringe the patent was established, and thus, the patent remained valid and enforceable.

In conclusion, the court rejected InterPharma's challenge to the validity of the patent and found that the patent remained valid and enforceable. The court ordered that the parties submit proposed minutes of orders and address the form of the orders and costs. The court also granted leave to amend the particulars of invalidity and set a deadline for the parties to inform each other of any confidentiality issues with the reasons. The question of costs was left to be determined on the papers unless a party wished to be heard orally.

Orders

Orders of the court

1. Pursuant to s 136 of the Evidence Act 1995 (Cth) the use of the following documents be limited to the use stated below:

(a) The document entitled “Abbott-85499 Dexmedetomidine Clinical Study Report: A Phase III, Multicenter, Double-Blind, Randomized, Comparative Study Evaluating The Effect of Two Doses of Dexmedetomidine Versus Placebo In Adult Patients Undergoing Elective Coronary Artery Bypass Graft(s) Surgery”, be admitted and used solely as evidence of the previous representations that the study identified as DEX-95-004:

(i) was a Phase III, Multicenter, Double-Blind, Randomized, Comparative Study Evaluating The Effect of Two Doses of Dexmedetomidine Versus Placebo In Adult Patients Undergoing Elective Coronary Artery Bypass Graft(s) Surgery;

(ii) (ii) was initiated on 2 January 1996 and completed on 7 December 1997; and

(iii) was conducted in compliance with Good Clinical Practice (GCP) guidelines.

(b) The document entitled “Abbott-85499 Dexmedetomidine Clinical Study Report: A Phase II, Single-Center, Two-Part Study Evaluating the Safety, Efficacy, and Dose Titratability of Dexmedetomidine in ICU Sedation” be admitted and used solely as evidence of the previous representations that the study identified as W97-249:

(i) was a Phase II, Single-Center, Two-Part Study Evaluating the Safety, Efficacy, and Dose Titratability of Dexmedetomidine in ICU Sedation;

(ii) was initiated on 14 January 1998 and completed on 12 March 1998; and

(iii) was conducted in compliance with GCP guidelines.

(b) The document entitled “Duke University Medical Center Institutional Review Board (IRB)” and an attached document entitled “Duke University Medical Center – Informed Consent for a Research Project: A Phase III, Multicenter, Double-Blind, Randomized, Comparative Study Evaluating The Effect of Two Doses of Dexmedetomidine Versus Placebo In Adult Patients Undergoing Elective Coronary Artery Bypass Graft(s) Surgery: DEX-95-004, Version 2” (Duke Form) be admitted and used solely as evidence of the previous representations that:

(i) the patient informed consent form that was approved by the IRB for use in the DEX-95-004 study at the Duke Medical Center was the Duke Form;

(ii) the DEX-95-004 study was a Phase III, Multicenter, Double-Blind, Randomized, Comparative Study Evaluating the Effect of Two Doses of Dexmedetomidine Versus Placebo In Adult Patients Undergoing Elective Coronary Artery Bypass Graft(s) Surgery; and

(iii) the approval was given for a period of one year terminating on 11 October 1996.

(c) The document entitled “Information for Patients: A phase II, single-center, two part study evaluating the safety, efficacy and dose titratability of Dexmedetomidine in ICU sedation”, having the protocol “W97-249”, version 5 (part 1) dated 14 January 1998 (249 Form) and correspondence dated 19 January 1998 on behalf of the Board of Directors of the Academic Hospital Utrecht be admitted and used solely as evidence of the previous representations that:

(i) the patient informed consent form that was approved for use in part 1 of the W97-249 study was the 249 Form; and

(ii) the W97-249 study was a Phase II, Single-Center, Two-Part Study Evaluating the Safety, Efficacy and Dose Titratability of Dexmedetomidine in ICU Sedation.

2. Leave be granted to amend the Third Further Amended Particulars of Invalidity in accordance with these reasons (delivered on 20 June 2019) (these reasons).

3. The Proposed Fourth Further Amended Particulars of Invalidity stand as the Fourth Further Amended Particulars of Invalidity to the extent leave is granted in Order 2 above.

4. By 4:00 pm on 4 July 2019, each party file and serve proposed minutes of orders reflecting the conclusions in these reasons and short submissions (limited to 3 pages) addressing:

(a) the form of the proposed orders; and

(b) costs (other than with respect to the interlocutory application filed on 12 January 2018).

5. By 2:00 pm on 21 June 2019, each party inform the other parties and the associate to Justice Kenny whether it has any confidentiality issue with these reasons.

6. Until 2:00 pm on 21 June 2019 or further order, these reasons not be made available to or published to any person other than the parties and their legal advisors.

7. The question of costs be determined on the papers unless a party wishes to be heard on that question orally.

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

Background

Background to the litigation

The application for the Patent was made on 31 March 1999. Issues of infringement and validity are therefore to be determined under the Patents Act, in the form in which it existed prior to, among other Acts, the Patents Amendment (Innovation Patents) Act 2000 (Cth), the Patents Amendment Act2001 (Cth), and the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth).The background to the invention The invention the subject of the Patent relates to the use of dexmedetomidine or a pharmaceutically acceptable salt thereof (referred to in these reasons as dexmedetomidine unless specified otherwise) in intensive care unit (ICU) sedation; a method of sedating a patient in the ICU by administering dexmedetomidine; and the use of that compound in the manufacture of a medicament for ICU sedation. The specification explains:In addition to the actual sedation of a patient in the ICU, the word sedation in the ICU context also includes the treatment of conditions that affect patient comfort, such as pain and anxiety. Also, the word intensive care unit includes any setting that provides intensive care.…The aim of ICU sedation is to ensure that the patient is comfortable, relaxed, and tolerates uncomfortable procedures such as placement of iv-lines or other catheters, but is still arousable. According to the specification:Particularly, the present invention relates to a method of sedating a patient while in the ICU by administering dexmedetomidine … wherein dexmedetomidine is essentially the sole active agent or the sole active agent administered for this purpose. The specification explains that ICU patients often receive a variety of drugs concurrently. It states: The agents used most commonly are given to achieve patient comfort. Various drugs are administered to produce anxiolysis (benzodiazepines), amnesia (benzodiazepines), analgesia (opioids), antidepression (antidepressants/benzodiazepines), muscle relaxation, sleep (barbiturates, benzodiazepines, propofol) and anaesthesia (propofol, barbiturates, volatile anaesthetics) for unpleasant procedures. These agents are cumulatively called sedatives in the context of ICU sedation, though sedation also includes the treatment of conditions that affect patient comfort, such as pain and anxiety, and many of the drugs mentioned above are not considered sedatives outside the context of ICU sedation. The specification describes the side effects associated with ICU sedatives as follows:The presently available sedative agents are associated with such adverse effects as prolonged sedation or oversedation (propofol and especially poor metabolizers of midazolam), prolonged weaning (midazolam), respiratory depression (benzodiazepines, propofol, and opioids), hypotension (propofol bolus dosing), bradycardia, ileus or decreased gastrointestinal motility (opioids), immunosuppression (volatile anaesthetics and nitrous oxide), renal function impairment, hepatotoxicity (barbiturates), tolerance (midazolam, propofol), hyperlipidemia (propofol), increased infections (propofol), lack of orientation and cooperation (midazolam, opioids, and propofol), and potential abuse (midazolam, opioids, and propofol).

Evidence

Evidence Before The Court

Claim 39 is a second omnibus claim, for a method according to claim 13 or 15 “substantially as hereinbefore described”. OVERVIEW OF WITNESS EVIDENCE Intensive care specialists Three specialists in intensive care medicine gave evidence at trial. They were: Professor Russell Booth Hall; Professor Rinaldo Bellomo; and Associate Professor (Assoc Professor) Craig John French. Professors Hall and Bellomo and Assoc Professor French met together on 2 May 2018, and created their Joint Expert Report (Joint Report). The Joint Report was in evidence. InterPharma called Professor Hall. Since 1981, Professor Hall has been an Attending Physician, Critical Care Services, at the University Of Chicago Pritzker School Of Medicine. Amongst other things, he holds a certification in Critical Care Medicine from the American Board of Internal Medicine and is a Member of the Society for Critical Care Medicine. He is an author or co-author of very many articles published in leading medical journals. Professor Hall had a specific interest in ICU sedation as at the priority date (April 1998). It may be accepted that his interest and knowledge about ICU sedation would have been significantly greater than that of the average ICU specialist at that time. Professor Hall’s research interest is particularly relevant to the invention of the Patent. He was a co-author of Kress 2000, a highly influential paper leading intensive care specialists to question the previously accepted practice of deep sedation (see [537], [549] below). He was also a co-author of Kress 1996 and Pohlman 1994 (see [550] below). Professor Hall is an experienced witness, who, on his own account, gives evidence in 15 to 20 cases a year, and has given evidence in United States (US) courts in two cases concerning the US equivalent of the Patent in suit. Pfizer called Professor Bellomo, who has been delivering intensive care medicine to patients in Australia for well over 25 years. Professor Bellomo is the Director of Intensive Care Research at the Austin Hospital and has worked and continues to work as an intensive care specialist at that hospital and other hospitals, including the Royal Melbourne Hospital (RMH) ICU. Since 2002 he has been a Professor in the Faculty of Medicine at the University of Melbourne and since 2016 he has been a Board Member of the Australian and New Zealand College of Intensive Care Medicine. Professor Bellomo came to intensive care medicine from a general physician’s background. Throughout his career, he has been engaged in clinical research in intensive care medicine, with a particular interest in the kidneys. He has an extensive list of publications, and has held editorial and reviewer positions for leading international medical journals, including US journals. Pfizer also called Assoc Professor French, who has been practising in both anaesthesia and intensive care medicine in Australia since 1995. Assoc Professor French was undergoing training in both anaesthesia and intensive care medicine between 1992 and 1997. He was working as an anaesthetics registrar during 1995 and, from midway through that year, as an intensive care registrar. In 1998, he was admitted to the Fellowship of the Faculty of Intensive Care of the Australian and New Zealand College of Anaesthetists.

Decision

Reasons for decision

Accordingly, I accept that the claims did not travel beyond the specification; and there was a real and reasonably clear disclosure in the body of the specification of the use of dexmedetomidine for ICU sedation across the complete spectrum of sedation achievable by the administration of that agent. CONCLUSION For the reasons stated, InterPharma threatened to infringe the Patent in suit prior to its expiry on 31 March 2019 and InterPharma’s challenge to the validity of the Patent should be rejected. The parties will be afforded an opportunity to submit minutes of orders in accordance with these reasons.

Ratio Decidendi

Legal Principle Established

Full text does not contain this section.