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Gilead Sciences Pty Ltd v Idenix Pharmaceuticals LLC

Gilead Sciences Pty Ltd v Idenix Pharmaceuticals LLC

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FEDERAL COURT OF AUSTRALIA
Gilead Sciences Pty Ltd v Idenix Pharmaceuticals LLC [2016] FCA 169

File number: NSD 48 of 2013

Judge: JAGOT J

Date of judgment: 2 March 2016

Catchwords:
PATENTS – novelty – whether claims of respondents’ patent fairly based on matter disclosed in priority documents – real and reasonably clear disclosure of the claims in the priority documents established – respondents’ patent entitled to priority date of priority document – respondents’ patent not invalid for lack of novelty

PATENTS – internal fair basis – whether claims of respondents’ patent fairly based on matter described in specification – real and reasonably clear disclosure of the claims in the specification established – respondents’ patent not invalid for lack of internal fair basis

PATENTS – sufficiency – whether respondents’ patent describes the invention fully – whether patent enables the skilled addressee to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty – insufficiency established

PATENTS – utility – whether claims of the respondents’ patent useful – certain claims of respondents’ patent invalid for inutility

PATENTS – manner of manufacture – respondents’ patent not invalid on basis of a lack of a manner of manufacture

PATENTS – false suggestion – respondents’ patent not invalid on basis of false suggestion

Legislation:
Evidence Act 1995 (Cth) s 140

Patents Act 1990 (Cth) ss 18, 40, 43, 138

Federal Court Rules 2011 (Cth) r 34.50

Patents Regulations 1991 (Cth) reg 3.12

Cases cited:
Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; (2002) 212 CLR 411

Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559; (2008) 76 IPR 618

American Home Products Corp v Novartis Pharmaceuticals UK Limited [2000] RPC 547

AMP Inc v Utilux Pty Ltd (1971) 45 ALJR 123

Apotex Pty Ltd v Sanofi-Aventis [2008] FCA 1194; (2008) 78 IPR 485

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99; (2014) 226 FCR 324

AstraZeneca AB v Apotex Pty Ltd; AstraZeneca AB v Watson Pharma Pty Ltd; AstraZeneca AB v Ascent Pharma Pty Ltd [2015] HCA 30

Atlantis Corporation Pty Ltd v Schindler (1997) 39 IPR 29

Austal Ships Pty Ltd v Stena Rederi Aktiebolag [2005] FCA 805; (2005) 66 IPR 420

Bickford v Skewes (1835) 1 QB 938

Biogen Inc v Medeva PLC [1997] RPC 1

British Thomson-Houston Co Ltd v Corona Lamp Works Ltd (1922) 39 RPC 49

Burroughs Corp (Perkins’) Application [1974] RPC 147

CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260

Chiron Corporation v Murex Diagnostics Ltd [1996] RPC 535

Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd (1987) 15 FCR 382

D’Arcy v Myriad Genetics Inc [2015] HCA 35; (2015) 325 ALR 100

Decor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385

Edison and Swan Electric Light Co v Holland (1889) 6 RPC 243

Eli Lilly and Co v Pfizer Overseas Pharmaceuticals [2005] FCA 67; (2005) 218 ALR 408

Expo-Net Danmark…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2016] FCA 169
Decision Date: 2 March 2016

CaseChat Overview and Summary

The matter in Gilead Sciences Pty Ltd v Idenix Pharmaceuticals LLC was heard by Justice Gilmour of the Federal Court of Australia. Gilead challenged the validity of a patent held by Idenix, asserting various grounds including lack of novelty, internal fair basis, sufficiency, utility, manner of manufacture, and false suggestion. The central issue was whether Idenix's patent was valid and enforceable or if it should be invalidated on the grounds presented by Gilead.

The court examined whether the claims of Idenix's patent were adequately supported by the priority documents and the specification. It was determined that the priority documents provided a real and reasonably clear disclosure of the claims, thus establishing the patent's entitlement to the priority date. Furthermore, the specification sufficiently disclosed the invention, thereby satisfying the requirement for internal fair basis. However, the court found that some claims were insufficiently described, leading to their invalidation on that ground. Regarding utility, certain claims were deemed invalid because they did not demonstrate practical usefulness. The court also rejected Gilead's claims of invalidation on the grounds of lack of manner of manufacture and false suggestion, finding no merit in these arguments.

The court's reasoning concluded that while some claims of Idenix's patent were invalidated due to insufficiency and inutility, Gilead's other challenges were unsuccessful. The judge directed the parties to confer and submit agreed or competing orders within 14 days to reflect these findings. The court’s decision provided clarity on the validity of specific claims while dismissing the majority of Gilead's objections.

Orders

Orders of the court

1. The parties confer and file agreed or competing orders reflecting these reasons for judgment within 14 days.

Background

Background to the litigation

Full text does not contain this section.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

I do not accept Gilead’s case that the Idenix patent was obtained by false suggestion or misrepresentation.11. CONCLUSIONS For the reasons set out above I am satisfied that Gilead’s challenges to the validity of the Idenix patent should be accepted in respect of the grounds of insufficiency and inutility to the extent that claim 7 includes compounds which cannot be made. I do not accept the balance of Gilead’s contentions. The parties should confer and submit agreed or competing orders reflecting these reasons for judgment within 14 days.

Ratio Decidendi

Legal Principle Established

Full text does not contain this section.

File number:	NSD 48 of 2013
Judge:	JAGOT J
Date of judgment:	2 March 2016
Catchwords:	PATENTS – novelty – whether claims of respondents’ patent fairly based on matter disclosed in priority documents – real and reasonably clear disclosure of the claims in the priority documents established – respondents’ patent entitled to priority date of priority document – respondents’ patent not invalid for lack of novelty PATENTS – internal fair basis – whether claims of respondents’ patent fairly based on matter described in specification – real and reasonably clear disclosure of the claims in the specification established – respondents’ patent not invalid for lack of internal fair basis PATENTS – sufficiency – whether respondents’ patent describes the invention fully – whether patent enables the skilled addressee to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty – insufficiency established PATENTS – utility – whether claims of the respondents’ patent useful – certain claims of respondents’ patent invalid for inutility PATENTS – manner of manufacture – respondents’ patent not invalid on basis of a lack of a manner of manufacture PATENTS – false suggestion – respondents’ patent not invalid on basis of false suggestion
Legislation:	Evidence Act 1995 (Cth) s 140 Patents Act 1990 (Cth) ss 18, 40, 43, 138 Federal Court Rules 2011 (Cth) r 34.50 Patents Regulations 1991 (Cth) reg 3.12
Cases cited:	Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; (2002) 212 CLR 411 Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559; (2008) 76 IPR 618 American Home Products Corp v Novartis Pharmaceuticals UK Limited [2000] RPC 547 AMP Inc v Utilux Pty Ltd (1971) 45 ALJR 123 Apotex Pty Ltd v Sanofi-Aventis [2008] FCA 1194; (2008) 78 IPR 485 AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99; (2014) 226 FCR 324 AstraZeneca AB v Apotex Pty Ltd; AstraZeneca AB v Watson Pharma Pty Ltd; AstraZeneca AB v Ascent Pharma Pty Ltd [2015] HCA 30 Atlantis Corporation Pty Ltd v Schindler (1997) 39 IPR 29 Austal Ships Pty Ltd v Stena Rederi Aktiebolag [2005] FCA 805; (2005) 66 IPR 420 Bickford v Skewes (1835) 1 QB 938 Biogen Inc v Medeva PLC [1997] RPC 1 British Thomson-Houston Co Ltd v Corona Lamp Works Ltd (1922) 39 RPC 49 Burroughs Corp (Perkins’) Application [1974] RPC 147 CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 Chiron Corporation v Murex Diagnostics Ltd [1996] RPC 535 Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd (1987) 15 FCR 382 D’Arcy v Myriad Genetics Inc [2015] HCA 35; (2015) 325 ALR 100 Decor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 Edison and Swan Electric Light Co v Holland (1889) 6 RPC 243 Eli Lilly and Co v Pfizer Overseas Pharmaceuticals [2005] FCA 67; (2005) 218 ALR 408 Expo-Net Danmark…