Gliknik, Inc. v CSL Behring Lengnau AG - [2020] APO 46

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Gliknik, Inc. v CSL Behring Lengnau AG [2020] APO 46

Patent Application: 2012392760

Title:Immunomodulatory Proteins

Patent Applicant:                   CSL Behring Lengnau AG
Opponent:  Gliknik, Inc
Delegate:  Felix White
Decision Date:  12 October 2020
Hearing Date:  8 July 2020, by videoconference

Catchwords: PATENTS – recombinant Fc hexamer as a substitute for intravenous immunoglobulin – section 59 – opposition to grant of a patent – grounds of lack of manner of manufacture, lack of novelty, lack of inventive step, best method, clarity, support, clear and complete enough disclosure – consideration of reg 5.23 – plausibility of methods of treatment and “Swiss” claims - opposition successful on grounds of lack of support and clear and complete enough disclosure but fails on other grounds– opportunity to amend – costs awarded to opponent

Representation: Applicant appeared by written submissions filed on 1 July 2020
Patent attorneys for the applicant: Griffith Hack

Patent attorney for the opponent: Anthony Shaw, Allens

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2012392760

Title:Immunomodulatory Proteins

Patent Applicant:                   CSL Behring Lengnau AG
Date of Decision:                   12 October 2020
DECISION
The opposition succeeds on the grounds of lack of support and clear and complete enough disclosure.
The applicant is given a period of two (2) months to file amendments under s104.
Costs according to Schedule 8 are awarded against CSL Behring Lengnau AG
REASONS FOR DECISION
Background
1.    Patent application 2012392760 (the application) is the Australian national phase entry of PCT/GB2012/052561 filed in the name of the Liverpool School of Tropical Medicine. The application enjoys the international filing date of 17 October 2012 and does not claim any earlier priority. The application was subsequently assigned to CSL Behring Lengnau AG (the applicant) which assignment was recorded at IP Australia on 1 November 2019.

2.    The application was examined and advertised as accepted on 28 June 2018 after two adverse examination reports. The complete specification at issue is AU 2012392760 B2 (the specification).
3.    Gliknik Inc. (the Opponent) filed a notice of opposition under s 59[1] on 28 September 2018.

[1] References to legislation and regulations are to the Patents Act 1990 (“the Act”) and the Patents Regulations 1991 (“the Regulations”) unless indicated otherwise.
4.    The statement of grounds and particulars (SG&P) was filed on 8 January 2019. An amendment to the SG&P to add two additional citations (D14 and D15) was allowed on 4 December 2019.
Evidence
5.    The parties relied upon evidence as set out in the table below.

Evidence Declarant Date of Declaration Reference Exhibits

In support Dr. Anthony Shaw 2 April 2019 Shaw #1 ALS-1 to ALS-17[2]

In answer Dr. Beate Peter 3 July 2019 Peter BP1 to BP9[3]

Sarah Cox 3 July 2019 Cox SC1

In reply Dr Anthony Shaw 4 September 2019 Shaw #2 ALS-18 to ALS-19
[2] The Opponent’s exhibits included a number of citations that are referred to with D numbers as follows:

D1 (WO2011/073692) ALS-5 D2 (WO2008/151088)

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: [2020] APO 46
Decision Date: 12 October 2020

CaseChat Overview and Summary

The case of Gliknik, Inc. v CSL Behring Lengnau AG before the Federal Court of Australia involves an opposition to the grant of a patent for a recombinant Fc hexamer as a substitute for intravenous immunoglobulin. CSL Behring Lengnau AG sought to patent the invention, which was opposed by Gliknik, Inc. on various grounds including lack of manner of manufacture, lack of novelty, lack of inventive step, best method, clarity, support, and clear and complete enough disclosure. The court was required to decide whether the patent was valid and whether Gliknik's opposition was well-founded.

The court found that the opposition was successful on the grounds of lack of support and clear and complete enough disclosure. However, it failed on the other grounds, including lack of manner of manufacture, lack of novelty, lack of inventive step, best method, and clarity. The court considered the plausibility of the methods of treatment and "Swiss" claims, and found that they were plausible enough to support the patent. The court also considered regulation 5.23, which provides an opportunity to amend the patent specification. The court found that the specification was not clear and complete enough to support the claims and that it did not provide enough detail to enable a person skilled in the art to carry out the invention.

The court awarded costs to Gliknik, Inc. as the successful opponent of the patent. The court found that the opposition was well-founded and that Gliknik had acted reasonably in bringing the opposition. The court also found that CSL Behring had not acted reasonably in defending the patent, and that it had wasted the court's time by pursuing unfounded arguments. The court ordered CSL Behring to pay Gliknik's costs of the opposition, which included legal fees and other expenses. The decision provides guidance on the requirements for patent specifications and the grounds on which a patent may be opposed. It also highlights the importance of providing clear and complete disclosure in patent applications, and the consequences of failing to do so.

Orders