Merck & Cie - [2020] APO 45

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Merck & Cie [2020] APO 45

Patent Number: 2012200512

Title:Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride

Patentee: Merck & Cie

Delegate: Dr Leslie F. McCaffery, Deputy Commissioner of Patents

Decision Date: 7 October 2020

Hearing Date: 30 April 2020 by teleconference.

Catchwords: PATENTS – Re-examination – Inventive step – Insufficient evidence to establish obviousness – Re-examination completed.

Representation: Patent attorney for the applicant: Davies Collison Cave, Sydney

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Number: 2012200512

Title:Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride

Patentee: Merck & Cie

Date of Decision: 7 October 2020

DECISION

I am not practically certain that the granted patent is invalid in view of the evidence provided with the re-examination request.

The present re-examination process is therefore completed.

REASONS FOR DECISION

Onus

The request for examination for the present application was filed on 12 April 2013. Substantive amendments of the Patents Act 1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (RTB) therefore do not apply to the present application. This includes the amendment to subsection 60(3A) that allows the Commissioner to refuse a patent if satisfied on the balance of probabilities that a ground of opposition exists. Prior to 15 April 2013, the Commissioner had the power to revoke a patent but only where the Commissioner was practically certain that the granted patent was invalid.[1]
[1] F. Hoffmann-La Roche AG v New England Biolabs Inc. (2000) 50 IPR 305 at [67]; Commissioner of Patents v Sherman (2008) 79 IPR at [18].

Unless otherwise indicated, any subsequent reference in this decision to sections of the Act relate to the Act prior to amendment by the RTB.

Background

Polymorphs are different crystal forms of an organic or inorganic compound. One definition is the ability of a material to crystallise as two or more distinct crystal species, while other authors use the term more broadly to include not only the distinct crystal states but also the amorphous (disordered) state and solvates (where solvent molecules are incorporated in the crystal lattice).[2] I note the references to polymorphs of the present patent include solvates, which is consistent with the latter approach. I will follow this approach in the present decision.
[2] Exhibit JSR-9 at 1.1.

Polymorphism is apparently commonly encountered in pharmaceuticals, with literature indicating between 32-51% of small chemicals exist as polymorphs, and if solvates are included this ratio increases to 56-87%. This feature is an important consideration in pharmaceutical formulations since most drug products are administered orally, and the most popular dosage forms are tablets and capsules.[3]
[3] Supra.
Australian Patent 2012200512 (the patent), in the name of Merck & Cie (the Patentee) was granted on 11 February 2016. The patent claims an earliest priority date of 17 November 2003. The patent claims formulations of a specific polymorph of the compound (6R)-L-erythro-tetrahydrobiopterin dihydro-chloride (referred to as Form B). The formulations comprise one, or both, of the pharmaceutical excipients polyvinylpyrrolidone (PVP) and/or…

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 45
Decision Date: 7 October 2020

CaseChat Overview and Summary

Merck & Cie was a case before the Federal Court of Australia, involving a dispute over the validity of a patent held by Merck. The dispute centred around the inventive step of the patent and whether there was sufficient evidence to establish that the patent was obvious. The court was tasked with re-examining the patent in light of new evidence and arguments presented by the parties.

The legal issues before the court included determining whether the patent met the requirements for inventive step and whether there was sufficient evidence to establish that the patent was obvious. The court had to consider the evidence presented by both parties, including expert testimony and prior art references, to determine whether the patent was valid.

The court found that the evidence presented was insufficient to establish that the patent was obvious. The court held that there was no evidence to suggest that a person skilled in the art would have arrived at the invention in question. The court also noted that the patent in question had been granted by the Australian Patent Office and had not been successfully challenged in other jurisdictions. The court concluded that there was no basis to revoke the patent and that the re-examination was completed.

The court's decision upheld the validity of the patent held by Merck. The court found that the evidence presented was insufficient to establish that the patent was obvious and that the patent met the requirements for inventive step. The court's decision provides clarity for patent holders and ensures that patents are not revoked without sufficient evidence.

Orders