Fall from Grace: Patent Office allows extension of time for claim to grace period but patent still found invalid

Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2
Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 79

14 January 2022, 2 December 2022

Australian Patent Office

Keith Wagg, Leslie F.McCaffery

Background

Neurim Pharmaceuticals Pty Ltd (Neurim) filed Australian patent application 2016426598 on 29 November 2016 (the Application). The Application includes claims for a controlled-release melatonin mini-tablet comprising a therapeutically effective amount of melatonin and one or more pharmaceutically acceptable carriers, with a specified tablet size and release profile, and a method for their manufacture.

On 1 February 2019, Generic Partners Pty Ltd (Generic Partners) filed a notice of opposition to the grant of the Application under s 59 of the Act, citing as prior art a book chapter published on 15 April 2015 disclosing confidential information about a clinical study carried out by Neurim (D1).

On 9 December 2019 Neurim filed a request for an extension of time to rely on the 12-month grace period, based on evidence that D1 was published without Neurim’s consent.  This grace period expired on 15 April 2016, being 12 months after publication of D1.  Neurim sought an extension of 8 months, as the Application was filed eight months after expiry of the 12 month grace period.  Generic Partners opposed the grant of the extension.

Key Issues

Extension of time

Section 223 of the Patent Act 1990 (Cth) (Act) provides that the Commissioner of Patents (Commissioner) must extend the time for the doing of a ‘relevant act’ by the ‘person concerned’ where the act cannot be done because of an error or omission, where that error or omission was because of circumstances beyond the control of the person concerned.  A ‘relevant act’ includes filing a patent application.

This power of the Commissioner to grant extensions has been extensively considered in the authorities, and there are clear principles to be applied by a Delegate, including:

• the provision to extend time is beneficial in nature and should be applied beneficially;
• ‘error or omission’ encompasses accidental slips, inadvertences, and failure to exercise due diligence;
• the error or omission must have a causal connection with the relevant act failed to be done;
• the applicant must demonstrate an intention to do the relevant act within the time; and
• the applicant must frankly expose all of its conduct, knowledge, beliefs and mental processes.

Generic Partners argued that the extension should not be granted because:

• filing a patent application is not an act ‘required’ to be done within a certain time and therefore is not relevant for s 223;
• there was no error or omission;
• there was no causal connection between the failure to identify publication of the thesis and the failure to file in time to claim the grace period benefit; and
• there was an undue delay in Nerium bringing its extension of time application.

Invalidity

Generic Partners argued that the Application lacked support, sufficiency, clarity, inventive step (relying on D1, and another document also falling within the purported grace period) and best method.  It submitted that the specification (excluding consistory clauses) only provided a disclosure of mini-tablets using specific manufacturing and specified ratios, for the treatment of particularised groups of paediatric patients, and that the contribution to the art did not go beyond the above specific disclosures.

Outcome

Extension of time

In the first decision, the Delegate granted Neurim an eight-month extension pursuant to ss 223(2)(a) and (b) of the Act to file the Application in time to claim the benefit of the grace period.  As a result D1 could no longer be cited as prior art to the Application.  Factors the Delegate considered when deciding to exercise their discretion included whether there was undue delay in seeking the extension, the interests of the parties as well as the public interest.

The Delegate found:

• the Act makes clear that to claim the grace period benefit, an applicant must file the complete application 12 months from the day the information concerned was publicly available, amounting to a legislated time period, effectively finding that this constituted a relevant act required to be filed at a certain time;
• the failure of the Neurim employee to notify the relevant person of the disclosure of D1 was an error for the purposes of s 223;
• the error had a causal connection to the failure to file and claim the grace period; and
• there was no undue delay in Nerium bringing its extension of time application, despite considering that the seven month delay between discovery of the error and filing the extension caused prejudice to the opponent as they wasted resource in providing evidence on D1 in the main opposition proceedings.

It was ultimately held, after weighing the discretionary considerations that “the detriment to the public interest is not of sufficient warrant to outweigh” the factors in favour of exercising discretion, highlighting generally beneficial nature of s223.

Invalidity

Despite the grace period and the exclusion of D1 from the prior art, Generic Partner’s opposition to the grant of the patent was successful on clarity, support and sufficiency grounds.

The Delegate found that certain claims lacked support because the specification did not disclose a principle of general application, only specific embodiments with specific excipients in a limited range of proportions.  For similar reasons, the Delegate held that the specification was insufficient and all the claims lacked clarity.

The delegate held the remaining claims exceeded the technical contribution disclosed in the specification.  The Delegate also noted the lack of clinical basis for the use of mini-tablets with geriatric patients, discussed in the specification, as the specification only included a clinical trial for paediatric patients. 

In Neurim’s favour, the Delegate found that all claims were inventive in light of the common general knowledge alone and in view of prior art aside from D1.   There was little discussion of D1, other than an acknowledgement that the grace period applied pursuant to the first decision. 

Implications

It is worth remembering that the Commissioner (and therefore her Delegates) have a wide and generous power to grant extensions of time in relation to patent applications.  This is relevant for patent opponents and patentees alike, as it may result in the exclusion of documents from the prior art, with potentially catastrophic consequences to opponent’s lack of novelty or inventive step arguments.

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