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Patent Opposition Fails to Block Patent Term Extension for COPD and Asthma Drug

 

Date of decision:

Body:

Adjudicator:

 

28 May 2024

Patent Office

Delegate of the Commissioner or Patents – Dr S J Smith

Background

Glaxo Group Limited (Glaxo) applied for an extension of term of Australian Patent No. 2018282427 (AU2018282427) based on the product TRELEGY ELLIPTA, first listed on the Australian Register of Therapeutic Goods (ARTG) on 16 January 2018 (extension application).

Before deciding on the extension application, the Commissioner re-examined AU2018282427, considering it not to meet certain requirements of the Patents Act 1990 (the Act).  Glaxo proposed amendments limiting the claims of AU2018282427 to an admixture composition, which, once allowed, overcame the invalidity issues raised during re-examination.

Banki Haddock Fiora (Banki) opposed the accepted extension application on the ground that it incorrectly treated the first regulatory approval date as the inclusion of TRELEGY ELLIPTA on the ARTG, rather than that of ANORO ELLIPTA on 4 July 2014.  Banki also contended that the relevant specification for determining the extension application should be the specification as it stood at the time the extension application it was made, that is, the specification prior to amendment when the claims defined a composition, not an admixture.

Key Issues and Findings

We previously reported on the regime governing patent term extensions under Australian law here.

Briefly, under Australian law, patents that cover pharmaceutical inventions are eligible for an extension of term of up to five years if:

  • The patent relates to a pharmaceutical substance per se or a pharmaceutical substance when produced by recombinant DNA technology;
  • The pharmaceutical is included on the ARTG before the 20-year term of the patent expires and the entry is current at the time of the application for an extension; and
  • At least five years have elapsed between the effective filing date of the patent and the first inclusion of the pharmaceutical on the ARTG.

The opposition focused on determining the date of first inclusion of the pharmaceutical substance per se on the ARTG for the extension application.  However, it was first necessary for the Delegate to assess which version of the specification was relevant to the extension application.

The Delegate concluded that the relevant version of the specification for the analysis of the extension application was AU2018282427 as amended to address the invalidity issues raised during re-examination, reasoning that a patentee may seek an amendment under s104 of the Act at any time, and if allowable, the patent no longer subsists in its unamended form.

The Delegate also found that the TRELEGY ELLIPTA goods were the correct pharmaceutical substance per se, being an admixture composition as approved for supply; the ANORO ELLIPTA goods, while an admixture composition in use, were not supplied in that form.

The extension of term has been granted, subject to appeal.  Costs were awarded against Banki.

Takeaways

This decision makes it clear that the relevant version of the specification for analysis of an extension of term application is that subsisting at the time the Commissioner decides the application, which in this case, was the specification as found allowable after re-examination.  As re-examination of Australian pharmaceutical patents by the Commissioner now occurs routinely, particularly where there are differences in scope between the claims as granted in Australia versus those granted in corresponding foreign patents, any necessary specification amendments should be made before filing an extension of term application, or at the very least, before the application is considered.

This decision also clarifies that assessment of the pharmaceutical substance per se is made on the product form as approved for supply, and not in use.

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation – Australia)

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.

Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.

Chris Vindurampulle PhD

Chris Vindurampulle PhD

Executive, Patent & Trade Mark Attorney

Chris is a senior Patent and Trade Mark Attorney who is registered to practice before the intellectual property offices of Australia and New Zealand.  He is experienced in patent drafting, patent and trade mark prosecution and opposition, and freedom to operate, opinion and due diligence work.  Through his experience and delivery of highly-regarded client service, Chris has been recognised as a leading patent practitioner having been listed in the IAM Patent 1000 as a recommended individual for patent prosecution, and a Rising Star in 2021, 2022 and 2023 by Managing IP.

Rosie Stramandinoli

Rosie Stramandinoli

Special Counsel, Patent & Trade Mark Attorney (AU, NZ)

Rosie is a highly accomplished and experienced patent attorney and strategist with a passion for innovation and growth. She manages complex local and global matters for clients in the life sciences industries, including the pharmaceutical, biopharmaceutical, biotech, med-tech, animal health, food and cosmetic industries.

Rosie has more than X years’ experience as a patent attorney, and has a background in chemistry. She has  won multiple accolades for her work as an IP practitioner, including a Silver Globee Award for Committed Professional of the Year (2023) and recognition as one of the top 250 leading female IP practitioners (2019).  Managing Intellectual Property, IAM Patent 1000, and Asia IP Experts, amongst others, have also commended Rosie as one of Australia’s leading patent practitioners.

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