Working With Clever People Let us guide you through the global IP landscape 1 Patent Enforcement in the Chemical Arts in Australia Stephen Sharp 28 October 2013 2 Overview 1. “Raising the Bar” Amendments 2. Innovation Patents 3. Contributory Infringement 3 Intellectual Property Laws Amendment (Raising the Bar) Act 2012 Purposes: – Simplify the IP system – Raise the quality of patents by strengthening the requirements for patentability – Bring Australian patent law closer to international standards – Faster resolution of patent applications Most changes came into effect on 15 April 2013. 4 Raising the Bar cont. Many changes to the patents legislation in Australia, including changes to: – Prior art base for assessing inventive step – Sufficiency – Support These changes apply to standard patent applications for which examination is requested on or after 15 April 2013. (The previous law will therefore continue to apply to many patents and pending patent applications). 5 Raising the Bar cont. Inventive Step Previously • • Now • • CGK not limited to Australia The requirements that the prior art information be ascertained, understood and regarded as relevant have been removed Consequences • • • 6 Assessed against the background of common general knowledge (CGK) in the art in Australia Can combine CGK with prior art information that the skilled person could be reasonably expected to have ascertained, understood and regarded as relevant Raises the threshold of patentability for standard patents May result in grant of narrower claims No longer need Australia-based experts to prove CGK in Australia Raising the Bar cont. Sufficiency Previously – Now – – Must “disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art” Intended to align the disclosure requirement with that in the UK and EPC Consequences – – 7 Must describe the invention fully (a low threshold) Raises the standard for description of the invention May result in grant of narrower claims Raising the Bar cont. Support Previously – – Now – – – “Fair basis” language in the Patents Act replaced with “support” Intended to align the Australian requirement with that in other jurisdictions, such as the UK Two aspects: - basis in the description for each claim; and - claims not broader than is justified by the extent of the description, drawings and contribution to the art Consequences – – 8 Claims must be “fairly based” on the specification Generally just requires conformity between claims and description More difficult test to satisfy Judicial interpretation is awaited to confirm this Innovation Patents A patentee’s best friend. 9 Innovation patents cont. Key features: • • • • • • • 10 8 year term Invention claimed must be novel and involve an innovative step over the prior art base No substantive examination before grant Must be certified (examined) before it can be enforced Granted for similar subject matter to standard patents (plants and animals, and the biological processes for the generation of plants and animals, are excluded) Limitation on the number of claims Same remedies for infringement as a standard patent Innovation patents cont. Advantages for Enforcement •Same remedies for infringement as a standard patent •No inventive step requirement - can be obtained for obvious “inventions”, and therefore innovation patents can be difficult to challenge •Can be granted and certified quickly 11 Innovation patents cont. Innovative Step “an invention is to be taken to involve an innovative step when compared with the prior art base unless the invention would, to a person skilled in the relevant art, in the light of the common general knowledge as it existed (whether in or out of [Australia]) before the priority date of the relevant claim, only vary from the [relevant prior art information] in ways that make no substantial contribution to the working of the invention.” 12 Innovation patents cont. Examples: -Roadside post made of sheet spring steel instead of plastic -Roadside post having a marker hole to show depth as it is inserted in the ground -Roadside post where the base is tapered to enable the post to be driven into the ground Delnorth Pty Ltd v Dura-Post (Aust) Pty Ltd [2008] FCA 1225 13 Innovation patents cont. Comparison of innovation patents filed each year Source: Advisory Council on Intellectual Property, Review of the Innovation Patent System Options Paper, August 2013 14 Contributory Infringement A new weapon for patentees. 15 Contributory infringement cont. Infringement by supply of products Section 117 of the Patents Act 1990 provides: 16 (1) If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent. (2) A reference in subsection (1) to the use of a product by a person is a reference to: (a) if the product is capable of only one reasonable use, having regard to its nature or design - that use; or (b) if the product is not a staple commercial product - any use of the product, if the supplier had reason to believe that the person would put it to that use; or (c) in any case - the use of the product in accordance with any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier or contained in an advertisement published by or with the authority of the supplier. Contributory infringement cont. Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No. 2) [2012] FCAFC 102 • • Sanofi-Aventis’s patent claimed a method of preventing or treating psoriasis Apotex’s product information (PI) disclaimed the treatment of psoriasis “not associated with manifestations of arthritic disease”, but did indicate its product for the treatment of psoriatic arthritis (PsA) Disclaimer: “Apo-Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease” 17 Contributory infringement cont. • • • • • 18 The evidence established that: (a) psoriasis is a diagnostic criterion of PsA; (b) nearly every person with PsA has or will develop psoriasis; and (c) the administration of leflunomide to a person with PsA will treat that condition and also treat or prevent psoriasis. The primary judge found Apotex’s product was not a “staple commercial product” and that Apotex had reason to believe its product would be used for the treatment of psoriasis. Subsection 117(2)(b) therefore applied. The primary judge found the statement of indications in the PI was an instruction to use the product for the treatment of psoriasis. Subsection 117(2)(c) therefore applied. The primary judge’s findings that Apotex’s intended supply of its product would infringe the patent pursuant to s117 was upheld by the Full Federal Court of Australia. The matter has been appealed to the High Court of Australia. www.griffithhack.com.au Thank you for your time… any questions? 19
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