1. The following review of published Australian Patent Office decisions in January 2019 may be useful for IP practitioners, patent attorneys, or those who manage patent and patent application assets. It provides guidance about:
(a) what constitutes a ‘pharmaceutical substance per se’ for grants of pharmaceutical patents- including some mixtures of therapeutically active ingredient, excipients, solvent and other components, not just the therapeutically active ingredient (Wyeth LLC);
(b) when a chemical process in the prior art will defeat novelty – being when that prior art chemical process produces the same reaction products in the application’s specification, even if in a complex mixture not contemplated by the specification (Cytec Industries Inc. v Nalco Company);
(c) when Patent amendments will claim subject matter not already disclosed in a specification (Wulff v GB Design);
(d) the grant of extensions of time for error or omission – if the main reason for the extension is to permit a claim of priority from another document, rather than it being a genuine error, the applicant will have little success (Magnum Magnetics Corporation).
Wyeth LLC  APO 1 (7 January 2019)
2. The Patent Invention was sodium ibuprofen cores and coated tablet/caplet compositions which have a low sodium content relative to other commercially available sodium ibuprofen dosage forms.
3. The Patent Holder requested an extension of its Patent term under section 70 of the Act. .
4. The Delegate opposed the extension on the basis that the qualifying feature of the patented composition, being, less than 140mg sodium per 1200mg of free ibuprofen, was not a ‘pharmaceutical substance per se’ (as required by section 70(2)(a) of the Act).The Delegate noted that the sodium content does not alter the way the active pharmaceutical ingredient (ibuprofen) works, or provide any new pharmacokinetic profile.
5. The Commissioner considered what constitutes a ‘pharmaceutical substance per se’ having regard to Boehringer,  Pharmacia, and Spirit. In those cases, claims relating to mixtures of therapeutically active ingredient, excipients, solvent and other components were acceptable, not just the therapeutically active ingredient. For example, in Spirit, the claims were limited by the result achieved by the formulation (controlled release of oxycodone), rather than the active ingredient oxycodone.
6. The Commissioner found that the ratio of sodium to free ibuprofen described in the Patent was to ensure stabilising agents (filler) was selected which did not contain more sodium than that which would have diminished the effect of the composition. The relevant claim was not limited by a method of preparation or use, or to use in a particular environment, it was directed to a composition per se. It was not necessary for the Patentee to demonstrate that the stabilising compound gave rise to a different therapeutic profile to previous formulations of the therapeutically active component.
7. The application for extension of term was accepted.
Cytec Industries Inc. v Nalco Company  APO 2 (8 January 2019)
8. The Application Invention related to a method of reducing aluminosilicate scale in a process stream by the addition of a composition with at least one small molecule that has three components, to the stream. Aluminosilicate is a compound incidentally produced as a result of certain chemical reactions in the process stream, which form scales that accumulate and disrupt the processing equipment.
9. The Opponent opposed the Patent Application on the basis of lack of: (a) clarity; (b) enablement; (c) novelty; (d) inventive step.
10. Clarity: The Commissioner considered H Lundbeck v Alphapharm and section 40(3) of the Act noting: “this requirement is understood to be satisfied if a person could ascertain whether or not what he proposes to do falls within the ambit of the claim”. The words ‘small molecule’ used in claim 1 were vague but not unclear, because ‘small molecule’ was defined as three components arranged according to a general formula (and a structure was given). A dependant claim which expanded the independent claim was also not unclear for that reason. An included definition for an unused terms was also not fatal to clarity. However, claims which referred to a certain number of carbons did lack clarity, because they did not provide any information about the structure of the carbon atoms, or if double bonds of cyclic groups were present. A claim was also unclear because it failed to describe how components in a small molecule were orientated. A claim which gave a general formula for the production of a molecule, without properly explaining how the molecule could form, was also unclear.
11. Enablement: The Opponent submitted that the specification did not provide information that would enable the person skilled in the art to make the compounds within the scope of the claims. The description and claims led to the production of some molecules, but as part of a complex mixture. There was no information about how to extract them. The Commissioner found that organic chemists routinely isolate and extract compounds, and so a person skilled in the relevant art would not need this stated in the claims. However, the reaction protocols, which involved the reaction of three species with more than one reaction site on a molecule, would require significant reworking to yield a single compound. The use of individual compounds was part of the scope of the claims and so was not enabled by the disclosure in the description.
12. Priority Date: The Commissioner considered the proper priority date. The Opponent submitted that the Patent Application could not claim priority from the priority document (a divisional parent), because the latter did not provide a clear enough and complete enough disclosure.  The Commissioner applied CSR v United States Gypsum and considered Grant v TollGen Incorporatedand noted that different forms of the invention in a single claim may have different priority dates. The Commissioner considered that the priority document did not enable the use of a single compound alone and in isolation (which was part of the claims in the Patent Application). This form of the invention could only claim priority from the filing date of the Patent Application. However, the form which used compound mixtures was enabled by the priority document and so could claim priority from the filing date of the priority document.
13. Novelty: The Commissioner noted the prior art must contain clear and unmistakeable directions to do what the patentee claims to have invented. The Commissioner considered a patent application (WO ‘873) filed later than the ‘priority document’ above, but before the filing date of the Patent Application. WO ‘873 was directed to the reduction of aluminosilicate scale and contained a general formula for the production of compounds, but did not mention a batch, batch-on-batch of semi-batch process as disclosed in the Patent Application. The Commissioner asked itself whether following the directions in WO ‘873 would ‘inevitably result in the production of the reaction products of the Opposed claims’. The formula in WO ‘873 was found to be a disclosure of many compounds, depending on which starting products were selected. This was found on the balance of probabilities to produce some of the same compounds claimed in the Patent Application, albeit in a complex mixture. Several claims were said to lack novelty on this basis.
14. Inventive Step: The Commissioner asked whether it would have been a matter of routine to proceed to the claimed invention. The Commissioner considered Generic Health v Bayer,  among others. The Commissioner noted its earlier findings that the later priority date (by which WO ‘873 was considered part of the prior art) only applied to claims where one compound is used alone and isolated. WO ‘873 did not direct the isolation and separation of reaction product so it was not prejudicial to the inventive step. The Commissioner also considered another patent application (WO ‘677) to disclose similar process to the Patent Application, but that were directed towards a mixture of polymers, rather than small molecules.
Robert Philip Wulff v GB Design Limited  APO 4 (11 January 2019)
15. The Patent Invention was a canopy extension and tensioning mechanism for umbrellas….
16. The Opponent objected to amendments sought by the Patent Holder in response to the re-examination report requested by the Opponent, on grounds of: (a) clarity; and (b) fair basis.
17. The relevant provisions of the Act applied pre-Raising the Bar amendments, so the opposition was grounded on an amendment not being allowable, if it claimed matter not in substance disclosed in the filed specification. 
18. The Commissioner considered whether there had been a ‘real and reasonably clear disclosure’ of an amended claim when compared against the original disclosure.
19. The Opponent successfully objected to that part of the specification which provided that force would be delivered ‘along a line or load-spreading surface formed by legs 16 and 17’ on the basis that this meant the legs formed the load spreading surface and were not separate to it. The Commissioner held the specification did not envisage an embodiment in which the force spreading means includes legs and yet forms a load spreading surface independently of them.
20. The Commissioner also found that the specification as filed was limited to a rib comprised of an inner rod and an outer tube, each of which is rigid, but only one of which (the inner rod) extended through to the canopy periphery. In stipulating that the rib comprises ‘one or more rigid members…’, proposed claim 27 provided for the extension of both the inner rod and the outer tube through to the canopy periphery. Proposed claim 40 provided ‘one or more rigid members comprising at least the rib’. Theses claims were inconsistent with the original disclosure.
21. Fair Basis: The Commissioner considered that any amendment made to the specification after the time of filing is to be excluded from the assessment of fair basis. The assessment must have regard to the specification as it would stand if amended as proposed and not the specification as filed. The Commissioner held that even if the amendments proposed to the specification were to ensure its language coincides with the independent claims, there is still no fair basis if there are “disconformities” between the proposed claims and the specification read as a whole. The Commissioner found there was non-compliance with the fair basis requirement.
22. Clarity: Proposed claim 44 detailed ‘a stopper with a bore on the force spreading means’. The Opponent successfully argued that the original disclosure provided the stopper provides part of the force spreading means, and so could not be ‘on’ (as distinct ‘from’) the force spreading means. The claims were unclear in that respect.
23. Some of the amendments were refused.
Magnum Magnetics Corporation  APO 3 (11 January 2019)
24. The Patent Application was a divisional of Australian application 2016’401 (filed 2016). An adverse examination report for 2016’401 identified key prior art that defeated its novelty (Rummer) and it was not accepted. The grandparent to 2016’401 (PCT 2013‘119, filed 2013) invalidly claimed priority to Rummer.The present matter was the Applicant’s application for an extension of time of 22 months to claim for the Patent Application, divisional status of and derive priority from patent application 2011’401 (filed 2011), on the basis that there was ‘an error or omission by the person concerned’. 2011’401 claimed priority from an earlier PCT application which had priority over Rummer.
25. The Commissioners’ Delegate considered the request to be because, deriving priority from the ‘401, would allow the Patent Applicant to avoid a key prior art – Rummer.
26. The Commissioner noted that the Applicant did not provide full and frank disclosure of the circumstances that lead to the error, including: (a) why Rummer was not identified as invalidating PCT 2013’119, when it was identified as an ‘X’ document in the international search report in 2013, and cited as relevant prior art in the first examination report for the Australian patent in April 2014; (b) discussions or records between the Patent Applicant and its then patent attorneys around the time the errors occurred; (c) discussions or records between the patent Applicant and its subsequent attorneys in 2017.
27. The Commissioner considered the Applicant was not clear on its basis for believing that if the error had been identified, it would have amended the application to claim divisional status from 2011’401. The Commissioner held that the “the evidence suggests that it is a likely plausibility, that the realisation was formed with the benefit of hindsight, which does not constitute an error or omission.”
28. The request for an extension of time was refused.
 Patents Act 1990 (Cth).
 Boehringer Ingelheim International GmbH v Commissioner of Patents  FCA 647; 52 IPR 529 at .
 Pharmacia Italia SpA v Mayne Pharma Pty Ltd FCA 305; 69 IPR 1.
 Spirit Pharmaceutical Pty Ltd v Mundipharma Pty Ltd  FCA 658; 102 IPR 55.
 Cytec Industries Inc.
  FCAFC 70, 81 IPR 228 at  – .
 s 43(2A), Patents Act 1990 (Cth).
 Grant Fisher v ToolGen Incorporated  APO 65.
 CSR Building Products Limited v United States Gypsum Company  APO 72.
 The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited  RPC 457 at 486.
 Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft  FCAFC 73.
 Robert Philip Wulff.
 Section 102(1), Patents Act 1990 (Cth).
 ICI Chemicals & Polymers Ltd v Lubrizol Incorporation Inc  FCA 1349 (ICI Chemicals) at ;Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 1)  HCA 58 (Lockwood) at .
 s 223(2)(a), Patent Act 1990 (Cth) (Pre-Raising the Bar Amendments).