In the recent Australian patent office decision of Gary B Cox v MacroGenics, Inc.  APO 13, Wrays’ Chairman, Gary Cox, successfully opposed the grant of Macrogenics, Inc.’s Australian patent application no. 2012259162 directed to polypeptides with extended serum half-lives.
The decision is one of only a small number of Australian patent office decisions where a patent specification was held deficient for failure to satisfy sufficiency under Section 40 of the Australian Patents Act 1990 (post the 2013 ‘Raising the Bar’ amendments). The decision highlights the experience and calibre of the Wrays’ opposition team.
The full decision is available here: http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/cth/APO/2019/13.html?context=1;query=macrogenics;mask_path=
The relevant claims were directed to de-immunized polypeptides comprising an albumin-binding domain (ABD) “comprising” certain specified variations to the ABD. In the decision, the Delegate, Dr Sarah Smith, considered that the language of “comprising” was non-limiting in this case. The Delegate therefore considered that other mutations to the ABD, in addition to specified variations, also fell within the scope of the claim, provided that the polypeptide when bound to the ABD fell within the functional limitations of the claim (paragraph 51).
In the decision, the Delegate, considered whether the specification as originally filed and as construed by the skilled person, provides ‘a reasonably credible technical or scientific basis’ that an invention can be worked across the full claim scope (paragraph 61). The Delegate confirmed that ‘consideration of what constitutes an undue burden is necessarily dependent upon the nature of the technology, and factors relevant to the consideration include the level of predictability in the art and the level of guidance in the specification’ (paragraph 66).
The Delegate found that it would be plausible to identify different classes of the polypeptides described that satisfy the functional limitations of the claim. However, given the vast number of possible additional mutations to the ABD, identification of variants with the desired properties, while systematic and iterative, would be unpredictable, with limited guidance in the specification (paragraph 107). The Delegate concluded that there would be an undue burden to work the invention across the full scope of the claims. The Delegate found the specification insufficient (Section 40(2)(a)) and also concluded that the claims lack support under Section 40(3).