Human beings and biological processes for their generation are excluded from patentability under s18(2) of theAustralian Patents Act 1990.  A recent Australian Patent Office decision, International Stem Cell Corporation [2016] APO 52 (16 August 2016), considered whether two applications claiming methods directed to the parthenogenic activation of a human oocyte for the production of human stem cells defined patent eligible subject matter.

The issues and findings

The decision concerned two applications: 2012216371 (‘371) – directed to the production of synthetic cornea from stem cells; and 2013205483 (‘483) – directed to parthenogenic activation of human oocytes for production of human stem cells. The stem cells used to produce cornea in ‘371 were obtained by the method defined in ‘483. Parthenogenesis is defined in ‘483 as a process by which activation of an oocyte occurs in the absence of sperm penetration, which can result in an early stage embryo known as a blastocyst.

In the first instance, the examiner concluded that the cultivation of an activated unfertilised oocyte as claimed represented the cultivation of a human embryo and therefore the method encompassed a biological process for the generation of a human being. Moreover, the examiner considered that although the claimed methods were not explicitly directed to a method of generating a human being, they included a step where a human being (a blastocyst) is produced. For these reasons the examiner found that the claims did not define patent eligible subject matter.

Two key issues were considered by the Delegate of the Patent Office:

  1. Do the provisions of s18(2) extend to methods that include a step producing a potential human being?; and
  2. Can a blastocyst produced by parthenogenesis be considered a human being?

In relation to point 1, the applicant submitted that there is no legal basis to reject a claim merely because it includes a step that is not patent eligible. The Delegate, however, considered that this view was inconsistent with the intended purpose of s18(2) and thus found that a method that includes a step which creates a human being, regardless of any other steps defined, is excluded from patentability.

Regarding point 2, the Delegate emphasised that a fertilised ovum and all its subsequent manifestations are excluded from patentability. The Delegate ultimately found, however, that a blastocyst produced by parthenogenic oocyte activation does not have the potential to lead to the birth of a human and thus cannot claim the status of a human being. For this reason the Delegate found that the claimed methods defined patent eligible subject matter.

Conclusion

This Patent Office decision makes clear that if a method includes a step that result in the production of a cell-based entity that can give rise to a human being, the method is not patent eligible in Australia. If, on the hand, a method includes a step that produces an entity that cannot give rise to a human being, that method is patent eligible.