Patents – statin the test: what is an invention

The High Court has recently had to consider the question of the requirements for a valid patent in the context of a cholesterol-lowering agent[1].  Particularly in the pharmaceuticals area, patents may be very valuable.  Patents provide monopoly conditions for a number of years during which the developing company may recoup its development costs and make handsome profits before generic substitutes are able to enter the market place and drive down prices. 

The first appellant was the registered proprietor of the patent.  It had granted an exclusive licence to the second appellant. The patent was a method patent defining low dosage levels at which an agent was said to be efficacious in lowering cholesterol with less need for upward tritation of doses over time and associated patient supervision and management over other statins existing at the priority date of the patent.  In short, it was a better way to confirm cholesterol.  

The key challenge was whether there was an entitlement to a patent because it was said the claimed method of treatment lacked novelty because it had no inventive step having regard to common general knowledge as at the priority date, whether considered by itself or in conjunction with either of two prior art publications published at the priority date.

The priority date of the patent was February 1999. The patent made various claims defining this invention.  The patent was revoked by a judgment of the Federal Court.  An appeal against that decision to the Full Court of the Federal Court was dismissed.  In due course, a further appeal to the High Court of Australia was dismissed.  Accordingly, the patent was lost. 

That finding led to the consequence of the finding was that the patent was lost and the monopoly granted by the patent was also lost.  The key factors for a partner did not exist.

For something to achieve the monopoly protection of a patent, it requires that there be an invention: something that is inventive and novel.  In return for the privileges attaching to the grant of the patent, the inventor is prepared to disclose and share the invention to increase general knowledge.

Part of that test is to determine whether or not something involving an inventive step when compared to the existing prior art that is, whether it was something beyond that which would have been obvious to a person skilled in the relevant art in light of common general knowledge as it existed in the patent area before the priority date for the claim. 

The onus to establish the absence of an inventive step relies upon the party challenging the validity of the patent.

The consequence in this case was that the particular pharmaceutical developed by the appellant, having lost its patent, became open to be reproduced by others to be sold into the marketplace as a generic product, at a considerably lower price than doubtless would have been achieved by the patented product, had it held its monopoly.  Further, the obvious consequence is that the ability of the appellant to recoup its research and development costs via the protection of the patent will have been diminished.

The case reveals that questions of patentability can be very challenging and technical matters and that the ability to sustain or successfully to challenge a patent may turn on a significant number of factors and on the outcome of extensive searches.  The loss of a patent may have severe economic impacts on the party who loses the patent and significant gains to those who may, during what would otherwise have been the monopoly period, enter the marketplace.

[1] Astrazeneca AB & Anor v Apotex Pty Ltd [2015] HCA30

Disclaimer – the information contained in this publication does not constitute legal advice and should not be relied upon as such. You should seek legal advice in relation to any particular matter you may have before relying or acting on this information. The Lavan team are here to assist.