The Cost of Sufficiency
|Date:||16 March 2017|
In Australia, sufficiency is a requirement for patentability and goes to whether a patent specification provides adequate information to the skilled person to perform the claimed invention. Legislative change in 2013 ushered in new patentability standards including a raised test for sufficiency.
The first consideration of this raised test in a contentious environment arose before the Australian Patent Office in CSR Building Products Limited v United States Gypsum Company  APO 72 (CSR). Here it was found that a patent may be invalidated because the financial cost of performing the claimed invention is prohibitive for the skilled person.
This result is inconsistent with accepted legal principle and has alarming implications for those seeking patent protection in cost intensive technology fields. It is well established that a patent is invalid for sufficiency only if the work to perform the claimed invention is not routine or beyond the competence of the skilled person. Financial cost should not enter the equation.
The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (RTB) introduced new requirements for patent applications including replacing the old sufficiency requirement (“the complete specification must fully describe the invention”) with a new disclosure requirement (“the complete specification must disclose the invention in a manner which is clear enough and complete enough”). Sufficiency/disclosure requirements go to whether there is an adequate disclosure to enable the skilled person to perform the claimed invention - “an enabling disclosure”.
A raised test for sufficiency
The crux of the old test for sufficiency as stated in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd  HCA 8 is whether the skilled person is enabled to produce something within each claim without undue burden. The heart of the new test for disclosure, as set out in CSR at , is whether the skilled person is enabled to perform the invention across the full scope of each claim without undue burden.
Thus, the test for sufficiency has risen from a pre-RTB “single embodiment” threshold to a more stringent test for disclosure post-RTB where “all embodiments” are required to be enabled.
Sufficiency raised further?
However, it would appear that the sufficiency bar has been raised further due to a stricter interpretation of “undue burden” post-RTB in CSR by linking “undue burden” with the potential financial costs incurred by a skilled person for performance of the invention.
Comparing the new with the old: building panels and blockbuster drugs
To demonstrate this, we compare CSR with Apotex Pty Ltd v Warner-Lambert Company LLC (No 2)  FCA 1238 (Lyrica). CSR is a “New Act” case and the first opposition matter to come before the Australian Patent Office proceeding fully under post-RTB provisions. Lyrica is a judgement of the Federal Court under “Old Act” pre-RTB provisions - but handed down after the CSR decision was published. In both matters, “undue burden” was considered in terms of the resource available to the skilled person.
Gypsum building panels and blockbuster drugs: both are regulated for safety
The subject matter of the opposed application, 2012222102 (‘102), in CSR, relates to building panels made from gypsum. The subject matter of the patent in suit in Lyrica is a block-buster drug for pain treatment. Despite the different subject matter, there are parallels as each application relates to a regulated product: gypsum panels and blockbuster drugs have to be certified/approved for safety.
The challenge in producing combination gypsum panels, and fire resistance
Claim 1 of ‘102 is directed to a gypsum panel having a combination of several physical features and several properties including fire resistance. The Delegate found that the specification did not provide clear guidance telling the person skilled in the art how to adjust the process and materials so as to achieve with certitude the full combination of properties, in particular the fire resistance of the panel (see CSR at ). Hence, the claims were found to be invalid on the ground that there was no enabling disclosure.
Fire resistance testing prohibitively expensive at US$50,000?
Rather than turning on the question of whether the skilled person would have to apply inventive skill to reach the claimed combination, the decision turned on the “undue burden” of fire testing a panel. The rarity of fire testing is discussed with the conclusion that: “it would be far from reasonable for a person in this art to carry out fire resistance testing according to the UL or ASTM procedures as part of normal trial and error” (see CSR at ).
The decision then turns to the cost of standard fire testing of gypsum panels for certification. At an estimated cost of US$50,000 or more, fire testing was deemed to be prohibitively expensive and contributed to the finding that the claims were invalid for lack of an enabling disclosure. There is the implication that if the tests were less expensive the decision would have been different and the claims found to be enabled (see CSR at ).
Drug development is expensive at US$2.6 billion
Compare this to the Lyrica judgement. Here, it was found that claims directed to a method of treating pain in mammals, particularly humans, with an eventual blockbuster drug were valid even though the patent contained no human drug development data - only animal data was provided. The disclosure of animal data was found to be adequate. It was held there was no evidence to suggest that the steps of developing a human drug from the provided animal data would have been beyond the competence of the skilled person (see Lyrica at ). Financial cost is not considered at all.
This is despite the fact that the expense of taking a lead active ingredient with unknown bioavailability, toxicity, efficacy and safety through human clinical trials comes at a cost of some 2.6 billion dollars according to a Tufts University estimate. And let’s not forget several thousands or millions of compounds may be screened to get to that one lead active ingredient. Pre-clinical testing, let alone full clinical testing of a lead compound is a rare and costly exercise.
Linking undue burden and financial cost is inconsistent with established principle
Despite pre-RTB versus post-RTB considerations, the decision in CSR on the aspect of “financial cost” is inconsistent with the judgement in Lyrica when it comes to interpreting the legal principle of “undue burden” in terms of financial burden. In this regard, it is well established that “the description of the invention will not be insufficient merely because the skilled addressee is expected to apply considerable skill effort and resources to make it work. If the steps required to be taken to work the invention are readily apparent to the notional skilled addressee, and they are standard or routine steps within the competence of the notional skilled addressee, then the test for sufficiency will be satisfied” (Lyrica at ). The financial cost of performing the claimed invention is not taken into account.
The “financial cost” aspect of the CSR decision has alarming implications if applied to fields where the price tag for product development is high, as observed above for pharmaceuticals. The alleged rarity and cost of safety testing of products in highly regulated fields where such safety testing is mandatory and commonplace should not amount to “undue burden”.
The CSR matter is still running with a final determination to be made. We look forward to providing an update.
|Tags:||patent specification, sufficiency, new patentability standards, FB Rice, Michael Moore, CSR, Lyrica|