Spruson&Ferguson Australian Biotech Enews

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The US Patent and Trademark Office (USPTO) in determining obviousness of an invention have traditionally relied on the TSM test adopted by the US Federal Circuit court, that is whether there is a teaching, suggestion or motivation to combine the prior art either in the prior art itself, the nature of the problem or the knowledge of a person having ordinary skill in the art.

A recent Supreme Court decision, KSR International Co. v Teleflex Inc. 127 S. Ct. 1727 (2007) (“the KSR decision”), arguably provides a more liberal approach in making out obviousness of a claimed invention.

The case concerned a dispute regarding gas pedal systems. Teleflex submitted that the combined features of electronic sensor pedals and adjustable accelerator pedals over which KSR was seeking patent protection, was obvious. In applying the TSM test, the Federal Circuit had found that there was no teaching, suggestion or motivation to combine those features and deemed the invention to be inventive. However, the US Supreme Court considered that approach to be “rigid” and overturned the Federal Circuit’s decision.

In so doing, the KSR decision has arguably broadened the TSM test by stating that only “an apparent reason to combine the known elements in the fashion claimed by the patent at issue” such as “interrelated teachings of multiple patents; the effects of [design or marketplace] demands…and the background knowledge possessed by a person having ordinary skill in the art” must exist to make out obviousness. In addition, the KSR decision provides that one skilled in the art possesses a measure of creativity (i.e. “ordinary creativity”) and notes that the skilled addressee is not an “automaton”.

A recent decision by the USPTO Board of Patent Appeals and Interferences (“the Board”) provides an indication of how the US Patent Office will apply the KSR decision when assessing the obviousness of an invention in the field of biotechnology, which is inherently an unpredictable art. The alleged invention at issue in the decision Ex parte Kubin (B.P.A.I. 2007 “Kubin”) was a cDNA molecule encoding Natural Killer Cell Activation Inducing Ligand (NAIL) in which the method for isolating the cDNA, the corresponding amino acid sequence and a mouse ortholog of NAIL were acknowledged as being previously known.

In Kubin, the “obviousness” question was framed by the Board as: Would the claimed nucleotide sequence [the cDNA] have been obvious to one of ordinary skill in the art, based on the disclosure of p38 [the NAIL protein] and express teachings how to isolate that cDNA with conventional techniques?

In arguing against obviousness, the patent applicants argued that the cited documents raised by the Examiner do not provide an adequate written description of the claimed nucleic acid sequences themselves and as such could not render a claim to the cDNA obvious. In so doing, the Applicants relied on a decision of the Federal Circuit which has guided the USPTO since 1995. In that decision (In re Deuel (51 F.3d 1552, Fed. Cir 1995), the Federal Court emphasised that a claim to an actual sequence of nucleotides could not be rendered obvious by establishing that the motivation and method to isolate the sequence were obvious.

In contrast, the Board in Kubin stated that “it’s now apparent ‘obvious to try’ may be an appropriate test in more situations than we previously contemplated" and applied the following reasoning from the KSR decision:

“When there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under section 103” (i.e. the section dealing with obviousness within US statutory law).

The Board considered that the “problem” facing the skilled artisan was to isolate NAIL cDNA in which there were a finite number of techniques to do so and that “the skilled artisan would have had reason to try these techniques with the reasonable expectation that at least one would be successful”.

In light of this reasoning, the Board concluded that the method of isolating NAIL cDNA was “the product not of innovation but of ordinary skill and common sense and thus NAIL cDNA per se is not patentable as it would have been obvious to isolate it”. As a first indication, this decision suggests that there may be important changes in USPTO examination practice emerging at least in the biotech field in the light of KSR decision.

The USPTO has prepared “Draft KSR Training Guidelines” for use by patent examiners in determining if an invention is obvious in light of the KSR decision. Those guidelines are currently under review by the US Office of Management and Budget (OMB) and, we understand, will be made public after completion of that review.

We will keep you informed of developments in this important area of patent practice.

For more information please contact David Miles: david.miles@sprusons.com.au

In many countries claims directed to methods of medical treatment, especially treatment of humans, are not patentable. Where an inventor has identified a new pharmaceutical compound which is useful for treatment of a medical condition, the prohibition on patents covering the method of treatment is arguably not so much of a problem, as the inventor is able to protect the invention by obtaining a monopoly over the new compound itself. Where the invention lies in the identification of a new medical use for a known compound, however, the prohibition potentially diminishes an incentive to undertake such research.

Acknowledging that “once it is accepted that there can be new invention in the discovery of previously unrecognised advantageous properties in a chemical compound, the obligation to make patent protection available must apply”¹, New Zealand and many other countries have addressed this issue by permitting claims in the so-called “Swiss-style” form. Typically, such claims are worded as “The use of [known substance X] for the manufacture of a medicament for the treatment of [new therapeutic indication Y]”.

Notwithstanding the general allowability of Swiss-style claims in New Zealand, there remained a ‘gap’ in patentability and hence incentive to research: namely, where the invention lay not in the identification of a new therapeutic indication, but rather in the identification of a new method, time, frequency or dosage of administration. This 'gap' was reflected in the official Guidelines² issued by the Intellectual Property Office of New Zealand (IPONZ) relating to Examination of Swiss-type claims. For inventions based on a new method, time, frequency or dosage of administration, the Guidelines referred to conflicting decisions issued by different Assistant Commissioners in two New Zealand cases: Abbott Laboratories³ and Merck & Co v Arrow Pharmaceuticals^.4 In essence, the former did not allow Swiss-style claims which included mode of administration, dosage etc whereas the latter did. The Guidelines specifically stated that IPONZ "will follow the more conservative approach of the Assistant Commissioner in Abbott Laboratories" (ie, to not allow such claims).

A recent decision issued by IPONZ in which the same Assistant Commissioner who made the Abbott Laboratories decision has now allowed such claims.⁵Paraphrased, the claims at issue were directed to the use of IGF-1 in the preparation of a medicament formulated for administration according to a particular dosage regime whereby the IGF-1 is administered intermittently.

After a comprehensive review of the relevant case law the Hearing Officer stated:

"...I do not agree with the statement in the Guidelines that claims such as those in suit in the present case are not valid Swiss-type claims...The Applicants have produced a means of overcoming or alleviating these problems [IGF-1 becomes ineffective with continued use] by the application of a specific dosage regime and I think it proper that they should be able to obtain patent protection for their contribution. As I see it the claims are not claims to medical treatment or 'an attempt to monopolise a new method of treatment' any more than are normal Swiss-type claims. Nor, as I read them do these claims limit the actions of a doctor or other medical specialist; they are clearly limited, as are the usual Swiss-type claims, to the preparation, and presumably the labeling, of the medicament by the manufacturer".

It will be interesting to see if IPONZ issues updated Guidelines on allowability of claims directed to dosage regimens. In any case, we now have a conflict between the Guidelines and the decisions of the Assistant Commissioners and the case provided an opportunity to argue in favour of such claims in NZ applications. We will keep you informed of any relevant changes.

For more information please contact Martin O'Brien: martin.obrien@sprusons.com.au