Isolated Genetic Material Patentable in Australia
In Cancer Voices Australia v Myriad Genetics Inc the Federal Court recently confirmed that isolated genetic/biological material is patentable subject matter in Australia.
While Myriad dropped its attempt to enforce patent rights over the BRCA1 and BRCA2 genes in Australia following public backlash, CVA subsequently brought a test case against Myriad arguing that isolated genes / biological material are not patentable subject matter in Australia. In particular, it was argued that even in isolated form the genes are products of nature. The claims in contention defined isolated nucleic acids encoding mutant or polymorphic BRCA I polypeptides linked to breast and ovarian cancer.
In its judgment, the Court clarified that naturally occurring DNA and RNA as they exist in a cell are not within the scope of any of the contentious claims and could never, at least not until they had been isolated, result in the infringement of any such claim. In determining what constitutes a manner of manufacture the Court found that:
• the concept of ‘manner of manufacture’ has a ‘broad sweep’ intended to encourage developments that are by their nature often unpredictable;
• a product that consists of an artificially created state of affairs which has economic significance will constitute a ‘manner of manufacture’; and
• the relevant state of affairs must be the result of some human intervention.
The Court found that the defined isolated genes constitute an artificial state of affairs consistent with a ‘manner of manufacture’ since, in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and ‘isolated’ nucleic acid does not exist inside the cell. Consequently, patentability of such isolated genetic material does not depend on any changes in chemical composition, being isolated is sufficient even if chemically identical. Further, the Court considered that, in line with the wide ambit given by the NRDC decision, it was appropriate that the skill and effort that culminated in the isolation of the biological material should be rewarded by the grant of a patent.
Mere Computer Implementation of Method Insufficient for Patentability
In Research Affiliates LLC v Commissioner of Patents the Federal Court considered the patentability of computer implemented methods. The application claimed a computer implemented method for generating an index (for example an index of shares upon which an investment strategy may be devised or benchmarked). The method involves generating an index from gathered data that is processed in a particular way. Research Affiliates claimed that the method met the ‘manner of manufacture’ test of being an artificially created state of affairs in the field of economic endeavour.
However, the Court contested that by finding that the claim did not meet the physical effect requirement, given that the only physical effect was a computer file, and that the computer implementation did not add anything to the claim.
"A mere scheme, abstract idea, or mere information, is not, of itself, patentable. Some physical effect is required. … The index is simply information: it is a set of numbers. It is no more a manner of manufacture than a bank balance, whether represented as data in a bank’s computer, written on a piece of paper or kept in a person’s memory. While it is true that the index may be stored in the computer’s RAM, or on a memory device, or can be transmitted, that can be said of any data generated by a computer. If that were sufficient to satisfy the requirement of an artificially created state of affairs, any computer-implemented scheme would be patentable, merely by reason of the fact that it happens to be implemented by a computer. … The Specification asserts a patentable invention, not in the use of a computer, but in the particular series of steps that give rise to the generation of the index. Those steps could have been carried out manually. The aspect of computer implementation is nothing more than the use of a computer for a purpose for which it is suitable. That does not confer patentability."
The Court also took issue with the lack of specific disclosure regarding how to produce the index and the stating of the data selection step in negative rather than positive terms.
Inevitable Result is a Recipe for Anticipation
In Novozymes AS v Danisco AS the Full Court of the Federal Court recently considered anticipation by inevitable result. Danisco’s patent claimed a process for preparing a foodstuff, including the addition of an enzyme to a food material to generate two functional ingredients. When Danisco sued Novozymes for patent infringement, Novozymes challenged the validity of the patent. One of Novozymes arguments was that a prior art document disclosed a method of baking that, if followed, would inevitably involve every integer of the process claimed.
The first instance judge held that the novelty of a process claim with identified results will only be deprived by following instructions of a prior publication that inevitably produces the identified results if those results would be perceived or understood by the skilled addressee to have occurred. On the basis of the skilled addressee qualification the first instance judge found Danisco’s patent was not anticipated by inevitable result. However, on appeal, the Full Court held that the skilled addressee was not relevant in this instance and that the prior art disclosure was sufficient to invalidate Danisco’s patent by inevitable result.
The first instance judge also held that anticipation by inevitable result requires actual working of the invention before the priority date. The prior art had been published only a month before the priority date of the Danisco patent and the first instance judge found that this was not enough time to practically carry out the process. The Full Court also reversed this point, holding that it is the content of the information that amounts to anticipation, not the doing of the act or even the ability to do it.
Consumer Expectation of Reasonable Use Affects Patent Scope
A German court held that the marketing of coffee capsules suitable for a Nespresso machine does not infringe the patent on an extraction system for the coffee capsules. Instead, the user of the machine is also permitted to use capsules which are not marketed by the patent holder. This is at least the case if the coffee capsules are not the ‘functional core’ of the invention. In this case the consumer can expect to be allowed to also use third party coffee capsules.
Clinical and Field Trials Exception to Infringement
Following a UKIPO consultation on patent infringement in pharmaceutical clinical and field trials, the Government announced that it will change section 60(5) of the Patents Act 1977 to allow clinical and field trials and health technology assessment for new drugs to be carried out without running the risk of being sued for patent infringement. It is expected that the change to the law will improve the clinical trial environment, making the UK a more desirable location in which to perform trials and bringing economic benefits to the country. It is not yet clear how long it will take to effect the legislative change.
United States of America
USPTO Publishes Preferred Patent Drafting Practice
The USPTO has published a list of 9 application drafting practices that it considers will facilitate examination and bring more certainty to the scope of issued patents. The first 6 relate to clarifying the scope of claims while the last 3 relate to clarifying the meaning of claim terms in the specification.
1. Presenting claims in a multi-part format by way of a standardized template that places each claim component in separate, clearly marked, and designated fields (e.g., preamble, transitional phrase, and individual claim limitations).
2. Identifying corresponding support in the specification for each of the claim limitations (e.g., using a claim chart).
3. Indicating whether examples in the specification are intended to be limiting or merely illustrative.
4. Identifying whether the claim preamble is intended to be a limitation on claim scope.
5. Expressly identifying clauses within particular claim limitations for which the inventor intends to invoke 35 U.S.C. § 112(f) (which pertains to means-plus-function limitations for applications filed on or after September 16, 2012) and pointing out where in the specification corresponding structures, materials, or acts are disclosed that are linked to the identified § 112(f) claim limitations.
6. Using textual and graphical notation systems known in the art to disclose algorithms in support of computer-implemented claim limitations, such as C-like pseudo-code or XML-like schemas for textual notation and Unified Modeling Language (UML) for graphical notation.
7. Indicating whether terms of degree -- such as substantially, approximately, about, essentially -- have a lay or technical meaning and explaining the scope of such terms.
8. Including in the specification a glossary of potentially ambiguous, distinctive, and specialized terms used in the specification and/or claims.
9. Designating, at the time of filing the application, a default dictionary or dictionaries to be used in ascertaining the meaning of the claim terms.
The USPTO also intends to issue a separate notice identifying potential practices that the Office can employ to also facilitate examination and bring more certainty to the scope of issued patents.
2. Trade Marks
Possible Single Economic Space Within Eurasia
A draft agreement has been reached between Russia, Kazakhstan, and Belarus that would harmonize the IP laws of these countries and create a Single Economic Space (SES). Under the SES a unitary trade mark right would be created that would co-exist with national registrations in much the same way as occurs in Europe. There are no plans yet to set up a SES trademark office, ‘SES trademarks’ would instead be made through the national IPO’s of Belarus, Kazakhstan and Russia. The agreement will only come into force when ratified by all three members.
Croatia to Accede to European Union
Croatia will accede to the European Union on 1 July 2013. Consequently, provisions of the EU's Community Trademark Regulation and Community Design Regulation will apply to Croatia and, accordingly, all registered EU trademarks and designs will automatically be extend to Croatia. Existing rights holders of Croatian trade marks can object to CTM applications filed between 1 January 2013 and 30 June 2013.
United States of America
USPTO Issues Guide on Webpage Specimens
The USPTO has issued a trade mark examination guide on webpage specimens used to show that the mark is being used in commerce in connection with the claimed goods. The guide describes the elements of an acceptable webpage display associated with goods, explains the various grounds for refusal and provides examples of webpage display specimens.