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make it patentable. In fact, the plaintiffs declined to challenge numerous other claims in Myriad’s patents that might have shed light on this issue, including claims directed to nucleic acid probes, replicative cloning vectors that contain the isolated DNA, and pairs of DNA primers useful for DNA amplification experiments. Tus, even if the court’s decision is sustained on appeal, these are issues that would need to resolved in the future. Stated differently, a variety of claim strategies will remain available to patent applicants who invent new and useful nucleic acids, even if the decision in the Myriad case is upheld.

In an unusual development, the US Department of Justice (DoJ) filed an amicus brief with the Federal Circuit, ostensibly representing the position of the executive branch of the Federal government, which includes the USPTO. In its brief, and again at oral argument, the DoJ urged the Federal Circuit to affirm the District Court’s holding of invalidity with respect to certain claims directed to isolated DNA (but urged reversal with respect to other claims directed to cDNA).

However, it is far from certain that the court’s decision will be sustained. In oral arguments before the Federal Circuit, the three-judge panel spent significant time questioning the parties as to whether the Federal Courts had jurisdiction to hear the litigation. If the Federal Circuit determines that the collection of plaintiffs did not have a sufficiently immediate bona fide controversy with the patentee Myriad—e.g. caused by a legitimate threat of litigation from Myriad—it may dismiss the case on jurisdictional grounds without reaching the merits.

While it is oſten folly to predict the outcome of a case from questions posed at oral argument, it was clear that the judges appreciated the importance of the case to the biotechnology industry and its implications for thousands of existing patents. Te questions posed to counsel for the patent challengers suggested to many pundits that the Federal Circuit may reverse the District Court’s holding on the merits. For example, Judge Bryson questioned whether Myriad’s “isolated DNA” actually represents a product of nature, or whether a chemical distinction should be drawn by virtue of the breaking covalent chemical bonds during the isolation process. Te judges also appeared to recognise that the BRCA1 and BRCA2 genes, when isolated, had practical uses—e.g. in medical diagnostics—that the naturally occurring DNA counterparts in the human genome did not have.


Patentability of diagnostic methods

In Myriad, the Southern District of New York held that certain of Myriad’s patent claims directed to diagnostic/prognostic methods that involved ‘analysing’ or ‘comparing’ BRCA1 or BRCA2 ‘sequences’ were invalid for failure to define patent-eligible subject matter. Te court cited the Federal Circuit’s recent Bilski decision. Although Bilski related to the patent-eligibility of a ‘business method’ patent, the Federal Circuit’s opinion provided an analytical framework for analysing the patent-eligibility of other method claims. Although phenomena of nature, mental processes or abstract intellectual concepts are not patentable, the court reasoned that a process may be patentable if it passes a ‘machine or transformation test’. Under this test: for a claim to be patentable, it must be tied to a particular machine or apparatus or transform a particular article into a different state or thing. In Bilski v Kappos, the US Supreme Court unanimously agreed that Bilski’s patent claims were invalid, but it was divided on the proper rationale for evaluating method

claims. Te court

indicated that the Federal Circuit’s machine or transformation test was an important test for evaluating whether process inventions are patent-eligible, but refused to hold that it was the exclusive test, as the Federal Circuit had held.

50 Life Sciences Intellectual Property Review 2011

Te US District Court concluded that Myriad’s method claims failed the machine or transformation test of Bilski and were invalid. Te court found that the BRCA diagnostic processes do not specify any further action beyond the act of analysing or comparing DNA sequences, and concluded that these are abstract mental processes.

On appeal, Myriad argued that its claims do satisfy the machine or transformation test. Myriad reasoned: “Te claims involving ‘analysing’ and ‘comparing’ DNA sequences require extraction and processing of human tissue or blood samples.” Te District Court had construed the term ‘sequence’ as mere information—the letters representing a series of nucleotides—and held that ‘analysing’ (or ‘comparing’) could be performed on an abstract level, by comparing letters on a page, for example. It remains to be seen whose claim construction is adopted by the Federal Circuit.

A decision by the Federal Circuit in the Myriad case could be forthcoming at any time. If the challengers lose on jurisdictional grounds, another challenge at the District Court level is widely expected. If the appeal is decided on the merits, a petition for review by the US Supreme Court by the losing party is likely.

Gene and diagnostic patents in Europe

In Europe, aſter several years of discussion as to what constitutes a patentable biotechnological invention, the patentability of gene sequences isolated from their natural environment was clarified in statute by the EU Biotechnology Directive in 1998.

Te directive states that “biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention, even if it previously occurred in nature”.

It also provides that (emphasis added):

“An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element”.

However, for genes to be patentable, in addition to the other patentability requirements of novelty, inventive step, etc., the industrial application of a gene sequence must be disclosed in the patent application as filed. Tus, at least the function of a gene sequence needs to be established and disclosed in the patent application itself.

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