20 June 2014GeneticsNabeela Rasheed

Patent eligibility: a fourth category?

Recent years have seen a decisive shift in the patent eligibility of biotechnology inventions in the US. At the end of 2011, the medical diagnostic testing industry was comfortable that patent claims relating to diagnostic methods were patent-eligible. Today, that sense of comfort has all but evaporated.

In March 2012, the Supreme Court pronounced in Prometheus v Mayo that a claim to a method of optimising a therapeutic regimen in which the method was defined by specific steps was ineligible for patent protection. Arguably, this decision crippled the validity of thousands of foundational patents that support the diagnostic methods industry and stunted the growth of the newly burgeoning personalised medicine sector of the healthcare industry.

In arriving at the conclusion that methods of optimisation of a therapeutic regimen are patent ineligible, the Supreme Court not only disagreed with Prometheus and the Federal Circuit, but also specifically disagreed with the position of the US government. The government had urged the court to decide in favour of patent eligibility for such methods. This would have afforded the US Patent and Trademark Office (USPTO) the opportunity to determine patentability using stringent application of the remaining sections of the patent statute (namely 35 USC §§102; 103; and 112).

Despite the government’s pleadings, the Supreme Court opted to agree with Mayo, physicians and the healthcare sector lobbyists. In effect, the ramifications of this decision are that it places serious doubt on the validity of diagnostic methods patents and seriously affects business decisions in the diagnostic and therapeutic methods industry.

The claim at issue in Prometheus was held to be patent-ineligible because it recites laws of nature—in this case, the relationship between the concentrations of certain metabolites in the blood and the likelihood that a particular therapy dose willbe ineffective or harmful—and such laws of natureare patent-ineligible.

However, the decision contains little guidanceas to what diagnostic steps would be ‘significant’ enough to convert a law of nature to a patent-eligible application. The decision creates substantial uncertainty and ample room for argument in litigation settings.

Nowhere in the Prometheus claim is there any mention of the practitioner of the method being a ‘doctor’. However, in a tone generally unfavourable to patentees in this field, the entire decision repeatedly focused on upholding a doctor’s right to choose a therapy. This decision has profound and far-reaching consequences not only for the patents that have already been issued, but also for the patent eligibility of new methods that combine therapy with diagnosis of a particular condition.

These ‘theragnostic’ applications are at the heart of personalised medicine, which allows the tailoring of therapy so that only people who will benefit from a particular drug are given that drug, limiting unnecessary exposure to unwanted side-effects. Assessment of the risk of the side-effects compared to the benefits can occur only if the practitioner, regardless of whether that is a doctor, nurse or lab technician, performs the test.

One must not overlook the fact that while the end user of the test may be that practitioner, the entities that are garnering the economic benefit of that testing are typically companies that supply the kits to perform those tests.

Thus, while there are many economic and policy-based arguments in this decision, they have failed to recognise the impact of the decision on an entire sector of the biotechnology industry. In particular, the decision confounds the business plans of companies seeking to transform failed drugs into successful, more targeted therapies that are recognised through screening for biomarkers that are predictive of the responsiveness of the patient to the drug.

It is a valuable, significant, often patentable, insight to discover why a particular drug works in only a small fraction of the patient population. This is not an insight into a law of nature. It is the discovery of the very nexus that allows the scientist to transform a failed or useless drug into a life-changing drug that enters the marketplace and benefits the lives of patients, some with debilitating diseases.

"it is the first time the IPAB has held that patent applications/patents should not be rejected without giving the applicant an opportunity to amend the claims."

How, then, is a diagnostic company incentivised to publicly disclose discoveries that lead to identification of useful therapies and the methods for performing diagnostic tests that will benefit the patient population? In Prometheus, the Supreme Court noted: “We must recognise the role of Congress in crafting more finely tailored rules where necessary. We need not determine here whether, for a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.” However, considering that patent reform took almost a decade to pass through Congress, it is unlikely that such intervention is imminent.

The slippery slope

The Prometheus decision slid a long way down the slippery slope of reducing the protections available to biotechnology arts. Soon afterwards, the Supreme Court remanded a further case involving biological features to the Federal Circuit to be decided in line with its pronouncements in Prometheus. The Federal Circuit decided Association for Molecular Pathology v Myriad Genetics, Inc and it went straight back to the Supreme Court.

Myriad owned several patents relating to the location and sequence of the BRCA1 and BRCA2 genes. Mutations in these genes can dramatically increase the risk of breast and ovarian cancer and hence allowed for the development of specific medical tests useful for detecting mutations in these genes which in turn could be used to diagnose a patient’s risk of developing cancer. The District Court had declared Myriad’s patents invalid under 35 USC §101 as being directed to “products of nature”.

The Federal Circuit had previously held Myriad’s gene claims to genes and methods of screening for cancer compounds patent-eligible and patentable. Questions remained about the screening claims.

On remand, the Federal Circuit applied Prometheus, and found both isolated DNA and complementary DNA (cDNA) patent-eligible. So Myriad found its way back to the Supreme Court; the decision, rendered by Justice Clarence Thomas, came in June 2013. The Supreme Court held that a naturally occurring DNA segment, being a product of nature, does not become patent-eligible merely because it has been isolated, but cDNA is patent-eligible because it is not naturally occurring.

The Myriad Supreme Court decision did note that its decision did not stretch to innovative methods of manipulating genes while searching for the BRCA1 and BRCA2 genes or new applications of knowledge about the BRCA1 and BRCA2 genes; the court also indicated that it did not consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Instead, the court indicated that it was “merely holding that genes and the information they encode are not patent-eligible under §101 simply because they have been isolated from the surrounding genetic material”.

To summarise, the Prometheus case dealt with methods of treatment claims which were invalidated for reciting laws of nature, and the Myriad case dealt with DNA compositions of matter claims which were invalidated as products of nature. The court in Myriad noted that innovative methods of gene manipulation and new applications of the knowledge of those genes may be patent-eligible. Given the direction the court took in Prometheus, it remains uncertain as to which applications of the knowledge of newly identified genes are patent-eligible and which are not.

These two decisions alone can act in concert to invalidate numerous previously issued patents directed to DNA and uses thereof in various methods of screening. Moreover, there is significant room for the argument that Myriad is not limited to isolated genes, but would be applicable to isolated proteins or even small molecules that have been identified from natural sources.

Woolly thinking

The Federal Circuit has since been called upon to apply these two decisions in another famous technology case. In May 2014, relying heavily on the precedent set by the Prometheus and Myriad courts, Dolly the cloned sheep was summarily declared to be ineligible for patent protection.

Prior to these three decisions, there was a sense of comfort that the exceptions to patent eligibility under 35 USC §101 fell into three distinct categories: laws of nature, abstract ideas, and natural phenomena.

Clearly, a clone of a living animal is not an abstract idea, nor a law of nature. With In re Roslin Institute, in combination with Prometheus, Myriad and the fallout of those cases, the courts and the USPTO seem to be creating a fourth category of patent ineligibility: where the product has ‘genetic identity’ with something already found in nature, that product is an exception to patent eligibility regardless of the level of ingenuity involved in creation of that product, or the fact that such a product simply does not exist in nature.

It must be recognised that these biotechnology-specific cases were not decided in a vacuum, but were decided against a backdrop of software and business method cases where the Supreme Court is grappling with the idea of patent eligibility of software claims. In both areas, biotechnology and software, it is clear that with cases continuing to move back and forth in the courts, the question of patent eligibility will remain mired in uncertainty.

Nabeela Rasheed is a shareholder at Chicago-based McAndrews, Held & Malloy. She can be contacted at:

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