Monday, February 9, 2009

Another Amicus in Support of Prometheus: Myriad Genetics

I have already posted (here and here) most of the amicus briefs that have been filed in Prometheus v. Mayo, all arguing for a reversal of the district court’s decision finding that Prometheus’ personalized medicine claim are patent-ineligible under section 101. This third installment brings you the brief filed by Myriad Genetics in support of Prometheus (Myriad Brief) – to my knowledge this was the only outstanding brief that I had not yet posted.

Myriad is a leader in the commercialization of genetics diagnostic testing, probably best known for its BRCA tests used to assess a woman’s genetic predisposition to breast cancer. Since the late 1990s the company has been the subject of widespread criticism, both in the U.S. and abroad, over what many have perceived to be overly aggressive patent enforcement policies, particularly with regard to its BRCA patents. In fact, much of the criticism directed at so-called “gene patents” traces back to the controversy surrounding Myriad. To this day, allegations that Myriad’s patent policies have somehow unduly limited access to BRCA testing services, or even prevented competing laboratories from providing superior BRCA testing services, are cited in support of proposals to ban the patenting of genes and DNA.

Personally, I am skeptical of the charges that have been leveled against Myriad, and to my knowledge many of the allegations have little or no basis in reality. Clearly Myriad has sought to use its patents to block commercial competitors, but my understanding is that the tests they provide are generally high quality, the cost of their testing services is not significantly greater than comparable tests for genetic conditions not covered by patents, and patients are not being denied access to superior testing options by Myriad’s patent enforcement policies. Nevertheless, it is clear that Myriad’s public relations have suffered as a result of the publicity generated by the BRCA patent controversy.

In assessing Myriad’s amicus brief, it is important to realize that for Myriad it is not enough for the Federal Circuit to decide in favor of Prometheus; the manner in which the Federal Circuit reaches its decision is almost as critical Myriad. In other words, Prometheus could prevail in a manner that would nevertheless cast doubt on the patent-eligibility of many of Myriad’s patents, including its BRCA method-of-testing patents. As pointed out in its brief, these process patents play a much greater role in protecting genetic diagnostic testing than do composition of matter claims.

In particular, Prometheus and many of its amicus supporters argue that the Federal Circuit should reverse the district court’s erroneous conclusion that the correlation between a non-naturally occurring drug breakdown product and the optimal dosage of the drug (which is itself a non-naturally occurring chemical compound) is a "natural phenomenon." In my Law Professors Brief, for example, we argue that whatever the Supreme Court might have meant when it held that "natural phenomena” are patent-inelgibile, the term cannot be interpreted so broadly as to encompass a correlation that exist solely as a consequence of active human intervention. We also point out that the controversial claim 13 at issue in LabCorp, in contrast to the Prometheus claims, relates to a true natural phenomena involving naturally occurring metabolites and existing independently of any human intervention. Thus, the Federal Circuit could easily find the Prometheus claims patent-eligible without necessarily finding the LabCorp claim patent-eligible.

Importantly, the distinction between natural and non-natural correlations at the center of our argument would not only rescue Prometheus’ claims, but a host of other personalized medicine and method of treatment claims involving non-naturally occurring drugs. However, it would not necessarily save Myriad’s patents, many of which, which like the LabCorp claim, relate to naturally occurring correlations, e.g., the correlation between a mutation in the BRCA gene and a predisposition for cancer.

In its brief, Prometheus characterizes itself as a "personalized medicine company," rather than a genetic diagnostic testing company. To me, it seems a bit of a stretch to label a test for mutations relating to a predisposition for cancer as "personalized medicine." I suppose that in a sense any diagnostic method is designed to address the specific medical needs of an individual patient, but usually the term personalized medicine is meant to suggest something more. Personalized medicine usually refers to a synergistic application of diagnostic testing in conjunction with a specific drug or drugs.

Nevertheless, it is not surprising that Myriad would want to position itself as a personalized doesn't company, in hopes of benefitng from all the positive buzz currently surrounding the field of personalized medicine. All of the amici supporting Prometheus argue that patents could be important incentives in the development of personalized medicine. On the other hand, many have argued that patents are generally not necessary to incentivize the identification of genetic mutations and the development of diagnostic testing services; some have even gone so far as to argue that patents impede the availability of certain diagnostic testing. In 2002, for example, legislation was introduced in Congress that would have shielded certain providers of genetic testing services from patent liability (it did not go anywhere).

In any event, for Myriad it is important that the Federal Circuit decide Prometheus in a manner that does not rely on any distinction between natural and unnatural compounds, but instead in a manner that would also find the LabCorp claim (and by implication Myriad’s genetic diagnostic claims) patent-eligible.

To this end, Myriad argues :

[Although the] recitation of administering an unnatural drug is one valid basis for finding the Prometheus claims patent-ineligible, [the court should] find that the Prometheus claims are patent-eligible . . . on a more fundamental level shared by the claims in LabCorp. . . . From a policy perspective, this is the critical point in this case. If this Court finds Prometheus is claims patent-ineligible, the industry of personalized medicine as a whole will be in jeopardy. If, on the other hand, this Court holds that Prometheus is claims are patent-eligible solely because they recite an unnatural drug, then only a very small segment of personalized medicine will be spared. Virtually all of the rest of the industry will be wiped away because most personalized medicine products are unrelated to drug therapies.

For more on personalized medicine and patents, you might want to check out this recent PTO presentation on the patenting of personalized medicine. Notice that the PTO presentation defines personalized medicine in a manner that would exclude Prometheus' claims (by limiting itself to information from a patient's genotype), but that would broadly encompass Myriad's BRCA claims (because the definition is not limited to the use of drugs). The presentation suggests to me that the PTO would find some of Myriad's issued BRCA testing claims patent ineligible under Bilski, because they are not tied to a machine/apparatus or performing a transformation (see Example 3 in particular).

Patent Doc Kevin Noonan provides his own commentary on the PTO presentation here . For example, he explains that under the PTO approach a patentee might need to include a method of treatment step in order to render a diagnostic claim patent-eligible, but including a treatment limitation raises a practical obstacle to enforcing the patent - there might not be a single entity who infringes all of the claim limitations. Methods of treatment are generally performed by health care providers. As explained by Kevin:

[I]t may frequently be the case that the actor who performs the diagnostic step of determining whether a patient bears a diagnostically-relevant SNP is a different actor than the one who performs the method of treatment step. This dichotomy of action then directly implicates the principle enunciate[d] in the Muniauction case, that a claim cannot be infringed by joint tortfeasors unless there is one actor exercising direction and control over the others.

Thursday, February 5, 2009

Novartis Files Amicus Brief Supporting Prometheus

For those following Prometheus v. Mayo, I am posting an amicus brief filed by Novartis in support of Prometheus, and the patentability of the personalized medicine claims at issue (Novartis Brief). Prometheus’ appellate brief, and amici briefs filed by myself on behalf of a group of patent law professor, BIO, and AIPLA are provided on an earlier post, along with some commentary.

In its brief, which asks the court to reverse the district court’s grant of summary judgment to Mayo on the grounds of section 101 invalidity, Novartis echoes many of the arguments made in the other briefs, i.e., that the district court erred in focusing its analysis on certain elements of the claim (in particular the "wherein clauses") while failing to consider the claim as a whole, that the claim as a whole satisfies the Bilski machine-transformation test, that the district court’s rationale, if taken to its logical extreme, would put claims to methods of treatment employing new drugs at risk, and that the decision threatens to stifle innovation in personalized medicine and health care in general.

Novartis also makes an argument that I don’t think appears in any of the other briefs that have been filed. In particular, Novartis argues that the district court’s claim construction is flawed because the court erroneously disregarded the claim’s preamble. In considering this argument, it is useful to look at the actual claim language.

Claim 1 of U.S. Patent No. 6,355,623 is representative:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Patent claims can generally be broken down into three discrete elements – the preamble, transition and body. Most commonly, the transition is the word “comprising” (a word that has special significance in claim interpretation), the preamble is the language preceding the transition, and the body is the remainder of the claim. Thus, the preamble of Prometheus’ claim is “a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder,” and the body of the claim is everything after “comprising.”

Significantly, the general rule is that the claim preamble is not taken into account when construing the scope of the claim. Rather, the function of the preamble normally is merely to identify what kind of invention is being claimed. It is the body of the claim which provides the claim limitations which define the claimed subject matter. However, as correctly noted by Novartis, the general rule against using the preamble in claim construction does not apply in certain circumstances, particularly when the preamble is “necessary to give life, meaning, and vitality” to the claim. Novartis argues, I think rather persuasively, that the claims at issue might warrant a consideration of the preamble in a manner that constrains the scope of the claims. I’m not sure if Prometheus ever made this argument; I don’t believe it appears in their appellant brief.

According to Novartis, consideration of the preamble and claim construction limits the claim to a “method of optimizing treatment whereby a dose administered to a patient is adjusted based on the determination of a level of drug metabolite.” If Novartis is correct, it could have some bearing on the patent eligibility of the claim. For example, in Bilski the Federal Circuit noted that the fundamental test for patent eligibility involves a determination of whether the claim “wholly preempts” a fundamental principle. In Prometheus, the alleged fundamental principle is the correlation between the level of drug breakdown products and optimal drug dosage. Alternatively, one might argue that the “wherein” clauses (which are really at the heart of the discovery upon which Prometheus' invention is based) constitute an attempt to patent a mental process, i.e., the recognition of a correlation. But when the claim is construed as limited to a method of optimizing treatment, it would appear that there are other substantial and useful non-infringing uses of the correlation, thus avoiding preemption of the principle.