biotech and life science intellectual property news and developments
Federal Circuit Going to Electronic Filing
Except as otherwise prescribed by Circuit rule or court order, all briefs, appendices, motions, petitions for rehearing, and other documents filed in cases assigned to the CM/ECF system, must be filed electronically using the CM/ECF system by a filer registered in accordance with ECF-2.
[Link to New Rules]
Myriad Remanded Back to Federal Circuit
The United States Supreme Court has granted certiorari in the case of AMP v. Myriad Genetics, vacated the previous Federal Circuit opinion, and remanded the case back to the Federal Circuit for reconsideration in view of its recent decision in Mayo v. Prometheus.
Even though the claims in Prometheus were method claims, whereas the challenged claims in Myriad are compositions of matter claims directed to "isolated DNA" sequences, the policy reasons for keeping laws of nature in the public domain to protect innovation set forth in Prometheus could just as easily be transmuted and applied to composition claims. Particularly troubling for "isolated DNA" claims is the rationale in the Prometheus opinion that activities which are routine or conventional in the scientific community, without more, are not patent eligible. Since isolating DNA is a commonly used technique in many labs, this could signal trouble for Myriad. Given the strong precedent set by Prometheus, as it was a unanimous decision, it will be interesting to see if the Federal Circuit still finds the Myriad claims to "isolated DNA" sequences to be patent eligible subject matter, and if Myriad will find its way to the Supreme Court again someday.
Prometheus: Supreme Court Disagrees with the Federal Circuit on Determining Patent-Eligibility of Diagnostic Method Claims
Yesterday, in a unanimous (9-0) decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Supreme Court held that claims directed to methods of optimizing the dose of specific drugs used in treatment of specific diseases are invalid under 35 U.S.C. § 101 because they are effectively claiming “laws of nature” (which are not patent-eligible). This decision reverses the Federal Circuit, which had twice upheld the validity of the claims at issue.
The Court’s opinion provides numerous explanations and analogies from previous case law to scientific laws, such as Newton’s law of gravity, in an effort to distinguish claims to “laws of nature” and claims to specific applications of “laws of nature,” the latter being patentable subject matter in some cases.
The claim language of (now) invalidated Claim 1 of U.S. Patent No. 6,355,623 is as follows:
In all, the Court’s opinion lets it be known that laws of nature are unpatentable and that the “application” of such a law of nature is also unpatentable if such an application relies on elements already known in the art. In the Court’s view, the “application” must be “significant” and include elements that provide an “inventive concept” that is significant and separate from the natural law. As such, it appears as though a fact-specific, case-by-case analysis will be commonplace for a while in determining whether diagnostic claims contain patent-eligible subject matter.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 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject andwherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
The opinion of the Court can be read here.
Should Patents on Pharmaceuticals be Extended?
A recent Wall Street Journal debate article focused on whether patents on pharmaceuticals should be extended to encourage innovation. Two individuals, Dr. Josh Bloom of the American Council on Science and Health and Dr. Els Torreele of the Access to Essential Medicines Initiative of the Open Society Foundation's Public Health Program, provide their differing opinions on the issue.
Dr. Bloom, in support of extension of patent protection, suggests that without the extension on new discoveries, the pharmaceutical industry will not be able to fund the current level of research. He warns that the consequences will be profound: a decrease in innovation, fewer new drugs and more job losses.
On the other side of the debate, Dr. Torreele suggests that it makes no sense to grant patent monopolies unless innovation results that will benefit society. She argues that the already high prices that companies charge for patented drugs hinder the societal benefit of the medications because of inability of many people to afford the treatment needed. She suggests that extending patent protection would worsen this type of situation.
To read more about their opinions and proposed remedies for the pharmaceutical industry, click here.
U.S. Supreme Court Considers Patent on Treatment Process
A few days ago, the United States Supreme Court heard oral arguments in the case of Mayo Collaborative Services v. Prometheus Laboratories, Inc., in which Mayo petitioned the Court to determine whether claims of Prometheus' patent directed to optimizing dosage levels of thiopurine for the treatment of various autoimmune disorders is patent eligible subject matter under 35 U.S.C. 101. More specifically, the claims call for "administering" a certain amount of thiopurine to a patient and "determining" from the resulting metabolite level whether or not to increase or decrease the dosage.
Mayo argues that the patent impermissibly tries to claim laws of nature, and that the claims are so broad and preempt natural phenomena such that there is no room for competition. According to Mayo's reading of the patent, a doctor drawing blood from a patient and simply thinking about an appropriate range of drug to apply amounts to infringement, and that this is far too broad for patent protection to extend.
On the other hand, the patent owner, Prometheus, emphasized that their patent protects the application of a law of nature, which is patentable, rather than the law of nature itself. They highlighted that they use specific drugs (thiopurines) to treat specific diseases (certain autoimmune diseases) by a particular process that involves certain claimed levels of metabolites "indicating a need" to increase or decrease the dosage of the administered drug. They maintain that this is therefore a process based in the physical world and that it does not preemt follow-on innovation.
A common theme running throughout the arguments, and the Supreme Court Justices' questions, was falling back to a discussion of novelty and obviousness under 35 U.S.C. 102 and 103 rather than addressing the threshold inquiry of patent eligibility under 35 U.S.C. 101, which was the reason for challenging the patent and the topic of the question before the Court. This may be a result of the law being more settled with regard to novelty and obviousness than for patent eligibility. This may, however, as the United States as amicus curiae argued, be because novelty and/or obviousness is a more appropriate challenge for this patent than patent eligibility.
The Court acknowledged that laws of nature are not patentable, but that applications of laws of nature are patentable. They seemed most concerned with delineating where the line between the two is - in other words, how much does an inventor have to add to a law of nature to get patent eligible subject matter? The Justice's inquiries from the parties on this line failed to provide clear examples. Hopefully, the Supreme Court will be able to provide concrete guidance on this point when they issue their opinion in the coming months.
For those interested, a copy of the transcript can be found here.