Showing posts with label method. Show all posts
Showing posts with label method. Show all posts
Wednesday, March 29, 2017
Magistrate Judge Finds Drug Method of Treatment Claim Patent Ineligible in Endo Pharmaceuticals v Actavis
Magistrate Judge Finds Drug Method of Treatment Claim Patent Ineligible in Endo Pharmaceuticals v Actavis
In 2009, I filed an amici brief on behalf of myself and several other law professors inPrometheus v. Mayo, which was the first time the Federal Circuit heard the case. In the decision below, the district court held that the interaction of a synthetic, non-naturally occurring pharmaceutical compound with the human body is a “natural phenomenon.” In our brief, we basically argued that the interaction of a synthetic compound with the human body is not a natural phenomenon, but that if the definition of “natural phenomena” is interpreted so broadly as to encompass the interaction of human-made drugs with the human body, then by implication drug method of treatment claims seemed vulnerable to invalidation under 101 for encompassing patent ineligible subject matter.
Nonetheless, the Federal Circuit and the Supreme Court invalidated the Prometheus claims based on an assumption that the interaction of the pharmaceutical agent (the metabolic breakdown product of a drug) with the human body is a natural phenomenon. In the Supreme Court’s decision, Mayo v. Prometheus, Justice Breyer seemed cognizant of this concern, and affirmatively stated that drug method of treatment claims should not be threatened by the holding in Mayo. Still, I have continued to wonder how secure drug method of use claims are post-Mayo, particularly given the expansive interpretation of the Mayo/Alice by the district court’s and the Federal Circuit in decisions such as Ariosa (discussed in a previous post).
Thus, it came as no surprise when I saw a September 23, 2015 Report and Recommendation from a magistrate judge in the District of Delaware recommending invalidation of a drug method of treatment patent for patent ineligibility on a motion to dismiss under Rule 12(b)(6). The case, Endo Pharmaceuticals v. Actavis, is an ANDA litigation brought by Endo Pharmaceuticals against Actavis in connection with a Generic Oxymorphone ER Tablets. The Report and Recommendation is available here.
The patent is US Patent Number 8,871,779, and representatives of claim one recites:
1. A method of treating pain in a renally impaired patient, comprising the steps of:
a. providing a solid oral controlled release dosage form, comprising: i. about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient; and ii. a controlled release matrix;
b. measuring a creatinine clearance rate of the patient and determining it to be (a) less than about 30 ml/min, (b) about 30 mL/min to about 50 mL/min, (c) about 51 mL/min to about 80 mL/min, or (d) above about 80 mL/min; and
c. orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief;
wherein after said administration to said patient, the average AUC of oxymorphone over a 12-hour period is less than about 21 nghr/mL.
The magistrate judge applied the Mayo/Alice two-part test for patent eligibility. The first step is to determine whether the claims at issue are “directed to a patent-eligible concept,” in this case a natural law. The magistrate judge notes that the “Mayo court provided a broad definition for a law of nature: ‘[a] patent that… describes a relationship that is the consequence of entirely natural processes sets forth a natural law.’” The judge went on to conclude that “the connection between the severity of renal impairment and the bioavailability of oxymorphone” was the relevant natural law to which the claims are directed.
The second step is to determine whether the claims “add enough” to the “natural law” to render the claim patent eligible. The magistrate judge essentially determined that the “providing,” “measuring,” and “administering” steps were analogous to the steps in the claims held to be patent ineligible in Mayo, and thus did not provide “enough” extra.
The claims at issue in Mayoessentially recited a method of performing a diagnostic test and determining the optimal dosage of drug for a patient. The claim did not recite a step of actually administering the optimized dosage to a patient, and many have held out the hope that in the future a claim that included this additional step of actually applying the information derived from the diagnostic test would be found patent eligible.
But note that Endo’s claim does expressly recite administering a lower dosage of drug to a patient based on the results of the diagnostic test, i.e., the claim does include the extra step that many thought would have rendered the claims in Mayo patent ineligible. But, at least in the view of this magistrate judge, the inclusion of this extra step was not sufficient to render the claim patent eligible. And given the sweeping language of Mayo, particularly as interpreted by the Federal Circuit in Ariosa, it is not hard to see how the magistrate judge came to this conclusion.
It is important to note that the Endo claim is not a straightforward method of treatment claim, i.e., “a method of treating disease X by administering drug Y,” and does not necessarily indicate that the magistrate judge would have ruled such a claim patent ineligible. The decision does explicitly note that “oxymorphone is ‘widely used’ for acute and chronic pain relief, the showing that the utilization of oxymorphone is not the invention.” Thus, the magistrate judge seemed to imply that in a case where the “invention” is the discovery of a new pharmaceutical agent for the treatment of some medical condition a method of treatment claim could still be patent eligible under Mayo.
It seems inevitable that before long we will be seeing a decision involving an allegation that a more conventional method of treatment claim is patent ineligible. It will be interesting to see how the courts handle that case, and also how the district court judge in Endo v. Actavis (and perhaps the Federal Circuit eventually) responds to the magistrate judge’s recommendation.
Available link for download
Monday, February 6, 2017
Long Wave Infrared Imaging A new detection method for ADHD
Long Wave Infrared Imaging A new detection method for ADHD
Detecting ADHD using the long-wave infrared spectrum:
I always enjoy covering new breakthroughs in the diagnosis and treatment methods in the medical field. A new study just came out which may have a number of potential applications to aid in the diagnostic process of ADHD, which I believe is worth sharing. Called Long-Wave Infrared Imaging, this method utilizes the infrared spectrum to detect biological activity (namely bloodflow patterns) via the differences in radiation emitted by these activities. The study, titled Sensitivity and Specificity of Longwave Infrared Imaging for Attention-Deficit/Hyperactivity Disorder, found that this method may be a surprisingly powerful way of separating ADHD from other related disorders, aiding in the always-difficult process of differential diagnosis.
The basics of Long-Wave Infrared Imaging:
The term "long-wave" is a relative term, of course, referring to wavelengths of approximately 10 nanometers (or only one one-hundred millionth of a meter). Differential bloodflow patterns can result in temperature differences by a full degree (Celsius), making this technology useful in tracking bloodflow disorders. A recent publication in the Journal of Medical Physics by Bagathaviappan and coworkers suggests describes how this long-wave infrared imaging can detect areas in the circulatory system where bloodflow activity is sluggish or reduced. Typically, these areas appear "cooler" on the spectrum, due to the lack of a new, replenishing blood supply.
Applications for ADHD:
A number of studies have confirmed the hypothesis that individuals with ADHD have reduced bloodflow levels marking a recuction of activity to multiple key brain regions. Additionally, while several disorders have a number of overlapping symptoms (which can make the diagnostic process more complicated, especially if multiple comorbid disorders are present), differential blood flow patterns to the brain may be able to help make these distinctions. For example, blood flow patters to the brains of ADHD and OCD (Obsessive Compulsive Disorders) can show pronounced differences, which can aid the diagnostic process between these two disorders (while ADHD and OCD are often considered to be on "opposite" ends of the spectrum with regards to neuro-chemical signaling levels, these two disorders can often exhibit similar symptoms, such as a severe impairment in the response to verbal directions. This is especially true in younger children).
This technology may even be extended to measuring or predicting which medications may work for an individual diagnosed with ADHD, based on blood flow in specific localized brain regions. Cerebral blood flow patterns may help predict the response to common ADHD drugs such as methylphenidate (Ritalin, Concerta, Metadate, Daytrana). For example, a study by Cho and coworkers found increased blood flow in at least three different brain regions for individuals who showed poor response to methylphenidate treatment compared to their peers who did show improvements under the drug.
While the medication response study was done utilizing a different type of brain imaging device known as SPECT, which utilizes gamma rays and radioactive tracers to detect brain activity in 3-dimensional patterns. While SPECT has proven to be an extremely powerful and effectively safe method of detection (the radioactive isotope used in this method is relatively non-invasive and breaks down quickly, and the gamma rays are carefully controlled), concerned parents may still have an inherent fear of the terms "radioactivity" and "gamma rays" tend to shy away from this powerful detection method on their kids.
While this blogger personally has a very high opinion about the use of SPECT as a diagnostic tool for ADHD and related disorders, it is at least worth mentioning the possibility that long-wave infrared imaging methods may be a viable alternative method in at least some of these imaging cases (SPECT technology has been around for over 30 years, but the recent advances in computational power resurrected this technology in the very recent past, similar possibilities may abound by this infrared technology, which has been around even longer).
Keep in mind that the studies utilizing this range of infrared imaging technologies for detecting and differentiation disorders such as ADHD are still relatively scarce. Nevertheless, long-wave infrared imaging appears (at least in this bloggers personal opinion) to be a powerful diagnostic tool for ADHD and related disorders in the near future.
Available link for download
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