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By Peter Leung
A new guidance memo to patent examiners should make it easier to get medical treatment patents that relate to laws of nature.
The Patent and Trademark Office is directing examiners to follow the approach outlined in Vanda Pharmaceuticals v. West-Wart Pharmaceuticals. The U.S. Court of Appeals for the Federal Circuit in April validated Vanda’s patent claims, which cover methods for treating schizophrenia.
The guidance could lead to more patents on personalized medicine and biomedical-related inventions, and alleviate the industry’s criticism on the issue.
The June 7 memo only applies when an examiner analyzes a patent claim covering a method of treatment.
Patent filers and practitioners have struggled over when inventions involving laws of nature are eligible for protection. The U.S. Supreme Court’s 2012 decision in Mayo v. Prometheus laid out the framework for analyzing the issue. But critics say the test is hard to apply and doesn’t offer patent protection to genuine innovations. Some of the sharpest criticism has come from companies in the biomedical and personalized medicine fields.
Inventions that are “directed to” a law of nature aren’t eligible for patent protection unless there’s an inventive concept, under the Mayo framework.
The Vanda ruling is important because it distinguishes between inventions directed to a law of nature, which often can’t be protected by a patent, and a particular “application” of that relationship, which can be protected, the patent office said in the memo.
Vanda’s U.S. Patent No. 8,586,610 relates to treating schizophrenia with iloperidone. It calls for checking for a particular gene that relates to an enzyme that metabolizes the drug. Iloperidone in certain doses can cause heart problems in patients that produce low amounts of the enzyme. Those patients should receive 12 milligrams or less of iloperidone per day, according to the patent claim, whereas other patients can receive up to 24 milligrams per day.
The Federal Circuit said Vanda’s patent claims aren’t directed at a natural phenomenon. The patented invention uses a law of nature— specifically the relationship between the enzyme, the metabolizing of iloperidone, and the related side effects—but it’s not “directed to” it. Instead, the patent claims a specific application of that relationship and requires a doctor to administer the drug in particular ways, the court said.
The invalidated patent claim in Mayo, by contrast, discussed administering a drug to a patient, but the claim as a whole was really about gathering data about natural relationships, the memo said.
Examiners should look at a patent claim as a whole to determine if it’s directed at a law of nature, the patent office said. Looking at the claim steps individually could lead to the wrong conclusion, the memo stated.
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