Oh, boy. Methods of treating patients. So many issues.

Many countries exclude methods of treatment from patent eligibility. They believe it is unethical to restrict treatment of a patient. They probably have a point. However, this must be balanced against the lost benefits. (They don’t notice the unknown patients that did not get treated because no one was motivated to invent the treatment – and no one notices something that does not happen.) However, in some of these countries, you can still claim the method of treatment using “Swiss style” claiming, e.g., the use of a substance for the manufacture of a medicament for treating disease X, even where the substance was previously known.

Then, there are the section 101 patent eligibility issues in the U.S., wherein the response of the body to the treatment may be considered a patent ineligible “natural phenomenon”. How can we forget Mayo v. Prometheus ( http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf ) where monitoring the metabolites of an Unnatural drug in a patient to adjust dosage was held ineligible by the (somewhat ignorant) Supreme Court as an ineligible natural phenomenon:

Mayo claimed – 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 …

Note the two steps. Even if the Mayo claim were valid, one (two?) could avoid infringement by having the administering step done by a first person and the determining step by another person.

The article gives good advice on how to draft method claims to include only one actor. For customized treatments, the use of a past tense step seems like a good idea. For example, treating the patient for a indication (disease) “previously determined”, where it is immaterial who did the determining (identifying, assaying) step.

I like the back-up advice on using the doctrine of claim differentiation to confirm that a broad treatment claim does not require a determining step. The doctrine of claim differentiation creates a presumption that each claim of a patent has different scope. So, the article presents the great idea of including dependent claims wherein the parent genus claim “further comprises” the determining step. Logically, if the broad parent claim already included a determining step, then there would be no need for the claim “further comprising” a determining step. The presence of the dependent claim further comprising the determining step gives the Patent Attorney strong evidence against the Patent Examiner (or infringer) interpreting the broad parent claim to require a determining step. Simple!

Now, for my best advice. Do not write the claim that makes the ill patient the infringer. Let’s see, don’t write: “the steps of having your blood tested and receiving a treatment”. You don’t want to be the bad guy making the evening news for suing a sick person.

http://www.mondaq.com/article.asp?articleid=436944&email_access=on

source: https://www.linkedin.com/groups/78665/78665-6064132733276344322