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Monday, 3 August 2009

Method of treatment claims in the US: a foreigner asks ...

A colleague who practises a long way from the United States has some questions concerning that country's patent law ("the envy of the world", as recently described in an Innovation Alliance circular) and thinks the IPKat's readers (or at least some of them) might be able to assist in answering them:

"USPTO allows “direct” method of treatment claims, ie, “A method of treating disease X, comprising …” I understand that the US Patents Code exempts from patent infringement a medical practitioner’s performance of a medical activity, ie, “A method of treating…”.

If the Code provides a blanket exemption to medical practitioners, then

(i) who infringes “method of treatment claims” in the US?
(ii) who is the target of such claims in US?

Could someone please point to a relevant case law in US.

A check of the MPEP (35 USC 287 (6)(c1 &2)) confirms the above but reveals that
(2) For the purposes of this subsection:
(A) the term "medical activity" means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.
Does that mean that "method of treatment" claims follow rights granted for, say, "use of patented composition/patented machine", and therefore afford but a very "thin" blanket of exemption for medical practitioners?".
The IPKat would not dream of answering any questions involving US law, even though he's always happy to guess them, so he leaves it to his learned readers to provide some guidance.

8 comments:

Duncan Bucknell said...

It’s targeted as contributory infringement towards drug companies that provide instructions to infringe to medical practitioners.

Anonymous said...

I'm not a US practitioner, so take this with a pinch of salt:

Presumably "(ii) who is the target of such claims in US?" is not really the right question to ask - I don't imagine the US law was drafted in the light of the European exemption for medical methods, with the intention being that a certain class of people should infringe in the US who don't in Europe. Both the US and European legislators wanted doctors to be able to doctor without worrying about patent infringement, so they put in place exemptions for them. It turns out they came up with two different solutions to the same public policy problem. The US exemption happens to be narrower than the European, but it doesn't follow that there must be a reason for that. (For all I know there were weeks of debate as to whether it should be possible to sue drug companies for contributory infringement of medical method claims, as in the previous comment, but on the other hand that possibility might just be an unintended consequence.)

As to who infringes method of treatment claims, the answer is anyone who isn't a licenced medical practitioner, presumably. (In additon to the drug company example, I suppose complementary therapists might on occasion want to use an infringing method?)

Anonymous said...

"the envy of the world"

This is classic US redefinition. As it's not torture, because we only half-killed him, whereas the definition says that it's torture when he's 75+% killed, we take the the correct description of the US patent system, "laughing-stock", and redefine it as "envy".

Derek Freyberg said...

Duncan is basically right, the direct infringer is the patient for taking the drug to treat the condition, the prescribing doctor is an infringer [inducement of infringement, for telling the patient to take the drug to treat the condition - 35 USC 271(b)], and the manufacturing drug company is another infringer in the same way as the doctor, because the label says "take the drug to treat the condition". The doctor is protected under 35 USC 287(c) as to both direct infringement and inducement of infringement; and the target is the drug company. You can also argue contributory infringement, as to which the doctor is not protected by 287(c), but no-one wants to sue the doctor (or the patient].

Derek Freyberg said...

It's going to be slightly different where the claim is to treating a condition by performing a medical (surgical) procedure. There the doctor is the direct infringer, not the patient, and the manufacturer of any device used might be an infringer by contributory infringement (I'm assuming that the device is not patented - when the manufacturer can be sued directly; and I don't believe that there is labeling on a device to induce infringement - pharma is my thing, not devices). My recollection of the exemption of 35 USC 287(c) is that it was brought in primarily to address this kind of claim [and in particular claims to treatments that did not require specific devices, just claims to methods of surgery, for example] - for the surgical method there may be no contributory infringement (the device used may be "staple", such as a scalpel) and no inducement to infringe (no labeling). For the prescription of a drug, the drug manufacturer is an easy target because of labeling.

Anonymous said...

Wondering what are the other aspects of US patent law that "method of treatment claims" touch upon?

Anonymous said...

Can someone cite cases of successful enforcement (i.e., a finding of infringement) of patented method of treatment claims in the US?

Anonymous said...

Look at the fosomax claims, all methods of treatment because the composition was old.

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