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« SmartGene, Inc. v. Advanced Biological Laboratories SA (D.D.C. 2012) | Main | Promega Corp. v. Life Technologies Corp. (Fed. Cir. 2012) »

April 11, 2012

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Listed below are links to weblogs that reference Do Diagnostic Method Claims Fall under the Safe Harbor of 35 U.S.C. § 287(c)?:

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Lemme get this straight: you want Congress to either legislatively overturn Prometheus by amending 101 or by creating a new category of patent (call it a "biomarker" patent) and then simultaneously exempt from infringement the performance of the biomarker assay by physicians. Sound right? Here's my question to you: what makes you think SCOTUS won't strike down the legislative override on the ground it exceeds Congress' authority under Art. 1, Sec. 8? Why not do what I have suggested for years: require every LDT to undergo an approval process (right now they do not, unless you call CLIA an "approval process"), and give "pioneer" LDTs a period of marketing exclusivity? If you truly care about ensuring the development and commercialization of tests, then you might think about this objectively. I understand that Prometheus hurts patent attorneys whose clients hire them to obtain and enforce biomarker patents, but they just need to move on with their lives. As I told someone recently, instead of thinking that Prometheus is taking something away from you, consider that you should never have had it in the first place.

Kevin,

I would be perfectly fine with doctors having an exemption with respect to medical diagnostic tests performed by them (or personnel under their direction). Suing doctors for patent infringement is a huge PR issue that we don't need.

I also find the view startling that 287(c) doesn't cover assays, taking blood samples, and the like performed by doctors (or personnel under their supervision). Then what does "other than clinical laboratory services provided in a physician's office" in (3) mean? In my view, the provision of performed "on the body" is being read far too narrowly by those who consider taking biological samples to be excluded.

The reality of many biomarker patents is that the patent holder has NO interest in suing a doctor anyway. I obtain biomarker patents for my client in order to protect innovations in the drug label or in a companion diagnostic kit sold with the drug. The parties my clients are interested in whacking with the patents are the generic company seeking to copy the brand label or the diagnostic company seeking to knock off the brand's kits. This is all done via the theory of inducement. A doctor is a direct infringer, but the generics are the inducers. Its the same with method of treatment patents. Pharmaceutical companies don't sue doctors - because that is a great way to ensure that a doctor will NEVER prescribe your product. Pharmaceutical companies sue generics. Did SCOTUS have any practical advice on this case?????

lxf001, please tell me that you don't think the holder of a biomarker patent would be able to exclude via inducement the manufacturer of a drug whose label indicates it is more effective, or safer, in people with the biomarker than without. PLEASE TELL ME THAT YOU DON'T THINK THIS. This is quite possibly the dumbest thing ever proposed in the history of patent law. I actually know some geniuses that think this way. They think they're being creative. They are delusional and dangerous.

Hi Kevin,

Interesting point and this issue was raised in an amicus brief filed in the Prometheus dispute but essentially ignored by the court. See my post on //www.personalizedmedicinebulletin.com/2011/09/17/subject-matter-jurisdiction-challesubject-matter-jurisdiction-challenged-in-supreme-courts-review-of/#more-

OK, Gary, let's not get ahead of ourselves. The Court held that the Prometheus claims were not patent eligible; that is the limit of the holding. The rationale the Court used to support its holding was two-fold: first, that there is a precedent-established ban against patenting laws of nature that is properly traversed if (but only if) the invention is an application of the law. (Admittedly the Court did not answer the question of "how" or "how much more" is needed to pass to patent eligibility, but that is as it is.)

The second rationale was policy-based: permitting such patents would interfere with the practice of medicine; this was more forcefully argued in the Labcorp v. Metabolite case but was clearly a factor in the Court's thinking here.

Thus the impetus for my idea. Expressly including diagnostic methods within the confines of the 287(c) safe harbor would answer the Court's concerns about interference with physicians and patient care, while not letting big corporate testing labs free-ride on the fruits of basic research (most of which will come from universities, as in the Prometheus case).

As for the Constitutional concerns, the Court clearly did not think the change in Section 101 I propose is per se unconstitutional lest it would not have invited Congress to change the law if it felt that was appropriate. Of course, how Congress changes the law will impact whether it will pass Constitutional muster, but I expect that a legislative history replete with statistical evidence that patents on diagnostic method claims promote commercialization of basic research identifying the kind of correlations that are the subject of claims in Prometheus, Myriad, etc. might do the trick.

Finally,it is not surprising that there will be claims in any patent regime that will be overbroad and be interpreted to be ineligible for patenting for that reason. Many patent practitioners have taken offense with the Court's identification of "artful claim drafting" as a problem. I see it differently: the Court is exhorting us to do a better job at crafting claims that recite "enough" in addition to the law of nature to be eligible for patenting. This is not too much to ask, and I am confident that the Prometheus case will be a watershed introducing an era of much better patent claims.

Thanks for the comment.

Gary, it depends on the language of the label. The label has to actively induce one to perform a patented test. The label can't simply "mention" a marker - and in that case, there is no inducement. But, if a Gx label actively directs a party to undertake a patented method, whether it is a first use, a second use, or biomarker-directed use (e.g., test patient for X, administer drug A if X is present, but administer drug B if X is not present), then it is most assuredly inducement. The problem isn't in arguing inducement in this sense, but rather in being able to overcome the multiple-infringer issue that Prometheus has left us with.

Dear A: the Court seemingly selectively considered amici argument. Not surprisingly, anything that might contradict at least Justice Breyer's prejudices were unwelcome.

Thanks for the comment.

"The problem isn't in arguing inducement in this sense, but rather in being able to overcome the multiple-infringer issue that Prometheus has left us with."

A very, very good point, lxf001. Trying to construct diagnostic or other analytical method claims that reach the patent-eligibility zone, but also avoid joint infringement problems gives me Excedrin headaches.

Kevin; I like your suggestions, and you beat me to doing a similar post. As I recall, in the "eye surgery" case, the AMA acted rapidly to get Congress to except doctors from infringement. I also agree with the comment above that medical procedures should include diagnostic procedures - or why bother to except clinical procedures performed in the doctor's office? Warren

lxf001, assume a third party markets a drug whose label includes an indication for treating condition X in patients with biomarker Y (think Herceptin to treat breast cancer in HER2+ women). Assume you have a patent for a method of treating condition X by administering the drug to those having biomarker Y. You will never, EVER, be successful in suing the third party for infringing that patent under a theory of inducement. Trust me.

Now assume a third party markets a drug whose label includes a black box for some adverse event, which black box requires docs to routinely test patients to determine if the patient is experiencing the adverse event. Assume that the only known way to determine if the patient is experiencing the adverse event is to test for the presence of biomarker X, which biomarker X is perfectly inversely correlated with the adverse event (if you have biomarker X, you are not experiencing the adverse event, and vice versa). Assume all of this is in the label. Assume now that you discover that biomarker Y is perfectly positively correlated with biomarker X. Assume you obtain a patent for a method for using the drug to treat patients having biomarker Y. Can you successfully use that patent to block others from marketing the drug under a theory of inducement?

See where I'm going with this?

"assume a third party markets a drug whose label includes an indication for treating condition X in patients with biomarker Y (think Herceptin to treat breast cancer in HER2+ women). Assume you have a patent for a method of treating condition X by administering the drug to those having biomarker Y. You will never, EVER, be successful in suing the third party for infringing that patent under a theory of inducement."

I would be very hesistant to make that statement, GJ, especially in view of the ruling in AstraZeneca v. Apotex, 97 U.S.P.Q.2d 1029 (Fed. Cir. 2010) which affirmed the grant of a preliminary injunction against a proposed generic's label which would induce consumers to infringe a patented method for treating a disease state (asthma) with a particular drug. You've already admitted you're aren't an attorney and I, on other hand, am one. Trust me.

Oh yeah, that's right, I forgot that I said that I wasn't an attorney. I think I said I was a "fluffer." Trust me, this "fluffer" knows all about AZ v. Apotex, etc. The patent is invalid anyway, so it doesn't matter. The correlation between the efficacy of the drug and the presence/absence of biomarker Y is not an invention so it's moot. But if the patent was valid, there is still no way the third party will be held liable for inducing the doc to infringe. Want to know how I know this? How does the doc directly infringe? Think about it. To suggest that the doc infringes if he gives the drug to a patient having biomarker Y, but does not infringe if he gives the drug to a patient not having biomarker Y, is pure psychosis. Get outta here with your evergreening!

GJ, you're dodging the point being made. (Telling me the "patent is invalid anyway" in AstraZeneca v. Apotex says that "loud and clear.") All that's needed for "inducing infringement" under 35 USC 271(b) is that direct infringement can and does occur, not that it must always occur. Even AstraZeneca v. Apotex addresses that point. And if you really "knew all about" AstraZeneca v. Apotex, you would know that too. But then again, you're aren't an attorney, right?

Gary, no, I don't see where you are going. You seem to be drafting claims that lack novelty, which isn't a good start. The claim I propose is this:

A method of treating BAD DISEASE in a patient, comprising:
a) testing the patient for X; and
b) administering drug A to the patient if X is present, or administering a different drug to the patient if X is not present.

That isn't a correlation - it is a method of treatment. While you are correct in your conclusion that a Dr. (or a patient) DOES NOT infringe this claim, you are not correct in your logic. The lack of direct infringement arises because there are multiple actors in this claim (i.e., testing lab and Dr. Smith). Without direct infringement, there can be no inducement.

Th following claim is infringeable by a single actor:

A method of treating BAD DISEASE in a patient comprising, administering drug A to the patient if the patient has X or administering a different drug to the patient if the patient does not have X.

...but is suspect due to anticipation.

Making the following claim your best bet to deal with Prometheus and inherency .....

A method of treating BAD DISEASE in a patient comprising, selectively administering drug A to the patient on the basis of the patient having X or selectively administering a different drug to the patient on the basis of the patient not having X.


Aside from the multi-actor issues recited above - these claims are absolutely infringeable by a physician/patient and thus inducible by a label, as per EG.

EG, AZ v. Apotex was decided pre-Global Tech v. SEB. If the maker of a drug with a label that includes an indication for treating condition X in biomarker Y-positive people is ever held liable for inducing infringement of a patented method for treating condition X by administering the drug to biomarker Y-positive people, then I will give up my lucrative career as a fluffer.

lxf001, with respect to your first claim, even if the doc did the test himself/herself (thereby getting around the Muniauction/Akamai problem), there is still no inducement because there is always the possibility that the doc doesn't give the patient not having X a "different drug." Is no drug at all a "different drug." Next you're going to change your claim to say "not administering drug A to the patient if X is not present." Stop. Please.

With respect to your second and third claims, um, what's the difference between these two? You are adding the word "selectively" before the word "administering" and you are replacing "if the patient has X" (or "if the patient does not have X") with "on the basis of the patient having X" (or "on the basis of the patient not having X"). And you think this solves an inherent anticipation problem? Wow.

All of this is pointless: the fact that there exists a marker that is correlated with a drug's efficacy or safety is not something that someone invented. It's just 2 + 2 = 4. So none of this matters. But like I said to EG, I will give up my job as a fluffer if anyone is held liable for inducement under the facts you describe.

GJ,

Even under the "willful blindness" standard of Global-Tech, the result would be no different in AstraZeneca v. Apotex. Apotex knew full well they had an infringement problem. Accordingly, I would suggest you give up being a "fluffer" as you call it now. An attorney you're definitely not.

EG, you are not thinking. Even Kevin acknowledges that Global Tech creates problems for inducement in this situation. But forget about Global Tech for a minute, and lemme add a new wrinkle to my claim, and to lxf001's claim: What if the drug and its use to treat the condition were old? This is basically the Prometheus situation, but in that case, the claims didn't say anything about the drug being administered to people having the biomarker and not being administered to people not having the biomarker (it just said to administer the drug, and then determine the metabolite levels, wherein...). That case was just about titrating the dosage, although the claim didn't even require that.

Evergreening has always been highly suspicious, but with the biomarker patenting "boom," it's gotten even more dangerous. Thankfully we have a 9-0 decision that should put a stop to it.

The trouble is that I'm thinking like an attorney, and you're not, GJ. Global Tech involved a "head in the sands" type of inducement where the accused inducer suspected they had a problem, and deliberately failed to instruct their attorney that the product to be evaluated was simply a knockoff of the item sold by the patentee.

By contrast, in the AstraZeneca v. Apotex situation, the generic has to file an ANDA and also make one of 4 certifications based on the Orange listing of patents made by the NDA filer. It's going to be very difficult to make the proper certification if the patent for the method of use is on the Orange list and ANDA filer fails to acknowledge that patent in their ANDA filing.

I also understand you're concern about "evergreening." But Mayo Collaborative Services won't help you there, at least not based on patent-ineligiblity under 35 USC 101. Even Breyer's opinion acknowledges that a new use of a drug will pass muster under 35 USC 101, and that's the scenarios that lxf001 is presenting to you.

In particular, your comment regarding the existence of a marker that is correlated with a drug's efficacy or safety as "not something that someone invented" won't get you anywhere on the "evergreening" issue. What lxf001 proposes as the claimed method is selective adminsitration of that drug based on the existence of that biomarker in the patient to whom the drug is being administered. (As lxf001 is well aware, simply administering that drug blindly to anyone, whether or not they have that biomarker is likely inherently anticipated and therefore unpatentable.) Also, what if knowledge of that biomarker is necessary to avoid giving the patient an expensive drug that is essentially useless, or even worse, has significant side effects? That would be far more "dangerous" to the prospective user of that drug.

But if you show that this correlation to the biomarker is known or obvious, there won't be any "evergreening." Again, rely upon lack of novelty under 35 USC 102 or obviousness under 35 USC 103 of the correlation, not patent-ineligibility under 35 USC 101.

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