Do Diagnostic Method Claims Fall under the Safe Harbor of 35 U.S.C. § 287(c)?

(And If So, Would That Address Justice Breyer's Concerns in Mayo v. Prometheus)?

By Kevin E. Noonan --

Sometimes solutions to thorny issues are within our grasp if only we looked in the right place.  The Supreme Court's recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. raises the specter of the Court throwing out the patent system baby in order to preserve the medical community's bathwater, with (paradoxically) the prospect of fatally harming both.  It is clear that trying to address these issues through a reasoned explication of patent law is like trying to teach the proverbial donkey to count (or perhaps trying to explain compound interest to a disinterested teenager).  So instead, perhaps the way to address the concern that patents may somehow "harm" a medical practitioner's ability to treat patients is to give doctors what they want -- a "get out of jail free" card for infringement.

This has been done before, of course, to address patent claims directed to methods for performing eye surgery.  The patent, U.S. Patent No. 5,080,111 to Dr. Pallin, was being asserted (Pallin v. Singer, 1996 WL 274407 (D. Vt., Mar. 28, 1996)) against medical doctors and eye clinics in the mid-1990's and prompted swift Congressional action (relative to the glacial pace of patent reform over the past three Congresses).  The measure that ultimately passed, introduced by Senator Bill Frist of Tennessee (himself a physician) was codified as 35 U.S.C. § 287(c):

35 U.S.C. 287 Limitation on damages and other remedies; marking and notice.

                                                            * * *

(c)(1) With respect to a medical practitioner's performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

(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.
    (B) the term "medical practitioner" means any natural person who is licensed by a State to provide the medical activity described in subsection (c)(1) or who is acting under the direction of such person in the performance of the medical activity.
    (C) the term "related health care entity" shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the medical activity, including but not limited to a nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.
    (D) the term "professional affiliation" shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner pro- vides the medical activity on behalf of, or in association with, the health care entity.
    (E) the term "body" shall mean a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans.
    (F) the term "patented use of a composition of matter" does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method.
    (G) the term "State" shall mean any state or territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.

(3) This subsection does not apply to the activities of any person, or employee or agent of such person (regardless of whether such person is a tax exempt organization under section 501(c) of the Internal Revenue Code), who is engaged in the commercial development, manufacture, sale, importation, or distribution of a machine, manufacture, or composition of matter or the provision of pharmacy or clinical laboratory services (other than clinical laboratory services provided in a physician's office), where such activities are:
    (A) directly related to the commercial development, manufacture, sale, importation, or distribution of a machine, manufacture, or composition of matter or the provision of pharmacy or clinical laboratory services (other than clinical laboratory services provided in a physician's office), and
    (B) regulated under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Clinical Laboratories Improvement Act.

(4) This subsection shall not apply to any patent issued based on an application the earliest effective filing date of which is prior to September 30, 1996.

The policy justification for the bill was, as eloquently expressed by Senator Frist, because "innovations in surgical and medical procedures do not require the midwifery of patent law."  As enacted into law, the bill reflects a carefully crafted ("narrowly tailored") balance between the concerns of the medical community and the patent community, particularly the biotechnology community.  For example, "biotechnology patents" are expressly excluded from the exemption; such patents are defined (under 35 U.S.C. § 103(b)) as "a process of genetically altering of inducing a single or multi-celled organism" or "cell fusion procedures yielding a cell line that expresses a specific protein" or "methods of using a product produced" by the above processes.  Also not exempt are individuals involved in the commercialization of "a machine, manufacture, or composition of matter" related to a medical activity.  Importantly, the provision does not exempt commercial clinical labs, including ones regulated under CLIA, who perform medical diagnostic methods.

Expressly and by implication, these exclusions to the exemption do not include clinical laboratory services provided in a physician's office, and the statute is expressly directed to the "performance of a medical activity," which is defined as "a medical or surgical procedure on a body."  The statute does not include "diagnostic methods" within this definition of a "medical activity," but this is not an instance where the absence can be used to read anything into the legislative history, because the excluded provision was in fact in a different bill that was not considered by Congress.  But (perhaps) significantly the exclusions to the exemption eschew mention of only one category of patent-eligible subject matter, methods.

Including diagnostic methods (limited to those performed in a physician's office) to the exemption might address the policy concerns raised by Justice Breyer in Mayo (and before that in Laboratory Corp. v. Metabolite Labs., Inc.).  Such balancing of policy concerns has been done in the other patent law provisions, such as the safe harbor provisions of 35 U.S.C. § 271(e)(1); there, the policy purpose was to permit generic drug makers to prepare for market entry upon innovator drug patent expiration (ignoring for the moment the real effect of providing strong incentives for generic companies to utilize the provisions of § 271(e)(2) to challenge those patents rather than waiting for them to expire).  It is thus possible to read the law as containing (sub silentio, to be sure) diagnostic methods within the scope of the safe harbor.

Commentators are almost uniform in rejecting this interpretation, however, believing that Congress must more expressly enunciate the exemption in order for it to be effective.  See, Sirjani & Keyhani, "35 U.S.C. 287(C): Language Slightly Beyond Intent," 3 Buffalo Intellect. Prop. Law J. 13 (Fall 2005); Rundle, "The Physician's Immunity Statute: A Botched Operation or a Model Procedure?" 34 Iowa J. Corp. L. 943 (Spring 2009); Hu and Mallin, "Medical Method Patents: Treating 'The Physicians' Immunity Statute,'" 23 Syr. Sci Technol. Law Reporter 63 (Fall 2010).  In part, this conclusion is based on the phrase "medical or surgical procedure on a body," which is interpreted to exclude assays of blood, urine, tissue, or other biological samples that are taken from a body.

Should Congress deign to make inclusion of medical diagnostic methods within the scope of the exemption, such an action would comport with Justice Breyer's invitation at the end of the Mayo opinion ("[a]nd we must recognize the role of Congress in crafting more finely tailored rules where necessary").  Congress also has the opportunity to act (without having to take up the measure anew), having scheduled and held hearings on "technical" amendments to the Leahy-Smith America Invents Act that create the possibility for additional fine tuning of the patent system.  Perhaps Congress could take up this issue, and while it's at it complete revision to 35 U.S.C. § 101.  That provision of the statute now includes Section 23 (the Weldon amendment provisions: "Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism"), and it could readily be further amended to expressly recite that diagnostic method claims are patent eligible subject matter.  Coupled with revisions to § 287(c) to expressly exempt clinical laboratory services provided by physicians (and not commercial clinical labs), this legislative scheme might reduce the temperature of those whose concern over the possibility that patent protection might inhibit medical services delivery has created the greater likelihood that innovation will be harmed by a lack of patent protection (or worse, that disclosure will decline, reducing the pace of innovation).

It is clear that the philosophical disconnect between the Supreme Court and the Federal Circuit (and the failure of the Supreme Court to credit the Federal Circuit's particular area of expertise in deciding over the past decade to assert its hierarchical prerogatives over the lower court) has disrupted the system envisioned by Congress in creating the specialized appellate court.  Accordingly, it is now time for Congress to impose by legislation the corrective measures needed to restore American patent law to its position in "promoting the Progress of . . . the Useful Arts."

Comments

[Gary Johnston]

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.

[EG]

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.

[lxf001]

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?????

[Gary Johnston]

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.

[A. Konski]

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-

[Kevin E. Noonan]

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.

[lxf001]

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.

[Kevin E. Noonan]

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.

[EG]

"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.

[Warren Woessner]

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

[Gary Johnston]

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?

[EG]

"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.

[Gary Johnston]

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!

[EG]

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?

[lxf001]

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.

[Gary Johnston]

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.

[Gary Johnston]

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.

[EG]

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.

[Gary Johnston]

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.

[EG]

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.