E-mail Newsletter

  • Enter your e-mail address below to receive the "Patent Docs" e-mail newsletter.

Enter your email address:

Delivered by FeedBurner

Contact the Docs

Docs on Twitter


About the Authors

  • The Authors and Contributors of "Patent Docs" are patent attorneys and agents, many of whom hold doctorates in a diverse array of disciplines.

Disclaimer

  • "Patent Docs" does not contain any legal advice whatsoever. This weblog is for informational purposes only, and its publication does not create an attorney-client relationship. In addition, nothing on "Patent Docs" constitutes a solicitation for business. This weblog is intended primarily for other attorneys. Moreover, "Patent Docs" is the personal weblog of the Authors; it is not edited by the Authors' employers or clients and, as such, no part of this weblog may be so attributed. All posts on "Patent Docs" should be double-checked for their accuracy and current applicability.

  • Law Blogs

Become a Fan

« Genetic Marker Map of Sunflower Species Reported | Main | CBI Life Sciences Congress on Paragraph IV Disputes »

August 23, 2012

TrackBack

TrackBack URL for this entry:
http://www.typepad.com/services/trackback/6a00d83451ca1469e20177444ed249970d

Listed below are links to weblogs that reference Patent Eligibility and Biology:

Comments

Dr. Noonan,

Your example of dolphin testing would not be patent eligible according to Prometheus.

In "comprising the step of administering the compound to a bottlenose dolphin and detecting an antiglycemic effect in the dolphin." you are doing nothing above a law of nature. Just as in Prometheus, the administering step only sets the table for the claim and would be parsed out. The antiglycemic effect is only nature doing its thing. Here, you are not even saying "just apply it;" but you are saying "just observe it."

You have to do more to illustrate patent eligibility.

On the other hand, the sunflower iem would be patent eligible as it evinces the application of the hand of man to actually achieve something.

If it was not conventional to administer the compound to dophins, then wouldn't the claim involve other than routine or conventional steps and thus be patent-eligible? Also, if the combiniation of a step of adminitering a compound to a dolphin and then detecting an antiglycemic effect had not previously been combined, this new combination would be applying the natural process in a new and limited context.

Skeptical,

I would be careful about saying the dolphin testing isn't patent-eligible, even in view of Prometheus/Mayo. First, the method in Prometheus/Mayo was about determining a level of the metabolite that would indicate too high or too low a dosage. Second, the claimed method might have been written differently (and was written differently in other patents owned by Prometheus) to reach the patent-eligibility zone.

By contrast, what Kevin's proposed "dolphin testing" method is essentially is an animal model for screening potential diabetes treatment drugs for humans. I might also suggest rewriting Kevin's proposed method this way:

A method which comprises the following steps:

(a) administering a compound having a potential for treating type 2 diabetes in the human; and (b)

(b) measuring the degree of antiglycemic effect in the dolphin to thereby determine whether the compound is or is not effective for treating type 2 diabetes.

What I think is important is to move the preamble from Kevin's proposed method claim into the body of the claim. In my opiinion, relying on the preamble language for anything is fraught with danger. (Prometheus' claimed method had this issue too.)

You might also add to step (b) that the "measuring" is carried out with an analytical instrument of some type to avoid a potential "mental steps" issue. The problem is that if animal drug screens like this one are patent-ineligible, you are really putting a crimp on the ability to protect such drug screens except in a very rare circumstance.

Bob,

I suggest you read (again) the Prometheus decision and then see if you can apply your comments (please note that I NOT saying that your logic is flawed).


EG,

Respectfully, I stand by my post and maintain that the claim as provided would be found NOT patent eligible in view of Prometheus (the difference in subject matter is immaterial, and "re-writing" the claim may or may not help - but is not part of the discussion).

I am not sure what you are talking about as to a preamble, as the inset claim has no preamble.

Further, I doubt that the addition of a step of 'measuring carried out with analytical instruments' would even help, as I am sure that you recall, Prometheus had that very type of step (which Breyer parsed out) in its claim that was ruled patent ineligible (again, I am not saying that the Supreme Court logic was correct).

Bottom line is that drug screen methods (written as provided) are not patent eligible methods because they do not even approach the "just apply it" threshold.

Wouldn't you be skeptical to accept "just observe it," if "just apply it" is "not enough"? A research plan is not an invention. Research results are not an invention.

Skeptical,

You could well be correct in view of the "fuzzy" flawed reasoning in Prometheus/Mayo. See my comment below about reconciling Prometheus/Mayo with Diamond v. Diehr.

What is the "preamble" in Kevin's proposed claim is everything before "comprising the following steps"; everything afterwards is the "body" of the claim. Federal Circuit case law on the impact of the "preamble" on the validity of the claim is all over the place.

Actually, Breyer didn't parse out in Prometheus/Mayo a claim which required any mechanical device. All Breyer said was: "For present purposes we may assume that the other claims in the patents do not differ significantly from claim 1." What may have bothered Breyer (especially given all I heard about this claimed method patenting "thought", possibly based on an ill-advised infringement assertion by Prometheus) is that the claimed method might potentially cover "mental steps." (There is a reference in Prometheus that "mental processes" are not patentable.)

In effect, the dolphin is being used in this method just like a mechanical instrument to evaluate whether a compound is or is not a potential drug for treating diabetes. How is this different from a mechanical instrument doing the same thing? How is this different from "measuring the temperature inside the mold and feeding the temperature measurements into a computer that repeatedly recalculates the cure time" as in the Diamond v. Diehr case? (And you don't need to tell me that the reasoning in Prometheus/Mayo can't be squared with Diehr, no matter what Breyer says.)

All I'm saying is that until something like this dolphin drug screen method is evaluated in the "crucible of litigation," any judgment we make now as to what will fly is about as good as using a Ouija board (my favorite metaphor now on determing patent-eligibility under 35 USC 101).

A method which comprises the following steps:

(a) administering at least two compounds having a potential for treating type 2 diabetes in the human;

(b) measuring the degree of antiglycemic effect of the at least two compounds in the dolphin; and

(c) recording the results in a manner that allows identification of one or more compounds with greatest antiglycemic effect.
---------------------

If (a) or (b) are not in the prior art the case is immediately distinguished from Prometheus. The claim might still be ineligible under some other 101 theory but the facts here (i.e., the elements in the claim and their relationship to excepted subject matter and the prior art) are completely different from the facts in Prometheus. This true even if step (c) is omitted.

"any judgment we make now as to what will fly is about as good as using a Ouija board (my favorite metaphor now on determing patent-eligibility under 35 USC 101)."

Actually there are an infinite number of claims that are very very easy to swat down as ineligible under 101, especially after the clear guidance in Prometheus.

EG,

A dolphin is not a mechanical device and any biological interaction will fall according to the Law of Nature doctrine as explained in Prometheus (along the lines of a human may introduce a substance, but the reaction of the substance, and the metabolites, thus created, merely follow natural law).

Malcolm,

I see that you are still trying to sneak a 102/103 analysis into the 101 analysis. Your (b) will not distinguish for a 101 analysis even if the measurement of effect is not in the prior art. It is not "some other" 101 theory. It is the same 101 theory used in Prometheus.

Skeptical,

You're still missing my point: the dolphin model is still be used like it was a mechanical/analytical device. Also, how is this different from using Chakrabarty's microorganism which contained 4 plasmid vectors from other microorganisms to degrade oil spills? SCOTUS in Chakrabarty has already ruled that the fact the claimed subject matter involves life forms doesn't make it automatically patent-ineligible under 35 USC 101.

Dolphins, in nature, don't ingest the potential anti-diabetic drugs; that requires human intervention. This is one of the great fallacies of Prometheus/Mayo being based on a "law of nature" exception as the drugs administered there don't exist in "nature." I can rationalize the result in Prometheus/Mayo on "abstract idea" grounds, but not on "law of nature" grounds.

Again, your view could be adopted by the courts, but it still needs to be tested in the courts. What Prometheus/Mayo says is so nebulous and in conflict with the reasoning in Diehr that it will take potentially many subsequent cases to sort out what is and is not within the patent-eligibility zone. I, for one, am not going to assume what the boundaries are based Prometheus/Mayo.

With all respect EG, no I am not missing the point.

I understand full well what you are saying.

I disagree that that line of thought works.

You are engaging in what can only be called a combiantion of wishful thinking/buyer's remorse. You cannot undo what the 9-0 Supreme Court said in Prometheus.

You are confusing yourself by thinking the question is concerning a life form or not - it is not.

The question is what is being done with that life form.

In the dolphin example, there is nothing inventive - just observation. In Chakrabarty, a manufacture (even though of living things) was undertaken.

You are also missing the point made in Prometheus that the introduction of the drug - even by human action - is MEANINGLESS to the patent eligibility of the claim. All that is, per Breyer, is setting the stage - pre-solution activity that does not count. Yes, we both may agree that this may be considered a "great fallacy," but you would be incorrect to say that the courts COULD adopt the view. Courts are BOUND to adopt the view because the Supreme Court said so. There is no "to be tested."

To suggest otherwise is to fly in the face of the direct words the court has used, removing the logical pinning that the decision iteslef requires and making a dead letter of the decision. Do you think that such would survive judicial scrutiny? Me, I'm skeptical.

With all due respect to all of "Bob", "EG" and "Skeptical", in addition to the Prometheus decision, we now have the CAFC (admittedly a lower court) decision in Myriad after GVR to the effect that a claim to a method for screening drugs by observing their effect on a model system is patent eligible.

Notwithstanding all of the controversy surrounding both decisions, I think that the Supreme Court decision in Prometheus was driven mostly by an understanding (right or wrong) that patents on diagnostic methods drive up their cost to the public, and such costs are to be minimized now.

So, to the degree that model systems make development of drugs less expensive, and that savings is passed on to consumers ultimately (or maybe to the insurance companies and Medicare/Medicaid, who are the entities actually buying), I think it is probable that the CAFC's decision on the question of patent eligibility of drug screening methods will stand if reviewed by the Supreme Court.

Skeptical: "You are also missing the point made in Prometheus that the introduction of the drug - even by human action - is MEANINGLESS to the patent eligibility of the claim. "

That's because the step of administering the drug was old in the art and the only additional step was a step of thinking about an unpatentable correlation. The claim was therefore effectively a patent on the correlation itself and was declared ineligible for that reason. You really have not idea what Prometheus was about, Skeptical. We've established that already.

"Do you think that such would survive judicial scrutiny? Me, I'm skeptical."

You're also wrong pretty much 100% of the time.

EG "This is one of the great fallacies of Prometheus/Mayo being based on a "law of nature" exception as the drugs administered there don't exist in "nature.""

Not a great fallacy, but certainly an unnecessary distraction that has caused great confusion amongst those who are inclined to be confused whenever the Supreme Court finds a patent invalid.

If you read the decision with an intent to understand what the Court is talking about, you'll see that they make no distinction between "natural correlations" and "laws of nature." A key point of the case (or "holding" if you will) is that you can't practice the prior art, discover something new that "naturally" results from that practice, and then obtain a patent that turns practitioners of the prior art into infringers when they THINK about your discovery. There has to be more in the claim.

Jaded: "we now have the CAFC (admittedly a lower court) decision in Myriad after GVR to the effect that a claim to a method for screening drugs by observing their effect on a model system is patent eligible."

Except that's not the correct holding of the case. The correct holding is that "a claim to a method for screening drugs by observing their effect on a NOVEL, NON-OBVIOUS model system is patent eligible."

This is, in fact, an example of the permitted and correct application of the machine-or-transformation test (in this case, it's a biological machine).

Note that if all limitations in the claim are old, the mere recitation of a step of "observing [something new]" will not rescue the claim from ineligiblity under 101 (although it will rescue the claim from being anticipated). That is because such a recitation lands us right back in the Prometheus problem: people practicing the prior art will become infringers merely because they look at something in a new way.

Skeptical: "I see that you are still trying to sneak a 102/103 analysis into the 101 analysis. "

I'm not trying to "sneak" in any analysis. I don't need to "sneak" in any analysis. The Supreme Court didn't "sneak" in a "102/103 analysis" into their 101 analysis. They performed the 102/103 analysis expressly, and even explained why they did so.

You've already been asked to explain WHY the Supreme Court chose to use the language "old" and "conventional" when they explained the failure of the transforming steps at converting the ineligible recited mental step (thinking about a "natural correlation") in Prometheus' claim into eligible subject matter.

You failed to provide an answer, Skeptical. And you won't be able to provide one now. That much is absolutely certain.

The comments to this entry are closed.

October 2014

Sun Mon Tue Wed Thu Fri Sat
      1 2 3 4
5 6 7 8 9 10 11
12 13 14 15 16 17 18
19 20 21 22 23 24 25
26 27 28 29 30 31