“Generic drug manufacturers accused of infringement should fully appreciate the subjective nature of a § 101 defense when evaluating their litigation risk.”
The Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. The case confirms that amending an Abbreviated New Drug Application (ANDA) to address a patent issued after the original ANDA’s filing can infringe the later-issued patent. The decision also upheld the district court’s decision finding Vanda’s personalized medical treatment claims patent eligible under § 101.
Much of the decision compares Vanda’s claims to those found ineligible for patent protection in the U.S. Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, 132 S. Ct. 1289 (2012). While the ultimate patentability conclusions are opposite, the claims in Vanda and Mayo are very similar, highlighting the thin—and often unpredictable—line that divides eligible and ineligible subject matter. Generic drug manufacturers must account for this unpredictability in gauging their litigation risks.
Vanda owns a New Drug Application (NDA) for FANPAT (iloperidone), an antipsychotic drug used to treat schizophrenia. Id. at 4. Upon filing the NDA, Vanda listed U.S. Reissue Patent No. 39,198 in the Food and Drug Administration’s Orange Book for iloperidone. Id. at 2. In 2013, West-Ward filed its ANDA seeking approval to manufacture and sell a generic version of iloperidone. Id. at 5. While West-Ward’s ANDA was pending, the Patent Office issued U.S. Patent No. 8,586,610. Soon thereafter, Vanda listed the ‘610 Patent in the Orange Book. Id. at 6. West-Ward amended its ANDA to include a certification that the ‘610 patent was invalid or not infringed. Id.
The ‘610 patent discloses a method of treating schizophrenia patients with iloperidone, including analyzing the patient’s genotype and determining the proper iloperidone dosage based on that genotype. Id. at 3. The human body metabolizes iloperidone with an enzyme encoded by the CYP2D6 gene. Id. Some individuals have low CYP2D6 activity, and therefore poorly metabolize drugs like iloperidone. Id. These poor metabolizers are at a higher risk for an abnormal heartbeat when treated with iloperidone. Id. The ‘610 patent teaches that poor metabolizers, who can be identified by a genetic test, should be treated with a lower dose of iloperidone to reduce that risk. Id.
Vanda sued West-Ward for infringement of the ‘610 patent in the District of Delaware. Id. West-Ward raised several defenses at trial, including (1) that amending its ANDA could not constitute an act of infringement because the ‘610 patent issued after the original ANDA filing date and (2) that the ‘610 patent was invalid under § 101 as directed to patent-ineligible subject matter. Id. at 12, 26. After a bench trial, Judge Sleet found that West-Ward’s proposed generic drug-induced infringement and that the ’610 patent was not invalid. Id. at 6-7. West-Ward appealed.
The Hatch-Waxman Act states that “it shall be an act of infringement to submit an application” seeking to manufacture, use, or sell “a drug. . . the use of which is claimed in a patent.” Id. at 13-14 (quoting 35 U.S.C. § 271(e)(2)). This allows brand-name and generic drug manufacturers to litigate issues of infringement and invalidity before a generic version of the drug is actually sold or marketed. Id. at 14. ANDA applicants who want to market their generic drug prior to patent expiration can certify that the patents listed in the Orange Book for the relevant drug are either invalid or would not be infringed by the proposed generic drug. Id. at 5. These certifications are referred to as “Paragraph IV certifications.” Id. West-Ward alleged that filing an amended ANDA with an updated Paragraph IV certification did not constitute an act of infringement when the updated certification addressed a patent that was not listed in the Orange Book when the ANDA was originally filed. In other words, does amending a Paragraph IV certification to address a subsequent patent constitute “submit[ting] an application” under § 271(e)(2)?
The Federal Circuit found that it does. First, the ’610 patent was a patent “for a drug. . . the use of which is claimed in a patent” under 35 U.S.C. § 271(e)(2)(A) regardless of whether it issued before or after West-Ward’s initial Paragraph IV certification. Id. at 14. Second, the proper infringement analysis must consider the amended ANDA, including the amended Paragraph IV certification. Id. (citing Ferring B.V. v. Watson Labs., Inc.-Fla., 764 F.3d 1382, 1390 (Fed. Cir. 2014) and Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130, 1135 (Fed. Cir. 1995)).
Third, the FDA regulatory framework “expressly contemplates certifications for patents that issue after the ANDA is filed.” Id. at 16. NDA applicants have a continuing obligation to update patent information even for patents that issue after the FDA approves the drug. Id. Furthermore, ANDA applicants have a corresponding duty to update Paragraph IV certifications, even as to subsequently issued patents, until the ANDA is approved. Id.
Finally, legislative history further supports a finding that amendments to Paragraph IV certifications addressing subsequent patents can infringe. Id. Under certain circumstances, the FDA’s approval of an ANDA will be stayed for thirty months if the drug manufacturer brings suit for patent infringement. Id. at 17. Earlier versions of the statute permitted a stay if suit was brought within 45 days of a Paragraph IV certification, including amended certifications. Id. This allowed for multiple 30 month stays if patents issued after the ANDA filing date. Id. In 2003, Congress amended the provision to provide a stay only for Paragraph IV certifications made in response to patents existing when original ANDA was filed. Id. In light of this, the Federal Circuit concluded that an amended Paragraph IV certification addressing a subsequent patent could be an infringing act.
After affirming that West-Ward’s ANDA induced infringement of the ‘610 patent, the court addressed whether the infringed claims were even patent-eligible. West-Ward argued that the claims were ineligible under § 101 because they were directed to a natural relationship between iloperidone, CYP2D6 metabolism, and the abnormal heartbeat iloperidone can induce. Id. at 26.
Determining subject-matter eligibility requires a two-step process. Id. at 27. First, the court must determine whether the claims of the ‘610 patent are directed to a patent-ineligible concept, in this case, a law of nature. Id. If the claims are directed to an ineligible concept, then the court must determine whether the claims reflect an “inventive concept.” Id. Here, the majority did not reach the second step of the inquiry, finding that the claims were not even directed at ineligible subject matter. Id. at 28.
Much of the court’s opinion compares the ‘610 patent’s claims with those the Supreme Court found ineligible in Mayo Collaborative Services v. Prometheus Laboratories. In Mayo, the representative claim recited “a method for optimizing treatment of a . . . disorder” comprising the steps of (1) administering a particular drug, (2) determining the level of that drug in the patient’s blood, and (3) adjusting the patient’s dose upward if the drug appears below a certain threshold and adjusting the dose downward if the drug appears above a certain threshold. The ‘610 patent recites a method of “treating a patient” with a drug, comprising the steps of (1) determining how a patient will metabolize the drug using a genetic test, and (2) administering one of two dosages depending on the results of that genetic test. Representative claims of the ’610 patent and the patent at issue in Mayo are presented below:
Both claims correlate an individual’s ability to metabolize the drug with the proper dosage for that individual. But, according to the majority opinion, the claims in Mayo merely recited that natural relationship, while the ‘610 patent “claims an application of that relationship.” Id. at 30. The court found that the ‘610 patent’s recitation of specific dosages, and the specification’s explanation of the significance of those specific dosages, distinguished this case from Mayo. Id. The court also seemed persuaded by the representative claims’ respective preambles. Vanda’s claimed, “a method for treating a patient” while Mayo’s claimed “a method for optimizing therapeutic efficacy for treatment” of a particular disorder. Id. at 29.
While the subject matter-eligibility inquiry inherently requires some line-drawing, the court relied on a very thin line to distinguish Vanda’s claims from Mayo’s ineligible ones. Chief Judge Prost dissented from the majority opinion, stating that she would have held the ‘610 patent claims were directed to a law of nature and therefore ineligible. Id., dissent at 2. In her opinion, claims that merely apply a law of nature are not patent-eligible either. Id.
This decision highlights the difficulty courts have had in applying the Supreme Court’s subject-matter eligibility, including from Mayo and Alice Corp. v. CLS Bank. Generic drug manufacturers accused of infringement should fully appreciate the subjective nature of a § 101 defense when evaluating their litigation risk.
Join the Discussion
18 comments so far.
AnonMay 21, 2018 09:50 am
Thank you for the thoughtful (and thorough) reply.
While I do not fully agree with your views (in part, your tendency to want to use your strengths because they are your strengths, rather than being a legally appropriate avenue), I do enjoy reading your inputs.
By the way, the “deprive tax” angle remains a non-starter. Even though the very essence of a patent appears to be undergoing a (judicial branch) sea change from a personal property right to a Franchise property right, patents remain a negative right and there is simply no guarantee of any “making money” that serves as a basis for taxes that would inure to any such “making money.”
As to the 1952 Act, and the thrust of the point at present, again I would suggest that you read Judge Rich and his ruminations on 103 (and how that carve-out from the same prior single paragraph directly impacts the 101 question).
Joachim MartilloMay 21, 2018 04:54 am
[email protected] May 20, 2018 7:48 pm,
Ever since the USPTO in the course of an unlawful attempt to reject patent applications
a) that are owned by a family trust and
b) that pertain to completely statutory inventions
threw every possible eligibility rejection, all but one possible § 112 rejection, and a bunch of completely ridiculous § 103 rejections at the patent prosecutors, I have been quite careful to distinguish claim eligibility from claim patentability.
I have been looking at the legislative history of the 1952 patent act. There seems to have been a strong effort to render legal issues in federal courts completely statutory and no longer matters of judge-made law. It is not obvious that Congress was trying to eliminate the use of judge-made law during patent application prosecution. Congress could have explicitly written the judicial exceptions, doctrine of equivalents, unpatentability of non-statutory double patented claims, reverse doctrine of equivalents, printed matter doctrine, and any other patent-relevant judge-made law either into or out of statutory patent law, but Congress did not do so.
It does seem that Congress has been trying to create a specific patent law legal realm first by making the CCPA an article III court in 1958 and then by recreating it as the CAFC in 1982 — two years after Congress legislated re-examination. All patent-related federal district court appeals, ITC appeals, CFC appeals, and all USPTO appeals now go to the CAFC.
Newman seems correct in Knowles Electronics LLC v. Cirrus Logic, Inc., 2018 WL 1095253 (Fed. Cir. Mar. 1, 2018) (Newman (dissenting), WALLACH, Chen) to hold that a patent claim fully litigated with respect to a party all the way through the CAFC from one of its subordinate federal article III courts or from one of its subordinate administrative tribunals is precluded from relitigation with respect to said party and said claim.
The refusal of a subset of CAFC judges to apply issue preclusion is one source of chaos. Isn’t there an equal protection violation in this part of the mess? SCOTUS rarely cites Yick Wo v. Hopkins, 118 U.S. 356 (1886), but the current situation surely seems to discriminate against patent owners as a class and practically invites corruption of the sort that is taking place of the USPTO and that involves a criminal conspiracy both
(a) to falsify documents for manipulation of decisions at the CAFC and also
(b) to defeat taxes.
The failure of Congress to deal explicitly in some way with federal common law in the patent realm is another source of chaos. Because a scientific discovery as a natural phenomenon judicial exception to § 101 is not patent-eligible, natural phenomena whether known or unknown are not available as prior art under § 103, and patentability cannot be negatived by showing obviousness from prior art in combination with a natural phenomenon.
Here is the relevant text.
Thus, a new claim obvious in a non-legal sense by combining prior art with a natural phenomenon is legally non-obvious and even a possibly legal means to extend patent term despite public policy.
Yet as long as the USPTO is playing criminal games:
(a) to prevent patents from issuing to applicants that are entitled to them or
(b) to make sure that patent term is lost,
it is hard to consider Prometheus-like attempts to extend patent term to be illegitimate.
During oral arguments the CAFC telegraphed the future now delivered decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707.
There is nothing at all subjective in arguing § 101 validity under the the Alice/Mayo two-part test as I point out in Administer–”Do Standard Detection”–”Modify Administration” Method Claims and 35 USC § 101 Eligibility Analysis (Part I: Vanda and Prometheus).
Thanks to Berkheimer v. HP Inc. (Fed. Cir. 2018) both plaintiff and also defendant can present factual arguments in District Court for or against § 101 eligibility.
The CAFC holds the following.
I will try to create my recommended recipe for introducing the necessary facts and for making the factual arguments. These arguments are straightforward but require material, which may be unfamiliar to most attorneys that don’t have a background in 18th century thought on epistemology.
A case for or against § 101 eligibility requires a factual basis that can be presented by the following experts:
(a) an epistemologist,
(b) an expert in the epistemic jargon of the art in question,
(c) a philologist or expert in linguistics, and
(d) an expert in the technological art to which the invention belongs.
For the purposes of creating the necessary expert reports or of providing the necessary expert testimony, it is possible that a single expert may wear two hats. Because of the unfamiliarity of material that experts (a)-(c) must present, a lot of hand-holding will be required as an attorney presents his arguments.
AnonMay 20, 2018 07:48 pm
I would stress a few points:
1) Patent eligibility is a different animal than patentability.
Be careful when discussions of 101 arise – very often there is confusion and conflation.
2) 35 U.S. Code § 112 is both an allocation of responsibility (in order to obtain) and authority (it is the inventor that sets forth the invention – as claimed).
It is NOT the Court that “feels” like the inventor is merely playing “scrivening games” and that the “real invention is whatever the Court deigns as “Gist” or “directed to” or any of the other dozens of like phrases that the Court dallied with PRE-1952 when it had a common law power (provided by the Legislative Branch) to “set” the meaning of the word “invention.”
I suggest that you study the writings of Judge Rich on this matter – the single most knowledgeable person of the judicial branch (because he helped write the words that Congress used in the Act of 1952).
Joachim MartilloMay 20, 2018 03:36 pm
[email protected] May 17, 2018 10:19 am,
We should probably state that basic law of a patent claim “particularly pointing out and distinctly claiming the subject matter” according to 35 U.S. Code § 112 (b) makes it completely possible for said claim, even if eligible under judicial interpretation of 35 U.S. Code § 101, to fail to be patentable under at least one of both 35 U.S. Code § 102 and also 35 U.S. Code § 103.
One should not confuse judicial exception with either anticipation or obviousness.
AnonMay 18, 2018 08:24 am
And I would further point out that the presence in section 100 is NOT in line with the actions of the Supreme Court – so thanks in that your attempt at being snarky is yet another bite out of the pedestal upon which you would like to place the Supreme Court.
AnonMay 18, 2018 08:22 am
Are you being purposefully obtuse?
Your snark is most unbecoming.
Yes, the word is there – but please check our history of the Act of 1952 and especially how and why section 103 came about. A very famous person (who helped write the Act) as well as later served as a member of the judicial branch (with the most knowledge of the Act) has discussed this point.
Paul ColeMay 18, 2018 04:54 am
I recall that the word “invention” has cunningly crept into 35 USC 100 at least, and that 10w begins WHOEVER INVENTS….”
Funny how these contemptible subversive words can creep into the most patriotic documents.
AnonMay 17, 2018 02:00 pm
Further, as you attempt here (or rather, as you reflect what the Court attempted), “invention” was explicitly removed from the US Law as of the Act of 1952 – in the manner of the use being reflected.
That the Court acts as if the Act of 1952 did not happen does NOT make it so.
AnonMay 17, 2018 01:58 pm
You “rest” your case on the (re)written law of 101 – and not the actual law as written by Congress.
That “(re)written law” is not even free of fatal self-conflictions.
Point blank, Mr. Cole, eligibility is NOT a dissected “element” being eligible or not item.
Four words: “Claim as a whole.”
Paul ColeMay 17, 2018 01:43 pm
The claim in Prometheus was:
“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
FEATURE A: administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
FEATURE B: determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
FEATURE C: wherein the level of 6-thioguanine less than about 230 pmol per 8×10 to the 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
FEATURE D: wherein the level of 6-thioguanine greater than about 400 pmol per 8×10 to the 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.”
Justice Breyer cut straight to the chase, and considered first the two purportedly novel features. With regard to them he said:
“Prometheus’ patents set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. Claim 1, for example, states that if the levels of 6–TG in the blood (of a patient who has taken a dose of a thiopurine drug) exceed about 400 pmol per 8×108 red blood cells, then the administered dose is likely to produce toxic sideeffects. While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists inprinciple apart from any human action. The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.”
On a more positive view, neither feature C nor feature D is in itself patent-eligible because they are mere factual information not requiring any human intervention. Once the test has been carried out, the claim though providing information does not require any human action to be performed.
Feature A and feature B were old and were non-transformative. Features C and D were mere statements of a natural law. The conclusion was:
“To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.”
As previously explained, the administration and the tests were known, and the added features were mere information and did not require any transformative human activity.
The point is NOT novelty or its absence. The point is that you cannot rely for invention under Section 101 on features which are non-eligible, which is what the patentee was trying to do,
AnonMay 17, 2018 12:21 pm
Respectfully THAT was NOT the problem in Prometheus.
And if you really think that THAT was the problem, then you really do not understand the basics of US patent law.
As I stated – US patent law provides for the fact that innovations that ENTIRELY rely on items that individually are not novel can very much be patent eligible.
This you must accept – or I suggest that you stop posting views on the US system, because what you post is not indicative of our laws.
Paul ColeMay 17, 2018 11:43 am
The point is that a perfectly novel claim may be entirely or substantially composed of non-eligible features. THAT was the problem in Prometheus.
AnonMay 17, 2018 10:19 am
You suffer a legal error (and enjoin others to suffer the same error):
Eligibility is not (under the law as written by Congress) a matter of “novel features.”
A perfectly eligible claim may be entirely comprised of non-novel features.
ANY view that does not recognize this – and advocates for practices that do not recognize this – are not only wrong, but are a retreat to (and thus promotes) the propaganda against patents.
Paul ColeMay 17, 2018 09:35 am
If you have a claim whose only novel features are ineligible because they are mere items of information not in themselves involving any intervention by the hand of man, you are on a LOOSER. A thoughtful grasshopper could get the point.
What is needed is careful claim drafting accompanied by legally informed advocacy understandable by judges trained neither in patent law nor in one of the sciences. Then there is a chance of winning. If we cannot get our points across that may because (a) the cases we present are not good ones, and (b) our advocacy is wanting. Both of these things we can control.
MoocowMay 17, 2018 09:17 am
Sorry, Paul, but I don’t think the distinction between this case and Mayo is straightforward. I believe this case illustrates that the Mayo test produces random results, and is just never going to be a productive tool for fairly and reliably deciding cases. Mind you, I’m glad the case was decided this way (for now), but when you look at the opinions below they all make equal sense or non-sense. The district judge found the claim directed to a natural phenomenon but upheld it at step 2 of the test. The CAFC panel majority found it not directed to a natural phenomenon; the dissent did. We have 2 judges saying step 1 is met, and 2 saying it’s not. I bet you dollars for donuts, if we assembled hundreds of judges for a vote the result would approach 50:50, in any patent eligibility case. I completely agree with you that this case shows the effect of positive thinking among decisionmakers, and that’s a problem.
Paul ColeMay 17, 2018 07:19 am
As lead author of the two Sequenom amicus briefs referred to (one from CIPA and the other from the EPI), I cannot but regard the failure to grant certiorari as an astonishing dereliction. In saying that, I must acknowledge not only the standing of many of the other parties, but also the outstanding cogency and scholarship of their amicus briefs. We should all reflect on this, and drink a toast to the Charming Betsy (S,C. early 1800’s).
In the present case, the hand of man (the supervising physician) adjusts the dose to be administered and then the hand of man (the supervising physician) causes that adjusted dose to be administered to patients. The new result is safer and more effective treatment for the patients. Accordingly the claim falls within the definition of a transformative “process” within Section 101.
Very shortly after the Prometheus decision came out, I pointed out just this distinction in a seminar at a major firm that I was visiting in Minneapolis. It is pleasing to have been found correct, and that the power of positive thinking is evidenced by the present decision.
But the distinction between this case and Prometheus is straightforward.
In Prometheus the two novel features were upper and lower limits of the therapeutic window. The remaining features in the claim were administering a thiopurine drug which was known and analysing metabolites in the bloodstream which was also known. There was nothing new created by the hand of man in the claimed subject-matter, so hence no arguable positive eligibility under section 101. That is the essential basis of the decision and all else is dicta.
EGMay 16, 2018 11:05 am
Hey [email protected],
Couldn’t agree with you more. The Royal Nine created this mess, especially as it relates to medical diagnostic methods. Witness the “cop out” in denying the petition for cert in Sequenom despite urgent pleas from the Federal Circuit for clarification, as well as almost 2 dozen amicus briefs, one from Europe hinting that SCOTUS 101 jurisprudence was putting the U.S. in serious danger of violating TRIPs. (Does the Royal Nine even understand what a violation of TRiPs would/could mean to international trade for the U.S., especially as international treaties are as much the “law of the land” as any other statute?)
AnonMay 16, 2018 10:51 am
While a certain learned frequent contributor (Mr. Cole) likes to not be harsh to our Supreme Court, I truly believe that MUCH of what ails the judicial branch is a direct flow-down from the Supreme Court and that body’s handling of patent law matters in a “desired-Ends” approach with far too little care for the Means to those ends.
One of the direct results of this type of behavior (and make no mistake, the behavior of the Supreme Court acts as training for the lower courts), is that “Void for Vagueness” runs rampant not only in any particular single court case, but in the “ping-pong” effect that (due to the CAFC lack of control from the Chief Judge) the panel-to-panel decisions afford zero actual stare decises.
I DO put this problem back up to the Supremes in how they berate the lower court, but then themselves create a Gordian Knot of conflicting jurisprudence, while pretending that they have created no such problems.
(my answer in a nutshell: Congress must wake up, apply their Constitutionally granted power to strip the non-original patent appeal jurisdiction from the Supreme Court, and set up a new and untainted – preferably ably trained – Article III court dedicated to patent matters)