Endo Pharmaceuticals Inc. et al v. Actavis Inc., et al.

Filing 67

ORDER Adopting 51 REPORT AND RECOMMENDATION. The Motion to Dismiss Counts I, III, and IV of Plaintiffs' Complaint (D.I. 11 ) is Granted. Signed by Judge Richard G. Andrews on 11/17/2015. (nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

ENDO PHARMACEUTICALS INC. and
MALLINCKRODT LLC,
Plaintiffs,

v.

Civil Action No.·14-1381-RGA

ACTAVIS INC. andACTAVIS SOUTH
ATLANTIC LLC,
Defendants.

ORDER ADOPTING REPORT AND RECOMMENDATION

The United States Magistrate Judge made a Report and Recommendation dated
September 23, 2015. (D.I. 51). Plaintiffs filed objections (D.I. 56), to which Defendants
responded. (D.I. 63). My review of these objections is de nova. FED. R. CN. P. 72(b)(3).
The Magistrate Judge recommended that Defendants' Moiion to Dismiss Counts I, III
and IV of Plaintiffs' Complaint (D.I. 11) be granted. (D.I. 51 at 19). Specifically, the Magistrate
Judge concluded that U.S. Patent No. 8,808,737 (the '"737 patent") was facially invalid under 35
U.S.C. § 101, because it is directed to patent-ineligible subject matter. (Id. at 1). Because this
conclusion would invalidate the patent, the Magistrate Judge did not address Defendants'
additional argument that Plaintiffs alleged insufficient facts to support a claim for induced
infringement under 35 U.S.C. § 271(b). (Id. at 18).
Plaintiffs first argue that the Magistrate Judge erred in finding that the claimed method
was directed to a law of nature, because it "is instead directed to a new and useful process (the
altered treatment regimen) that provides a practical, tangible benefit (relief of pain) in a

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particular patient population." (D.I. 56 at 6). Second, Plaintiffs argue that the Magistrate
Judge's reliance on the similarities between the '737 patent's representative claim and the claim
involved in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012), was in
error because the claim at issue in Mayo did not require that anyone act upon or apply the
method in a tangible way, while claim 1 of the '737 patent actually requires that the lower dose
be administered. (Id. at 7-8). Third, Plaintiffs contend that the Magistrate Judge failed to apply
the Federal Circuit's decision in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057
(Fed. Cir. 2011), which "distinguished between a pharmaceutical patent claim'that is merely
directed to a natural law itself, and a claim (like the method-of-treatment claims at issue here)
that applies that natural law in a new and useful away." (Id. at 9). Fourth, relying on the District
of Maryland's decision in Classen-upon remand after the Supreme Court decided MayoPlaintiffs criticize the Magistrate Judge's statement that "nor is the relationship between renal
impairment and this drug unknown." (D.I. 51 at 16-17). Specifically, Plaintiffs contend that this
relationship was not previously known, by reiterating that the patentee's discovery was that "the
bioavailability of controlled released oxymorphone is affected by renal function or that renally
impaired patients could or should be treated safely and effectively by administering to them a
reduced [] dosage of controlled release oxymorphone." (D.I. 56 at 11 ). Lastly, Plaintiffs make a
policy argument, seizing upon dicta from Mayo, that the reasoning employed by the Magistrate
Judge's Report and Recommendation would in effect invalidate all pharmaceutical method-oftreatment patents using an existing, well-known compound. (Id. at 13).
Defendants respond by arguing that the specification of the '737 patent, and Plaintiffs'
briefing, essentially admit that the claims are directed to a natural law, namely that "the
bioavailability of oxymorphone is increased in patients with renal impairment." (D.I. 63 at 6).

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Defendants provide a side-by-side comparison of the claim limitations at issue in Mayo and those
of Claim 1 of the '737 patent, arguing that the Supreme Court's Mayo analysis-and the
Magistrate Judge's reliance upon it-is directly on point. (Id. at 7-8). Defendants also point out
that the Federal Circuit's Classen decision predated Mayo. (Id. at 9). They argue that the
principle from Classen upon which Plaintiffs rely was effectively overruled by the Supreme
Court in Mayo, as it rejected the argument that the mere "inclusion of an application step"
rendered otherwise non-patentable subject matter patentable. (Id.). Lastly, in rebutting
Plaintiffs' policy argument, Defendants argue that the Magistrate Judge's Report and
Recommendation "stands only for the unremarkable proposition that one cannot observe the way
the body metabolizes an old drug used for an old purpose, and seek to patent the use of that
knowledge." (Id. at 11).
The Magistrate Judge applied the two-step framework set forth by the Supreme Court in
Mayo and Alice Corp. Pty. Ltd. v. CLS Bank Intern., 134 S. Ct. 2347 (2014). (D.I. 51 at 9-10).

This framework requires the Court 1) to determine whether the claims are directed to a patentineligible concept-such as a law of nature, natural phenomenon, or abstract idea-and, if they
are, 2) to determine whether there is an "inventive concept ... sufficient to ensure that the patent
in practice amounts to significantly more than a patent upon the ineligible concept itself." Alice,

134 S. Ct. at 2355 (internal quotation marks and, alterations omitted). In applying this
framework, the bulk of the Magistrate Judge's Report and Recommendation emphasized the
factual similarity between representative Claim 1 of the '737 patent and the representative claim
at issue in the Supreme Court's Mayo decision. (D .I. 51 at 10-16). Because the claim
limitations at issue in Mayo do in fact mirror the analogous limitations of Claim: 1 of the '737
patent, I think it was correct for the Magistrate Judge to do so.

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In order to highlight why the Mayo comparison is apt, below is a summary of the
Supreme Court's reasoning in Mayo:
Beyond picking out the relevant audience, namely those who administer doses of
thiopurine drugs, the claim simply tells doctors to: (1) measure (somehow) the
current level of the relevant metabolite, (2) use particular (unpatentable) laws of
nature (which the claim sets forth) to calculate the current toxicity/inefficacy limits,
and (3) reconsider the drug dosage in light of the law. These instructions add
nothing specific to the laws of nature other than what is well-understood, routine,
conventional activity, previously engaged in by those in the field. And since they
are steps that must be taken in order to apply the laws in question, the effect is
simply to tell doctors to apply the law somehow when treating their patients.
Mayo, 132 S. Ct. at 1299-1300. Here, the '737 patent similarly tells doctors to take an existing
pharmaceutical compound for treating pain and 1) measure the creatinine clearance rate of the
patient using an existing method, 2) use an unpatentable law of nature to assess the
bioavailability of oxymorphone in light of the patient's creatinine clearance rate, 3) reconsider
drug dosage in light of the law, and 4) administer that dosage. 1 (D.I. 1-1 at 42). Much like in
Mayo, the claims of the '737 patent essentially state the discovery of a natural law and "simply[]
tell doctors to apply the law somehow when treating their patients." Mayo, 132 S. Ct. at 1300.
Accordingly, I agree with the Magistrate Judge's more thorough analysis of this issue.
Nevertheless, I will briefly address Plaintiffs' objections.
Plaintiffs' argument that the '737 patent does not claim a law of a nature, but instead "a
new and useful process," is thoroughly unconvincing. As the Magistrate Judge points out,
Plaintiffs essentially admitted in their briefing that the '737 patent claims a natural law as its
invention. (D.I. 18 at 20 ("[I]t is true that the claimed inventions relate to the unexpected
discovery that the bioavailability of oxymorphone is increased in patients with renal impairment .
. . .")). The abstract of the '737 patent describes a method of treating pain by giving a patient an

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I address further below Plaintiffs' argument that this administering step is the inventive leap that differentiates
the '737 patent from the claim in Mayo.

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oxymorphone dosage form-which the specification refers to as a method "widely used in the
treatment of acute and chronic pain"-and merely adds "informing the patient or prescribing
physician that the bioavailability of oxymorphone is increased in patients with renal
impairment." (D.I. 1-1 at 2, 19). After reviewing the '737 patent and the parties' arguments, I
agree with the Magistrate Judge's conclusion that the subject matter of the invention is "the
connection between the severity ofrenal impairment and the bioavailability of oxymorphone,"or,
in other words, the reaction of the human body of a renally impaired individual to oxymorphone,
which is unquestionably a natural law. (D.I. 51 at 13).
Second, I am not convinced that the distinction Plaintiffs raise between the claim
language in Mayo and the '737 patent renders the Magistrate Judge's comparison between the
two inapt. Below is a side-by-side comparison of the language Plaintiffs highlight:
"orally administering to said patient, in
dependence on which creatinine clearance
rate is found, a lower dosage of the dosage
form to provide pain relief' (D.I. 1-1 at 42).

"indicates a need to [increase/decrease] the
amount of said drug subsequently
administered to said subject" Mayo, 132 S.
Ct. at 1295.

The slight difference in phrasing is immaterial, because neither formulation provides any sort of
"inventive concept" to suggest that more than just the natural law is being claimed. See Alice,
134 S. Ct. at 2355.2 As the Supreme Court expressly stated in Mayo, "to transform an
unpatentable law of nature into a patent-eligible application of such law, one must do more than
simply state the law of nature while adding the words 'apply it."' Mayo, 132 S. Ct. at 1294
(emphasis in original) (citation omitted). Accordingly, Plaintiffs' objections to the Magistrate
Judge's Mayo comparison are without merit.

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In any event, the claim language in Mayo undoubtedly contemplates that the stated method is ultimately applied .
when it refers to "the amount of said drug subsequently administered to said subject." Mayo, 132 S. Ct. at 1295,
1299-1300 ("And since they are steps that must be taken in order to apply the laws in question, the effect is simply to
tell doctors to apply the law somehow when treating their patients." (emphasis added)).

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Third, in light of the Supreme Court's 2012 admonition in Mayo that a claim must do
more than simply state the law of nature while adding the words "apply it," it is difficult to
conceive how Classen, a 2011 Federal Circuit case, still holds any precedential value, at least
with regard to the proposition for which Plaintiffs offer it. Plaintiffs' reliance on Classen
amounts to an assertion that a mandatory application step is sufficiently transformative to save
claims that are otherwise unpatentable under § 101. (D.I. 56 at 9-10). The Supreme Court
clearly stated in Mayo that this is not the case. 3 Accordingly, I have little trouble rejecting
Plaintiffs' arguments based on Classen.
Fourth, Plaintiffs' Classen-:-related objections make much of arguing that there is no
factual basis in the specification for the Magistrate Judge's statement that: "nor is the
relationship between renal impairment and this drug unknown." (D.I. 56 at 11 (quoting D.I. 51
at 16-17)). Because this statement is not essential to the decision, I decline to further address it. 4
Lastly, I disagree with Plaintiffs' policy argument that the Magistrate Judge's reasoning
is so far-reaching that it would invalidate all pharmaceutical method-of-treatment patents that
employ an existing pharmaceutical compound. Patentees can still avoid invalidation under§ 101
by demonstrating an inventive leap beyond merely claiming a law of nature. Plaintiffs here
claimed a widely-used, well-known method of treating pain. The only new aspect of the '737
patent was to tell doctors to adjust the dosage of oxymorphone based upon their discovery of a
natural law-namely, how the bodies of individuals with renal deficiencies process the drug. No

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In fact,"it is difficult to square Plaintiffs' argument with any of the Supreme Court's§ 101 jurisprudence since
Classen was decided in 2011.
4
In attempting to argue this point, however, Plaintiffs contend that the specification does not in fact disclose that
it was previously "known that the bioavailability of controlled release oxymorphone is affected by renal function ...
." (D.I. 56 at 11). Plaintiffs' emphasis on the fact that this relationship between renal function and the effectiveness
of oxymorphone was a new discovery, however, only adds support to the Court's understanding that Plaintiffs merely
discovered a natural law (the way the human body reacts to a specific drug) and sought to patent the application of
that natural law.

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creative steps or inventive leaps aside from the discovery of a natural law are contemplated here.
The patent merely tells doctors to apply the natural law. Accordingly, this case is hardly the
poster child for a policy argument on the wide-ranging implications of a § 101 rejection of a
pharmaceutical method patent.
Thus, Plaintiffs' objections are OVERRULED and the Report and Recommendation
(D.I. 51) is ADOPTED. Accordingly, Defendant's Motion to Dismiss Counts I, III and IV of
Plaintiffs' Complaint (D.I. 11) is GRANTED.
It is SO ORDERED this

Jl day of November, 2015.

~~.~

United State~District Judge

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