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Boehringer Ingleheim v. HEC Pharma

Representative Claim(s)

10. The method according to claim 1 [of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin comprising orally administering to the patient a DPP-IV inhibitor wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance] wherein the metabolic disorder is type 2 diabetes mellitus and wherein the contraindication is renal disease, renal impairment or renal dysfunction, and wherein said DPP-4 inhibitor is used for said patient in the same dose as for a patient with normal renal function.

24. A method of treating [type] 2 diabetes mellitus in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin comprising orally administering to the patient 1-[(4-methyl-quinazolin-2-yl)-methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance.

Posture:

Motion to Dismiss

Exception Category: Abstract Idea

The court analyzed claim 1 (claims 10-17 depend from claim 1), and determined that the act of administering a claimed inhibitor was an abstract idea.

“The case of Mayo is more analogous to the claims at issue here. In Mayo, the Supreme Court found that ‘[c]laim 1 […] 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 side effects. 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 […] apart from any human action.’ In Mayo, the Supreme Court noted that the relation between the blood levels and the thiopurine drug was a consequence of the ways where thiopurine compounds were metabolized by the body, which the Court determined to constitute ‘entirely natural processes.’ ”

“Similarly, here, claim 1 recites to, orally administer a DPP-IV inhibitor. Upon administering the DPP-IV inhibitor, the natural biological process in the human body operates to increase the insulin secretion. Thereby, decreasing the glucagon secretion and reducing the level of glucose in the blood. Subsequent thereto DPP-IV inhibitor is substantially or mainly excreted via the liver and only to a minor extent via the kidney…”

“However, the Court notes that unlike the claims in Mayo, which required administering a dose upon determining that certain levels in the blood were increased; claim 1 of the ‘156 patent, at its core, simply recites the act of ‘administering’ a DPP-IV inhibitor because it does not require any prior determination that natural body levels have changed or altered before performing the step of administering the DPP-IV inhibitor. As such, the act of administering the DPP-IV inhibitor to the targeted patient population, as noted in claim 1 of the ‘156 patent, is an abstract idea.”

Significantly More: No

The court first analyzed independent claim 1.

“Here, when considering claim 1 of the ‘156 patent as a whole, the Court finds that the additional features recited in claim 1 do not amount to ‘significantly more,’ which transform the abstract idea of administering the DPP-IV inhibitor to a patent eligible subject matter. That is, when considering the following additional features—(i) the preamble of claim 1, ‘treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin;’ and (ii) the body of claim 1, ‘wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance’—in conjunction with ‘orally administering to the patient a DPP-IV inhibitor,’ as recited in claim 1, the Court finds that these additional features recite well-understood, routine, and conventional activity that do not transform the abstract idea into an ‘inventive concept.’ ”

“…[C]laim 1 of the ‘156 patent does not amount to significantly more than an abstract idea of providing an instruction for a medical care professional who is treating the targeted patient population. The instruction of claim 1 can be conducted via mental processes, which is not tied to any tangible embodiments.”

“…[T]he Court finds that the aforementioned additional features of claim 1, singly and in an ordered combination, recite a well-understood, routine, conventional activity, as recognized by the ‘156 patent, which do not transform the abstract idea of administering DPP-IV inhibitor to a patent eligible subject matter.”

Next, the court found the limitations in dependent claims 10-17 were well-understood, routine, and conventional features that do not transform the abstract idea recited in claim 1 into a patent eligible subject matter.

  • Claim 10: i) the metabolic disorder recited in claim 1 to type 2 diabetes mellitus; (ii) the contraindication recited in claim 1 to renal disease, renal impairment or renal dysfunction; and (iii) the dose of DPP-4 inhibitor for patients with normal renal functions.
  • Claim 11: the DPP-4 inhibitor and its major active metabolite(s) are primarily eliminated via hepatic metabolism or biliary excretion.
  • Claim 12: the DPP-4 inhibitor is excreted mainly via the liver.
  • Claim 13: excretion via the kidney represents a minor elimination pathway.
  • Claim 14: the DPP-4 inhibitor is excreted mainly unchanged.
  • Claim 15: elimination via metabolism represents a minor elimination pathway.
  • Claim 16: the DPP-4 inhibitor has placebo-like safety/tolerability and/or is eliminated primarily as the parent drug via the liver.
  • Claim 17: the main metabolite of the DPP-4 inhibitor is pharmacologically inactive.

Finally, the court analyzed claims 24 and 25, which recite a particular DPP-IV inhibitor. “…[T]he Court notes that the additional features recited in claims 24 and 25 do not add significantly more to the abstract idea of administering a DPP-IV inhibitor such that they transform the abstract idea into patent eligible subject matter.