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Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.

United States Court of Appeals, Federal Circuit

March 28, 2019


          Appeals from the United States District Court for the District of Delaware in Nos. 1:14-cv-01381-RGA, 1:14-cv-01382-RGA, 1:14-cv-01389-RGA, Judge Richard G. Andrews.

          Martin Jay Black, Dechert LLP, Philadelphia, PA, argued for plaintiff-appellant. Also represented by Sharon K. Gagliardi; Blake Greene, Austin, TX; Jonathan Loeb, Mountain View, CA; Robert Rhoad, Princeton, NJ.

          William H. Burgess, Kirkland & Ellis LLP, Washington, DC, argued for defendants-appellees Actavis LLC, Ac-tavis South Atlantic LLC, Teva Pharmaceuticals USA, Inc. Also represented by John C. O'Quinn; James F. Hurst, Chicago, IL; Leslie M. Schmidt, New York, NY; Howard S. Suh, Charles A. Weiss, Eric H. Yecies, Holland & Knight, LLP, New York, NY.

          Huiya Wu, Goodwin Procter LLP, New York, NY, for defendants-appellees Teva Pharmaceuticals USA, Inc., Barr Laboratories, Inc.

          Before Wallach, Clevenger, and Stoll, Circuit Judges.


         Endo Pharmaceuticals Inc. appeals the district court's decision holding the claims of U.S. Patent No. 8, 808, 737 ineligible under 35 U.S.C. § 101. See Endo Pharms. Inc. v. Actavis Inc., No. 14-cv-1381-RGA, 2015 WL 7253674 (D. Del. Nov. 17, 2015) ("District Court Op."), adopting report and recommendation, 2015 WL 5580488 (D. Del. Sept. 23, 2015) ("Magistrate Op."). Because the district court incorrectly concluded that the claims at issue are directed to a natural law, we reverse.



         Endo owns the '737 patent, entitled "Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment." '737 patent Title. As explained in the specification, the patent covers a method of using oxymorphone to treat pain in patients with impaired kidney function. Id. at col. 1 ll. 19-32. Controlled-release dosage forms that maintain optimal levels of pain relief for longer periods are useful to patients and clinicians. Id. at col. 2 ll. 13-16. Patients' pain relief levels can be impacted by the way their body processes oxymorphone. For example, patients with impaired kidney function, also known as renal impairment, can experience buildup of waste products and some drugs that are typically filtered out by the kidneys. Id. at col. 2 ll. 17-24.

         The inventor of the '737 patent studied the effect of renal impairment on the pharmacokinetics-including metabolism-of oxymorphone. Id. at col. 27 ll. 60-67. The '737 patent relates to his discovery that patients with renal impairment in need of pain relief can be treated in a new, different way than other patients. Specifically, the inventor discovered that patients with moderately or severely impaired kidney function need less oxymorphone than usual to achieve a similar level of pain management. Id. at col. 10 ll. 15-19. Accordingly, the inventor's treatment method advantageously allows patients with renal impairment to ingest less oxymorphone while still treating their pain. Stated somewhat differently, the inventor developed a method that allowed renally impaired pain patients to be treated safely and effectively notwithstanding their impaired kidney function.

         In technical terms, the inventor found that there was a statistically significant correlation between plasma AUC[1]for oxymorphone and a patient's degree of renal impairment, as indicated by their creatinine clearance rate.[2] Id. at col. 46 ll. 38-40. The subjects were separated into four groups based on their creatinine clearance rates:


Creatinine Clearance Rate

[Healthy] Controls

> 80 mL/min

Mild Renal Impairment

51 to 80 mL/min

Moderate Renal Impairment

30 to 50 mL/min

Severe Renal Impairment

<30 mL/min

Id. at col. 30 ll. 30-35. These four groups were studied for their pharmacokinetic responses to oxymorphone as measured by their AUC levels. There was relatively little change in oxymorphone AUC until the subjects had moderate-to-severe renal impairment (creatinine clearance rates below 50 mL/min). Subjects with severe renal impairment (creatinine clearance rates below 30 mL/min) had the highest AUC values. See id. at col. 46 ll. 38-46, col. 30 ll. 30- 35.

         (Image Omitted)

          Id. at Fig. 16 (excerpted, annotated). "Because of this, the oxymorphone levels in the blood of a patient with [] renal impairment are higher than the levels that would be seen in a healthy patient receiving the same dose." Id. at col. 10 ll. 19-22. For example, subjects with severe renal impairment had a mean oxymorphone AUC, on average, 1.7 times greater than healthy subjects. Id. at col. 46 ll. 25-30.

         Mean Plasma Pharmacokinetic Results

Analyte/Variable Level of renal impairment
Severe Moderate Mild Healthy controls
Oxymorphone AUC (ng·hr/mL) 32.46 27.93 21.68 18.86

Id. at col. 38 Table 33 (excerpted).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Armed with this discovery, the inventor developed a new method of using oxymorphone to treat patients with renal impairment, claimed in the &#39;737 patent. As the specification explains, "the present invention provides methods using oxymorphone in the treatment of pain," including "providing a patient [with renal impairment] with a therapeutically effective amount of oxymorphone." Id. at col. 3 ll. 33-36. The specification further explains that the method "avoid[s] possible issues in dosing" and allows for treatment with "the lowest available dose" for ...

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