April 27, 2010
6,919,373 is a drug patent that claims a treatment regime for folks with short attention spans. The claims specifically go to "an ascending release rate over an extended period of time." A bench trial found '373 not infringed, and "invalid for lack of enablement because the specification does not enable the full scope of claim 1, which covers both osmotic and non-osmotic dosage forms." Enablement hinged on whether undue experimentation was needed to deliver an oral dosage that didn't rely upon osmosis. The district court found too much tinkering was needed based upon scant disclosure, hence the claims were not enabled. Appeal found the same deficit of attention.
Alza v. Andrx (CAFC 2009-1350) precedential
ALZA concedes that even with the guidance provided in the specification, a person of ordinary skill in the art would be required to engage in an iterative, trial-and-error process to practice the claimed invention; however, it disputes that the amount of experimentation required is undue. Instead, ALZA argues that non-osmotic dosage forms with ascending release rates could be made with only routine effort by those skilled in the art because the methods and materials used to produce dosage forms with constant, descending, or ascending release rate profiles are essentially the same and well known.
Andrx argues that the evidence presented at trial indicates that even one skilled in the art would find it difficult to develop a non-osmotic dosage form exhibiting an ascending release rate, particularly in light of the sparse guidance provided in the specification.
The run-up to enablement let-down:
The enablement requirement is codified in 35 U.S.C. § 112, ¶ 1, which states:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Enablement is determined as of the effective filing date of the patent's application. See Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1371-72 (Fed. Cir. 1999). "To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation.'" Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)). "Whether undue experimentation would have been required to make and use an invention, and thus whether a disclosure is enabling under 35 U.S.C. § 112, ¶ 1, is a question of law that we review de novo, based on underlying factual inquiries that we review for clear error." See Enzo Biochem, 188 F.3d at 1369. Because patents are presumed valid, lack of enablement must be proven by clear and convincing evidence. See Auto. Tech. Int'l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1281 (Fed. Cir. 2007); AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1238-39 (Fed. Cir. 2003). The district court's determination of the hypothetical person of ordinary skill in the relevant art is a finding of fact we review for clear error. Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17 (1966); Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80 (Fed. Cir. 1986).
Enablement is not precluded where a "reasonable" amount of routine experimentation is required to practice a claimed invention, however, such experimentation must not be "undue." Enzo Biochem, 188 F.3d at 1371; Wands, 858 F.2d at 736-37. In Wands, we set forth the following factors that a court may consider when determining if a disclosure requires undue experimentation:
(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
858 F.2d at 737. We explained that "[w]hether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." Id. The district court found that seven of the eight Wands factors weighed in favor of a finding that undue experimentation would be required to enable the full scope of the claims. ALZA fails to demonstrate that the court's factual findings in this regard are clearly erroneous. We conclude that they are not.
Alza pointed to 10 lines in the specification for enablement.
We agree with the district court that this disclosure provides "no guidance as to how to achieve ascending release with non-osmotic oral dosage forms." Alza, 607 F. Supp. 2d at 655. The "omission of minor details does not cause a specification to fail to meet the enablement requirement. However, when there is no disclosure of any specific starting material or of any of the condition under which a process can be carried out, undue experimentation is required." Auto. Tech., 501 F.3d at 1283-84 (quoting Genentech, 108 F.3d at 1366).
The specification here does not contain "such full, clear, concise, and exact terms as to enable any person skilled in the art" to make and use non-osmotic oral dosage forms with ascending release rates. 35 U.S.C. § 112, ¶ 1. Instead, it provides "only a starting point, a direction for further research." Auto. Tech., 501 F.3d at 1284; Genentech, 108 F.3d at 1366. Indeed, even ALZA concedes that a person of ordinary skill in the art would have been required to engage in an iterative, trial-and-error process to practice the claimed invention even with the help of the '373 patent specification. Thus, we agree with the district court that resolving the enablement issue in this case rests on the underlying factual findings regarding whether undue experimentation is required to make non-osmotic oral dosage forms with ascending release rates.
Alza pointed to the prior art for enablement.
Despite ALZA's assertions, we find no clear error in the district court's finding that the field of ascending release dosage forms was not mature at the time the '373 patent was filed and was a "breakaway" from the prior art, and thus, the preparation of such dosage forms was not routine. Alza, 607 F. Supp. 2d at 652. These findings are supported by the '373 patent specification and prosecution history, and bolstered by witness testimony.
The summing up:
"Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable." Genentech, 108 F.3d at 1366 (citing Brenner v. Manson, 383 U.S. 519, 536 (1966)).
Asserted claims invalid for lack of enablement affirmed.
Posted by Patent Hawk at April 27, 2010 1:01 PM | § 112
Great case. Must now read the Decision. Had not realised that the "over the full scope" enablement requirement goes back to 1993.
Posted by: MaxDrei at April 27, 2010 10:48 PM
Superb opinion. A nuanced case laid out very nicely. Subtitle: Be careful of what you ask for.
Brilliant work by the trial court, too. (Not many USDC patent cases deserve that compliment.)
Posted by: Babel Boy at April 28, 2010 8:09 AM
First Liebel_Flarsheim, now ALZA. How often does it happen, that accused infringer deliberately imposes a "squeeze" on the patent owner. Thus
"If you say your claim is wide enough to catch me, then it's invalid. Conversely if it is to be construed narrow enough to save its validity, then I don't infringe.
I win, either way. There is no "valid and infringed" middle position.
So, go away."
Or does the DoE prevent things being so simple?
Posted by: MaxDrei at April 29, 2010 3:27 AM