Alza Corp. v. Andrx Pharmaceuticals (Fed. Cir. 2010) (be careful what you ask for …)
On April 26, 2010, in ALZA Corp. v. Andrx Pharms., LLC, No. 2009-1350, the Federal Circuit affirmed the District Court of Delaware’s finding that ALZA’s U.S. Patent No. 6,919,373 (“the ’373 patent”), covering methods for treating Attention Deficit or Attention Deficit Hyperactivity Disorders (“ADD” or “ADHD,” respectively), was invalid for lack of enablement.[1] In doing so, the court held that the ‘373 patent specification failed to enable a person of ordinary skill in the art to make and use the claimed invention without undue experimentation based primarily on: the quantity of experimentation required, the lack of guidance in the specification, the absence of working embodiments, and the breadth of the claims. The court further held that these deficiencies could not be cured, as argued by ALZA, by relying on the knowledge of a person of ordinary skill in the art to serve as a substitute for teachings absent from the specification.
The ’373 patent claims methods for treating ADD and ADHD through a methylphenidate (“MPH”) drug dosage form that has an ascending release rate over an extended period of time (i.e., controlled release). Prior to the claimed invention, ADD and ADHD were treated with immediate-release formulations of MPH that needed to be administered several times daily, the most popular of which was Ritalin®. The ‘373 patent’s once-a-day method of treating ADD and ADHD with extended-release formulations helped solve the problem of patient compliance with a schedule that requires multiple daily doses, particularly for children who need to take at least one dose while at school.
Claim 1 of the ‘373 patent, the only independent claim at issue before the Federal Circuit, recites: ”A method for treating ADD or ADHD comprising administering a dosage form comprising methylphenidate that provides a release of methylphenidate at an ascending release rate over an extended period of time. (’373 patent at 23:12-15.) Plaintiff ALZA markets and sells the drug Concerta®, which is encompassed by this claim. Andrx Pharmaceutical, LLC and Andrx Corporation (collectively, “Andrx”), produce a competing generic version of Concerta®, which ALZA alleges infringes the ‘373 patent.
At the Markman hearing, the lower court agreed with ALZA’s proposed broad construction of claim 1 covering both “osmotic” and “non-osmotic” oral dosage forms with ascending release rates of MPH, not just the non-osmotic oral dosage forms, as Andrx proposed. Alza Corp. v. Andrx Pharms., LLC, No. 05-642, at 2 (D. Del. Oct. 5, 2007) (order on claim construction).[2] As the Federal Circuit noted, however, the lower court’s adoption of ALZA’s proposed construction ultimately undermined ALZA’s lawsuit, because claim 1 is not enabled with respect to the non-osmotic oral dosage forms. Slip Op. at 9 & 14.
The ’373 patent specification primarily describes osmotic dosage forms to administer MPH at an ascending release rate over an extended period of time, and the Federal Circuit agreed with the district court that such dosage forms were enabled. Id. The court held, however, “that the specification of the ’373 patent … does not provide sufficient guidance for a person of ordinary skill in the art to make the non-osmotic dosage forms as claimed.” Id.
ALZA argued that non-osmotic dosage forms were enabled by the following passage in the specification:
“There are many approaches to achieving sustained release of drugs from oral dosage forms known in the art. These different approaches include, for example, diffusion systems such as reservoir devices and matrix devices, dissolution systems (including, for example, “tiny time pills”) and matrix dissolution systems, combination diffusion/dissolution systems, osmotic systems and ion-exchange resin systems as described in Remington’s Pharmaceutical Sciences, 1990 ed., pp. 1682-1685.”
Id. at 10 (quoting ‘373 patent at 3:53-62. This passage, according to ANZA, is sufficient to allow a person of ordinary skill in the art to practice the aspect of the claimed invention covering non-osmotic dosage forms. The Federal Circuit disagreed.
The court explained that this passage provides “no guidance as to how to achieve ascending release with non-osmotic dosage forms.” Id. (quoting Alza Corp. v. Andrx Pharms., LLC, 607 F. Supp. 2d 614, 655 (D. Del. 2008). “Instead, it provides only a starting point, a direction for further research.” Slip Op. at 10-11 (internal quotation omitted). Then, the court noted that ALZA even concedes that a person of ordinary skill in the art must engage in an “iterative, trial-and-error process to practice the claimed invention even with the help of the ‘373 patent specification.” Id. at 11. Thus, resolving the enablement issue requires a factual determination of whether “undue experimentation” is required to carry out this process. Id.
The Federal Circuit agreed with the lower court’s findings that despite the specification’s disclosure, undue experimentation would be required to make non-osmotic dosage forms of the claimed invention. Id. In particular, the Federal Circuit noted that ALZA’s reliance on its expert’s testimony was problematic because the expert, who contended that this process was “routine” and “easily made by those skilled in the art,” applied a higher level of skill in the art than that which the lower court properly adopted. Id. at 11, 12-13. Further, the lower court properly relied on the testimony of two ALZA employees, who explained that despite its efforts, ALZA had not been able to develop the non-osmotic dosage forms. Id. at 12.
Moreover, the Federal Circuit held that the factors set forth in In re Wands, 859, F.2d 731, 735 (Fed. Cir. 1988),[3] “weigh in favor of finding that the experimentation required to practice part of the claimed invention was not routine.” (Id. at 13.) In particular, the court noted that seven of the eight Wands factors supported a finding of undue experimentation, id. at 9, and particularly: the quantity of experimentation, lack of guidance in the specification, absence of working embodiments, and breadth of the claims, id. at 14. Thus, claim 1 of the ‘373 patent fails to satisfy the enablement requirement of 35 U.S.C. § 112, ¶ 1.[4]
At least two major points emerge from this case. First, arguing for broader claim construction may render the claim invalid because the specification may not fully enable the more expansive claim scope. Therefore, when asserting a patent in litigation, the patent holder must be careful to temper its desire for a broader claim scope with considerations of whether a broader claim scope will undermine other aspects of patentability, e.g., enablement. Second, the knowledge of the ordinarily skilled artisan, as established by the court, may fail to compensate for information absent from the specification with regard to enabling novel functional limitations. Therefore, the patent applicant must ensure that the specification does more than suggest a mere starting point for a person of ordinary skill in the art to practice novel aspects of the claimed invention. And, unlike ANZA in this case, the applicant must have a reasonable view of what constitutes a person of ordinary skill in the relevant art.
[1] The district court also found the patent to be non-obvious and not infringed. The Federal Circuit did not reach these issues.
[2] While this was not clear from the Federal Circuit’s opinion, presumably, ALZA believed that Andrx’s product was a non-osmotic dosage form.
[3] The Wands factors for undue experimentation are: (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) predictability or unpredictability of the art; and (8) breadth of claims. Wands, 858 F.2d at 737.
[4] Though not addressed by the Court, the same arguments ALZA made to support its argument that claim 1 is fully enabled could also support a finding that the asserted claim is invalid on obviousness grounds. For example, ALZA argued that “creating non-osmotic dosage forms and manipulating their release rates was well known to a person of ordinary skill in the art at the time the ’373 patent application was filed.” Slip Op. at 6. Further, ALZA argued 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.” Id. at 7. Either of these arguments could also support a finding that the disclosed invention was obvious to a person of ordinary skill in the art, and therefore, invalid under 35 U.S.C. § 103.
