CPLRG™ 0057 - Alza Corp. v. Andrx Pharmaceuticals, LLC - Apr. 27, 2010

Alza Corp. v. Andrx Pharmaceuticals, LLC, 693 F.3d 935, CPLRG 0057 (Fed. Cir. 2010) (PROST, Dyk & Schall) AlzaAndrx04262010

MAJOR ISSUES: enablement; full scope of claim; claim broadly construed to show infringement not enabled; undue experimentation

COMMENT.  To show infringement by an accused product or process that varies from that illustrated in a patent, a patent owner may press for an expansive construction of the patent’s claim.  But a success in inflating the claim’s scope increase its vulnerability to attack for invalidity on multiple grounds: anticipation, obviousness, lack of written description, or, as in this case, lack of enablement.
     An apt adage: “be careful of what you wish for, you may get it!”

1. EXTENDED RELEASE OF DRUG; ASCENDING RATE.  A patent concerned a method for treating hyperactivity disorders by a drug (MPH) in dosages providing an ascending release rate over an extended time period.
U.S. Pat. No. 6,919,373. USPatNo6919373

2. Properly construed, as the patent owner requested to establish infringement, the claims cover both osmotic and non-osmotic dosage forms.  The patent specification gave examples of how to achieve an ascending release rate with an osmotic form but only briefly noted possible use of non-osmotic dosage forms.  Applying the Wands factors, set forth in In re Wands, 858 F.2d 731, 735 (Fed. Cir. 1988), a district court held, correctly, that the patent’s claims were invalid because the patent required undue experimentation to practice the claim’s full scope by making non-osmotic as well osmotic dosage forms.

3. SPECIFICATION: TEN LINES; INSUFFICIENT GUIDANCE ON ASCENDING RELEASE RATE.  The specification contained ten lines of text mentioning non-osmotic systems and citing a pharmaceutical text.  It provided no guidance on how to achieve an ascending release rate.

4. FIELD OF ASCENDING RELEASE RATES: NOT MATURE; PREPARATION NOT ROUTINE.  Evidence supported the district court’s findings that development of ascending release dosage forms was not a mature field and, therefore, that preparing such dosage forms was not routine.
     a. The patent owner’s expert testified that only routine experimentation was required, but the expert “based his analysis [on] a higher level of skill than the one the court adopted.”
     b. Two of the patent owner’s employees, Lam and Hamel, testified as to difficulties they encountered in attempting to develop a non-osmotic dosage form.
     c. The accused infringer’s expert, Needham, testified that six months or more experimentation would be required to develop a single non-osmotic dosage form whereas, based on the specification, only a month would be required to create osmotic dosage forms.

1. On consistency in claim construction for purposes of both infringement and validity, see Chisum Patent Law Digest 5262.30; Chisum on Patents 18.03[2][h].
2. On the enablement requirement and the Wands factors, see Chisum Patent Law Digest 2111, 2112; Chisum on Patents 7.03[4].

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