In Trustees of the University of Pennsylvania v. Eli Lilly and Co., the U.S. District Court for the Eastern District of Pennsylvania refused to correct improper multiple dependent claims and instead held them invalid under 35 U.S.C. § 112, ¶ 5, and therefore not infringed. While some may consider improper multiple dependent claims as failing to comply with a mere formality, this case serves as a reminder that a court may consider any statutory requirement when assessing patent validity.
The Patent At Issue
The patent at issue was U. Penn.’s U.S. Patent No. 7,625,558, directed to methods of treating individuals having an erbB mediated tumor comprising administering an antibody that inhibits the formation of erbB protein dimers followed by exposing the patient to radiation treatment. The patent was granted with independent claims 1, 5-7, 11, 26 and 27. Claims 28-41 were multiple dependent claims. The invalidity of claims 32-40 was before the court on Defendants’ Motion To Dismiss.
32. The method according to any one of claims 26 to 31 wherein the radiation is administered as multiple doses.
33. The method according to any one of claims 1 to 32, wherein said radiation is gamma radiation.
34. The method according to any one of claims 1 to 33, wherein said erbB protein mediated tumor is a p185 mediated tumor.
35. The method according to any one of claims 1 to 33, wherein said erbB protein mediated tumor is an EGFR mediated tumor.
36. The method according to any one of claims 1 to 35, wherein dimerization is inhibited by a physical alteration of the erbB protein monomer so that it is less thermodynamically disposed to form a dimer.
37. The method according to claim 36, wherein the physical alteration comprises a steric alteration of the erbB monomer.
38. The method according to claim 36 wherein the physical alternation comprises a conformational alteration of the erbB monomer.
39. The method according to claim 36, wherein the physical alteration comprises an electrostatic alteration of the erbB monomer.
40. The method according to any one of claims 1 to 39, wherein said tumor is an adenocarcinoma.
U. Penn asserted infringement by Lilly’s Erbitux® (cetuximab) product.
Defendants’ Motion to Dismiss
In their Memorandum of Law in Support of Defendants’ Motion to Dismiss, Defendants alleged that “[c]laims 32-36, 40, and 41 are improper multiple dependent claims, meaning that they are (1) multiple dependent claims that (2) depend from claims that are, themselves, multiply dependent.” As set forth in 35 U.S.C § 112, ¶ 5, “[a] multiple dependent claim shall not serve as a basis for any other multiple dependent claim.” Defendants argued that determining whether multiple dependent claims are improper does not depend on claim construction, analysis of the patent specification, knowledge of the skilled artisan, or assessment of prior art. Rather, it “is apparent from the face of the ‘558 patent.”
In its Opposition, U. Penn argued that because the improper dependencies are apparent from the face of the ‘558 patent, they are obvious errors and can easily be corrected by the Court. U. Penn. also argued that the Court has judicial power to correct analogous errors, such as a claim that is dependent from a non-existing claim considered indefinite under 35 U.S.C. § 112, citing Hoffer v. Microsoft Corp., 405 F.3d 1326 (Fed. Cir. 2005).
In their Reply, Defendants argued that correction by the court would not be proper here because there are a variety of ways in which the claims could be rewritten.
The District Court Decision
The District Court granted Defendants’ motion to dismiss with regard to claims 32-40, holding the claims invalid and therefore not infringed. In reaching this decision, the court explained:
While it is true that Courts can correct some patent mistakes, Courts can only correct “minor typographical and clerical errors”. Novo Industries, L.P. vs. Micro Molds Corp., 350 F.3d 1348, 1357 (2003).The mistake by Plaintiff in this case is not a misspelling or a wrong keystroke or a mistake of punctuation, it is a legal error that clearly violates 35 U.S.C. § 112, ¶ 5. Legal errors as to how to draft a claim cannot be fixed by a Court. Federal Courts have long recognized that Courts may not redraft claims, whether to make them operable or to sustain their validity. Chef America vs. Lamb-Weston, Inc., 358 F.3d 1371 (2004).
Even if this was the type of mistake that Courts, as opposed to the PTO, could correct, “A District Court can correct a patent only if (1) the correction is not subject to reasonable debate based on consideration of the claim language and the specifications and (2) the prosecution history does not suggest a different interpretation of the claim.” Novo Indus., 350 F.3d at U.S. at 1357. As the Defendants point out in their Reply Brief 5-7, there are multiple ways to correct the error in the present case. See, Novo Indus., 350 F.3d at 1358 (refusing to correct claims when the Court “cannot know what correction is necessarily appropriate”).
Technical Versus Statutory Deficiencies
The decision here is interesting when contrasted with Hyatt v. Boone, 146 F.3d 1348 (Fed. Cir. 1998). In that interference case, priority was questioned based on compliance with 37 C.F.R. § 1.60 (“Rule 60”), because the Applicant had filed amended claims with its continuation applications without submitting new oaths (instead relying on photocopies of the prior application’s oaths). Neither the Examiner nor the APJ questioned the priority claim based on this issue, and the Federal Circuit found no reversible error, explaining:
The issue here raised is not one of substantive continuity of disclosure, but solely of whether a photocopy of the prior oath, instead of a new oath, was acceptable for filing, when it was in fact accepted for filing. Any technical deficiency in meeting the formal requirements of Rule 60 must be viewed in light of the agency’s acceptance of the applications as in compliance with the Rule.
The Federal Circuit also noted that the “oath is not a requirement of Section 112, first paragraph, but of 35 U.S.C. Section 115; therefore the sufficiency of [the prior] oath is not material under Section 120”, which governs priority claims.
Viewing these cases together, it appears that the court will not second-guess the USPTO’s acceptance of matters governed only by its rules, but will review whether even formal statutory requirements have been satisfied.
Although 35 U.S.C § 112, ¶ 5, does not permit multiple dependent claims that depend from a multiple dependent claim, such claims are permissible in some non-U.S. jurisdictions. This case illustrates the importance of carefully reviewing claims written with a different jurisdiction in mind to ensure compliance with all aspects of U.S. law, including those that relate to “formalities”. This case also highlights the limits of a court’s authority to “correct” claims to situations where the correction is not reasonably debatable.