By Kevin E. Noonan —

Harold Wegner, dean of patent law cognoscenti and a partner at Foley & Lardner LLP in Washington, DC, regaled the audience at ACI’s Biotech Patent Law conference on Monday with a talk on "Key Biotech Cases to Watch and How They May Impact Your Practice."  Ranging from § 101 through injunctive relief, Professor Wegner (at right) not only discussed the cases but handicapped the expected outcomes based on his appraisal of the makeup of the panels hearing the cases (including a few en banc cases).

These are Professor Wegner’s cases to watch:

• Nuitjen v. Dudas, Supreme Court No. 07-1404
• Biomedical Patent Management Corp. v. State of California, Supreme Court No. 07-956
• In re Bilski, Fed. Cir. No. 2007-1130
• Classen Immunotherapies, Inc. v. Biogen IDEC, Fed. Cir. No. 2006-1634
• Prometheus v. Mayo, Fed. Cir. No. 2008-1403
• Lupin Ltd. v. Abbott Labs., Fed. Cir. No. 2007-1446
• Abbott Labs. v. Sandoz, Inc., Fed. Cir. No. 2007-1400
• Egyptian Goddess, Inc. v. Swisa, Inc., Fed. Cir. No. 2006-152
• In re Kubin, Fed. Cir. No. 2008-1184
• In re Alonso, Fed. Cir. No. 2008-1079

Two of these cases are on petition for certiorari before the Supreme Court:  Nuitjen v. Dudas and Biomedical Patent Management Corp. v. State of California.  The Nuitjen case involves the question of whether a signal per se is patentable subject matter; its relevance to biotech patent law stems from the nature of the question presented:

Whether the [ ] Federal Circuit erred by adding new requirements to 35 U.S.C. § 101 that patentable manufactures must be tangible articles that are nontransitory and perceivable without special equipment, thereby denying patent protection to all signals and other important advances in technology that do not meet these requirements, no matter how innovative, unique, or useful they are.

Professor Wegner suggested that this question might be equally applied to processes occurring in vivo (observable by behavioral or other non-tangible phenotype).  The decision on the petition is expected later this year.

The Biomedical case involves the issue of sovereign immunity, and the ability of states to benefit from the patent system on the one hand and avoid infringement liability under the 11th Amendment.  Professor Wegner characterized this case as an opportunity to limit Florida Prepaid Postsecondary Education Expense Board v. College Savings Bank, 527 U.S. 627 (1999).  The relevant question presented is as follows:

Whether a state waives its Eleventh Amendment immunity in patent actions by regularly and voluntarily invoking federal jurisdiction to enforce its own patent rights.

In re Bilski is another statutory subject matter case, awaiting en banc decision expected in October or November (Judge Michel intimated in a speech given last week at Harvard that the decision is forthcoming).  While directed towards patent eligibility of business method patents, the second en banc question posed by the Court asks for opinions on the standard for determining whether a process is patent-eligible, a question having evident relevance to other types of method claims (such as diagnostic methods).

Diagnostic method claims are once more at issue in two pending cases:  Classen Immunotherapies, Inc. v. Biogen IDEC and Prometheus v. Mayo.  Classen for the first time frames the question under 35 U.S.C. § 101 — the Metabolite Labs. case was argued under the utility requirement of 35 U.S.C. § 112, first paragraph.  The decision is greatly overdue, argument having been heard on August 8, 2007.  The delay might be due to the composition of the panel (including Judge Newman, Judge Moore, and District Court Judge Farnan, sitting by designation from the District of Delaware) — Professor Wegner speculated that Judge Farnan might be the tie-breaker between two Federal Circuit judges whose opinions on the patent-eligibility of diagnostic claims can be expected to be widely divergent.  He also speculated that the panel might be waiting for the en banc Bilski decision before releasing its opinion in Classen.

The Prometheus case also parallels the facts in Metabolite, this being the claim at issue:

Claim 1.  A method of optimizing therapeutic efficacy for treatment of an immune mediated gastrointestinal disorder, comprising:
    (a)  administering a drug providing 6-thioguanine . . . ; and
    (b)  determining the level of 6-thioguanine in said subject . . . and
    (c)  wherein the levels of 6-thioguanine greater than about 400 pmol per 8×10(8) red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Unlike in Metabolite, however, in this case the district court found the claim to be invalid under 35 U.S.C. § 101.  The district court opined that just because the inventors:

have framed the claims as "treatment methods" does not make the claims patentable.  Indeed, "one can reduce any process to a series of steps.  The question is what those steps embody."  Lab. Corp. of Am. Holdings v. Metabolite, Inc., 548 U.S. 124 (2006) (Breyer, J., dissenting from dismissal of certiorari) (emphasis in original); see also In re Grams, 888 F.2d 835, 839 (Fed.Cir.1989) (explaining that the critical question is: "What did applicants invent?") (quoting In re Abele, 684 F.2d 902, 907 (C.C.P.A.1982)) . . .[T]he "administering" and "determining" steps are merely necessary data-gathering steps for any use of the correlations.  However, an "unpatentable principle" will not transform into a "patentable process" simply by adding conventional method steps.  . . .  [The [wherein or] "warning" step [in a mental step that] does not require that dosage be adjusted, or any other action.  . . .  [I]t is the metabolite levels themselves that "warn" the doctor that an adjustment in dosage may be required.

The Lupin case promises to address (if not resolve) a long-standing dispute concerning product-by-process claims:  whether the claim is infringed by sale of a claimed product produced by a different method.  The Scripps Clinic & Research Foundation v. Genentech case (opinion by Judge Newman) held that it would, while Atlantic Thermoplastics Co., Inc. v. Faytex Corp. (opinion by Judge Rader) held that it did not.  The question presented characterized the issue as whether the district court had any discretion to decline to follow the Federal Circuit’s Scripps Clinic precedent (which was the earlier-decided case and thus precedential) in favor of 19th Century Supreme Court precedent (Cochrane v. Badische Anilin & Soda Fabrik).  Since Judge Rader is on the panel (the case was argued on May 7, 2008 before Judges Rader, Plager, and Bryson), the expectation is that the CAFC will decide that the district court was correct in following the Atlantic Thermoplastics and earlier Supreme Court precedent.  Interestingly, the Abbott Labs. case addresses the same issue and was argued before the same panel on the same day as the Lupin case.

Professor Wegner characterized the questions presented to the Federal Circuit with regard to obviousness in the In re Kubin case (discussed in greater detail here) as follows:

Whether the Board erred as a matter of law in finding Kubin’s claims obvious where the Board:

"1) improperly applied an ‘obvious to try’ test for an invention in the field of molecular biology – a field of technology which the Board expressly found was an ‘unpredictable art;’
"2) lacked substantial evidence to support its finding that one of skill in the art would have had a reasonable likelihood of success in arriving at the claimed DNA molecules using ‘conventional methodologies,’ in the context of the record as a whole;
"3) disregarded the lack of any structural information available in the art relating to the claimed DNA molecules – not a single polynucleotide encoding even a portion of the recited NAIL-peptide was known in the art;
"4) dismissed, as no longer binding or applicable law, this Court’s prior decisions regarding the analysis of 35 U.S.C. §103 in the context of isolated DNA molecules, including [In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995)]; and
"5) failed to consider the claimed subject matter as a whole by completely ignoring claim limitations regarding the newly discovered ability of NAIL-peptides to bind to a ligand, CD48."

Regarding written description (the other aspect of the Board’s decision on appeal in Kubin), the questions are:

Whether substantial evidence supports the Board’s finding that Appellants did not possess the full scope of their claimed invention under 35 U.S.C. § 112 (written description requirement) where Appellants:

"1) disclosed a functional characteristic, CD48-binding, common to members of the claimed genus, correlated with a structure that was sufficiently disclosed;
"2) disclosed a representative number of DNA molecules within the scope of the claims; and
"3) recited structural features, the nucleotide sequence of the claimed binding region, common to the genus and which constitute a substantial portion of the genus."

The Patent Office brief was due last Friday, and seven amici have filed briefs in the Kubin case, which has not been docketed for argument.

The In re Alonso case concerns the written description requirement and was argued before the CAFC on September 2nd.  The invention relates to a genus of antibodies that bind and attack neurofibrosarcomas, and the Board determined that the specification did not disclose a sufficient number of species to satisfy the requirement for the genus under Regents of the University of California v. Eli Lilly and Company and University of Rochester v. G.D. Searle & Co.  Alonso argued that tumor cell binding was a common functional feature that is evidence that the different antibody members of the genus "will necessarily have common structural features," and that the Board did not properly consider this in applying the legal standard for written description.

Professor Wegner also noted that the Egyptian Goddess case, although concerning design patents, might contain dicta relating to obviousness in utility patents.

Professor Wegner ended his talk with a brief overview of the proposed "improper Markush group" rules, which he noted had not been formally implemented but seemed to have been formally adopted in certain art units.  He excoriated as improper the use of these new "rules" being applied "ad hoc" to deny generic claim coverage to linking claims, by Examiner’s requiring the claims to be withdrawn responsive to a restriction/election requirement.  Citing a variety of CCPA and CAFC cases, the Professor stated that the law was clear that a generic claim (whether in Markush format or otherwise) must be examined provided that it includes 1) a common structural nucleus and 2) all compounds "contemplated by the Markush group" have at least one utility in common.  He also graciously provided a "blueprint" for overcoming these rejections, an article entitled "The Right to Generic Chemical Coverage," 6 APLA Quart. J. 257 (1978).