Jumping Down the Rabbit Hole: Federal Circuit Ducks the Patent-Eligibility Issue in King Pharmaceuticals
|Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: August 3, 2010 @ 11:50 pm
As Alice once said things are growing “curioser and curioser.” I just opined about the “fuzzy” looking glass called Bilski v. Kappos for determining what is (or remains) patent-eligible subject matter under 35 U.S.C. § 101. See Through the Fuzzy Bilski Looking Glass: The Meaning of Patent-Eligible under 35 U.S.C. § 101 . After reading King Pharmaceuticals, Inc. v. Eon Labs, Inc., I’m now ready to throw my Ouija board though that Bilski looking glass. With an opportunity to render some order out of the Bilski chaos, the Federal Circuit instead completely ducked the patent-eligibility issue clearly presented in King Pharmaceuticals. The Federal Circuit then created (and I do mean “created”) the new “an anticipated method claim doesn’t become patentable if it simply includes an informing step about an inherent property of that method” doctrine. With this new “doctrine,” we have now “jumped down the rabbit hole” into a surreal “Bilski in Patentland” world.
The King Pharmaceuticals case starts off innocently enough with an appeal from a district court decision invalidating four claims under 35 U.S.C. § 101, three claims under 35 U.S.C. § 103, and the remaining claims under 35 U.S.C. § 102 from U.S. Pat. No. 6,407, 128 (the ‘128 patent) and U.S. Pat. No. 6,683,102 (the ‘102 patent) on a motion for summary judgment. What became the focus of the subsequent bizarre ruling by the Federal Circuit was dependent method claim 21 of the ‘128 patent.
Claim 21 depended directly from method claim 1 of the ’128 patent. Claim 1 recited “a method of increasing the oral bioavailability of metaxalone” (in the preamble) by “administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.” Claim 21 recited the additional feature of “informing” the patient that taking that metaxalone with food would increase the bioavailability of the metaxalone.
The district court found that claim 1 of the ‘128 patent was inherently anticipated under 35 U.S.C. § 102 by prior art showing that taking metaxalone with food was already known and that all the ‘128 patent disclosed/claimed was an inherent property (i.e., increased bioavailability from taking metaxalone with food) of this known method. In other words, what claim 1 recited was recognition of a new benefit of what was essentially an old “method of use.” Accordingly, the Federal Circuit quite correctly affirmed the district court’s ruling that the method of claim 1 was on the basis that “merely discovering and claiming a new benefit of an old process cannot render the process again patentable” (citing the 1990 Federal Circuit case of In re Woodruff).
Where Judge Gajarsa’s opinion in King Pharmaceuticals “jumps down the rabbit hole” is the handling of dependent claim 21. The district court invalidated claim 21 under 35 U.S.C. § 101, citing the Federal Circuit’s en banc ruling in Bilski which foisted on us the unfortunate “machine or transformation” (MoT) only test. With SCOTUS having deemed that MoT was no longer the exclusive test for patent-eligibility under 35 U.S.C. § 101, claim 21 in King Pharmaceuticals presented the Federal Circuit with a perfect opportunity to inform us “mere mortals” what SCOTUS’ “fuzzy” ruling in Bilski really means in the context of methods such as those defined in claim 21.
Gajarsa’s opinion was obviously troubled by how to treat the “informing” feature in claim 21. In response to the patentee’s (King Pharmaceutical’s) contention that the district court incorrectly dissected claim 21 to separate out this “informing” feature, Gajarsa’s opinion pointed to SCOTUS’ Parker v. Flook decision that the analysis of patent-eligibility under 35 U.S.C. § 101 should be based on the claim “as a whole.” In fact, Gajarsa’s opinion observed that, prior to SCOTUS’s decision in Bilski, the Federal Circuit had “held that such medical treatment methods were patentable processes under [35 U.S.C. § 101 because they fell squarely within” the MoT test, referring the 2009 case of Prometheus Laboratories, Inc. v. Mayo Collaborative Services. So far so good.
Unfortunately, Gajarsa’s opinion then turned “white rabbit” and jumped down the hole into Bilski in Patentland: “The present case, however, does not present the proper vehicle for determining whether claims covering medical treatment methods are eligible for patenting under [35 U.S.C] § 101 because even if claim 21 recites patent eligible subject matter, that subject matter is anticipated for the reasons discussed below.” So what were those “reasons?” Initially, Gajarsa’s opinion stated that “we are not limited to a district court’s stated reasons for invalidating claims and can affirm a grant of summary judgment on any ground supported by the record and adequately raised below.” Already, “red warning flags” were going off in my head that Gajarsa’s opinion was about to head off into new territory in Patentland.
King Pharmaceuticals pointed out that the district court never found that the “informing” feature of claim 21 was disclosed in the prior art. But Gajarsa’s opinion brushed that objection aside by saying the “informing” feature “adds no novelty to the method, which is otherwise anticipated by the prior art.” Accordingly, because claim 1 was anticipated, “it readily follows that claim 21, which recites the same method with the sole additional step of informing the patient about this increase in bioavailability, is not patentable.” Voila, we have the new doctrine of “features which are not patentable cannot breathe novelty into an otherwise anticipated method.”
Gajarsa’s opinion tries to bolster support for this new doctrine by analogy to the “printed matter is not patentable” doctrine from the 1983 case of In re Gulack, and the more recent 2004 case of In re Ngai. I particularly cringe at the citation to the Ngai case. In Ngai, the patent applicant had created an admittedly new method for amplifying and normalizing RNA. In addition to method claims, the patent applicant included what many of us patent attorneys/agents referred to as “kit claims” which recited “instructions for use” where those instructions described the new method (in Ngai, the method for amplifying and normalizing RNA). The Federal Circuit in Ngai rejected those “kit claims” as either anticipated under 35 U.S.C. § 102 or unpatentable under 35 U.S.C. § 103 (isn’t clear which basis the Federal Circuit relied upon) under the “printed matter is not patentable doctrine.” What particularly offends me about the Federal Circuit’s reliance on the “printed matter is not patentable doctrine” in Ngai is the following statement: “If we were to adopt Ngai’s position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.” So what? The logic of that statement for supporting the invalidity of “kit claims” in Ngai as anticipated/obvious still escapes me.
In my view, the handling by Gajarsa’s opinion of the patent-eligibility issue with regard to claim 21 is as bizarre as the strained effort by Judge Lourie to shoe-horn the drug dosage calibration method of Prometheus into the “transformative” prong of the MoT test. See CAFC: Method for Calibrating Drug Dosage Is Transformative . Garjasa and company obviously found the patent-eligibility issue squarely raised in King Pharmaceuticals troublesome to deal with, but how they resolved the invalidity of claim 21 (“informing” feature about inherent property of method doesn’t make an otherwise anticipated method patentable) is as illogical as Justice Stevens saying in Parker v. Flook that an otherwise unknown algorithm is prior art under 35 U.S.C. § 103. The Federal Circuit needs to address the patent-eligibility issue of claimed methods/processes such as those presented in King Pharmaceuticals forthrightly and logically (and sooner rather than later) before we “mere mortals” are forced to jump down the rabbit hole after them into the chaotic Bilski in Patentland world.
© 2010 Eric W. Guttag.
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