Posts Tagged: "Eric Guttag"

Trying to divine what Mayo Collaborative Services v. Prometheus Laboratories, Inc. means for the future in judging the patent-eligibility of claimed methods and processes under 35 U.S.C. § 101 is like using a Ouija board. The first inkling came 10 days after Mayo Collaborative Services in a motion for partial summary judgment in SmartGene, Inc. v. Advanced Biological Laboratories, SA, a case from the District Court of Columbia. When I first read this case, my initial reaction was “oh no, here comes the collateral damage we feared would come from Mayo Collaborative Services.” But having reflected on this case some more, and especially the claims involved, I think Judge Howell’s ultimate conclusion of patent-ineligibility of the claimed process and system under 35 U.S.C. § 101 is defendable. Even so, the reasoning expressed in Judge Howell’s opinion for reaching that conclusion gives pause for concern about the impact of Mayo Collaborative Services on rendering consistent and objective determinations of patent-eligibility under 35 U.S.C. § 101.

Unfortunately this unspecific remand by the Supreme Court in AMP vacates as well the two-to-one ruling by this same Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) that the claimed isolated DNA sequences were also patent-eligible under 35 U.S.C. § 101. What, pray tell, does Mayo Collaborative Services change with regard to that ruling in the original AMP decision? For those, like the plaintiffs in AMP (including the ACLU), who would like to upset this “applecart,” they’re likely to be very disappointed. I can describe what should be the impact of the ruling (and reasoning) in Mayo Collaborative Services on the claimed isolated DNA sequences in three short monosyllabic words: NONE AT ALL. And the Federal Circuit can (and should) say likewise, perhaps in far more words.

The reasoning in Mayo Collaborative Services makes no patent law logical sense on numerous grounds, including disregarding an important paragraph in the Supreme Court’s 1981 case of Diamond v. Diehr that is not only binding precedent, but also tells us that Breyer’s opinion repeatedly does what this paragraph from Diehr says not to do in an analysis of method or process claims under 35 U.S.C. § 101. But the question now becomes what do we do to keep the reasoning in Mayo Collaborative Services from exploding into completely irrational, as well as patent law insane doctrine? The way forward to patent-eligibility rationality, as well as sanity, is through the remand decision in Classen Immunotherapies, Inc. v. Biogen IDEC. Put differently, there may yet be “light” in this currently “dark” patent-eligibility tunnel.

You could attribute what happened here to “selective precedent amnesia.” But frankly such mishandling of binding Supreme Court precedent in Mayo Collaborative Services is a huge problem. (As one commentator has astutely noted, we now have Supreme Court precedent going off in two diametrically opposed directions on essentially the same patent-eligibility issue.) Any persuasiveness (or balance) in the opinion in Mayo Collaborative Services is greatly undermined by failing to directly (and fairly) address Diehr.

Well, Justice Breyer, the writer of the dissenting opinion in Laboratory Corp. v. Metabolite Laboratories, Inc., finally got his wish. Writing the opinion for a unanimous Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Breyer ruled that a claimed drug dosage calibration method based on previously unknown “precise correlations between metabolite levels [of administered thiopurine drugs] and likely harm or ineffectiveness” was patent-ineligible under 35 U.S.C. § 101 because it “adds nothing to the laws of nature that is not already present when the steps [of the claimed method] are considered separately.” While I’m not surprised that Breyer ruled the claimed method patent-ineligible, his reasoning in Mayo Collaborative Services is, in my view, often nonsensical, and is fraught with unfortunate statements that could potentially eviscerate the patent-eligibility of drug testing methods generally under 35 U.S.C. § 101.

Where the en banc decision gets particularly interesting (and adversarial) is with respect to the second question, namely when does “intervening rights” apply to reexamined claims? By a 6 to 4 vote, (and a reversal of the panel decision), a majority of the en banc Federal Circuit also concluded “as an alternative ground for affirmance” of the district court’s judgment that “intervening rights do not apply to claims that have not been amended and are not new.” The majority opinion by Judge Lourie (the dissenter in the panel decision) was joined by Chief Judge Rader, and Judges Newman, Bryson, Prost, and Linn (who was one of the 5 “nay” votes on the meaning “biocompatible). The dissenting opinion on the “intervening rights” question by Judge Dyk (who wrote the majority opinion in the panel decision) was joined by Senior Judge Gajarsa (who also joined the majority opinion in the panel decision), Judge Reyna, and Judge Wallach.

In the recently issued case of ClearValue, Inc. v. Pearl River Polymers, Inc., Judge Moore, writing for the Federal Circuit panel, distinguished the holding in the 2006 case of Atofina v. Great Lakes Chemical Corp. In ClearValue, Judge Moore ruled that a process having a claimed raw alkalinity of “less than or equal to 50 ppm” was anticipated under 35 U.S.C. § 102 by a prior art process disclosing an alkalinity of “150 ppm or less.” I believe Judge Moore was correct in ruling that the claimed alkalinity of “less than or equal to 50 ppm” was anticipated by the art disclosed alkalinity of “150 ppm or less.” But her basis for distinguishing Atofina in ClearValue is very problematic in a number of respects, and could create further unnecessary confusion as to when a narrower claimed range in a process is anticipated by a broader range disclosed by the prior art. As illustrated by the ClearValue and Atofina cases, one area where the Federal Circuit sometimes struggles in articulating clear doctrine is when is a narrower claimed range in a process is anticipated under 35 U.S.C. § 102 by a broader range disclosed by the prior art.

The doctrines of “secret prior art” and “inherency” both merged in the case Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP to surprise, and unpleasantly upend the patentee. Judge Linn’s opinion ruled that “[a]n inventor need not understand precisely why his invention works in order to achieve an actual reduction to practice.” Relying upon the collective holdings in Dow Chemical, Mycogen Plant Science, and Invitrogen, the Federal Circuit panel then concluded that “it is apparent that the district court correctly entered summary judgment” of invalidity of the asserted claims in the ‘502 patent under 35 § 102(g)(2).

Over the years IPWatchdog.com has continued to try and add additional perspectives from a wide variety of guest contributors, ranging from well respected practicing attorneys and agents to high profile academics to inventors and pro-patent lobbyists. It is hard to imagine providing such depth of analysis on such an array of topics without having truly wonderful guest authors. So we take this moment to say a very special thank you and to shine the spotlight on them. Each deserve to share in any recognition of IPWatchdog.com. Without further ado, here are the guest contributors in alphabetical order, along with their contributions for 2011.

Some will undoubtedly view the Chief Judge’s basis in Ultramercial for distinguishing the ruling in CyberSource as being “slight of hand” and using “mirrors,” but it certainly illustrates the wide gulf of views between the various members on the Federal Circuit on the patent-eligibility question. I wouldn’t be surprised (and frankly it needs to happen) if both Ultramercial and CyberSource ended up before the en banc Federal Circuit. As I’ve noted previously, we’ve currently got what appear to be irreconcilable decisions in the Classen, Prometheus, and AMP cases in determining the patent-eligibility of certain medical (e.g., diagnostic) methods. With what appears to be similarly conflicting decisions in Ultramercial and CyberSource, the gauntlet has truly been thrown down. An en banc Federal Circuit needs to step in soon, or the conflagration that currently exists in the patent-eligibility “war” might soon consume us all.

That there was a majority (and a dissenting) opinion in the remand of Classen wasn’t surprising. But that there was yet a third “additional views” opinion would likely not have been predicted by anyone. And it is that “additional views” opinion, along with the majority and dissenting opinions, that will certainly generate a “firestorm” through the Federal Circuit, and which may eventually reach the Supreme Court. The judicial donnybrook on the question of what the standard is (or should be) for patent-eligibility under 35 U.S.C. §101 is about to begin in earnest.

In Duramed, the invention claimed in U.S. Pat. No. 5,908,638 (the “’638 patent”) involved a conjugated estrogen pharmaceutical compositions for use in hormone replacement therapies. The critical aspect of the claimed invention was the moisture barrier coating (MBC) which surrounded the composition. Claim 7 (which depended from independent Claim 1) specified that this MBC “comprises ethylcellulose.” During patent prosecution, the examiner rejected both Claims 1 and 7 for obviousness under 35 U.S.C. § 103. As a result of an interview with the examiner, Claim 1 was amended to include the recitation in Claim 7, and in due course, the ‘638 patent issued. Sounds to me like a classical instance of prosecution history estoppel coming into play and barring any application of the doctrine of equivalents.

Under the “first to file” AIA regime, the effective prior art date is what prior art exists before the U.S. patent filing date. In other words, the U.S. patent applicant no longer has the luxury of that potential up to one year “window” after the invention date. Instead, the danger of intervening prior art by others steadily (and potentially exponentially) increases as time passes between the invention date and the U.S. patent filing date. Put differently, U.S. patent applicants are now really in a “race to the U.S. Patent & Trademark Office (USPTO)” to minimize the ever increasing danger of intervening (and accumulating) prior art coming into play. For the Goliaths, they’ve been existing in this situation for many years because the rest of the world (ROW) is “first to file.” But for the American Davids, “first to file” under the AIA is going to be culture shock of the worst, and most expensive kind, with time pressure that these Davids aren’t prepared or trained to handle.

In going from the current “first to invent” to the new “first to file” regime mandated by the America Invents Act (AIA), much attention has been focused on the amorphous “grace period” provision provided to patent applicants for certain activities undertaken by them prior to filing for a U.S. patent. Much less attention was paid to the amendments made to sections 203(c)(2) and 203(c)(3) of the Bayh-Dole compliance obligations which were directly impacted by this change in definition from the old “statutory bar” provision (based on publication, on sale, or public use of the invention caused by the patent applicant), to this new “grace period” provision. But even more astounding (and unsettling) are the unrecognized consequences caused by the AIA in “realistically” meeting certain Bayh-Dole compliance obligations by going from the current “first to invent” to the new “first to file” regime.

What is startling about Wellman is how the patentee put the ‘863 and ‘317 patents squarely in the path of the “best mode” Patent-Raptor by deliberately keeping the Ti818 recipe a trade secret. As I’ve instructed numerous clients, you have a clear choice on “best mode” issue: (1) disclose the “best mode” and file the patent; or (2) don’t file the patent if you want to keep the “best mode” as a trade secret. There is simply no “in between” on this issue. The only question now is whether the Tyrannosaurus Rex of patent law (inequitable conduct) will devour what is left of the Wellman patents.