Patent Law Practice Center

Federal Circuit refuses en banc hearing in Ariosa v. Sequenom

Several weeks ago, in a per curiam decision with only Judge Newman dissenting, the United States Court of Appeals for the Federal Circuit denied the Sequenom petition for rehearing en banc. See Ariosa Diagnostics, Inv. v. Sequenom, Inc. Sequenom, the patent holder, had already hired Thomas Goldstein, the founder of SCOTUS blog and renowned Supreme Court advocate, as a part of their appellate team. The case will now undoubtedly move to the Supreme Court. We can only hope that the Supreme Court will take the case and once and for all decide whether they intended for all genomic innovations, no matter how revolutionary, to be patent-ineligible.

If you look quickly at the per curiam decision, you might mistakenly believe that there is a unanimity of thought at the Federal Circuit on the issue of patent eligibility. After all, the case was denied en banc rehearing. But there were three separate written opinions, two concurring with the denial and only Judge Newman dissenting. In truth, if you take the time to read the opinions, you realize that all four of the Judges who signed opinions believe the Supreme Court is wrong on patent eligibility. Given Judge Linn’s concurring opinion at the panel level, we can safely conclude that he too believes the Supreme Court is wrong on this matter.

After the brief per curiam decision, several written opinions followed. First, Judge Lourie, who was joined by Judge Moore, wrote that while the claims at issue may be susceptible to challenge for being too broad or indefinite, “they should not be patent-ineligible on the ground that they set forth natural laws or are abstractions.”

Lourie would go on to conclude:

In sum, it is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on grounds that they only claim a natural phenomenon plus conventional steps, or that they claim abstract concepts. But I agree that the panel did not err in its conclusion that under Supreme Court precedent it had no option other than to affirm the district court.

Even Judge Dyk, who is more skeptical of patents than most of the other judges on the Federal Circuit, thinks the Supreme Court went too far in Mayo, but wrote separately that he believes that any additional guidance must come from the Supreme Court, not the Federal Circuit.

In an uncharacteristically short dissent, Judge Newman wrote:

Precedent does not require that all discoveries of natural phenomena or their application in new ways or for new uses are ineligible for patenting… The new diagnostic method here is novel and unforeseen, and is of profound public benefit… The panel’s decision to withhold access to patenting, now endorsed by the en banc court’s refusal to rehear the case, is devoid of support.

Judge Newman also went on to remind us all that patenting “facilitate[s] the public benefit of provision of this method through medical diagnostic commerce, rather than remaining a laboratory curiosity.”

We haven’t heard the last of this case. The question remains, however, whether the Supreme Court will take the case when given the opportunity or whether they will allow this ruling and the confusion to remain indefinitely.

Classen v. Biogen: CAFC Tries To Target Patent Eligibility But Misses

Ryan Chirnomas, Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian, sent in this article discussing the Court of Appeals for the Federal Circuit’s recent Classen v. Biogen decision.  He highlights the key points of the decision and why he believes this case is a missed opportunity to clarify the machine-or-transformation test of Bilski.

Not long after issuing opinions in AMP v. USPTO and Prometheus v. Mayo, the CAFC has again taken on the difficult questions of patent eligible subject matter in Classen v. Biogen.  In 2008, the CAFC issued a three-sentence non-precedential opinion holding that Classen’s claims do not recite patent eligible subject matter.  This decision was appealed to the Supreme Court and subsequently remanded to the CAFC after the Supreme Court’s Bilski decision.  The instant decision includes a discussion of patent-eligible subject matter, as well as the safe harbor exception to infringement of pharmaceutical patents.  This discussion is limited to questions of patent eligible subject matter.  This decision relates to three patents:  U.S. Patent Nos. 6,638,739 (“the ‘739 patent”), 6,420,139 (“the ‘139 patent”) and 5,723,283 (“the ‘283 patent”). (more…)

Federal Circuit Reverses Course On Classen

Our friends at Foley & Lardner sent in this article discussing the Federal Circuit’s decision in Classen Immunotherapies, Inc. v. Biogen Idec.

On August 31, 2011, the Federal Circuit issued its second decision in Classen Immunotherapies, Inc. v. Biogen Idec (App. 2006-1643, -1649), on remand from the Supreme Court after Bilski v. Kappos (U.S. 2010). The Federal Circuit first decided Classen’s appeal in 2008, when a panel comprised of Circuit Judges Newman and Moore and District Judge Farnan (sitting by designation) held in a one-paragraph, non-precedential decision authored by Judge Moore that Classen’s claims do not satisfy 35 USC § 101. The second time around, the Federal Circuit (by a panel that included Chief Judge Rader in place of Judge Farnan) took a closer look at Classen’s claims, and determined that two of the three Classen patents at issue indeed are directed to subject matter that is patent-eligible under 35 USC § 101. In this decision, the Federal Circuit has provided useful guidance for method claims that involve some type of information gathering. It appears that if the claims recite a step of “putting this knowledge to practical use,” such as an active treatment step based on the information, they are likely to be patent-eligible under 35 USC § 101. On the other hand, if the claimed methods culminate in obtaining information, and nothing more, they may be vulnerable to challenge under 35 USC § 101.

Judge Newman wrote the opinion for the court, which was joined by Chief Judge Rader. Chief Judge Rader wrote a separate opinion to express “additional views,” which was joined by Judge Newman. Judge Moore wrote a dissenting opinion. (more…)

Foley & Lardner On The ACLU/Myriad Decision

The following discussion comes from Courtenay C. Brinckerhoff and Jacqueline D. Wright Bonilla of Foley & Lardner.

Federal Circuit Decides Highly Anticipated “ACLU/Myriad” Gene Patenting Case – Subject Matter Patent-Eligibility of Isolated DNA and Diagnostic Methods Addressed Head-On

On July 29, 2011, in one of the most controversial and publicized biotech patent cases in many years, the Federal Circuit decided the “ACLU/Myriad” gene patenting case, formally known as Assn. Mole. Path. et al. v. USPTO et al. In a majority opinion by Judge Lourie, the Court addressed the case on the merits, after finding standing. The Court held all “isolated DNA” claims at issue patent-eligible, but held as patent-ineligible diagnostic method claims that in effect recite only “comparing” or “analyzing” DNA sequences. While it is anticipated that this ruling may be the subject of en banc review before the Federal Circuit and/or will ultimately find its way to the Supreme Court, today’s decision and its impact will undoubtedly be of great interest to everyone working in the biotechnology and diagnostic medicine fields.

Background

After hearing oral arguments on April 4, 2011, Judges Lourie, Bryson, and Moore issued opinions relating to the appeal of the March 29, 2010 summary judgment decision of the U.S. District Court for the Southern District of New York (Sweet, J.) that invalidated the challenged claims in seven Myriad patents as patent-ineligible under 35 U.S.C. § 101. (See Foley’s April 4, 2011 Legal News Alert: The Federal Circuit Hears Oral Arguments in Myriad Isolated DNA Case.) (more…)

AMP v. USPTO: Myriad wins this battle, but will the war continue?

Ryan Chirnomas, Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian, sent in this article discussing Friday’s Court of Appeals for the Federal Circuit decision in the AMP v. USPTO case.  He highlights the key points of the decision and why this decision should come as a relief to anyone in the biotechnology industry.

After nearly four months of consideration[1], the Court of Appeals for the Federal Circuit issued a decision in the controversial AMP v. USPTO case on Friday, July 29, 2011.  Weighing in at just over a hundred pages total, the decision includes a majority opinion by Judge Lourie, a concurrence by Judge Moore and a dissent by Judge Bryson.  The main point of contention between the three opinions relates to the patent-eligibility of the composition claims, particularly the claims which recite isolated long DNA sequences.

Standing

The first issue considered by the CAFC was whether the Plaintiffs had standing to sue.  The Plaintiffs were a motley crew of doctors, patients, scientific organizations and advocacy groups.  This wide breadth of Plaintiffs was one of the unusual aspects of this case.  Some Plaintiffs, such as cancer patients, claimed standing based on the fact that they could not afford the costs of the genetic tests or obtain a second opinion, due to Myriad being the exclusive provider for this test in the United States.  The Court quickly dismissed this reasoning, stating that “we fail to see how the inability to afford a patented invention could establish an invasion of a legally protected interest for purposes of standing.”  Citing MedImmune, the Court succinctly stated: “[s]imply disagreeing with the existence of a patent or even suffering an attenuated, non-proximate, effect from the existence of a patent does not meet the Supreme Court’s requirement for an adverse legal controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”

(more…)