CAFC Affirms PTAB’s Decision That Printed Matter Doctrine Can Be Used In Claim Construction

By Reza Mollaaghababa
In an inter partes review proceeding, a challenger cannot raise patent-eligibility as a ground of invalidity.  Rather, the invalidity grounds are limited to lack of novelty and obviousness.  Notwithstanding, in construing claim terms, the PTAB can decide not to give patentable weight to certain claim limitations that are not patent-eligible. In Praxair Distribution., Inc. v. Mallinckrodt Hospital Products IP Ltd., No. 2016-2616, 2016-2656 (Fed. Cir. May 16, 2018) the PTAB had employed the so-called “printed matter doctrine” not to give patentable weight to certain limitations as merely “providing information”  and the CAFC affirmed the PTAB’s claim construction.

Mallinckrodt is the owner of U.S. Patent No. 8,846,112, which is directed to methods of distributing nitric oxide gas cylinders for pharmaceutical applications.

Claim 1 recites a method of providing pharmaceutically acceptable nitric oxide gas, which includes obtaining a cylinder containing compressed nitric oxide gas, supplying the cylinder to a medical provider who is responsible for treating neonates who have hypoxic respiratory failure, including some who do not have left ventricular dysfunction. Claim 1 further includes the step of providing to the medical provider “(i) information that a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure is 20 ppm nitric oxide and (ii) information that, in patients with preexisting left ventricular dysfunction, inhaled nitric oxide may increase pulmonary capillary wedge pressure (PCWP), leading to pulmonary edema, the information of (ii) being sufficient to cause a medical provider considering inhaled nitric oxide treatment for a plurality of neonatal patients who (a) are suffering from a condition for which inhaled nitric oxide is indicated, and (b) have pre-existing left ventricular dysfunction, to elect to avoid treating one or more of the plurality of patients with inhaled nitric oxide in order to avoid putting the one or more patients at risk of pulmonary edema.”

Independent claim 7 includes a “recommendation that, if pulmonary edema occurs in a patient who has pre-existing [LVD] and is treated with inhaled nitric oxide, the treatment with inhaled nitric oxide should be discontinued” (the “recommendation” limitation). Claim 9 depends on claim 7 and further comprises the following steps: performing at least one diagnostic process to identify a neonatal patient who has hypoxic respiratory failure and is a candidate for inhaled nitric oxide treatment; determining prior to treatment with inhaled nitric oxide that the neonatal patient has pre-existing left ventricular dysfunction; treating the neonatal patient with 20 ppm inhaled nitric oxide, whereupon the neonatal patient experiences pulmonary edema; and in accordance with the recommendation of [claim 7], discontinuing the treatment with inhaled nitric oxide due to the neonatal patient’s pulmonary edema. Id.

The Board applied the printed matter doctrine to interpret the providing information, evaluating, and recommendation claim limitations “to be either printed matter or purely mental steps not entitled to patentable weight, as those limitations lacked a functional relationship to the other claim limitations except in claim 9.” In particular, the PTAB was not persuaded by Mallinckrodt’s argument that the recitation of “a pharmaceutically acceptable nitric oxide gas” in the preamble of the claims would require considering information provided in the label of the supplied product.  Rather, the PTAB construed this limitation as simply “nitric oxide gas that is suitable for pharmaceutical use.” Continue reading “CAFC Affirms PTAB’s Decision That Printed Matter Doctrine Can Be Used In Claim Construction”

CAFC Affirms PTAB’s Decision To Invalidate Cialis and Adcirca Patents

By Reza Mollaaghababa
In a recent decision, the Court of Appeals for the Federal Circuit (CAFC) affirmed decisions in two inter-partes review (IPR) proceedings that patents owned by ICOS Corporation directed to tadalafil formulations (used in the erectile dysfunction drug, Cialis, and the pulmonary arterial hypertension drug, Adcirca) were invalid as obvious. (CAFC Decision Nos. 17-1071 and 1018, April 18, 2018.)

The challenged claims were directed to a pharmaceutical formulation comprising micronized tadalafil – the active ingredient of the drugs. The challenger, Actelion Pharmaceuticals, argued that the claims were obvious in view of the teachings of four prior art references: Daugan, Butler, Seth and Wadke.  In particular, the challenger argued that Daugan disclosed tadalafil and the excipients included in the claims, Butler disclosed that tadalafil was poorly water soluble, Seth disclosed that micronization was a frequently used method for improving the rate of dissolution of poorly soluble hydrophobic drugs, and Wadke disclosed that it was generally recognized that poorly soluble drugs will be more readily bioavailable when administered in a finely subdivided state preferably in a 10-40 micron range.  The challenger hence argued that it was obvious to combine the references with a reasonable expectation of success.

The Patent Trial and Appeal Board found that, while Seth recognized disadvantages to micronization, those disadvantages would not have stopped ordinarily skilled artisans from using the technique, and held that there was a reasonable expectation of success in combining the teachings of these references. (IPR2015-00561 and IPR2015-00562.)

The CAFC held that substantial evidence supported the Board’s findings. The CAFC did not agree with ICOS’ argument that the prior art taught away from micronization. In particular, the CAFC indicated that although Butler disclosed coprecipitation as a solution to tadalafil’s poor solubility, the Board had credited Actelion’s expert’s testimony that Bulter did not suggest that micronization would not work but rather it had chosen a different solution.  Further, while Seth recognized problems with agglomeration when micronizing, the Board had similarly credited Actelion’s expert’s testimony that there were recognized solutions in the art for the agglomeration problem.  Moreover, the Board determined that Wadke did not teach a sequential approach that favored coprecipitates over micronization but instead described two alternative approaches.

The outcome of these cases appears to demonstrate that “teaching away” arguments have a low probability of success before the Board in defending challenged claims.  The fact that a reference points out the disadvantages associated with a particular approach may not be sufficient to persuade the Board that the reference teaches away from that approach.  For example, the Board may find that the reference simply compares alternative approaches but does not dissuade one of ordinary skill from using the less advantageous approach, or the Board may find that there are known solutions to overcome the cited disadvantages.

PTAB gives Apple’s Foe a Second Bite by Granting Realtime Data’s Motion to Amend

By Reza Mollaaghababa
In an inter partes review (IPR) proceeding, a patent owner may file one motion to amend the patent in one or more of the following ways: (a) cancel any challenged patent claim, or (b) for each challenged claim, propose a reasonable number of substitute claims.  35 U.S.C. §316(d).  1290.  With regard to substitute claims, the Patent Owner needs to demonstrate that (1) the amendment is responsive to a ground of unpatentability raised in the IPR, (2) that amendment does not broaden the scope of the claims or introduce new subject matter, and (3) the amendment proposes a reasonable number of substitute claims.  37 C.F.R. §42.121.

Through the end of Fiscal year 2017 (which ended on September 30, 2017), only fourteen motions to amend had been granted out of 275 completed trials in which a motion to amend was filed.

In October of 2017, the patent appellate court (CAFC) ruled that that Board must assess the patentability of the substitute claims proposed by the patent owner “without placing the burden of persuasion on the patent owner.” Aqua Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017).  It is not yet clear whether this ruling will significantly impact the PTAB’s reluctance is granting motions to amend.  But in a recent IPR (IPR2016-01737) in which Apple had challenged certain claims of U.S. Patent 8,880,862 (the “’862 Patent”) owned by Realtime Data LLC, the PTAB granted the Realtime’s motion to amend.

The ‘862 Patent relates to “providing accelerated loading of operating system and application programs upon system boot or application launch,” and the use of data compression and decompression techniques for such purpose. Apple had challenged certain claims of the ‘862 Patent as being obvious in view of combined teachings of a number of references.  After the institution of trial, the patent owner filed a Patent Owner Response to rebut the petitioner’s obviousness allegations and further filed a contingent motion to amend.

The PTAB ruled that the challenged claims were in fact obvious in view of the art cited by Apple, but granted Realtime’s motion to amend. The PTAB noted that the patent owner sought to add 55 substitute claims to replace the 55 challenged claims, where each substitute claim added limitations that narrow the scope of the claim that it replaced.  The PTAB further noted that the patent owner identified support in the original disclosure for the proposed substitute claims including the narrowing amendments. Further, the narrowing amendments were in direct response to the grounds of unpatentability raised in the trial.  Thus, the PTAB concluded that the patent owner had satisfied the procedural requirements of filing a motion to amend.

With regard to the distinction of the substitute claims relative to the art cited by the petitioner, the PTAB emphasized that the patent owner did not have the burden of persuasion with respect to the patentability of the substitute claims. The PTAB indicated that it determines “whether the substitute claim is unpatentable by a preponderance of the evidence based on the entirety of the record, including any opposition made by the petitioner.” The PTAB concluded that based on the entirety of the record, the preponderance of the evidence showed that the petitioner had failed to establish that the proposed substitute claims were obvious over the art cited by the petitioner.

Notwithstanding patent owner’s success in this IPR, patent owners may need to wait for future decisions of PTAB regarding motions to amend to determine whether filing a motion to amend is a tool that can be effectively utilized in defending challenged patents before the PTAB.