Even when certain elements in a claimed method are not expressly disclosed in the prior art, the claim can still be held obvious if the missing elements are supplied in the form of an inherent property. In the pharmaceutical context, the PTAB decision in Dr. Reddy's Laboratories, Inc. v. Pozen Inc. (IPR2018-00894; PTAB 2019) illustrates the continuing difficulty in claiming methods of administering a known two-drug pharmaceutical composition with an expected pharmacokinetic and pharmacodynamic (PK/PD) profile. The patent at issue covers methods of administering morning and afternoon daily doses of the arthritis pain reliever Vimovo®. Specifically, the claims recite particular PK/PD profiles, including the highest plasma concentration of the drug following administration, drug bioavailability, and amount of drug exposure for compositions of naproxen (a nonsteroidal anti-inflammatory drug “NSAID”) and esomeprazole (a proton pump inhibitor (PPI)). Esomeprazole is used in conjunction with naproxen to reduce the risk of gastrointestinal injury from naproxen by raising the gastrointestinal tract pH.
Invalidity grounds in IPR that are not based on patents must be based on printed publications. But the nature of the evidence required at the time of institution to show that a non-patent reference is a printed publication has long been uncertain. The PTAB’s Precedential Opinion Panel (POP) in Hulu v. Sound View Innovations, IPR2018-01039 (Dec. 20, 2019), provided some clarity and left other issues for future PTAB panels to resolve.
This blog post is part of Wolf Greenfield's COVID-19 Resource Center. To access the full resource center, click here.
Appearing before the Patent Trial and Appeal Board (PTAB) looks different as a result of COVID-19. The PTAB recently held a “Boardside Chat” to talk about how PTAB practice has changed. Here are some important changes practitioners should know regarding case management, CARES Act extensions and remote hearings at the PTAB.
Last week, the Supreme Court released its opinion in Thryv, Inc. v. Click-to-Call. This case, as we previously reviewed, concerns whether the PTAB’s application of the one-year statutory time bar for an IPR is appealable. The Patent Statute says that the PTAB’s decision to institute an IPR is “final and nonappealable,” but the Federal Circuit interpreted that bar on judicial review narrowly and found it inapplicable to the question of whether the one-year statutory time bar applied. Oral arguments suggested that the Court would likely be divided. Ultimately, the court was split 7-2, with the majority holding that the time bar was not an appealable issue.
Prosecution history can be a minefield in patent cases, and IPR is no different. In the context of construing patent claims, much of the focus is often on whether the patent owner disclaimed particular subject matter from the scope of the claims. But two recent Federal Circuit decisions reviewing decisions in IPR illustrate that even absent disclaimer, patent owners may be able to save the challenged claims by pointing to their past statements during prosecution.
Patent claims that could be indefinite have long raised tricky issues for parties in IPR. Should petitioners challenge in IPR claims they think are indefinite? What should the PTAB do if it concludes that the claims are indefinite? The Federal Circuit’s recent decision in Samsung Electronics Co. v. Prisua Engineering Corp. provides some answers.
The key questions addressed in the case were, first, whether the PTAB may cancel claims for indefiniteness once IPR has been instituted on another grounds, such as anticipation under section 102 and obviousness under section 103. And second, whether the PTAB is strictly precluded from making anticipation and obviousness determinations on indefinite claims.
That is the gist of a recent decision by the court, which permitted an IPR Petitioner to use “general knowledge” to fill in missing claim limitations in certain circumstances, but also constrained the PTAB as to what grounds may serve as the basis for instituting trial.
Petitioners seeking IPR of a patent must make their case for unpatentability based on two types of prior art – patents and printed publications. However, in Koninklijke Philips N.V. v. Google LLC (No. 2019-1177), the Federal Circuit held that those references can be used as evidence of the general knowledge, and need not be made part of a specific combination. Specifically, the court found that the Petitioner had properly alleged that although the primary reference relied upon did not disclose each and every element of the claimed invention, the differences between the claimed invention and that reference would have been obvious to a skilled person based on their general knowledge.
The Supreme Court heard oral arguments in Thryv v. Click-to-Call Technologies last month. As we previously discussed, the case concerns whether the PTAB’s finding that a petition for IPR was timely filed is reviewable on appeal. If the Justices’ questions at oral arguments are any indication, a split decision is likely.
At issue in the case is Section 314(d) of the Patent Act, which bars appeal of the PTAB’s decision “to institute an inter partes review under this section.” The Justices must decide whether that statute applies to, and thus bars appeal of, the PTAB’s finding that the petitioner timely filed the petition before the end of Section 315(b)’s one-year window.
Too often some challenger in IPR declines to use non-patent literature (or “NPL”), such as academic and trade journal articles, because of the effort and risk associated with establishing that the NPL is prior art. The Federal Circuit’s recent decision in Telefonaktiebolaget LM Ericsson V. TCL Corp. (No. 17-2381) illustrates why that strategy can be a mistake and provides guidance on how to use NPL effectively.
As we have discussed, the PTAB often imposes specific requirements for establishing that an NPL reference is a prior art printed publication. Unlike with patent prior art, where challengers can ordinarily rely on the dates on the document itself, challengers typically have to introduce evidence that NPL was publicly accessible early enough to make it prior art. Getting that evidence can be challenging, which is why some challengers shy away from using NPL at all.
In the past, moving to amend the challenged claims during IPR was largely futile. The PTAB denied nearly all motions to amend, and many patent owners that might have benefited from amendment chose not to pursue it. But the rules concerning amendment in IPR are changing, and the number and success rate of motions to amend are ticking up. Patent owners have new reasons to think that amendment might save their patents from IPR.