Last year, in Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., the Federal Circuit confirmed that 28 U.S.C. § 1400(b) is the sole venue provision for domestic defendants in Hatch-Waxman actions.1 On Friday 5 November 2021, the Federal Circuit provided even greater clarity on venue rules in such cases, concluding that, for venue purposes, only submission of the ANDA qualifies as an act of infringement, not any action related to the submission.2Read More
The Federal Circuit’s decision last week in Fox Factory, Inc. v. SRAM, LLC provided clarity regarding the nexus requirement of secondary considerations of non-obviousness, particularly with respect to whether a patentee is entitled to a presumption of nexus.  Despite the Patent Trial and Appeal Board (“PTAB”) finding that the cited art disclosed all the limitations of the challenged patent—which claimed a bicycle chainring for engagement with a drivetrain—and that a skilled artisan would have been motivated to combine the cited prior art, the PTAB found that, based on an analysis of secondary considerations, the claims of the challenged patent were not obvious.  The Federal Circuit focused in on the comparison of the patentee’s product and the scope of the challenged claims.  In doing so, the panel found that “[a] patent claim is not co-extensive with a product that includes a ‘critical’ un-claimed feature . . . that materially impacts the product’s functionality.” Read More
In a Halloween decision, the Federal Circuit issued its opinion in Arthrex, Inc. v. Smith & Nephew, Inc. et al., an appeal from IPR2017-00275. Without wading into the technical merits of the decision, the three judge panel of Judges Moore, Reyna, and Chen, issued a decision that, at first glance, sent tremors through those who practice before the PTAB in AIA-based post-grant review proceedings: finding the appointment of PTAB judges unconstitutional.Read More
B.E. Technology LLC v. Facebook, Inc., Appeal No. 18-2356 (Fed. Cir. Oct. 9, 2019) identifies what it means to win in a case. More particularly, the Federal Circuit explained how to determine whether a party is “the prevailing party.” B.E. Technology (“B.E.”) brought a patent infringement suit in district court against Facebook and the case was stayed pending inter partes review. The Patent Trial and Appeal Board ultimately held the claims of the patent in question to be unpatentable, which was confirmed on appeal.Read More
Mayo Foundation v. Iancu reads more like an arithmetic problem than a Federal Circuit decision. The reason is the case involves the Patent Term Adjustment Act (PTA) (see 35 U.S.C. § 154(b)). PTA determinations require calculating how many days of delay, from the effective filing date to the Notice of Allowance, are attributable to the applicant and how many to the PTO. Under one PTA scenario, the applicant is entitled to an adjusted term, recovering every day the application is pending beyond three years past the effective filing date for the balance of delay attributable to the PTO. This is called a “B Delay” (§154(b)1)(B)). However, the B Delay is subject to several exclusions. The disputed exclusion in Mayo concerned a Request for Continued Examination (RCE) of the application, which Mayo filed before the PTO declared an interference.Read More
Part of the trademark registration process is submitting a specimen of the mark as used in commerce (“specimen of use”). Recently, the U.S. Court of Appeals for the Federal Circuit (CAFC) upheld the decision of a split Trademark Trial and Appeal Board (TTAB) panel that refused to register the trademark “CASALANA” for “knit pile fabric made with wool for use as a textile in the manufacture of outerwear, gloves, apparel, and accessories,” stating that Siny Corp. (the applicant) did not submit an acceptable specimen of use. See In Re: Siny Corp. (Fed. Cir. Case. No. 18-1077).Read More
On April 10, 2019, the Federal Circuit issued a precedential opinion, at the request of the U.S. Patent and Trademark Office (USPTO), regarding submissions of webpages as specimens of use. In re Siny Corp is an important reminder to applicants and practitioners to carefully consider whether webpage specimens to be submitted to the USPTO actually comprise the offering of goods and/or services at the point of sale, or whether they are mere advertising.Read More
The Federal Circuit, in a nonprecedential decision, held that claims of a reissue application were properly rejected because they recaptured subject matter surrendered during the original prosecution of U.S. Patent No. 8,282,591 (“the ’591 patent”).
The ’591 patent is directed to an arteriovenous shunt that connects a graft to an artery and passes returned blood through a “single lumen venous outflow catheter” into the right atrium of a patient’s heart. This system reduces the risk of infection, clotting, and hyperplasia compared to systems that remove and return blood through a graft connected to a vein.
On July 25, 2017, the United States Patent and Trademark Office (USPTO) issued Patent Eligible Subject Matter: Report on Views and Recommendations From the Public (Report). The Report summarizes public comments on the state of subject matter eligibility law. Comments came from varied sources including industry, private practice, academia, trade associations, inventors, and small business.
After beginning with an overview of eligibility law in the U.S. and abroad, the Report summarizes the comments supportive and critical of the Supreme Court’s Bilski, Mayo, Myriad, and Alice decisions regarding subject matter eligibility. It polls opinions from the two most-impacted technology sectors, and reviews recommendations on how to move forward.
The U.S. Courts have repeatedly invalidated patents under 35 U.S.C. § 101 as lacking patentable subject matter in areas such as business methods and computer-based inventions. However, decisions addressing inventions in the life sciences are substantially less frequent. In Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017), the Federal Circuit provided some additional guidance for patent eligibility of life sciences inventions.
Three of the patents at issue were directed to methods of detecting myeloperoxidase (MPO) (diagnostic patents), and the fourth patent was directed to methods of treating patients with heart disease based on the MPO detection methods of the other patents. The district court granted the defendant’s motion to dismiss under Fed. R. Civ. P. 12(b)(6) for failure to state a claim because the diagnostic patents lacked patentable subject matter, and the Federal Circuit affirmed that decision.
According to the Federal Circuit, the diagnostic patents were directed to a law of nature: the correlation between MPO level and heart disease. Interestingly, the opinion notes that the correlation was known in the art prior to filing the patents, however, there was no way to directly detect the MPO or correlate the levels to a risk of heart disease. The Court found that the claims did not teach a new test or laboratory technique, nor did they alter the MPO levels. Rather, the levels existed in nature without human action. Thus, the Court concluded that the claims did “not result in an inventive concept that transforms the natural phenomena of MPO being associated with cardiovascular risk into a patentable invention.”
The Court left open the question of whether the method of treatment patent contained patent-eligible subject matter because the Court held that the pleadings for that patent were deficient (this patent was only alleged to be infringed through inducement or contributorily infringed).
Unlike other decisions on patentable subject matter in the life sciences area, the holding did not turn on whether the claims broadly preempted application of a law of nature. The Patent Owner argued that the claims should be patent eligible because they were narrow and did not preempt all uses of the alleged law of nature, but the Court stated that the preemption argument was fully addressed and made moot by its determination that the claims only disclosed patent-ineligible subject matter.
In view of this decision, care should be taken when drafting claims directed to diagnostic methods to be sure to clearly claim more than the diagnostic correlation.