August 4, 2023
On July 28, 2023, Judge Williams of the Delaware District unsealed his decision on remand from the Federal Circuit addressing competing summary judgment motions regarding the patent eligibility of remanded claim 1. The Federal Circuit remanded the case to the district court to determine if claim 1 was directed to an abstract idea argued by Neapco on appeal for invalidity. Claim 1 provided:<... Read more
July 26, 2023
On July 24, the USPTO announced a revised Director interim review process. Although the USPTO in July 2022 had requested comments on its director review process and the comment period was closed on October 19, 2022, the USPTO has still not formalized the process or published any proposed rules to implement it. Instead, it revised its interim review process.<... Read more
July 14, 2023
On July 10, 2023, the Patent Trial and Appeal Board (PTAB) reversed an examiner’s finding of obvious on the basis of a failure to show a motivation to modify the prior art and a lack of a reasonable expectation of success. The appeal (No. 2023-002080, USSN 15/558,153, Technology Center 1700) of Ex parte MARK HETHERINGTON began with the filing of a Notice of Appeal on May 13, 2022, after filing the national stage application on September 13, 2017. The main appealed claim recited:<... Read more
July 11, 2023
The Federal Circuit on June 30 granted a petition for re-hearing en banc of its per curiam decision in LKQ Corp. v. GM Global Tch. Operations, LLC. finding the PTAB had correctly decided that GM’s design patent D797,625 was not unpatentable, i.e., valid. The issue raised was whether the Federal Circuit’s rulings in Durling v. Spectrum Furniture Co., Inc., 101 F.3d 100 (Fed. Cir. 1996); In re Rosen, 673 F.2d 388 in (C.C.P.A. 1982) followed by the PTAB in its decision created a “rigid” rule for obviousness in design patent in violation of Supreme Court’s 2007 KSR decision overturning the Federal Circuit’s rigid rule for obviousness of utility patents, the “teaching, suggestion motivation“ (TSM) test for obviousness. <... Read more
July 5, 2023
Amgen provides a window on the Supreme Court approach to patent issues - look to history and established policy as our patent law is not code based but rather common law based. The Court noted that the “enablement requirement” is found essentially unchanged in every version of the patent law since 1790. While Amgen concerned the enablement provision, the same approach applies to patent eligibility, the “judicial exceptions,” which have existed in our case law since the early 19th century. In deciding Amgen the Supreme Court did not consider previous Federal Circuit decisions but looked to history of the enablement provision which involved Court decisions from the 19th and early 20th century. While Amgen was the Court’s first antibody case, it found analogous cases which provided guidance as to how the enablement requirement had been interpreted. Since U.S. patent law is based on common law, this is the appropriate approach to provide the needed predictability. Without understanding the policy behind the exceptions, one will continue to wander aimlessly from one case to the next.<... Read more
June 27, 2023
Orphan drug exclusivity was created in 1983 to encourage pharmaceutical companies to develop drugs for diseases which affect less than 200,000 persons in the U.S. Jazz Pharmaceuticals developed Xwav® to treat narcolepsy, a rare sleep disorder characterized by excessive daytime sleepiness and cataplexy, voluntary muscle weakness. Xywav® received orphan drug exclusivity until July 2027 when it expires. Xywav® comprises the drug oxybate as mixed salts of calcium, magnesium, potassium, and sodium oxybate. The Orphan Drug Act 21 U.S.C. 360 cc (b) provides the exclusivity can be broken if: <... Read more
June 19, 2023
The USPTO has opened the discussion on its fees to be effective in 2025. While the PTO is to be applauded for getting ahead of the fee curve, unfortunately some proposed fees are not only outrageous but beyond the PTO’s fee setting authority. The PTO in its fee setting objectives listed as one objective to “Promote efficient operations and efficient filing behaviors.” [Emphasis added]. The PTO’s executive summary quoted in this post is found here along with other supporting documentation. The PTO’s fee setting authority is not unbounded but restricted by several laws. First, the House Report describes the fees in 35 U.S.C. § 41 as the reference point for future adjustments. It provides in part for these fees for over 3 independent claims with a column added for 45% inflation since 2011[1]:<... Read more
May 30, 2023
On May 16, the Supreme Court distributed the CareDX cert petition for consideration at the June 1 conference since the Respondents waived filing a reply. The CareDX family of three patents, licensed from Stanford University, U.S.Ps. 8,703,652, 9,845,497 and 10,329,607, are directed to the noninvasive diagnosis of the state of a transplanted organ. The test provides the doctor with information on whether everything is okay, or that the organ is showing signs of being rejected. Both the district court and the Federal Circuit held the patent to be patent ineligible based primarily on admissions appearing in the specification of all three patents which are identical. Given the low success rate (recently zero) of requests for certiorari in the diagnostic/biomarker area, this raises the question as to the possibility the petition will be granted. The CareDx petition’s chances seem better than recent certiorari petitions. <... Read more
May 18, 2023
In a unanimous opinion the Court decided that the Federal Circuit’s decision was correct.<... Read more
May 15, 2023
Today the Supreme Court denied cert in GSK v. Teva in which the Solicitor General filed a brief in support of granting cert. The Solicitor argued that the decision in GSK’s favor threatened the availability of lower cost generic drugs. <... Read more