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
May 12, 2023
On April 28 the Supreme Court heard oral arguments on Amgen’s petition of the Federal Circuit’s decision affirming the district court’s decision on JMOL that Amgen’s antibody claims lacked an enabling disclosure. Much of the argument revolved around what was the quantum of experimentation that was too much for a claim to be enabled. At the end of Sanofi’s argument its counsel cited the Morse case where the Supreme Court invalidated Morse claim 8 which defined the transmission of symbols in solely functional terms:<... Read more
May 11, 2023
On May 2, 2023, the Patent Trial and Appeal Board (PTAB) reversed the Examiner’s rejection of a claim directed to a method of creating an immobilized DNA library while preserving contiguity information of a target nucleic acid as being both anticipated and obvious (Appeal 2023-000053). Claim 1 of the application US 15/519,482 (the ‘482 Application) is directed towards:<... Read more
April 20, 2023
The USPTO today announced Advance Notice of Proposed Rulemaking for PTAB reforms regarding IPRs/PGRs. The proposal related to five areas:<... Read more
April 10, 2023
On March 15, 2023, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) issued an opinion in the appeal of US Appl. Ser. No. 15/395,642, Ex parte Chris Fish (Appeal 2022-001172, Technology Center 1700, Appellate Patent Judges Adrienne Lepiane HANLON, Catherine Q. TIMM, and Jeffrey B. ROBERTSON) reversing Examiner Nathan H. EMPIE’s finding of obviousness based on an alleged motivation to modify beyond the range taught by the prior art.<... Read more