Orphan Drug Exclusivity (ODE) – FDA Continues Its Attack

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

Show Me the Money – USPTO Fee Proposals Include Fee Provisions to Impact Applicant Behavior

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

The CareDx Petition For Certiorari, Maybe This Is The One

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

Supreme Court Affirms Federal Circuit Decision in Amgen v. Sanofi

May 18, 2023

In a unanimous opinion the Court decided that the Federal Circuit’s decision was correct.<... Read more

Supreme Court Denies Cert in Patent Eligibility Cases and the Skinny Label Case

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

Amgen v. Sanofi – Impermissible Functional Claiming?

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

Broadest Reasonable Interpretation, not Broadest Possible Interpretation

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

USPTO Issues Advance Notice of Proposed Rulemaking for America Invents Act (AIA) Proceedings Before the Patent Trial and Appeal Board

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

PTAB Finds Teaching Away in Non-Overlapping Range

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

A Broad Outline of a Genus's Perimeter Is Insufficient For Written Description of the Members of the Genus

April 7, 2023

The Regents of the University of Minnesota (“Minnesota”) appealed from a final decision of the U.S. PTO Patent Trial and Appeal Board (“the Board”) holding that the claims of U.S. Patent 8,815,830 were unpatentable as anticipated. The Court of Appeals for the Federal Circuit (“the Court”) affirmed.<... Read more