No Motivation to Modify Product-Specific Method with Method Features for Different Products

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

Lessons from Amgen v. Sanofi

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

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