Traversing Obviousness Rejections

Attorney: Richard D. Kelly
October 18, 2021

In Chemours Co. FC LC v. Daikin Industries Ltd. et al., 4 F.4th 1370 (Fed. Cir. 2021) reversed a PTAB decision finding the following claim to be unpatentable as obvious:<... Read more

PTAB ADOPTS IDENDEX IN FINDING MARKUSH GROUP NOT ENABLED

Attorney: Richard D. Kelly
September 7, 2021

     In Post Grant Reviews (PGR) the Patent Trial and Appeal Board (PTAB) may consider all statutory challenges to patent claims including those under 35 U.S.C. § 112. One such challenge was brought in Syngenta Crop Protection v. FMC Corp in PGR2020-00028 (Syngenta), decided August 31, 2021, against U.S.P. 10,294,202 (‘202 patent). The PTAB found all challenged claims, 1-3, 9-13, and 21-30, unpatentable as lacking an enabling disclosure commensurate in scope with the claims and a subset, claims 9 – 13, as lacking written description, 35 U.S.C. § 112(a).<... Read more

The Week That Was In Skinny Labels

Attorney: Richard D. Kelly
August 9, 2021

This week saw two cases reported with possible implications for skinny labels. The first was a recommendation be Magistrate Judge Hall, District of Delaware, that Hikma Pharmaceuticals could not dodge Amarin’s lawsuit claiming Hikma induced infringement of Amarin’s patents on the use of its heart drug Vascepa® . The patents in suit are U.S. Patent Nos. 9,700,537 (the ’537 patent), 8,642,077 (the ’077 patent), and 10,568,861 (the ’861 patent) under 35 U.S.C. § 271(b). In an interesting twist, Amarin also sued Health Net, an insurance provider, for also inducing infringement of the same patents. The suit against Health Net appears to be a first where an insurance company was sued for inducing infringement of method of using a drug.<... Read more

Prophetic "Examples" Past, Present and Future

Attorney: Richard D. Kelly
July 14, 2021

 On July1 the USPTO issued a notice regarding prophetic examples reminding practitioners of the need to distinguish between examples actually performed and theoretical or paper examples. Generally, this admonishment is considered to apply to the chemical and biologic arts where cookbook-type examples are found presenting data. MPEP 608 and Janet Freilich, Prophetic Patents UC Davis L. Rev. (2019). The MPEP was silent on prophetic examples prior to the 1981 edition.<... Read more

NCE Status Now Limited Active Moieties

Attorney: Richard D. Kelly
May 4, 2021

On April 23 President Biden signed into law changes narrowing the scope of eligibility for the non-patent “new chemical entity” (NCE) 5-year exclusivity provisions of 21 U.S.C. §301 et seq. The 5-year exclusivity comprises a 4-year data exclusivity provision during which time a generic applicant cannot rely on the drug application to establish either safety or efficacy which is followed by a 1-year marketing exclusivity. The exclusivity provision found in 21 U.S.C. § 355 (c)(3)(E)(ii) prior to the amendment described the NCE as applying to a drug where “no active ingredient” has been previously approved under § 355. Active ingredient is defined in 21 § 314.3(b) as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease ….” Some drugs become active only after being metabolized to what is called the active moiety. Prodrugs are an example of this phenomenon. Under the prior definition both a prodrug which metabolized into the active drug and the metabolite might each be capable of receiving separate NCE status.<... Read more

In re Rudy and the PTO 101 Guidance

Attorney: Richard D. Kelly
April 22, 2021

The USPTO 101 Guidance document has been under a cloud when Judge Brinkema refused to follow the guidance in Cleveland Clinic Found. V. True Health Diagnostics LLC., affirmed at 760 F. App'x. 1013, 1020 (Fed. Cir. 2019). Cleveland Clinic relied on Guidance example 29, claim 1 to assert that its claims were patent eligible since they were drafted in the same manner. The Federal Circuit in rejecting the argument found the 101 Guidance example 29, claim 1 to be "strikingly" similar to claim 1, see760 F. App'x. at 1020, which the Federal Circuit held was patent ineligible. The guidance teaches that example 29, claim 1 is patent eligible. The USPTO has not responded to the Court's criticism and example 29 continues to appear in the Guidance unchanged.... Read more

GlaxoSmithKline v. Teva - Not a Skinny Label?

Attorney: Richard D. Kelly
March 1, 2021

The decision in GlaxoSmithKline LLC. V Teva Pharms. (976 F.3d 1347 (Fed. Cir. 2020) has caused panic in the generic industry because it has been interpreted as killing the “skinny label” approach to generic drug approval. A “skinny label” allows a generic company where there are multiple approved indications for a drug and some are protected by patent and others are not, to omit the patented indications from its label and avoid the need for a paragraph (iv) certification and 35 U.S.C. 217(e)(2) litigation. During the oral argument on February 23, 2021, on remand to the original panel, it became clear that the skinny label exception is not under attack although you wouldn’t know it from the Federal Circuit’s decision or the press reports.<... Read more

The "Skinny Label" - The Federal Circuit Has Second Thoughts

Attorney: Richard D. Kelly
February 10, 2021

On Tuesday the Federal Circuit vacated its decision in GlaxoSmithKline LLC. V. Teva Parma., USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020) in response to GSK’s request for rehearing en banc. In vacating the decision and deciding to rehear the case, the panel limited the rehearing to Teva’s question in its en banc petition as “whether there was substantial evidence to support the jury’s verdict of induced infringement.”<... Read more

The Purple Book Continuity Act

Attorney: Richard D. Kelly
January 8, 2021

The Congress passed and President on December 22 signed into law the “Further Extension of Continuing Appropriations Act, 2021”; despite its name it was chock full of goodies having nothing to do the nation’s need for a budget to pay its bills. One of the unrelated measures was the “Purple Book Continuity Act of 2019” (aka H.R. 1520). While the official text hasn’t been released yet, the Act’s content can be gleaned from the House report on H.R. 1520. The Act requires the FDA within 180 days to create in electronic format a searchable compendium of all licensed biologic products containing the license number, its date of approval, the marketing or license status. It requires updates every 30 days to include newly licensed products in the preceding 30 days. The FDA is also required to list each exclusivity period for a listed product that is applicable and has not expired.  If a product’s license was withdrawn for safety, purity, or potency reasons the product must be removed from the list with notice published in the Federal Register.<... Read more

GSK v Teva – The Federal Circuit's First Look at Skinny Labels and 35 U.S.C. 271(b)

Attorney: Richard D. Kelly
December 7, 2020

In GSK v Teva the Federal Circuit reversed the district court’s JMOL and reinstated the jury’s verdict awarding $235 million in damages to GSK for Teva’s sale of $75 million dollars of carvedilol the generic equivalent of GSK’s Coreg®, even though the patents on the drug and all but one of its uses had expired.<... Read more