The PTAB Weighs in on Obviousness-Type Double Patenting and PTA

Attorney: Richard D. Kelly
May 16, 2022

Congress sought to keep Patent Office delays from prejudicing a patentee by granting PTA to compensate for the Patent Office delays. While one might expect the Patent Office to work mightily to avoid administrative delays in prosecution, today the average time to first action is about 17 months, three months longer than the target of 14 months adding on average 3 months to the patent term. Other delays during prosecution add still more time to the PTA period.  Since these are averages, the additional time can be significant. In pharmaceuticals the PTA added for delays of even a few months can mean hundreds of millions of dollars in revenue.  The two district courts have addressed this issue where an ODP defense is raised against the later expiring patent because of PTA and came to different conclusions. See Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc., 533 F. Supp. 3d 170 (D.N.J. 2021) (the judicially created ODP does not trump the statutory PTA) and MitsubishiMagna Elecs., Inc. v. TRW Automotive Holdings Corp., No. 12-cv-654, 2015 WL 11430786 (W.D. Mich. Dec. 10, 2015) (ODP trumps PTA).<... Read more

XML Format Effective July 1, 2022 For PCT Sequence Listings

Attorney: Richard D. Kelly
May 16, 2022

WIPO has announced that as of July 1, 2022, all sequence listings must be submitted in XML format. Information on the standard and a tool for complying is found at https://www.wipo.int/standards/en/sequence/.<... Read more

Written Description and Creating Ranges from Examples

Attorney: Richard D. Kelly
April 7, 2022

At the close of last year, the Federal Circuit affirmed a decision by the PTAB in IPR2019-00329 that a claimed range created from examples was not patentable because it lacked written description in the application as filed. In its decision the PTAB “second guessed” an examiner’s ex Parte decision that the claimed range had written description in the application as filed.  Written description was at issue because the patent challenged, U.S. Patent 9,687,454 (‘454), filed January 6, 2016, needed benefit of its parent application serial number 12/537,571 published on February 10, 2011, as 2011/0033541 (‘541), to avoid ‘541 from being prior art otherwise, most of the ‘454 claims were anticipated by ‘541. The ‘454 claim 1 is directed to a mucoadhesive film comprising about 40 wt.% to about 60 wt.% of a water-soluble polymeric matrix and claim 7 to a range of from about 48.2 wt.% to about 58.6 wt.%. Neither range was found in the ‘454 patent as filed; the claims were added during prosecution. The ‘454 describes the film as “may contain any desired level of self-supporting film forming polymer”; in “one embodiment, the film forming composition” may be at least 25 weight per cent of the composition; alternatively, at least 50 weight per cent of the composition. No upper limit was described.<... Read more

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