Attorney:
Richard D. Kelly
June 22, 2022
On June 21, 2022, the Federal Circuit acting on a request for panel rehearing in the decision by the Federal Circuit in Novartis v. Accord Health Care, Inc., 21 F.4th 1362 (Fed. Cir. 2022), affirming the district court’s decision of infringement and validity of the Novartis patent on Gilenya, U.S.P. 9,187,405, granted the request and proceeded to reverse the original decision and hold the asserted claim invalid for failing to comply with the written description of 35 U.S.C. § 112(a).<... Read more
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 Mitsubishi. Magna 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
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
Attorney:
Derek Lightner, Ph.D.
January 31, 2022
The Patent Trial and Appeal Board (PTAB) overturned the examiner’s obviousness finding in Ex parte PETER KAPITAN and ALEXANDER SAJTOS (Appeal 2021-001272; USSN 14/409,522) substantially on the basis of a recitation of “… the solvent … is an alkane selected from a group consisting of pentane and hexane” distinguishing over the prior art description of the optional use of petroleum ether, with evidence that petroleum ether is not simply pentane or hexane.<... Read more
January 25, 2022
Conclusion
Okay, let’s get this out of the way up front. The answer is maybe… but only with a lot more work and with substantially reduced claim scope.<... Read more
Attorney:
Grace Kim
October 15, 2021
Patents are undoubtedly essential to many industries, and in recent years, the decisions regarding patent eligibility, written description, and enablement have certainly shaken up the life sciences industry in particular. There is an increasing burden on patent applicants and patentees to provide complex, lengthy, thoroughly written disclosures to satisfy the rising standards for written description and enablement, as well as the added pressure to draft multiple claims of varying scope.<... Read more
Attorney:
J. Derek Mason, Ph.D., CLP
September 22, 2021
In a purported effort to lower drug prices, the Department of Health and Human Services (HHS) recently released a proposed plan calling for the US Food and Drug Administration (FDA) to work with the US Patent and Trademark Office (USPTO), suggesting that such collaboration would “facilitate greater awareness of their complementary work and introduce efficiency into their respective workstreams.” This is only one part of the proposed plan, the other parts of which are not the focus of this post.<... Read more
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
Attorney:
Derek Lightner, Ph.D.
April 26, 2021
In a Patent Trial and Appeal Board (PTAB) decision issued on April 16, 2021, in Ex parte Bhalla, Luthra, Reid I, and Levason (Appeal 2021-001535, USSN 14/373,413), the PTAB was presented with the issue of the obviousness of an imaging agent comprising an 18F-labelled compound of a formula below, with the relevant moieties indicated. The main claim covered a moderate genus of compounds[1], and was rejected over a combination of three references.<... Read more
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