Is There Any Hope For Antibody Patents in the United States?

Attorney: Vincent K. Shier, Ph.D.
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

Increased Burden in Drafting "Surviving" and "Useful" Utility Patents in the Life Sciences Industry Extends to Design Patents

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

THE RECENT HHS' PLAN FOR GREATER FDA – USPTO COLLABORATION TO LOWER DRUG PRICES: WHY PHARMA PATENT COUNSEL NEEDS TO REVIEW FDA SUBMISSIONS

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

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

PTAB Restates That Not All Combinations of Molecular Modifications are Obvious

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

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

NHK-Fintiv Rule - APA Violation?

Attorney: Grace Kim
April 21, 2021

I recently wrote an article (NHK-Fintiv Rule Challenges Look Futile at Federal Circuit) about a Federal Circuit decision that dismissed Mylan’s appeal of a PTAB decision that denied institution of an IPR. The Federal Circuit concluded that although judicial review is available by petition for mandamus and the Federal Circuit may consider Mylan’s request for mandamus, “there is no reviewability of the Director’s exercise of his discretion to deny institution except for colorable constitutional claims.” Mylan Laboratories Ltd. v. Janssen Pharmaceutica. N.V., No. 2021-1071, slip op. at 12 (Fed. Cir. March 12, 2021) (precedential).<... Read more

Indefiniteness: Bad Translation/Lack of Definition Redux

Attorney: Daniel J. Pereira, Ph.D.
April 15, 2021

            I previously wrote about a Federal Circuit Opinion that affirmed a lower court ruling that the term “half-liquid” was indefinite despite the apparent mis-translation of the original Italian term “semiliquido” https://www.lifesciencesipblog.com/indefiniteness-bad-translation-lack-of-definition-or-both. On March 1, 2021, the losing party (IBSA Institut Biochimique, S.A., Altergon, S.A., IBSA Pharma Inc.) filed a petition for writ of certiorari in the U.S. Supreme Court and so I thought it would be interesting to take another look at this case. Indeed, the petitioner presented a novel question for review of the lower courts’ decision of indefiniteness of the term at issue. The question presented in the petition is:<... Read more

NHK-Fintiv Rule Challenges Look Futile at Federal Circuit

Attorney: Grace Kim
April 6, 2021

The NHK-Fintiv rule allows the Patent Trial and Appeal Board (PTAB) to deny institution of an inter partes review petition based on the progress of a parallel U.S. district court proceeding of the same patent. The rule was established under former USPTO director Andrei Iancu in 2018, in NHK Spring v. Intri-Plex., No. IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) (precedential). As a result of the restrictions opposed by the NHK-Fintiv Rule, many petitioners have been facing increasing challenges in seeking review at the PTAB for patents where there is a parallel district court proceeding.<... Read more

Two-Step Eligibility for Genomic Analysis Systems

Attorney: Daniel J. Pereira, Ph.D.
February 4, 2021

For practitioners at the USPTO, the reversal of a 101 rejection in Ex parte Patil (PTAB January 7, 2021), APJs Grimes, Scneider and Valek, in Appeal 2020-002775 should be interesting if not provide some light on the dance floor for doing the two-step with the USPTO.

The invention focused on assessing genetic variability with a system including databases and processors and as recited in Claim 27 U.S. 15/169,498:<... Read more