New Legislation Supports Biosimilar Drugs, Clarifies Qualifications for Obtaining FDA Exclusivity

Attorney: Elissa Sanford
May 20, 2021

Recent litigation, including the Federal Circuit decision in Amgen v. Sanofi, has created concern among biologics manufacturers with regard to whether their existing intellectual property will remain protected, and whether they will be able to secure patents for future drugs. The uncertainty surrounding the patentability of biologics has led the industry to search for potential alternatives to patent protection. One such alternative could lead to pharmaceutical companies leaning on the exclusivity granted by the U.S. Food and Drug Administration ("FDA") as a way to avoid the patent route entirely. Where patents are a property right granted by the United States any time during the development of a drug, FDA exclusivity attaches upon approval of the drug and grants certain delays and prohibitions on the approval of competitor drugs. Biologics are covered by a considerably longer exclusivity period than other drug types, usually with 12 years total of market protection, as delineated by the Biologics Price Competition and Innovation Act ("BPCIA").... Read more

Reliance on a Single Non-Enabling Reference to Establish Obviousness

Attorney: Marina I. Miller, Ph.D.
May 10, 2021

Raytheon appealed a final inter partes review decision of the Patent Trial and Appeal Board (Board) finding claims 3 and 16 of US 9,695,751 unpatentable as being obvious in view of the Knip reference. The Board found that Knip discloses the claimed power density limitation for a geared gas turbine engine. During the proceeding, Raytheon submitted evidence establishing that Knip’s disclosure of highly aggressive performance parameters for a futuristic turbine engine was based on the use of nonexistent composite materials. In response, the petitioner, General Electric Company (GE), never provided any evidence suggesting a skilled artisan could have made a turbine engine with the claimed power density. “Because the relied-upon prior art fails to enable a skilled artisan to make and use the claimed invention,” the Federal Circuit (the Court) reversed.<... 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

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

Claims Directed to Computerized Statistical Methods for Determining Haplotype Phase Are Patent Ineligible

Attorney: Marina I. Miller, Ph.D.
April 6, 2021

The Board of Trustees of the Leland Stanford Junior University (“Stanford”) appeals the final rejection of patent claims in its patent Application No. 13/486,982. The patent examiner rejected the claims as involving patent ineligible subject matter. The PTAB affirmed the examiner’s rejection. On appeal, the Federal Circuit affirmed the decision of the PTAB that the rejected claims were drawn to abstract mathematical calculations and statistical modeling, and similar subject matter that is not patent eligible.<... Read more

Invalidation of Chemical Compound Claims

Attorney: Marina I. Miller, Ph.D.
March 8, 2021

Torrent Pharmaceuticals and Indoco Remedies Ltd. (Defendant-Appellant) appealed from the district court’s final judgment on Takeda’s (Plaintiffs-Appellees) invalidity challenges to claims 4 and 12 of U.S. Patent No. 7,807,689, owned by Takeda. In a non-precedential opinion, the Federal Circuit (“the Court”) affirmed the district court’s final judgment that Torrent and Indoco had failed to prove that the claims asserted by Takeda were invalid for statutory obviousness or non-statutory obviousness-type double patenting.<... Read more