Tag Archives: obviousness

In my view, Obviousness is the most fundamental of patent law doctrines, and certainly much of the work of patent attorneys is to convince patent examiners that the claims are not obvious.

Double Patenting and Patent Term Adjustment

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by Dennis Crouch

The Federal Circuit recently issued an important decision in In re: Cellect, LLC (Fed. Cir. Aug. 28, 2023) regarding how Patent Term Adjustment (PTA) interacts with terminal disclaimers and obviousness-type double patenting (ODP). This case establishes binding precedent that a terminal disclaimer cuts off any extended patent term granted through PTA.

This holding contrasts with the court's prior rulings regarding Patent Term Extension (PTE), where the extended term is calculated from the disclaimed expiration date, not the original expiration date. Thus, PTE extends beyond a disclaimed term, while PTA does not.

This result was expected by many patent experts, although some in the pharmaceutical industry had pushed for PTA to extend beyond disclaimed terms similarly to PTE. In the end, the statutory language expressly addressing disclaimers in the context of PTA proved decisive. This precedent will apply to all patents already in-force as well as those issued in the future.  Thus, applicants will want to carefully consider PTA and terminal disclaimer strategy for patent families.

If I were the judge, I would

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9th Circuit Revives False Claims Act Action for Fraud on the Patent Office

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by Dennis Crouch

The U.S. Court of Appeals for the Ninth Circuit recently issued a pair of decisions in the qui tam case Silbersher v. Valeant Pharmaceuticals concerning the False Claims Act's (FCA) public disclosure bar.  The case sets significant precedent in linking FCA claims to patent prosecution and fraud upon the patent office.  The case can be contrasted with Silbersher v. Allergan, Inc., 21-15420, — F.4th — (9th Cir. Aug. 25, 2022) [21-15420], that Silbersher lost.

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“Bald Girls Do Lunch” Unable to Sway the Federal Circuit in Case Involving Deuterated Drug for Alopecia Areata

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By Chris Holman

Sun Pharmaceutical v. Incyte, 2023 WL 5370639, Not Reported in Fed. Rptr. (Fed. Cir. Aug. 22, 2023)

Bald Girls Do Lunch (“BDGL”) is a nonprofit organization dedicated to improving the quality of life for females living with alopecia areata (“AA”).  AA has been described as “an autoimmune skin disease resulting in partial to complete hair loss on all hair-bearing areas of the body, including, for example, on the face, resulting in loss of eyebrows and eyelashes.” According to BDGL, “AA is not a simple cosmetic problem—it is a chronic, often devastating condition that has substantial and wideranging implications, affecting patient’s physical, mental, and emotional health.  Indeed, in severe cases, AA can lead to chronic depression.”

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PTAB Captains Take Notice: Carefully Weigh Secondary Considerations

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By Dennis Crouch

The nexus requirement serves as a threshold that must be met before secondary indicia will be even considered as relevant to the obviousness inquiry.  In its recent Volva Penta decision, the Federal Circuit found that the PTAB had  (1) created too high of a burden to prove nexus and (2) been unduly dismissive of the patentee's evidence of commercial success and copying.  The case reinforces the notion that patentees should attempt to include some claims that are largely coexistive with its product line, especially in today's world of likely copying. The case also serves as a reminder that product copying still caries significant weight in the obviousness analysis. Volvo Penta of the Americas, LLC v. Brunswick Corp., 22-1765, --- F.4th --- (Fed. Cir. August 24, 2022).

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Size Matters: Element-by-Element Analysis in Obviousness

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by Dennis Crouch

In re Universal Electronics, Inc., No. 2022-1716 (Fed. Cir. Aug. 15, 2023) (non-precedential)

This was a consolidated appeal from two Patent Trial and Appeal Board (PTAB) decisions affirming the rejection of claims from Universal Electronics, Inc.'s (UEI) U.S. Patent Application Nos. 12/645,037 and 16/279,095 as obvious under 35 U.S.C. § 103.  On appeal, the Federal Circuit has affirmed.

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Three issues: Law/Fact Distinction in Obviousness; Envisaging the Invention; and Newman in Dissent

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by Dennis Crouch

Incept LLC v. Palette Life Sciences, Inc., No. 21-2063 (Fed. Cir. Aug. 16, 2023) (Majority by Judges Schall and Taranto; Dissent-in-part by Judge Newman)

The most interesting line in the case for appellate attorneys (and legal scholars) is probably the court's law/fact distinction in the context of obviousness analysis.  The majority wrote: "We see no reversible error ... whether viewed as a factual one about the level of [commercial] success or a legal one about the weight of any such success in the overall obviousness analysis."  The law/fact divide is important because of the evidentiary requirements in the first instance and the standard for review on appeal. Here, the court makes clear that the weight given to any objective indicia of non-obviousness is a question of law rather than a question of fact.  The result then is that its analysis can generally be based upon reason rather than evidence, and that issue is one that will be heard de novo on appeal.

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ApoA1-Fc Fusion Proteins: Federal Circuit keeps Patent Hopes Alive, Holding that the USPTO Must Explain its Decisions

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In re Theripion, Inc., 2022-1346 (Fed. Cir. Aug. 10, 2023) (nonprecedential) (Opinion by Judge Stark, joined by Judges Hughes and Cunningham).

ApoA1 is a key component of HDL, also known as "good cholesterol." The founders of Therapin created a synthetic "fusion protean" of ApoA1 linked to the Fc portion of an antibody (the stem).  That fusion extends the half-life of injected HDL and allows it to be a better potential drug treatment. The claims require a specific linker protein of 10-40 amino acids between the ApoA1 and Fc portions. Theripion discovered that this longer linker improved cholesterol efflux activity compared to fusion proteins having shorter 2 amino acid linkers or no linker.  So the essence of the invention as claimed is an ApoA1-Fc fusion protein with an optimized 10-40 amino acid linker that enhances the fusion protein's ability to remove cholesterol from cells as compared to a much shorter or absent amino acid linker.  To be clear, the prior art (including some work by the inventors here) had created ApoA1-Fc fusions, but with a short linkage. And, various types of connectors of the claimed length were also known.

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