Tag Archives: Patent Eligibility

USPTO Patent Eligibility Guidance In View Of CellzDirect And Sequenom

On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the Federal Circuit decision in CellzDirect, and notes that the Supreme decision denying certiorari in Sequenom “does not elevate” the significance of the panel decision … Continue reading this entry

Supreme Court Deals Blow To Diagnostic Method Patents, Denies Cert In Sequenom

“If you can’t say something nice, don’t say anything at all” can be good words to live by, but in the context of the Supreme Court’s denial of certiorari in Sequenom (scroll down to page 3), the silence is deafening–and could have a chilling impact on innovation in the fields of diagnostic and personalized medicine. Without knowing … Continue reading this entry

USPTO 101 Guidance: Microneedles Versus Prosthetic Devices

When I first wrote about the new natural products Subject Matter Eligibility Examples issued by the USPTO on May 4, 2016, I noted a puzzling difference between the treatment of a claim reciting a vaccine coated on a microneedle device versus a claim reciting a vaccine formulated in a cream carrier. Suzannah Sundby at Canady … Continue reading this entry

New USPTO Guidance On Patent Eligibility Of Natural Products

The new USPTO patent eligibility examples include two examples for “natural products” based inventions which appear to be consistent with the examples provided in the December 2014 set of patent eligibility examples. Although the new examples include additional discussion and guidance that could be helpful in some cases, they largely remain perplexing. Unfortunately, although the new diagnostic methods … Continue reading this entry

District Court Applies Mayo To Treatment Claims But Denies Motion To Dismiss BMS Keytruda Litigation

The U.S. District Court for the District of Delaware accepted Merck’s arguments that method of treatment patents asserted by BMS against its Keytruda product “touch[] upon a natural phenomenon” such that they should be analyzed under the Mayo/Alice patent eligibility framework. However, in view of disputed issues of fact, the presumption of validity, and other presumptions arising from … Continue reading this entry

Having A Bad Hair Day? The Federal Circuit Agrees That Method Of Cutting Hair Is Invalid Under 101

While I do not usually write about non-precedential decisions, In re: Brown caught my eye as an interesting patent eligibility case. It does not relate to diagnostics or computer programs, but rather to the art of cutting hair.… Continue reading this entry

Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35 USC § 101. Although Judge Dyk found the claims at issue to be similar to claims held invalid in other Federal Circuit … Continue reading this entry

District Court Invalidates Cleveland Clinic Diagnostic Patents On Motion To Dismiss

Judge Gaughan of the U.S. District Court for the Northern District of Ohio granted the defendant’s motion to dismiss after finding three Cleveland Clinic Foundation diagnostic patents invalid under 35 USC § 101. While the result is not surprising in view of recent patent eligibility decisions, it serves as reminder of the real-world impact of recent Supreme … Continue reading this entry

Australian Patent Office Provides Patent Eligibility Guidance

The Australian Patent Office (IP Australia) has issued final patent eligibility guidance under the Australian High Court’s decision in D’Arcy v. Myriad Genetics, Inc. Where the USPTO extrapolated from the U.S. Supreme Court decision when it promulgated its patent eligibility guidance, IP Australia seems to have taken a more conservative approach. This means that despite similar rulings against … Continue reading this entry

Judge Lourie Suggests Jepson Claims For Patent Eligibility

As reported previously, the Federal Circuit has denied rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc. I wrote about Judge ‘Dyk’s opinion concurring in the denial but offering alternative views on patent eligibility in this article. Here, I look at the other concurring opinion, which was authored by Judge Lourie and joined by Judge Moore. … Continue reading this entry

Judge Dyk Would Add Reduction To Practice To Patent Eligibility Requirement

As noted in this article, the Federal Circuit has denied rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc.. The per curiam order was accompanied by two separate concurring opinions, one authored by Judge Lourie (joined by Judge Moore) and one authored by Judge Dyk, and one dissenting opinion authored by Judge Newman. Here, I look at Judge Dyk’s concurrence. … Continue reading this entry

Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

The Federal Circuit has issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court’s finding that Sequenom’s claims are invalid under 35 USC § 101. The court’s decision shows the sweeping impact of the Supreme Court’s decision in Mayo v. Prometheus on the patent eligibility of diagnostic methods, and could have a ripple effect … Continue reading this entry

Another Sequenom Patent Appeal Heads To The Federal Circuit

While Sequenom’s appeal of the district court’s summary judgment of invalidity of U.S. Patent 6,258,540 under 35 USC § 101 has been pending at the Federal Circuit, the USPTO has been considering the validity of the patent under 35 USC §§ 102 and 103 in an Inter Partes Review proceeding. Now that the decision of the Patent … Continue reading this entry

Waiting On Sequenom

As I write this there’s a voice in my head saying, “Be careful what you wish for!” but it has been five months since Sequenom was argued at the Federal Circuit, and the court has yet to issue its decision. (You can read my summary of the oral arguments here.) In the meantime, neither the … Continue reading this entry

Validity Of Sequenom Patent Still To Be Decided

Although Sequenom has settled its dispute over U.S. Patent 6,258,540 with some parties (as I noted here), its case against Ariosa Diagnostics, Inc. remains active. Thus, we all should be waiting with bated breath to see whether the Federal Circuit determines that the claims of the Sequenom patent satisfy 35 USC § 101.… Continue reading this entry

Federal Circuit Invalidates Myriad Primer And Method Claims As Lacking Subject Matter Eligibility

In a case styled as In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (also known as Myriad v. Ambry), the Federal Circuit held four of Myriad’s “primer” claims and two of Myriad’s detection method claims invalid for lack of subject matter eligibility under 35 USC § 101. The timing of this decision–coming two days after … Continue reading this entry

Sequenom Deal May Avoid Federal Circuit Decision

Less than a month after their case was argued at the Federal Circuit, Illumina Inc. and Sequenom Inc. have announced a deal to settle their patent infringement litigation. While I haven’t seen an order dismissing the case, that is a likely next step. … Continue reading this entry

Third Time Is The Charm For WildTangent Challenge Of Patent Eligibility Of Ultramercial Patent

In its third opinion reviewing the same district court decision, the Federal Circuit this time affirmed the district court’s grant of WildTangent’s motion to dismiss Ultramercial’s patent infringement complaint because the claims at issue fail to satisfy 35 USC § 101. The Federal Circuit applied the analytical framework set forth in the Supreme Court decision in Alice … Continue reading this entry

Federal Circuit Looks For Inventive Concept In Sequenom Patent

On November 7, 2014, the Federal Circuit heard oral arguments in Aria Diagnostics, Inc. v. Sequenom, Inc., where Sequenom is appealing the district court’s summary judgment of invalidity under 35 USC § 101. The active questioning by the judges suggests that they are wrestling with how to apply the Supreme Court’s decision in Mayo to different … Continue reading this entry

A Peek At The 60 Minutes GenePeeks Patents

Thanks to Kyle Canavera, an associate in the Electronics practice of Foley & Lardner LLP, for providing insight for this article. On October 26, 2014, 60 Minutes aired a story called “Breeding Out Disease” that included a segment about GenePeeks, a company that uses genetic information from prospective parents to make thousands of “digital babies” and “calculate … Continue reading this entry

Federal Circuit Hears Arguments In Other Myriad Gene Patents Case

On October 6, 2014, the Federal Circuit heard oral arguments in a case involving the claims of the Myriad gene patents that were not invalidated by the Supreme Court’s 2013 decision. The Federal Circuit is reviewing the district court’s denial of Myriad’s motion for a preliminary injunction against Ambry Genetics Corp., based on the finding that Ambry … Continue reading this entry

Australia Upholds Patent Eligibility Of Isolated DNA

Thanks to Adam Denley, Ph.D., Senior Associate at Freehills Patent Attorneys in Australia, for alerting me to the September 5, 2014 decision of the Full Federal Court of Australia upholding the patent eligibility of isolated nucleic acids, and for letting me share his initial summary here.… Continue reading this entry

Comments On Patent Subject Matter Eligibility Guidance Due By July 31

This week brings the July 31, 2014 deadline for submitting written comments on two USPTO patent subject matter eligibility guidance documents: The “Myriad-Mayo” Guidance issued March 4, 2014 (for claims involving laws of nature, natural phenomena, and natural products) and the “Alice Corp. v. CLS Bank” Guidance issued June 24, 2014 (for claims involving abstract … Continue reading this entry

Putting Structure And Function Into Context For USPTO Patent Subject Matter Eligibility Guidance

The USPTO’s “Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, and Natural Products” has been criticized for requiring a product to be markedly different in structure from a product of nature in order to be eligible for patenting, even though the Supreme Court has considered both structure and function when evaluating the … Continue reading this entry