News & Analysis as of September 21, 2024

Patent Litigation

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Patent-Eligible Subject Matter refers to the types of inventions that can be legally patented. The criteria for patentability varies depending on the jurisdiction. In the United States, for instance, if a researcher discovers a naturally occurring substance, the substance itself cannot be patented. This issue was examined in a United States Supreme Court case, AMP v. Myriad, in regard to the patentability of human genes. less -

Federal Circuit Weighs In On Patent Eligibility Of Isolated Vitamin

Foley & Lardner LLP on 2/23/2023

It has been a while since the Federal Circuit weighed in on the patent eligibility of so-called “natural product” claims. While the finding of non-eligibility in ChromaDex, Inc. v. Elysium Health, Inc. is not surprising, it...more

Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)

McDonnell Boehnen Hulbert & Berghoff LLP on 3/20/2020

The latest Federal Circuit decision on subject matter eligibility in the life sciences came down (by a divided court) in favor of eligibility, in Illumina, Inc. v. Ariosa Diagnostics, Inc. The claims at issue fell into the...more

News from Abroad: IP Australia Releases Myriad Examination Guidelines

McDonnell Boehnen Hulbert & Berghoff LLP on 1/14/2016

Following the recent public consultation in view of the Australian High Court's decision in D'Arcy v Myriad Genetics ("Myriad"), IP Australia has released new Examination Guidelines for applications which may be affected by...more

Australian Patent Office Provides Patent Eligibility Guidance

Foley & Lardner LLP on 12/17/2015

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...more

Does a Nucleic Acid Constitute Patent Eligible Subject Matter Under Australian Law?

JD Supra Perspectives on 10/18/2015

Clearly the High Court has given an answer to a question, but was that question the one we anticipated? That in itself is an open question!...more

Australian High Court Rules Gene Patents Unpatentable

BakerHostetler on 10/14/2015

Like the United States Supreme Court, the High Court of Australia has determined that Myriad’s patents directed to purified and isolated DNA molecules encoding the BRCA genes are unpatentable. Indeed, the Australian Court...more

News from Abroad: Australian High Court Has Ruled in Myriad Gene Patent Case

McDonnell Boehnen Hulbert & Berghoff LLP on 10/9/2015

The Australian High Court yesterday unanimously overturned six lower court judges and dismissed some very careful reasoning to not only follow the U.S. Supreme Court in invalidating claims to the BRCA1 and 2 gene sequences,...more

News from Abroad: High Court Rules Myriad's BRCA Genes Not Patentable Subject Matter in Australia

McDonnell Boehnen Hulbert & Berghoff LLP on 10/9/2015

Just over one year after the Full Federal Court of Australia unanimously upheld an earlier Federal Court decision that naturally occurring nucleic acid molecules are patentable in Australia, the High Court of Australia has...more

Australia High Court Rules Against Gene Patents

Foley & Lardner LLP on 10/9/2015

Colleagues in Australia have been spreading the bad news: The High Court of Australia followed the lead (?) of the U.S. Supreme Court and determined that Myriad cannot patent the isolated BRCA1 gene in Australia. Thanks to...more

News from Abroad: Isolated Nucleic Acids Not Patentable in Australia

McDonnell Boehnen Hulbert & Berghoff LLP on 10/8/2015

D'Arcy v. Myriad Genetics Inc & Anor [2015] HCA 35 - The High Court of Australia today handed down its decision in D'Arcy v Myriad, deciding once and for all that isolated nucleic acids do not define patent-eligible...more

News from Abroad: Isolated Gene Sequences Suffer A Cruel Fate in the Hands of the High Court of Australia

McDonnell Boehnen Hulbert & Berghoff LLP on 10/8/2015

D'Arcy v Myriad Genetics Inc [2015] HCA 35 - The High Court of Australia has today handed down its decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35, unanimously striking down the validity of the first three claims...more

Strong Support for Sequenom’s Petition for Rehearing En Banc

Patterson Belknap Webb & Tyler LLP on 9/10/2015

In Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.’s prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo...more

Protecting Diagnostic Innovation – Two Actor Infringement Liability

Foley & Lardner LLP on 8/25/2015

In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur...more

Sequenom Seeks Rehearing En Banc

Foley & Lardner LLP on 8/18/2015

Sequenom, Inc. has filed a petition for rehearing en banc of the Federal Circuit decision that held its diagnostic method claims invalid under 35 USC § 101. (You can read my synopsis of that decision here). Stakeholders in...more

Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

Foley & Lardner LLP on 6/15/2015

On Friday, June 12, 2015, the Federal Circuit 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...more

Game Over for Myriad - (Or, and then there was one)

McDonnell Boehnen Hulbert & Berghoff LLP on 2/11/2015

As discussed at the end of January, Myriad has given up its Quixotic quest to validate its BRCA gene testing franchise and has abandoned its several lawsuits (many of which were consolidated before the District of Utah under...more

Validity of Sequenom Patent Still to Be Decided

Foley & Lardner LLP on 1/28/2015

Although Sequenom has settled its dispute over U.S. Patent 6,258,540 with some parties, its case against Ariosa Diagnostics, Inc. remains active. Thus, we all should be waiting with bated breath to see whether the Federal...more

Can Any DNA Claims Still Be Patented?

Foley & Lardner LLP on 1/22/2015

In a decision issued December 17, 2014, in In Re BRCA1- And BRCA2-Based Hereditary Cancer Test Patent Litigation (Myriad II), the Federal Circuit invalidated Myriad’s primer claims and detection method claims under 35 USC §...more

Myriad Set for Another Round

Foley & Lardner LLP on 9/30/2014

On Monday October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test...more

News from Abroad: Myriad Patent Upheld by Full Federal Court of Australia

McDonnell Boehnen Hulbert & Berghoff LLP on 9/8/2014

The Full Federal Court of Australia has handed down its long awaited decision in D'Arcy v Myriad Genetics Inc today, affirming that isolated DNA and RNA are patentable subject matter under Australian law....more

Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations

McDonnell Boehnen Hulbert & Berghoff LLP on 8/12/2014

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

The USPTO Patent Subject Matter Eligibility Guidance TRIPS Over Treaty Requirements

Foley & Lardner LLP on 7/30/2014

The “Myriad-Mayo” patent subject matter eligibility guidance issued March 4, 2014 reflects the USPTO’s interpretation of Supreme Court cases interpreting and applying 35 USC § 101 to claims involving laws of nature, natural...more

Docs @ BIO: The Rest of the Story - Bloomberg BNA Hosts Panel on Subject Matter Eligibility

McDonnell Boehnen Hulbert & Berghoff LLP on 7/9/2014

Last month at the BIO convention, Randy Kubetin, Managing Editor of Bloomberg BNA's Life Sciences Law & Industry Report moderated a panel entitled "Patent Eligibility from the Trenches: Practical Implications of the Supreme...more

Federal Circuit Dismisses WARF Stem Cell Case – A Missed Opportunity

Foley & Lardner LLP on 6/16/2014

Recently in Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 2013-1377 (Fed. Cir. 2014), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) dismissed Appellant Consumer Watchdog’s appeal on the...more

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