Gene Patent Debate Returns to the Federal Circuit

by Dennis Crouch

Association for Molecular Pathology v. USPTO and Myriad Genetics (Fed. Cir. 2012)

The Supreme Court recently issued a GVR order in this case with instructions for the court to reconsider its decision in light of Mayo v. Prometheus.  The Federal Circuit has now released a new briefing schedule — asking the parties to file supplemental briefs by June 15, 2012 addressing the issue: What is the applicability of the Supreme Court’s decision in Mayo to Myriad’s isolated DNA claims and to method claim 20 of the ’282 patent? Non-parties may file briefs of  up to 15–pages in length that are due on the same date.  Oral arguments will be held July 20, 2012.

Claim 1 of Myriad’s patent is directed to “an isolated DNA coding for a BRCA1 polypeptide” with a particular amino acid sequence.  DNA coding for BRCA1 is a naturally occurring mutation and is clearly unpatentable. The catch here is that Myriad claims “isolated DNA” that the patent defines as “substantially separated from other cellular components which naturally accompany a native human sequence.”

Claim 20 of the patent is directed to the scientific method of finding a cancer treatment that involves (1) growing a host cell that has been genetically modified to include a BRCA1 gene and then (2) testing to see whether any compound particularly inhibits the growth of those cells.  A key question for this claim is whether its breadth effectively extends to cover an abstract idea — namely, using the scientific method to discover a treatment for BRCA1 cancer. 

15 thoughts on “Gene Patent Debate Returns to the Federal Circuit

  1. “I Am Not An Expert”

    LOLZ

    There’s more truth to that than the actual moniker acronym:

    “I Am Not An Examiner”

    btw, Arthur, IANAE is neither an examiner nor an expert. He is a shilling academic who often posts pretending to be a patent agent (or a patent attorney) whose stance is often confused with ceertain anti-patent examiners. When he shows up and spreads his usual misinformation, you have to scoot him back to his ivory tower.

  2. According to the Urban Dictionary:

    What is it about agents and their fondness for dictionaries lately?

    I Am Not An Examiner.

    Urban Dictionary, of all things. Good thing I didn’t post as “Rick Santorum”.

  3. @INANAE
    I am a little confused.
    According to the Urban Dictionary:
    Internet “Acronym: I Am Not An Expert Used in conversation when it is necessary to point out that this is not your field of expertise.”
    Are you saying I am not an expert in law, patent law and/or ethics, or are you saying you are not an expert?
    Respectfully Submitted,
    Arthur Gershman, RN 27,035

  4. sup bro: from what I understand of FDA regulations for drug approvals, it’s basically a requirement.

    Are you suggesting that FDA drug approval for an anti cancer drug requires that one do the following:

    1) identify a gene linked to the cancer;
    2) genetically modify a host cell to express the gene
    3) test the modified host cell’s growth in the presence of various drugs

    Show me the rule which says that anti-cancer drug approval requires these steps.

  5. As Justice Warren said “law floats in a sea of ethics.”

    Did he happen to mention whether law only manages to stay afloat by dumping the ethics over the side as quickly as they leak in?

  6. I believe Dennis is raising a good point about claim 20. It is more closely related to the subject matter of Mayo than other claims of Myriad. However, what about claim 1 and its ilK? I submit that these patents are just plain immoral and ethically indefensible. As Justice Warren said “law floats in a sea of ethics.”

  7. Perhaps not, but from what I understand of FDA regulations for drug approvals, it’s basically a requirement. So just how does a claim that puts a strangehold on the development of new cures by seeking patent protection on such an elementary (and often unfruitful) step of the drug discovery process not have problems of breadth with respect to covering abstract ideas?

  8. How did that get through the filter, and why hasn’t it been modded out?

  9. Claim 20 of the patent is directed to the scientific method of finding a cancer treatment that involves (1) growing a host cell that has been genetically modified to include a BRCA1 gene and then (2) testing to see whether any compound particularly inhibits the growth of those cells. A key question for this claim is whether its breadth effectively extends to cover an abstract idea — namely, using the scientific method to discover a treatment for BRCA1 cancer.

    Okay, if that’s the “key question” then the “key answer” is obviously “no” because there are (ahem) myriad different wasys of “using the scientific method” to “discover a treatment for BRCA1 cancer” that do not involve “growing a host cell that has been genetically modified to include a BRCA1 gene.” An extremely big clue to the lack of “pre-emption” of the “use of the scientific method to discover a treatment for BRCA1 cancer”, if you will, is that the claimed method does not recite the phrase “using the scientific method to discover a treatment for BRCA1 cancer.”

    While it is certainly useful to grow an engineered cell with the BRCA1 mutation and test the cells growth in the presence of various compounds, it’s not necessary to do so in order to find a treatment. To verify the accuracy of this statement, need only understand that people were using the scientific method to test disease cures long before the discovery of genetic engineering.

  10. DNA coding for BRCA1 is a naturally occurring mutation and is clearly unpatentable

    LOL. I believe this is one of issues to be decided by the courts, Dennis.

    A more accurate statement would be: “A claim that reads on any human gene comprising the BRCA1 mutation is clearly unpatentable because such a claim would literally encompass genes which indisputably existed in human chromosomes prior to the discovery of the mutation. In addition, claims that read on the human body and its parts are considered ineligible for patenting by the USPTO and the courts.”

  11. “DNA coding for BRCA1 is a naturally occurring mutation and is clearly unpatentable.”

    Huh? Please clarify with scientifically-informed, precise language.

    And while you’re at it, would you kindly stop using the ill-informed lingo of “gene patents” in favor of something more accurate like “patents claiming isolated nucleic acids.”

    Sorry to be a stickler, but it IS important to get it right, instead of spreading MORE uninformed drivel.

    Thanks.

  12. Maybe the FedCir will give Mayo an interpretation closer to that of the government’s brief in Mayo.

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