The Limitations of the Patent Australian Laws

The Limitations of the Patent Australian Laws

Plaintiffs Association for Molecular Pathology, et al. (collectively "Plaintiffs") has shifted for abstract judgment pursuant to Rule 56, Fed. R. Civ. P., to affirm invalid fifteen assertions (the "claims-in-suit") comprised in seven patents (the "patents-in-suit") pertaining to the human BRCAI and BRCA2 genes (Breast Cancer Susceptibility Genes 1 and 2) (collectively, "Bract/2") under each of (1) the Patent Act, 35 U.S.C. § 101 (1952), (2) Article I, Section 8, Clause 8 of the United States Constitution, and (3) the First and Fourteenth Amendments of the Constitution because the patent assertions cover goods of environment, regulations of environment and/or natural phenomena, and abstract concepts or rudimentary human information or thought. The defendant United States Patent and Trademark Office ("USPTO") handed out the patents-in-suit which are held by defendants Myriad Genetics and the University of Utah Research Foundation ("UURF") (collectively "Myriad" or the "Myriad Defendants"). Myriad has cross-moved under Rule 56, Fed. R. Civ. P., for abstract judgment brushing aside Plaintiffs' accusation, and the USPTO has cross-moved under Rule 12(c), Fed. R. Civ. P., for judgment on the pleadings. Based upon the outcome and deductions set forward underneath, the shift of Plaintiffs to declare the claims-in-suit invalid is conceded, the cross- shift of Myriad is refuted, and the shift of the USPTO is granted.

As considered infra in larger minutia, the disputed patent assertions are administered to (1) isolated DNA encompassing all or portions of the Bract and BRCA2 gene sequence and (2) procedures for "comparing" or "analyzing"BRCAl and BRCA2 gene sequences to recognize the occurrence of mutations correlating with a predisposition to breast or ovarian cancer. Plaintiffs' dispute to the validity of these assertions, and the contentions offered by the parties and amice, has offered an exclusive and demanding question:

 

Are isolated human genes and the evaluation of their sequences patentable?

Two perplexing localities of research and regulation are involved: molecular biological research and patent law. The task is to request the ruling values in each and to work out the absolutely crucial components of the asserted biological compositions and methods and their connection to the regulations of nature.

The tenacity of the matters offered to this Court profoundly anxieties breast cancerous infection patients, health professionals, investigators, caregivers, advocacy assemblies, living gene patent holders and their investors, and those searching to accelerate public health. The claims-in-suit administered to ~isolated DNA~ encompassing human BRCA1/2 gene sequences contemplate the USPTO's perform of allocating patents on DNA sequences so long as those sequences are asserted in the pattern of "isolated DNA."  This perform is premised on the outlook that DNA should be treated no distinctly from any other chemical aggregate, and that its purification from the body, utilizing well-known methods, renders it patentable by changing it into certain thing distinctly distinct in character. Many, however, encompassing researchers in the areas of molecular biology and genomics, have advised this perform a ”lawyer's trickle that circumvents the prohibitions on the  direct patenting of the DNA in ...