A CASE STUDY ON

Association for Molecular Pathology vs. Myriad Genetics, Inc.

By,Lavanya SureshJunior Associate - Patents & DesignsAltacit Global

OVER VIEW

Mere act of identifying a particular DNA gene sequence is not sufficient to form the basis of granting the person who identified it a comprehensive and exclusive patent regarding said sequence.

U.S.C. 101 Inventions patentable

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

CASE BACKGROUNDMyriad’s scientists made an extraordinarily useful discovery in 1994 — two genes now known as BRCA1 and BRCA2. The company filed for patents related to the discovery and associated assets.Certain patents were granted, and Myriad claimed exclusivity over various tests and other items related to the genes in question.

BRCA1 & BRCA2 BRCA1 and BRCA2 are normally expressed in the cells of breast and other tissue, where they help repair damaged DNA, or destroy cells if DNA cannot be repaired.

If BRCA1 or BRCA2 itself is damaged by a BRCA mutation, damaged DNA is not repaired properly, and this increases the risk for breast cancer.

Myraid’s PatentProduct claims directed to isolated DNA, cDNA, and fragments of BRCA1 & BRCA2

Product Claim: An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

Method claim directed to “analyzing” and “comparing” the isolated genes with those of a patient.

Process Claim: Drawn to a method for screening a tumor sample, which comprises comparing a first BRCA1 sequence from a tumor sample with a second BRCA1 sequence from a nontumor sample, wherein the difference in sequence indicates an alteration in the BRCA1 gene in the tumor sample.

Cont..

Process Claim: Drawn to a method for screening potential cancer therapeutics which comprises

1. Growing host cells transformed with an altered BRCA1 gene in the presence or absence of a potential cancer therapeutic;

2. Determining the growth rate of the host cells with or without the potential therapeutic; and

3. Comparing the growth rate of the host cells.

Cont..

LAWSUIT & THWARTSA coalition of petitioners filed suit seeking to have Myriad’s patents invalidated so that research, tests and treatments related to the BRCA1 and BRCA2 genes could be pursued in an unrestrained manner.★ Academic researchers cannot pursue studies in

connection with the genes★ Labs cannot offer tests related to the genes ★ Medical professionals cannot offer treatments

related to the genes.

THE HOLDING• The District Court invalidated

(i) composition of matter claims directed to the BRCA1 and BRCA2 human genes implicated in breast and ovarian cancer and

(ii) methods of detecting mutations in those genes that are linked to incidence of cancer.Reason: The mere isolation and identification of a gene sequence is not enough for a patent regarding that sequence, as nothing was “created”.

Cont..The Federal Circuit held that both isolated DNA and cDNA were patent eligible under §101.

Reason: The Court reasoned that "a portion of a native DNA molecule—an isolated DNA—has a markedly different chemical nature from the native DNA” and that "it is, therefore, patentable subject matter.”

Myriad’s claim directed to methods for screening potential cancer therapeutics based on changes in cell growth rates constituted patentable subject matter.

JUDGEMENT

On remand, the Federal Circuit again held that both isolated DNA and cDNA were patent eligible under §101.

December 7, 2011

The plaintiffs filed a petition for writ of certiorari in the US Supreme Court

March 26, 2012June 13, 2013

Court granted the petition, vacated the Federal Circuit judgment and remanded the case for further consideration.

CONCLUSION• Claim “isolated” not “purified” products• Include claims to cDNA if possible• Identify structural/chemical differences and point

out differences from product (DNA) in nature• Identify and describe “potential for significant

utility” of new product• Add claims to system using/including gene. E.g.

kits, assays, DNA chips, buffers• Cover commercial embodiment

Cont.. • Isolating/extracting gene, DNA or substance• Determining sequence or sequencing• Administering a drug• Determining growth rate of cells/physical

manipulation of cells• Growing transformed cells• Manipulation of cells in growing medium• Treatment

Thank you :)