Myriad The Future of DNA Claims Mercedes Meyer, Ph.D., JD AIPLA 1

Myriad is Back at the Supreme Court 1. The Question: 1. Are human genes patentable? 2. Issues ignored 1. Standing 2. Method claim 3. What does it mean? 2

35 USC 101 § 101:  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. The Exceptions to Eligibility:  Law of nature  Algorithm  Abstract idea  AIA § 33. Notwithstanding any other provision or law, no patent may issue on a claim directed to or encompassing a human organism.

Myriad Claims Claim 1 of the USPN 5,747,282:  1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO: 2.  This “isolated DNA” does not constitute a gene 4

Myriad DNA Claims USPN 5,693, An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers in SEQ. ID. NO:1. 6. An isolated DNA molecule coding for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein said mutated form of the BRCA2 polypeptide is associated with susceptibility to cancer. 7. The isolated DNA molecule of claim 6, wherein the DNA molecule comprises a mutated nucleotide sequence set forth in SEQ ID NO:1.

Myriad DNA Claims USPN 5,747, An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. 2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1. 5. An isolated DNA having at least 15 nucleotides of the DNA of claim An isolated DNA having at least 15 nucleotides of the DNA of claim An isolated DNA selected from the group consisting of:  (a) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having T at nucleotide position 4056;  (b) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having an extra C at nucleotide position 5385;  (c) a DNA having the nucleotide sequence set forth in SEQ ID NO: 1 having G at nucleotide position 5443; and, (d) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having 11 base pairs at nucleotide positions deleted.

7 The Science - 1 Eukaryotic Genes

8 The Science - 2  The RNA is spliced to form mRNA  For BRCA1 and BRCA 2 there are multiple splice forms  BRCA1 is 110 kb and BRCA2 is 70 kb  BRCA2 has 22 exons / BRCA1 has 27  Only 5,500 and 10,200 bases approximately are claimed Protein

The Politics Sec. 27 of the AIA Health Care  Laboratory developed tests (LDTs)  Breast Cancer Survivors Potential Relevance to Companion Diagnostics  Erbitux, Herceptin, Tarceva – Cancer Insurance reimbursement, anti-kickback and healthcare fraud statutes, contractual limitations, institutional policies, malpractice and other tort concerns, practice patterns, professional talent distribution, financial and time restraints, and more. 9

Some myths on gene patents Patents and Costs  No evidence was found demonstrating that patents accelerated or inhibited test development for certain conditions (e.g. hearing loss).  Price for genetic tests did not appear to correlate with patent status. Some for-profit providers had the same cost as not-for- profit testing providers.  Patents have been found not impede consumer utilization of the tests.  The marketplace is the driver of gene testing.  Incorrect data – the myth that 20% of the human genes are patented is false.  Whole Genome Sequencing – does not infringe a DNA patent.

Thank You MERCEDES MEYER, PH.D. DRINKER BIDDLE & REATH LLP WASHINGTON, DC