BIOTECHNOLOGY/FOOD AND DRUG

Overcoming Barriers ToProtection Of New Technologies

AIPLA October 25, 20133:30-5:30 p.m.

OVERCOMING BARRIERS TO PROTECTION OF NEW

TECHNOLOGIES

MODERATORSModerators: Co-chairs

Plant Biotechnology Subcommittee

Bruce VranaSyngenta Biotechnology, Inc.

Alice O. Martin, Ph.D., J.D.Partner

Barnes & Thornburg LLP

CLE Credit: 2 hours

Keynote Speaker (30 minutes)

Dr. Ananda ChakrabartyDistinguished University ProfessorUniversity of Illinois at ChicagoTopic: Patent Eligibility and Contentious Court Cases: Genetic Technology and Beyond

Speakers/Panelists (60 minutes)

Professor Jay P. KesanUniversity of Illinois, College of LawTopic: Administrative Agencies, Public Interest Groups and New Technologies

Dr. Humphrey FooteSenior AssociateAJ ParkTopic: International IP Protection for Plants

Speakers/Panelists: (con’td)

Thomas E. Nickson, Ph.D.International Policy LeadMonsanto Law DepartmentTopic: Accessing Genetic Resources: The Building blocks of New Technologies

Christine GouldHead of Next Generation EngagementSyngentaTopic: Industry Approaches to Public Policy and Education

Panel discuss followed by Q&A (30 minutes)

Bugging Cancer

Overcoming Barriers to Protection of New Technology40 Years After Diamond v. Chakrabarty

The 2020 Supreme Court Case: Gold v. ChakrabartyA.M. Chakrabarty

pseudomo@uic.eduCover Design By: ahohe2@uic.edu

Two Key Features of the Biotechnology Development in the United States

● The Bayh-Dole Act of 1980 — a landmark technology transfer legislation.

● The 1980 Supreme Court Decision on the patentability of Life Forms — Anything under the sun made by man can be patented in the United States.

Congress shall have the power …

to regulate commerce with foreign nations, and among the several states, and with Indian tribes.U.S. Const. art. I, § 8, cl. 3.

to promote the progress of science and useful arts, by

securing for limited times to authors and inventors the exclusive right to their

respective writings and discoveries.

U.S. Const. art. I, § 8, cl. 8

The Controversy over Patenting of Life Forms

● The United States Supreme Court Decision in 1980: A split 5:4 Decision

● Why such a split decision?

Two patent cases decided by the U.S. Supreme Court

1. Bowman v. Monsanto: The US patent 5,352,605 on glyphosate-resistant Roundup Ready soybean was found to be infringed by the US Supreme Court on May 13, 2013. The central question in this case was: is the patent right exhausted after the first sale of a patented product or does the patent remain valid for self-replicating entities such as a genetically-engineered seed that can produce the same progeny after many generations? Monsanto sued the Indiana farmer Vernon Bowman after he purchases the seeds, containing Roundup Ready seeds, from a grain elevator operator and planted the genetically-engineered weed-killer resistant seeds to grow soybean plants without paying royalty to Monsanto.

Two patent cases decided by the U.S. Supreme Court

2. Association of Molecular Pathology v. US PTO/Myriad Genetics: The central question in this case is: are human genes and mutations patentable?

● Myriad Genetics in Salt Lake City, Utah, had seven patents covering the genetic screening of breast/ovarian cancer susceptibility genes BRCA1 and BRCA2. A judge in the District Court in Manhattan revoked these patents in March 2010 in response to a lawsuit filed by a group of clinicians, patents and advocacy groups. This decision was reversed by the CAFC in July 2011, affirming patenting of human genes, but not mutations such as BRCA1 and BRCA2 mutations.

● On June 13, 2013, in an unanimous decision, the Supreme Court held that isolated and purified BRCA 1 and BRCA2 genes are naturally occurring DNA segment, without any modifications and are not patent eligible. C-DNAs are, however, patent eligible.

Azurin as an anticancer agent

Peritoneal macrophages

MCF-7

MCF- 10F

45 min 6 h

J774

45 min 6 h

Mast cells

Azurin in the prevention of precancerous lesions

p28 Phase I Clinical Trials in Stage IV Cancer Patients (metastatic,

refractory solid tumors)

Wild Type Wild Type

Lentiviral vector

Inhalation therapy withP28/azurin

K-ras with P53-

Lung Adenoma Grade 1, 2 and 3, Histological Analysis

Mouse with tumorMouse without tumor

Prevention of cancer onset by azurin/P28

K-ras lentiviral vector

?If successful in mice, what about humans? Can

azurin expression from the human genome protect humans from cancer (and HIV/AIDS)? Can the

process of cancer prevention through expression of a bacterial gene from the human genome be a

patentable process, complicating the 13th amendment?

P28/azurin expression