Patent Law Chakrabarty and its Progeny

“Old Business” P. 28 “Consisting of” transitional phrases Norian Corp. v. Stryker Corp., 70 USPQ2d 1508 (CA FC 2004) Use of term “consisting of” limits claimed invention by indicating that it contains only what is expressly set forth in claim, but term does not limit aspects unrelated to invention.

Norian v Stryker (cont’d) Patent No. 5,336,264 (the '264 patent): 8. A kit for preparing a calcium phosphate mineral, said kit consisting of: at least one calcium source and at least one phosphoric acid source free of uncombined water as dry ingredients; and a solution consisting of water and a sodium phosphate, where the concentration of said sodium phosphate in said water ranges from 0.01 to 2.0 M and said solution has a pH in the range of about 6 to 11.

Norian v. Stryker, cont’d In October 1999 Stryker began to market a BoneSource® kit that contained the sodium phosphate component as well as the mixture of tetracalcium phosphate and dicalcium phosphate; the kit also provided instructions for combining the components and a spatula for mixing them.

Norian v Stryker - holding [W]hile “consisting of” limits the claimed invention, it does not limit aspects unrelated to the invention. It is thus necessary to determine what is limited by the “consisting of” phrase... It is undisputed that the BoneSource® kit contains the same chemicals as set forth in claims 8-10 of the '065 patent. Infringement is not avoided by the presence of a spatula, for the spatula has no interaction with the chemicals, and is irrelevant to the invention.

Doctrine: Quick Summary Process patent – never a problem –Why not? P 68: Legislative history  statutory language –“Anything under the sun that is made by [humans]”

Doctrine II “Made by [humans]” –How does this limit the scope of patent law? –Is it predictable? Too open-ended?

Doctrine III P 68: The exceptions –What are they? –How do they square with the quasi-statutory language “anything under the sun...”

Doctrine IV Fleshing out the test... Redrafting the quasi-statute...

Doctrine IV Fleshing out the test... Redrafting the quasi-statute... Substantial Human Intervention?

The Life Sciences and § 101 A Brief history –Plant-specific acts, 1930 & 1970 –Early biotech – –Early animal modification: Ex parte Allen, 1987 –Gene patents: 1990-today –Gene therapy: mid-1990s-today –Dolly the sheep: late 1990s –Stem cell research: late 1990s-today

Commoncouragepress.com

Somebody owns your genes. Through the U.S. patent system, corporations and universities have claimed property rights not just on the rice and corn at your dinner table but also on you. Moving beyond patenting and "owning" diseases like staph, tuberculosis, and SARS, one American corporation owns the genetic heritage of the entire population of Iceland. A university has property rights on all human clones-even though human cloning is still being debated in Congress. Another company claims to have invented "junk" DNA. Through its patents, it stakes a claim to the research on 95% of human DNA.

Profits Pending examines the devastating affects of these patents on life, from the blatant theft of cultural resources to slowing down research into deadly diseases. Once used to reward the inventiveness of American scientists and entrepreneurs, the patent system is now being abused to control scientific exploration into human biology and to create monopolies over the world's food sources. Instead of promoting scientific research, patents on life now destroy crucial elements of the scientific method such as the free exchange of ideas between researchers. Profits Pending demonstrates that patents on life may ultimately destroy the biotechnology industry and ultimately hinder the innovation the American economy depends on.

Though we are only at the earliest stage of the establishment of patent monopolies over genes, cell lines, and even organisms, the current struggle over access to AIDS drugs is a harbinger of problems ahead. AIDS drug costs are a clear example of the use of patent monopolies to drive up the price of therapy.

Current Controversies The “Weldon Amendment” – passed late 2003 Bars the U.S. Patent Office from issuing any patent on any "human organism," meaning a member of the human species at any stage of development, including a human embryo or fetus. This "non-patentability" covers members of the species Homo sapiens who are created by human cloning, by in vitro fertilization, or by any other process.

Does Weldon Amendment Change the Law? PTO post-Allen policy announcement Does Weldon amendment go further? What is the best response on the part of industry, scientific community?