Patenting of a living organism

In 1971 a microbiologist, Ananda Chakrabarty, working in a research laboratory of General Electric, created a bacterium capable of breaking down hydrocarbon components of crude oil. The genetically-engineered micro-organism held potential for use for the bioremediation of oil spills.

The following year Chakrabarty filed a patent application in the United States Patent and Trademark Office (PTO), assigned to General Electric Co.

In the PTO the patent examiner rejected Chakrabarty’s claims for the genetically engineered bacteria on the grounds that

  1. that micro-organisms are “products of nature” and
  2. that as living things they are not patentable subject matter under 35 U.S.C. 101.

When Chakrabarty appealed the rejection to the PTO Board of Appeals, the Board affirmed the examiner on the second ground contending that 35 U.S.C. 101 was not intended to cover living things.Seal of the United States Supreme Court

Chakrabarty then appealed to an outside court: The Court of customs and Patent Appeals (CCPA). The CCPA reversed the PTO Board’s decision and found, in favor of Chakrabarty’s position, that living organisms are patentable subject matter. Sidney A. Diamond, Commissioner of Patents, then appealed to the Supreme Court.

The case of Diamond vs Chakrabarty was considered by the U.S. Supreme Court in 1980. The Court concisely stated the issue as follows:

“The question before us in this case is a narrow one of statutory interpretation requiring us to construe 35 U.S.C. 101, which provides:

“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.”

Specifically, we must determine whether respondent’s micro-organism constitutes a “manufacture” or “composition of matter” within the meaning of the statute.”

In a five to four decision (PDF) the court upheld Chakrabarty’s position that living man-made micro-organisms are patentable subject matter. In the decision Chief Justice Warren Burger noted that “The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to ‘include anything under the sun that is made by man’” He further wrote that

“the patentee has produced a new bacterium with markedly different characteristics from any found in nature and having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under 101.” (as a composition of matter or as a manufacture).

In the years since the 1980 Supreme Court decision the biotechnology industry has virtually exploded and the number of patents in the field has increased dramatically. In 1988 the so-called “Harvard Mouse” was patented (US Patent No. 4,736,866 PDF). It was the first patent issued for a transgenic animal.

Since then patents have issued for chickens, cows, mice, pigs, rabbits sheep, dogs, rats, and monkeys. Patents on the Harvard Mouse have been granted in Europe and Japan. However patent laws vary from country to country. In 2002 the Supreme Court of Canada ruled that the Harvard Mouse is not patentable subject matter in accordance with the Canadian Patent Act.

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New USPTO Rules for “Track I” Fast-Track Patent Processing

United States patent and trademark office made changes to the rules to allow inventors to pay a fee to cut the line and get their patents examined sooner.

Fpatent fast trackollowing passage of the Leahy-Smith America Invents Act in September 2011, the United States Patent and Trademark Office (USPTO) began accepting requests for prioritized examination of patent applications through the Track I Prioritized Patent Examination Program.

Simply put, Track I allows inventors and businesses, for a fee, to have their patents processed to completion in 12 months. No examination support documents or other admissions are required. But be aware that this has a hefty $4800 fee.

The United States Patent and Trademark Office (USPTO) announced  final rule change permitting applicants to request prioritized examination for applications after the filing of a request for continued examination. The changes in this final rule are applicable to any patent application in which a proper request for continued examination has been filed before, on, or after Dec. 19, 2011.

“Our goal is to continually provide patent applicants with a variety of processing options that are more responsive to their real-world needs,” said Under Secretary of Commerce for Intellectual Property and Director of the USPTO David Kappos.

Under the procedure set forth in this final rule, once the application is accorded special status after the filing of a request for continued examination it will be placed on the examiner’s special docket throughout its entire course of continued prosecution before the examiner until a final disposition is reached in the application.

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Case Study: Serendipitous Inventions

popsicle

“Patentability shall not be negatived by the manner in which the invention was made” (emphasis added). The statement above is the final sentence of the federal statute dealing with conditions for patentability (35 USC 103). Aside from the use of a confusing and uncommon verb: “negatived”, the sentence paves the way for a particular type [...]

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