DIAMOND v. CHAKRABARTY

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CITATION 1980 SCC OnLine US SC 128

DATE OF JUDGEMENT 16th June 1980

COURT Supreme Court Of United States

PETITIONER Sidney A.Diamond, Commissioner of Patents and trademarks

RESPONDENT Anand M. Chakrabarty

BENCH Before Warren E. Burger, C.J. and Lewis F. Powell, Jr., Harry A. Blackmun, William J. Brennan, Jr., John Paul Stevens, Thurgood Marshall, Byron R. White, Potter Stewart and William H. Rehnquist, JJ

INTRODUCTION

Genetic engineer Ananda Chakrabarty of General Electric submitted a patent application in 1972 for genetically engineered bacteria that breakdown crude oil. Dr. Chakrabarty modified the Pseudomonas bacteria to break down the hydrocarbon components of crude oil by introducing genetic elements into the bacterium through recombinant DNA technology. The microorganisms were designed by Dr. Chakrabarty to help clean up oil spills. The engineered bacteria are safe because they are not pathogens and resistant to harsh environments, they are particularly well-suited for bioremediation.

The examiner denied the application under Section 101 of the Patent Act, which covers subject matter that is patentable. The Board of Patent Appeals and Interferences, now known as the Patent Trial and Appeal Board, upheld the examiner’s decision. Nevertheless, the U.S. Court of Customs and Patent Appeals, which is now a part of the U.S. Court of Appeals for the Federal Circuit, sided with Dr. Chakrabarty. The Court of Customs reasoned that only naturally occurring things, not all living things, were ineligible for patenting; crucially, the court stated that, for the purposes of the patent law, “the fact that microorganisms are alive is itself a distinction without legal significance.” Finally, U.S. Patent and Trademark Office (USPTO) Commissioner Sidney Diamond appealed the case to Supreme Court.

The Apex Court of the United States held that Dr. Chakrabarty’s innovation consisted of patentable subject matter. Section 101 states: ‘subject to the terms and restrictions of this title, anybody who creates or discovers any new and useful machine, process, manufacturing, composition of matter, or new and useful improvement thereof, may be eligible to receive a patent for it.’ (Section 101 of U.S. Patent Act) Dr. Chakrabarty’s invention was declared to be a patentable human-made “composition of matter” or “manufacture” by the Court in a historic 5-4 ruling. Famously, Chief Justice Warren Burger cited a Senate Report that was included in the legislative background of the 1952 Patent Act, stating that “anything under the sun that is made by man” was patentable.

This ruling had vast significance for biotechnology. It resulted in patents for genetically engineered seeds, Polymerase Chain Reaction and mAb therapy. Numerous technical domains as well as society at large have been touched by the emergence of biotechnology. Mayo v. Prometheus [566 U.S. 66(2016) and AMP v. Myriad [569 U.S. 576(2013)] established the Supreme Court’s line of demarcation between artificial and natural phenomena. Both isolated DNA sequences and naturally occurring biological interactions were ruled ineligible for patents by the court.

FACTS OF THE CASE
Genetic engineer Ananda Mohan Chakrabarty of General Electric created a bacterium that can form petroleum or fossil oil by breaking down hydrocarbons which helps in production of the aforesaid. This bacterium is now known as Pseudomonas putida (a Gram-negative, rod-shaped, saprophytic soil bacterium), and it is derived from the genus called Pseudomonas. This characteristic is not exhibited by naturally occurring bacteria, and it is employed in the bioremediation and biodegradation of oil fields.

Chakrabarty submitted a patent application in 1972 that was given to General Electric Co. The 36 patent claims filed by Chakrabarty fell into three categories:

(1) Process claims, which included the process of generating the bacteria; (2) Claims for an inoculum (the process used to induce or increase immunity to a particular disease), which included the new bacteria and a carrier material floating on water; and

(3) Claims for the bacteria themselves. The claims that fit within the first two categories were accepted by the patent examiner, but those that the third on two grounds:

that microorganisms are a “product of nature”; and
that, because they are living entities, they are not patentable subject matter under Title 35 U.S.C. § 101.

Provision states that:

‘subject to the terms and restrictions of this title, anybody who creates or discovers any new and useful machine, process, manufacturing, composition of matter, or new and useful improvement thereof, may be eligible to receive a patent for it.’

The examiner was upheld on the second ground by the Patent Office Board of Appeals after Chakrabarty filed an appeal with the Board. On the basis of its earlier ruling in In re Bergy, 563 F.2d 1031, 1038 (1977), the Court of Customs and Patent Appeals subsequently overturned the ruling, concluding that “the fact that microorganisms…are alive…(is) without legal significance” in patent law.

On June 16, 1980, the Supreme Court affirmed, ruling that a live, artificially created microbe is patentable subject matter under Section §101 and that the microorganism owned by the respondent falls under the definition of a “manufacture” or “composition of matter” under that statute (pp. 447 U.S. 308-318). The date of patent issuance was March 31, 1981.

ISSUES RAISED

Whether the living organism, such as man-made bacteria, can be patented under the US Patent Act?

Whether Chakrabarty’s living micro-organism constitutes a “manufacture” or “composition of matter”?

CONTENTIONS OF PETITIONER

Petitioner Sidney A. Diamond, Commissioner of Patents and Trademarks, contended that living organisms, such as bacteria, should not be patented. Diamond mentioned about the various acts pertaining to plant like Plant Patent Act of 1930 and the Plant Variety Protection Act of 1970.
Diamond contended that these acts demonstrate that Congress did not intend the terms “composition of matter” and “manufacture” to include living creatures. He further noted that germs were specifically excluded from patent protection under the 1970 statute. Diamond contended that including living organisms in these acts would render them useless, and that the court’s implied premise that Congress was just rectifying the public record was erroneous.
Diamond claimed that microorganisms should not be patented because genetic technology was not in existence when section 101 of title 35 of USC was enacted. The petitioner also contended that microorganisms cannot be certified as patentable under the act until the Congress affirms it.

CONTENTIONS OF RESPONDENT

The Respondent asserted that the bacteria were not the outcome of any naturally occurring bacteria instead a product of ingenuity it is conceivable as “manufacture” or “composition of matter.”
The Plants Acts which were cited by the petitioner, were enforced to differentiate between the ‘non-naturally occurring’ and the ‘products of nature’ and not between biotic and abiotic.
The language used in the Patent Laws such as the use of all embracing words like “manufacture” and “composition of matter” indicates towards the room for wider interpretation of the terms used.

JUDGEMENT

The US Supreme Court taking note of all the arguments laid and the previously decided cases held that:

A live microbe created by humans is patentable under Section 101. According to that statute, the respondent’s microorganism is a “manufacture” or “composition of matter.”

Congress considered that the patent laws should be granted broad scope when it selected such vast terms as “manufacture” and “composition of matter,” modified by the comprehensive “any.” The pertinent legislative history also supports a broad interpretation. Although natural laws, physical events, and abstract concepts are not patentable, the respondent is claiming a non-naturally occurring production or composition of matter that is the result of human creativity and has a unique name, character, and application rather than a hitherto undiscovered natural occurrence. Pp. 447 U. S. 308-310; Hartranft v. Wiegmann, 121 U.S. 609, 121 U.S. 615.

The passage of the 1930 Plant Patent Act, which granted protection to certain plants by vegetative propagation and apomixis (asexual) , and the 1970 Plant Variety Protection Act, which authorized protection for certain angiosperms (sexually reproduced plants) but excluded bacteria from its protection, does not evidence congressional understanding that the terms “manufacture” or “composition of matter” in Sec 101 do not include living things. Pp. 447 U. S. 310-314.

Furthermore, the conclusion that microorganisms cannot be considered patentable subject matter until Congress specifically authorizes such protection is not required by the fact that genetic technology was not known when Congress passed Section 101.

Respondent’s invention is fairly embraced by Sec. 101’s clear language. Arguments opposing Sec. 101 patentability that stresses on possible risks arising from genetic research ought to be directed towards the Executive and Congress rather than the Judiciary US 314–318 on pages 447.

Therefore, the Court of Customs and Patent Appeals’ decision was upheld. While naturally occurring products are typically not eligible for patents, advancements in genetic technology brought about by modern science have led to some fascinating exceptions and inclusions, as the example of the Pseudomonas bacteria case demonstrates. Consequently, a patent for these claims was awarded to General Electric and Ananda Chakrabarty.

ANALYSIS

Regarding the case’s legal ramifications and recent biotechnology-related Supreme Court rulings, Judge Rader provided an amazing viewpoint. Judge Rader stated that the majority’s decision in the Chakrabarty case “embrace[s] any inventive activity that occurs at the hand of man and gave a very expansive reading to Section 101 of 35 U.S.C.”11 Chief Justice Burger’s viewpoint could not have been more expansive, in his opinion. According to Judge Rader, the distinction between a naturally occurring product and one enhanced by human ingenuity is that:

Something that already exists cannot be invented; it is a natural event. Isolate or purify is a crucial phraseology that I employed to create patentable material. A component is eligible for patent protection if it is extracted, purified, and isolated from its natural environment. In recent years, the Myriad ruling has cast doubt on this, stating that isolation and purification alone might not be sufficient. To demonstrate that you have a genuinely creative idea, you will need to put in some additional work.

Myriad recently ruled that since refined DNA occurs naturally, it is not patentable. Judge Rader sees this as contradicting Chief Justice Burger’s view that every natural product that has had some human intervention qualifies for patent protection. It is extremely subjective and challenging to determine what “a truly inventive concept” is, according to Judge Rader. He also said:

As demonstrated by the Myriad instance, isolation and purification alone are insufficient. You need to take further action. Many cases have attempted to clarify what that something extra is. It’s highly debatable. To be honest, I find the entire situation frightening. The criteria that applied following the Chakrabarty’s ruling, which states that it is sufficient if human intervention has removed the material from its natural habitat through isolation or purification, is, in my opinion, the one that made the most sense. However, jurisprudence in the modern era requires something more. The nature of that object varies from instance to instance.

Judge Rader addressed worries about developing harmful inventions or doing disastrous research by pointing out that:

The Supreme Court swiftly made it clear that the Patent Act doesn’t halt any particular advancement at all. It is only an incentive that offers extra protection and even exclusive rights to those who apply for and acquire patent protection; it has no bearing on the research directions that researchers may choose to take. However, the Supreme Court stated as much. The research of novel living forms could go on even in the absence of patent rights.

The critiques that surfaced after the ruling, together with concerns about manipulation and the commercialization of life, were the main topics of our conversation with Dr. Chakrabarty. Some people were against the patent, according to Dr. Chakrabarty, because they thought it would “create monsters and make human cloning possible. Nevertheless, the ruling led to a number of breakthroughs that have been immensely helpful to humanity, such as the possibility of “large-scale manufacturing of medications like insulin and the patenting of DNA segments for medical applications. I approve of all types of research, as long as they can cure a disease or improve the nutritional value of food,” Dr. Chakrabarty recalls saying in response to Chief Justice Burger’s embrace of the Senate Report’s assertion that anything created by man is patentable. Court elucidated that research should not be utilized to produce particular kinds of humans; that is the role of God, also that technology shouldn’t destroy life too.

CONCLUSION

This landmark case of Diamond v. Chakrabarty created incentives for the advancement of discoveries that improve human life, the biotechnology sector in the United States underwent a revolution. But as Judge; Randall Rader pointed out that:

“This whole patent eligibility question which was so clear and well-defined, was practically implementable and understandable, and gave life to our whole biotech industry after Chakrabarty now has had a heavy cloud cast over it in recent jurisprudence such as ‘Myriad Case’.”

When asked if our legislature should take action to clear up the confusion, Judge Rader stated:

“If the statute was the written law that was being interpreted by the Supreme Court, we wouldn’t need legislative change. But the sad truth is that the Supreme Court has created a whole overlay of doctrine that makes the statute almost irrelevant. And now we don’t look at whether there’s a process, a machine, an article of manufacture, or a composition of matter. Instead, we look at whether there’s something more beyond the conventional and the routine and the well-known. We argue over what is something and what is more, and what is an inventive concept. And so in that state of confusion, yes, we’re probably going to need legislation.”

Congress must define what currently qualifies as patentable subject matter in light of the dire COVID-19 epidemic and other nations rapidly surpassing the United States in the field of biotechnology.

REFERENCES

This Article is written by Komal Mishra student of Uttaranchal University, Law College, Dehradun; Intern at Legal Vidhiya.

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