Patenting Biotech in the U.S. and Europe (Part 1 of 2)

by VolpeKoenig on March 20, 2013

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The United States and Europe are the main jurisdictions where inventors in the field of biotechnology are seeking patent protection. They should be aware of similarities and differences in what constitutes patentable subject matter in the U.S. and Europe. In Part One of this post, we will explore patent protection for biotechnology in the United States.

United States

Many commentators described the biotech industry as being jolted by the decisions of the United States Supreme Court in 2012. This post examines patentability of the biotechnology inventions, such as genetically modified organisms and isolated DNA, in the U.S. in view of the latest activity of the Supreme Court.

In the United States, patentability is governed by section 101 of title 35 U.S.C.   providing that “whoever invents or discovers any new and useful process, machine, manufacture, or composition of a matter, or any new and useful improvements thereof, may obtain a patent thereof, subject to the conditions and requirements of this title.” 35 U.S.C. §101

The prevailing doctrine on patentability was formulated by the Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303, 206 (1980). According to this doctrine, anything under the sun made by man is deemed patentable.  However, exceptions are made for laws of nature, physical phenomenon, and abstract ideas, as well as newly discovered naturally occurring plants and minerals that are non-patentable.

Accordingly, the U.S. patent office routinely issues patents claiming genetically modified organisms, bacteria, plants and animals, as well as isolated and recombinant DNA molecules used for making such organisms, alone with probes, diagnostic kits and drugs that include or are based on isolated DNAs.

  • Mayo v. Prometheus

This practice may change after the recent decision of the Supreme Court in Mayo v. Prometheus, 132 S.Ct. 1289 (2012). In Prometheus, the patent at issue involved a method of treatment of an autoimmune disease. The Court ruled that method claims including steps of administering a certain drug to a patient and determining the efficacy of treatment were non-patentable, and merely describing a law of nature.

Of particular concern for commentators and owners of biotech patents alike is an issue of patentability of isolated DNA. In Ass’n for Molecular Pathology v. USPTO, 689 F.3d 1330 (2012), the Federal Circuit ruled that an isolated DNA, or a gene, is patentable because the DNA isolated from the body is “markedly different” in chemical structure from the DNA inside the body.

However, in light of the ruling in Prometheus, the Supreme Court ordered the Federal Circuit to revisit its decision in Myriad.  In August 2012, the Federal Court reviewed the case and affirmed that claims to isolated DNAs encoding human genes, BRCA1 and BRCA2, were patent-eligible. Not satisfied, the Supreme Court decided to hear this case on appeal to once again reconsider the patent-eligibility of isolated DNAs.

  • Monsanto v. Bowman

Of further concern in the U.S. is the issue of extending patent protection to progeny of self-replicating inventions, such as seeds produced from transgenic plants. In Monsanto Co. v. Bowman, 657 F.3d 1341 (2011), the Federal Circuit ruled for Monsanto against an infringing farmer and found that seeds containing proprietary traits are covered by patents and unauthorized use of such seeds for planting constitutes infringement.

At issue in Bowman was the right of a purchaser of proprietary transgenic “Roundup Ready” seeds to make subsequent plantings. Bowman purchased commodity soybean seeds from a grain elevator for a second year planting. Because a majority of the plants from the second year planting contained proprietary traits and were resistant to glyphosate (i.e. Roundup pesticide), Monsanto sued Bowman for patent infringement. Bowman argued that he was free to plant the seeds because Monsanto’s patent rights were exhausted after the authorized sale of the seeds to the elevator. The Federal Court disagreed, and stated  “[e]ven if Monsanto patent rights in the commodity seeds are exhausted, such a conclusion would be of no consequence because once a grower, like Bowman, plants the commodity seeds containing Monsanto’s Roundup Ready® technology and the next generation of seed develop, the grower has created a newly infringing article.”

On appeal from the farmer, the Supreme Court requested the Solicitor General to provide a brief expressing the position of the U.S. government of the application of the patent exhaustion doctrine to self-replicating inventions. Commentators suggest that such a request from the Supreme Court indicated that the Supreme Court has taken an interest in the case.

In Brief for the United States, the Solicitor General advised that the petition for a writ of certiorari should be denied. Further, the Solicitor General cautioned that ‘[i]f this Court granted certiorari…its decision could also affect the enforcement of patents for man-made cell lines, DNA molecules, nanotechnologies, organic computers, and other technologies that involve self-replicating features.” Despite the Solicitor General’s advice, the Supreme Court granted certiorari.

In light of the Supreme Court activity, biotech companies patenting self-replicating technologies, such as isolated DNA, should watch the cases closely and consider how to protect their inventions should the Supreme Court expand the scope of “patent exhaustion” for biotech patents or declare isolated DNA to be non-patentable subject matter.

– By Marina Sigavera

– See more at: Volpe and Koenig IP Law Blog

And look out for part two tomorrow morning!

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