Biotech timeline

Events

Plant Patent Act

June 17, 1930

"This law established patent rights for developers of new varieties of many asexually propagated plants, for example apple trees and rose bushes that are propagated by cutting pieces of the stem rather than by germinating seeds. Tuber-propagated plants, such as potatoes, were exempt from patent coverage because the part of the plant used for asexual propagation was also the part used as food. Similar laws were passed in Europe in subsequent years."

http://cls.casa.colostate.edu/transgeniccrops/patent.html

HeLa Cells Appropriated from Henrietta Lacks

Feb 9, 1951

Watson and Crick Describe Double Helix

Approx. 1953

In 1953, James Watson and Francis Crick described the double helix structure of deoxyribonucleic acid (DNA), the chemical compound that contains the genetic instructions for building, running and maintaining living organisms.

U.S. Plant Variety Protection Act

1970

This law establish patent rights for developers of new varieties of seed-propagated plants, but not F1 hybrids. Carrots, celery, cucumbers, okra, peppers, and tomatoes were specifically exempted from patent protection. Under the farmers' exemption, farmers were allowed to save patented seeds for use on their own farms and could sell patented seeds to other farmers. Under the breeders' exemption, plant breeders could use patented plants to develop new patentable varieties. Several European countries already provided this protection with the establishment of the International Union for the Protection of New Varieties of Plants (UPOV) in 1961.
Amendments:
1980 amendment: carrots, celery, cucumbers, okra, peppers, and tomatoes were added to the list of patentable plants.
1994 amendment: F1 hybrids such as hybrid corn and tuber-propagated plants such as potatoes were added to the list of patentable plants. The farmers' exemption was restricted. Farmers are still allowed to save patented seeds for use on their own farms, but cannot sell patented seeds to other farmers. The breeders' exemption was restricted. Plant breeders cannot patent new varieties that are essentially derived from already patented varieties. These changes made U.S. patent laws similar to those in effect in Europe under the 1991 UPOV convention.
http://cls.casa.colostate.edu/transgeniccrops/patent.html

Gene splicing from one organism to the next accomplished

1974

“ a team of researchers succeeded in copying a gene from one organism and splicing it into the DNA of another, creating the first genetically engineered bacterium”

Excerpt From: Steven Druker. “ALTERED GENES, TWISTED TRUTH: How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public.”

“Morrow, J.F., Cohen, S.N., Chang, A.C.Y., Boyer, H.W., Goodman, H.M., Helling, R.B., “Replication and transcription of eukaryotic DNA in Escherichia coli,” Proceedings of the National Academy of Sciences 71 (1974): 1743-47. ”

Asilomar Conference

February 1975

A group of molecular biologists convened to create self-imposed limits on genetic research in order to avoid outside involvement with their research agendas.

NIH Issues research guidelines

June 23, 1976

“Despite the absence of legal penalties for violating them, there were constraints, because they applied to any organization receiving NIH funds – and they were eventually extended through presidential order to encompass all federally funded research. So funding could be curtailed if a project ignored them. Further, the NIH guidelines went beyond those agreed upon at Asilomar and banned the deliberate release into the environment of any organism containing recombinant DNA.”

Excerpt From: Steven Druker. “ALTERED GENES, TWISTED TRUTH: How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public.”

Diamond vs. Chakrabarty

June 16, 1980

This case granted a patent rights for a genetically engineered bacteria that could clean up oil spills. This was a 5-4 decisions, explicitly meant to be narrowly interpreted and not intended to address the broader issue of patenting higher life forms.

https://supreme.justia.com/cases/federal/us/447/303/case.html

Bahd-Dole Act

December 12, 1980

Bayh–Dole changed ownership rules for inventions made with federal funding. Before the Bayh–Dole Act, federal research funding contracts and grants obligated inventors (where ever they worked) to assign inventions they made using federal funding to the federal government. Bayh–Dole permits a university, small business, or non-profit institution to elect to pursue ownership of an invention in preference to the government.

Ex Parte Hibbard

September 18, 1985

"US Patent and Trademark Office (USPTO) ruled that genetically modified plants, seeds, and plant tissue cultures can be patented. The decision was effectively an extension of Diamond v. Chakrabarty, which dealt specifically with the genetic modification of microorganisms. The patenting of genetically altered plants became a practical legal issue when scientists Kenneth A. Hibberd, Paul C. Anderson, and Pauline Hubbard of Molecular Genetics of Minnetonka, Minnesota, applied for intellectual property protection on a variety of corn that had been modified to contain more tryptophan, an amino acid. The Ex parte Hibberd decision resulted in a patent (No. 4,581,847, “Tryptophan Overproducer Mutants of Cereal Crops”) that laid the groundwork for further patenting of genetically modified plants."

http://biotechhistory.org/timeline/ex-parte-hibberd/

Human Genome Project

Approx. 1990 - April, 2003

In 1990, the National Institutes of Health (NIH) and the Department of Energy joined with international partners in a quest to sequence all 3 billion letters, or base pairs, in the human genome, which is the complete set of DNA in the human body. This concerted, public effort was the Human Genome Project.
The Human Genome Project’s goal was to provide researchers with powerful tools to understand the genetic factors in human disease, paving the way for new strategies for their diagnosis, treatment and prevention.

http://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=45&key=H#H

Celera Genomics founded by Craig Venter

May 1998

Celera's stated mission was to try to sequence the human genome before the publicly funded HGP.

Crispr-Cas9 technique published in Science

June 28, 2012

http://www.wired.com/2015/07/crispr-dna-editing-2/

"In January 2013, Zhang's team published a paper in Science showing how Crispr-Cas9 edits genes in human and mouse cells. In the same issue, Harvard geneticist George Church edited human cells with Crispr too. Doudna's team reported success in human cells that month as well, though Zhang is quick to assert that his approach cuts and repairs DNA better.

That detail matters because Zhang had asked the Broad Institute and MIT, where he holds a joint appointment, to file for a patent on his behalf. Doudna had filed her patent application—which was public information—seven months earlier. But the attorney filing for Zhang checked a box on the application marked “accelerate” and paid a fee, usually somewhere between $2,000 and $4,000. A series of emails followed between agents at the US Patent and Trademark Office and the Broad's patent attorneys, who argued that their claim was distinct.

A little more than a year after those human-cell papers came out, Doudna was on her way to work when she got an email telling her that Zhang, the Broad Institute, and MIT had indeed been awarded the patent on Crispr-Cas9 as a method to edit genomes. “I was quite surprised,” she says, “because we had filed our paperwork several months before he had.”

The Broad win started a firefight. The University of California amended Doudna's original claim to overlap Zhang's and sent the patent office a 114-page application for an interference proceeding—a hearing to determine who owns Crispr—this past April. In Europe, several parties are contesting Zhang's patent on the grounds that it lacks novelty. Zhang points to his grant application as proof that he independently came across the idea. He says he could have done what Doudna's team did in 2012, but he wanted to prove that Crispr worked within human cells. The USPTO may make its decision as soon as the end of the year.
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The stakes here are high. Any company that wants to work with anything other than microbes will have to license Zhang's patent; royalties could be worth billions of dollars, and the resulting products could be worth billions more. Just by way of example: In 1983 Columbia University scientists patented a method for introducing foreign DNA into cells, called cotransformation. By the time the patents expired in 2000, they had brought in $790 million in revenue.

It's a testament to Crispr's value that despite the uncertainty over ownership, companies based on the technique keep launching. In 2011 Doudna and a student founded a company, Caribou, based on earlier Crispr patents; the University of California offered Caribou an exclusive license on the patent Doudna expected to get. Caribou uses Crispr to create industrial and research materials, potentially enzymes in laundry detergent and laboratory reagents. To focus on disease—where the long-term financial gain of Crispr-Cas9 will undoubtedly lie—Caribou spun off another biotech company called Intellia Therapeutics and sublicensed the Crispr-Cas9 rights. Pharma giant Novartis has invested in both startups. In Switzerland, Charpentier cofounded Crispr Therapeutics. And in Cambridge, Massachusetts, Zhang, George Church, and several others founded Editas Medicine, based on licenses on the patent Zhang eventually received.

Thus far the four companies have raised at least $158 million in venture capital."

OSGATA et al. v. Monsanto SCOTUS decision

January 13, 2013

The court ruled in favor of Monsanto. "he Organic Seed Growers and Trade Association and a group of dozens of organic and conventional family farmers, seed companies and public advocacy interests sued Monsanto in March 2011. The suit sought to prohibit the company from suing farmers whose fields became inadvertently contaminated with corn, soybeans, cotton, canola and other crops containing Monsanto's genetic modifications.

Monsanto has genetically engineered its specialty seeds to withstand dousings of glyphosate, the main ingredient in the company's Roundup herbicide.

The group asked Monsanto for a pledge not to sue, but the company refused, saying: "A blanket covenant not to sue any present or future member of petitioners' organizations would enable virtually anyone to commit intentional infringement."

The biotech crops are widely used throughout the United States. Monsanto has sued more than 100 farmers for patent infringement, winning judgments against those found to have made use of its seed without paying required royalties."

Bowman vs. Monsanto ruling

May 13, 2013

Farmer bought soybeans from a grain elevator, used these as seeds without paying Monsanto royalties. Supreme court ruled in favor of Monsanto. http://www.nytimes.com/2013/05/14/business/monsanto-victorious-in-genetic-seed-case.html?_r=0