Not dressing up that night was Feng Zhang (see 35 Innovators Under 35, 2013), a researcher in Cambridge at the MIT-Harvard Broad Institute. But earlier this year Zhang claimed his own reward. In April, he won a broad U.S. patent on CRISPR-Cas9 that could give him and his research center control over just about every important commercial use of the technology.
How did the high-profile prize for CRISPR and the patent on it end up in different hands? That’s a question now at the center of a seething debate over who invented what, and when, that involves three heavily financed startup companies, a half-dozen universities, and thousands of pages of legal documents.
“The intellectual property in this space is pretty complex, to put it nicely,” says Rodger Novak, a former pharmaceutical industry executive who is now CEO of CRISPR Therapeutics, a startup in Basel, Switzerland, that was cofounded by Charpentier. “Everyone knows there are conflicting claims.”
No CRISPR drug yet exists. But if CRISPR turns out to be as important as scientists hope, commercial control over the underlying technology could be worth billions.At stake are rights to an invention that may be the most important new genetic engineering technique since the beginning of the biotechnology age in the 1970s. The CRISPR system, dubbed a “search and replace function” for DNA, lets scientists easily disable genes or change their function by replacing DNA letters. During the last few months, scientists have shown that it’s possible to use CRISPR to rid mice of muscular dystrophy, cure them of a rare liver disease, make human cells immune to HIV, and genetically modify monkeys (see “Genome Surgery” and “10 Breakthrough Technologies 2014: Genome Editing”).
No CRISPR drug yet exists. But if CRISPR turns out to be as important as scientists hope, commercial control over the underlying technology could be worth billions.
The control of the patents is crucial to several startups that together quickly raised more than $80 million to turn CRISPR into cures for devastating diseases. They include Editas Medicine and Intellia Therapeutics, both of Cambridge, Massachusetts. Companies expect that clinical trials could begin in as little as three years.
Zhang cofounded Editas Medicine, and this week the startup announced that it had licensed his patent from the Broad Institute. But Editas doesn’t have CRISPR sewn up. That’s because Doudna, a structural biologist at the University of California, Berkeley, was a cofounder of Editas, too. And since Zhang’s patent came out, she’s broken off with the company, and her intellectual property—in the form of her own pending patent—has been licensed to Intellia, a competing startup unveiled only last month. Making matters still more complicated, Charpentier sold her own rights in the same patent application to CRISPR Therapeutics.
In an e-mail, Doudna said she no longer has any involvement with Editas. “I am not part of the company’s team at this point,” she said. Doudna declined to answer further questions, citing the patent dispute.
Few researchers are now willing to discuss the patent fight. Lawsuits are certain and they worry anything they say will be used against them. “The technology has brought a lot of excitement, and there is a lot of pressure, too. What are we going to do? What kind of company do we want?” Charpentier says. “It all sounds very confusing for an outsider, and it’s also quite confusing as an insider.”
Academic labs aren’t waiting for the patent claims to get sorted out. Instead, they are racing to assemble very large engineering teams to perfect and improve the genome-editing technique. On the Boston campus of Harvard’s medical school, for instance, George Church, a specialist in genomics technology, says he now has 30 people in his lab working on it.
Because of all the new research, Zhang says, the importance of any patent, including his own, isn’t entirely clear. “It’s one important piece, but I don’t really pay attention to patents,” he says. “What the final form of this technology is that changes people’s lives may be very different.”
The new gene-editing system was unearthed in bacteria—organisms that use it as a way to identify, and then carve up, the DNA of invading viruses. That work stretched across a decade. Then, in June 2012, a small team led by Doudna and Charpentier published a key paper showing how to turn that natural machinery into a “programmable” editing tool, to cut any DNA strand, at least in a test tube.
The next step was clear—scientists needed to see if the editing magic could work on the genomes of human cells, too. In January 2013, the laboratories of Harvard’s Church and Broad’s Zhang were first to publish papers showing that the answer was yes. Doudna published her own results a few weeks later.
Everyone by then realized that CRISPR might become an immensely flexible way to rewrite DNA, and possibly to treat genetic diseases as diverse as hemophilia, rare metabolic problems, and even the neurodegenerative disease Huntington’s.
Venture capital groups quickly began trying to recruit the key scientists behind CRISPR, tie up the patents, and form startups. Charpentier threw in with CRISPR Therapeutics in Europe. Doudna had already started a small company, Caribou Biosciences, but in 2013 she joined Zhang and Church as a cofounder of Editas. With $43 million from leading venture funds Third Rock Ventures (see “50 Smartest Companies: Third Rock Ventures”), Polaris Partners, and Flagship Ventures, Editas looked like the dream team of gene-editing startups.
In April of this year, Zhang and the Broad won the first of several sweeping patents that cover using CRISPR in eukaryotes—or any species whose cells contain a nucleus (see “Broad Institute Gets Patent on Revolutionary Gene-Editing Method”). That meant that they’d won the rights to use CRISPR in mice, pigs, cattle, humans—in essence, in every creature other than bacteria.
The patent came as a shock to some. That was because Broad had paid extra to get it reviewed very quickly, in less than six months, and few knew it was coming. Along with the patent came more than 1,000 pages of documents. According to Zhang, Doudna’s predictions in her own earlier patent application that her discovery would work in humans was “mere conjecture” and that, instead, he was the first to show it, in a separate and “surprising” act of invention.
The patent documents have caused consternation. The scientific literature shows that several scientists managed to get CRISPR to work in human cells. In fact, its easy reproducibility in different organisms is the technology’s most exciting hallmark. That would suggest that, in patent terms, it was “obvious” that CRISPR would work in human cells, and that Zhang’s invention might not be worthy of its own patent.
What’s more, there’s scientific credit at stake. In order to show he was “first to invent” the use of CRISPR-Cas in human cells, Zhang supplied snapshots of lab notebooks that he says show he had the system up and running in early 2012, even before Doudna and Charpentier published their results or filed their own patent application. That timeline would mean he hit on the CRISPR-Cas editing system independently. In an interview, Zhang affirmed he’d made the discoveries on his own. Asked what he’d learned from Doudna and Charpentier’s paper, he said “not much.”
Not everyone is convinced. “All I can say is that we did it in my lab with Jennifer Doudna,” says Charpentier, now a professor at the Helmholtz Centre for Infection Research and Hannover Medical School in Germany. “Everything here is very exaggerated because this is one of those unique cases of a technology that people can really pick up easily, and it’s changing researchers’ lives. Things are happening fast, maybe a bit too fast.”
This isn’t the end of the patent fight. Although Broad moved very swiftly, lawyers for Doudna and Charpentier are expected to mount an interference proceeding in the U.S.—that is, a winner-takes-all legal process in which one inventor can take over another’s patent. Who wins will depend on which scientist can produce lab notebooks, e-mails, or documents with the earliest dates.
“I am very confident that the future will clarify the situation,” says Charpentier. “And I would like to believe the story is going to end up well.”
Source: MIT Technology Review
History of patent law
From Wikipedia, the free encyclopedia
|Intellectual property law|
|Sui generis rights|
|By region / country|
|By specific subject matter|
Early precedentsThere is some evidence that some form of patent rights was recognized in Ancient Greece. In 500 BCE, in the Greek city of Sybaris (located in what is now southern Italy), "encouragement was held out to all who should discover any new refinement in luxury, the profits arising from which were secured to the inventor by patent for the space of a year." Athenaeus, writing in the third century CE, cites Phylarchus in saying that in Sybaris exclusive rights were granted for one year to creators of unique culinary dishes.
In England, grants in the form of letters patent were issued by the sovereign to inventors who petitioned and were approved: a grant of 1331 to John Kempe and his Company is the earliest authenticated instance of a royal grant made with the avowed purpose of instructing the English in a new industry. These letters patent provided the recipient with a monopoly to produce particular goods or provide particular services. Another early example of such letters patent was a grant by Henry VI in 1449 to John of Utynam, a Flemish man, for a twenty-year monopoly for his invention.
The first Italian patent was awarded by the Republic of Florence in 1421. The Florentine architect Filippo Brunelleschi received a three-year patent for a barge with hoisting gear, that carried marble along the Arno River in 1421.
Development of the modern patent systemPatents were systematically granted in Venice as of 1450, where they issued a decree by which new and inventive devices had to be communicated to the Republic in order to obtain legal protection against potential infringers. The period of protection was 10 years. These were mostly in the field of glass making. As Venetians emigrated, they sought similar patent protection in their new homes. This led to the diffusion of patent systems to other countries.
Henry II of France introduced the concept of publishing the description of an invention in a patent in 1555. The first patent "specification" was to inventor Abel Foullon for "Usaige & Description de l'holmetre", (a type of rangefinder.) Publication was delayed until after the patent expired in 1561. Patents were granted by the monarchy and by others institutions like the "Maison du Roi" and the Parliament of Paris. The novelty of the invention was examined by the French Academy of Sciences. Digests were published irregularly starting in 1729 with delays of up to 60 years. Examinations were generally done in secret with no requirement to publish a description of the invention. Actual use of the invention was deemed adequate disclosure to the public.
The English patent system evolved from its early medieval origins into the first modern patent system that recognised intellectual property in order to stimulate invention; this was the crucial legal foundation upon which the Industrial Revolution could emerge and flourish.
By the 16th century, the English Crown would habitually grant letters patent for monopolies to favoured persons (or people who were prepared to pay for them). Blackstone (same reference) also explains how "letters patent" (Latin literae patentes, "letters that lie open") were so called because the seal hung from the foot of the document: they were addressed "To all to whom these presents shall come" and could be read without breaking the seal, as opposed to "letters close", addressed to a particular person who had to break the seal to read them.
This power was used to raise money for the Crown, and was widely abused, as the Crown granted patents in respect of all sorts of common goods (salt, for example). Consequently, the Court began to limit the circumstances in which they could be granted. After public outcry, James I of England was forced to revoke all existing monopolies and declare that they were only to be used for "projects of new invention". This was incorporated into the Statute of Monopolies in which Parliament restricted the Crown's power explicitly so that the King could only issue letters patent to the inventors or introducers of original inventions for a fixed number of years. It also voided all existing monopolies and dispensations with the exception of:
- ...the sole working or making of any manner of new manufactures within this realm to the true and first inventor and inventors of such manufactures which others at the time of making such letters patent and grants shall not use...
Queen Anne, patent applications were required to supply a complete specification of the principles of operation of the invention for public access. Legal battles around the 1796 patent taken out by James Watt for his steam engine, established the principles that patents could be issued for improvements of an already existing machine and that ideas or principles without specific practical application could also legally be patented.
This legal system became the foundation for patent law in countries with a common law heritage, including the United States, New Zealand and Australia. In the Thirteen Colonies, inventors could obtain patents through petition to a given colony’s legislature. In 1641, Samuel Winslow was granted the first patent in North America by the Massachusetts General Court for a new process for making salt.
Towards the end of the 18th century, and influenced by the philosophy of John Locke, the granting of patents began to be viewed as a form of intellectual property right, rather than simply the obtaining of economic privilege. A negative aspect of the patent law also emerged in this period - the abuse of patent privilege to monopolise the market and prevent improvement from other inventors. A notable example of this was the behaviour of Boulton & Watt in hounding their competitors such as Richard Trevithick through the courts, and preventing their improvements to the steam engine from being realised until their patent expired.
ConsolidationThe modern French patent system was created during the Revolution in 1791. Patents were granted without examination since inventor's right was considered as a natural one. Patent costs were very high (from 500 to 1500 francs). Importation patents protected new devices coming from foreign countries. The patent law was revised in 1844 - patent cost was lowered and importation patents were abolished.
Patent and Copyright Clause of the United States Constitution was proposed in 1787 by James Madison and Charles Cotesworth Pinckney. In Federalist No. 43, Madison wrote, "The utility of the clause will scarcely be questioned. The copyright of authors has been solemnly adjudged, in Great Britain, to be a right of common law. The right to useful inventions seems with equal reason to belong to the inventors. The public good fully coincides in both cases with the claims of the individuals."
The first Patent Act of the U.S. Congress was passed on April 10, 1790, titled "An Act to promote the progress of useful Arts." The first patent was granted on July 31, 1790 to Samuel Hopkins for a method of producing potash (potassium carbonate).
The earliest law required that a working model of each invention be submitted with the application. Patent applications were examined to determine if an inventor was entitled to the grant of a patent. The requirement for a working model was eventually dropped. In 1793, the law was revised so that patents were granted automatically upon submission of the description. A separate Patent Office was created in 1802.
The patent laws were again revised in 1836, and the examination of patent applications was reinstituted. In 1870 Congress passed a law which mainly reorganized and reenacted existing law, but also made some important changes, such as giving the commissioner of patents the authority to draft rules and regulations for the Patent Office.
CriticismUnder the influence of the ascendant economic philosophy of free trade economics in England, the patent law began to be criticised in the 1850s as obstructing research and benefiting the few at the expense of public good. The campaign against patenting expanded to target copyright too and, in the judgment of historian Adrian Johns, "remains to this day the strongest [campaign] ever undertaken against intellectual property", coming close to abolishing patents.
Its most prominent activists - Isambard Kingdom Brunel, William Robert Grove, William Armstrong and Robert A. MacFie - were inventors and entrepreneurs, and it was also supported by radical laissez-faire economists (The Economist published anti-patent views), law scholars, scientists (who were concerned that patents were obstructing research) and manufacturers. Johns summarizes some of their main arguments as follows:
- [Patents] projected an artificial idol of the single inventor, radically denigrated the role of the intellectual commons, and blocked a path to this commons for other citizens — citizens who were all, on this account, potential inventors too. [...] Patentees were the equivalent of squatters on public land — or better, of uncouth market traders who planted their barrows in the middle of the highway and barred the way of the people.
In England, despite much public debate, the system wasn't abolished - it was reformed with the Patent Law Amendment Act of 1852. This simplified procedure for obtaining patents, reduced fees and created one office for the entire United Kingdom, instead of different systems for England and Wales and Scotland. In France as well, a similar controversy erupted in the 1860s and reforms were made.
- Intellectual property
- History of copyright law
- History of United States patent law
- United States patent case law
- Scire facias
- Helmut Schippel: Die Anfänge des Erfinderschutzes in Venedig, in: Uta Lindgren (Hrsg.): Europäische Technik im Mittelalter. 800 bis 1400. Tradition und Innovation, 4. Aufl., Berlin 2001, S.539-550 ISBN 3-7861-1748-9
- Charles Anthon, A Classical Dictionary: Containing An Account of the Principal Proper Names Mentioned in Ancient Authors, And Intended To Elucidate All The Important Points Connected With The Geography, History, Biography, Mythology, And Fine Arts Of The Greeks And Romans Together With An Account Of Coins, Weights, And Measures, With Tabular Values Of The Same, Harper & Bros, 1841, page 1273.
- Phylarchus of Naucratis, "The Deipnosophists, or, Banquet of the Learned of Athenæus", Translated from Ancient Greek by H.Bohn 12:20, p.835
- Terrell on Patents, 8th edition edited by J R Jones, London (Sweet & Maxwell) 1934.
- E Wyndham Hulme, The History of the Patent System under the Prerogative and at Common Law, Law Quarterly Review, vol.46 (1896), pp.141-154.
- Terence Kealey, The Economic Laws of Scientific Research, St. Martin's Press, 1996
- Gregory A Stobbs, Software Patents, Aspen Publishers, 2000, ISBN 0-7355-1499-2, page 3.
- Christine MacLeod, Inventing the Industrial Revolution: The English Patent System, 1660-1800, Cambridge University Press, 2002, ISBN 0-521-89399-2, ISBN 978-0-521-89399-2, page 11.
- "Wolfgang-Pfaller.de: Patentgesetz von Venedig" (in German / Italian).
- M. Frumkin, "The Origin of Patents", Journal of the Patent Office Society, March 1945, Vol. XXVII, No. 3, pp 143 et Seq.
- Nowotarski, Bakos, “A Short History of Private Patent Examination”, Insurance IP Bulletin Oct. 2009
- Frank D. Prager, “Proposals for the Patent Act of 1790", Journal of the Patent and Trademark Office Society, March 1954, vol XXXVI, No. 3, pp 157 et Seq., citing J. Isore in Revue Historique de Droit Francais, 1937 pp. 117 et Seq.
- "Blackstone's Commentaries". Retrieved 2008-02-24.
THE king's grants are alſo matter of public record. For, as St. Germyn ſays, the king's excellency is ſo high in the law, that no freehold may be given to the king, nor derived from him, but by matter of record. And to this end a variety of offices are erected, communicating in a regular ſubordination one with another, through which all the king's grants muſt paſs, and be tranſcribed, and enrolled; that the ſame may by narrowly inſpected by his officers, who will inform him if any thing contained therein is improper, or unlawful to be granted. Theſe grants, whether of lands, honours, liberties, franchiſes, or ought beſides, are contained in charters, or letters patent, that is, open letters, literae patentes: ſo called becauſe they are not ſealed up, but expoſed to open view, with the great ſeal pendant at the bottom; and are uſually directed or addreſſed by the king to all his ſubjects at large. And therein they differ from certain other letters of the king, ſealed alſo with his great ſeal, but directed to particular perſons, and for particular purpoſes: which therefore, not being proper for public inſpection, are cloſed up and ſealed on the outſide, and are thereupon called writs cloſe, literae clauſae; and are recorded in the cloſe-rolls, in the ſame manner as the others are in the patent-rolls...
- "The 18th century". Intellectual Property Office.
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- James W. Cortada, "Rise of the knowledge worker, Volume 8 of Resources for the knowledge-based economy", Knowledge Reader Series, Butterworth-Heinemann, 1998, p. 141, ISBN 0-7506-7058-4, ISBN 978-0-7506-7058-6.
- Online at Library of Congress: "A Century of Lawmaking for a New Nation: U.S. Congressional Documents and Debates, 1774 - 1875": First Congress, Session II, chapter VII, 1790: "An Act to promote the progress of useful Arts".
- Chap. XI. 1 Stat. 318 from A Century of Lawmaking for a New Nation: U.S. Congressional Documents and Debates, 1774 - 1875". Library of Congress, Law Library of Congress. Retrieved Sept. 4, 2009.
- Editors, Time-Life (1991). Inventive Genius. New York: Time-Life Books. p. 11. ISBN 0-8094-7699-1.
- Chap. CCCLVII. 5 Stat. 117 from "A Century of Lawmaking for a New Nation: U.S. Congressional Documents and Debates, 1774 -1875". Library of Congress, Law Library of Congress. Retrieved Oct. 19, 2009.
- "National Portrait Gallery Building Chronology". Archived from the original on 2007-04-25. Retrieved 2007-04-27.
- Chap.CCXXX. 16 Stat. 198 from "A Century of Lawmaking for a New Nation: U.S. Congressional Documents and Debates, 1774 - 1875". Library of Congress, Law Library of Congress. Retrieved Oct. 19, 2009.
- Johns, Adrian: Piracy. The Intellectual Property Wars from Gutenberg to Gates. The University of Chicago Press, 2009, ISBN 978-0-226-40118-8, p.247
- Johns, Adrian: Piracy. The Intellectual Property Wars from Gutenberg to Gates. The University of Chicago Press, 2009, ISBN 978-0-226-40118-8, p.247
- Johns, Adrian: Piracy, p. 249, 267, 270
- Johns, Adrian: Piracy, p. 273, citing W.R. Grove: Suggestions for Improvements in the Administration of the Patent Law, The Jurist n.s. 6 (January 28, 1860) 19-25 (online copy at Google Books), and B. Sherman, L. Bently: The Making of Modern Intellectual Property Law (CUP 1999), 50-56
- Johns, Adrian: Piracy, p. 248
- Chang, Ha-Joon. "Kicking Away the Ladder: How the Economic and Intellectual Histories of Capitalism Have Been Re-Written to Justify Neo-Liberal Capitalism". Post-Autistic Economics Review. 4 September 2002: Issue 15, Article 3. Retrieved on 8 October 2008.
- Gabriel Galvez-Behar, La République des inventeurs. Propriété et organisation de l'innovation en France, 1791-1922, Presses universitaires de Rennes, 2008, ISBN 2-7535-0695-7, ISBN 978-2-7535-0695-4.
- Kenneth W. Dobyns, The Patent Office Pony; A History of the Early Patent Office, Sergeant Kirkland's Press 1994. 
- Howard B. Rockman, Intellectual Property law for Engineers and Scientists.
- Bugbee, Bruce W. Genesis of American Patent and Copyright Law. Washington, D.C.: Public Affairs Press (1967).
- Christine MacLeod, Inventing the Industrial Revolution: The English patent system, 1660–1800, Cambridge University Press.
- Galvez-Behar, G. La République des inventeurs. Propriété et organisation de l'innovation en France, Presses universitaires de Rennes, 2008.
- First patents
- X Series : U.S. Patent X000,001 "Improvements in making pot ash and pearle ash"
- 1st Numerical : U.S. Patent 0,000,001 "Traction Wheel"
- 1st Design : U.S. Patent D000,001 Script font type
- 1st Reissued : U.S. Patent RE00,001 "Grain Drill"
- An Economic History of Patent Institutions
- French Patent History
- Patents Research Guide (Australian)
...and I am Sid Harth