You Don't Own Me But I'm Your Genome - A Primer On Why Genetic Material Is Patentable
This post answers a call to the Bag and Baggage request line from Frank Paynter, who noticed that legal developments can sometimes divert me from more critical blogging concerns like whether Doc has made it safely home to the Southland (occupational hazard, both ways). Frank is interested in gene patents, and asks "How can they patent that?" This question continues to spark much debate in intellectual property and biotechnology circles. To understand the answer, it helps to break things down piece by piece.

Patents. Patents protect inventions, and allow the patent owner to prevent others from selling, using or making the particular item, usually for a term of twenty years. The United States Patent and Trademark Office (USPTO) recognizes three types of patent:

(1) Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or compositions of matters, or any new useful improvement thereof.

(2) Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture; and

(3) Plant patents may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plants.

In addition to falling within one of the classes listed above, to qualify for a patent an invention must be new (something that no one has created and made public), useful (more than merely theoretical) and unobvious (something that others in the field do not generally know about or take for granted).

Gene Patents.
Most of the debate about patents for gene-based inventions has focused on whether they satisfy the usefulness prong. The widespread availability of modern gene analysis tools also raises questions about the obviousness of these inventions. The law in this area is far from settled and differs from country to country, but here in the United States the USPTO addressed the major challenges to gene patenting in commentary and guidelines issued last year. The USPTO presumably will continue issuing gene patents in accordance with these guidelines until Congress enacts contrary legislation, or until the Federal Circuit (the U.S. Court of Appeals that hears patent matters) or the Supreme Court takes issue with the USPTO's reasoning in a case involving a challenge to a gene patent.

Specific Challenges To Gene Patents And The USPTO Response.
"Discoveries are not patentable." The USPTO rejects the argument that while inventions are patentable, discoveries are not. It feels that discoveries are patentable as long as the various statutory requirements (of newness, utility and nonobviousness) are met. The USPTO points out that the U.S. Constitution uses the word "discoveries" where it authorizes Congress to promote progress made by inventors. It also notes that the patent statutes themselves authorize the issuance of patents to those who "invent or discover" new things. "Thus, an inventor's discovery of a gene can be the bases for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it." One cannot patent the bare "nucleic acid molecular structure for a newly discovered gene." Instead, the inventor must provide "a specific, substantial, and credible utility for the claimed isolated and purified gene." When these requirements are satisfied, a patent may be granted.

"Genes exist in nature, are part of our heritage and are not inventions." According to the USPTO, isolated and purified genes and synthetic DNA compounds do not occur in nature in those forms. Looking to historical examples, it observes that there is nothing new about patenting compositions or compounds isolated from nature, such as Louis Pasteur's patent on yeast. "A patent of a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature. Thus, the concern that a person whose body 'includes' a patented gene could infringe the patent is misfounded. The body does not contain the isolated and purified gene because genes in the body are not in the patented, isolated and purified form. When the patent issued for purified adrenaline about one hundred years ago, people did not infringe the patent merely because their bodies naturally included unpurified adrenaline." Moreover, Congress intended patentable subject matter to be "anything under the sun that is made by man." The U.S. Supreme Court concurs that a patent may cover "a nonnaturally occurring manufacure or composition of matter - a product of human ingenuity." Thus, the USPTO concludes that "DNA compounds having naturally occurring sequences are eligible for patenting when isolated from their natural state and purified, and when the [patent] application meets the statutory criterial for patentability."

"Genes are at the core of what it means to be human, and no person should be able to own/control something so basic." In response to this challenge, the USPTO tries to clear up a common misconception - that a patent confers "ownership." It doesn't. A person holding a patent simply has the right to "exclude other people from making, using, offering for sale, selling, or importing the composition for a limited time. That is, a patent owner can stop infringing activities by others for a limited time." (Sounds a lot like ownership, though, doesn't it?) The Biotechnology Industry Organization (BIO) is quick to make this distinction as well: "A patent on a gene ... does not confer ownership of the invention to a company or university. The patent protects their invention from third party theft by a second company or university engaged in commercial activity."

"Gene patents are overbroad because they may cover uses which are unattainable, unproven or unforeseen." The USPTO responds that a patentee is required to disclose just one "utility" for the invention in order to obtain a patent. "The patentee is not required to disclose all possible uses, but promoting the subsequent discovery of other uses is one of the benefits of the patent system ... Other inventors who develop new and nonobvious methods of using the patented compound have the opportunity to patent those methods." Additionally, although a gene patent permits the patent owner to keep competitors from using the gene for any purpose during the life of the patent, when a new use is discovered "that new use may qualify for its own process patent, notwithstanding that the DNA composition itself is patented."

"Patents on genes will delay or discourage medical research." The USPTO does not agree, and believes instead that "the incentive to make discoveries and inventions is generally spurred, not inhibited, by patents." For its part, BIO likewise asserts that "a patent has no impact on an academic researcher not engaged in commercial activity." Academic researchers are protected from patent infringement actions by an "experimental use" exemption.

"DNA sequencing has become so routine that determining the sequence of a DNA molecule is not inventive." The USPTO rejects the argument that gene-based inventions should be assumed to fail the "obviousness" test. It prefers to review the applications on a case-by-case basis. "Whether a claimed DNA molecule would have been obvious depends on whether the particular structure of the DNA would have been obvious to one of ordinary skill in the art at the time the invention was made."

"Genes only should be patentable when the complete sequence is disclosed and a function for the gene product has been determined." The USPTO thinks such a requirement would set the bar too high. It is enough to "adequately describe the compound" - such as by structure, formula, chemical name or physical properties - and disclose how to make use of it.

Given the USPTO's positions on these and related arguments, genes are and will remain patentable in the U.S. unless Congress or the courts step in to impose broader limitations. For some thought-provoking further reading, check out Professor Lessig's The Future Of The Commons: The Fate Of Ideas In A Connected World, James Boyle's Shamans, Software and Spleens, and Seth Schulman's Owning The Future.

And, in other words - all your [nucleotide] base are belong to us.

Fair Use Parameters For Deep Linking

Fair Use Parameters For Deep Linking: It is pretty astounding, since most of the internet routinely relies on deep linking, that the legality of this practice remains the subject of such vigorous debate. Courts have had a difficult time determining when copyright or other laws might curatil links to other sites, particularly when the link circumvents a site's home page (where advertising, terms of use or disclaimers might be displayed). Last year, two federal trial courts in California reached opposite conclusions about how aggregation sites - like My Simon, or Best Book Buys, for example - are permitted to link to content within other sites. In one of those cases, Central District Judge Harry Hupp observed that purely factual material is not copyright protected, and providing a fact-based link - that states, for example, that Ticketmaster sells tickets for a given concert at a given price - is perfectly acceptable. According to Judge Hupp,

"What is protectable is the manner in which the idea or knowledge is expressed. Thus, Longfellow was free to take the famous facts of the ride of Paul Revere and tell the story in his own incomparable words - no one can copy the words, but anyone may tell the story in his own words (if not as well). The major difficulty with many of plaintiff's theories and concepts is that it is attempting to find a way to protect its expensively developed basic information what it considers a competitor and it cannot do so."

Judge Hupp's reasoning was not taken up, however, by his colleague Judge Ronald Whyte in considering a similar case involving eBay. Judge Whyte found the actions of auction aggregator Bidder's Edge to be a prohibited trespass, and granted a preliminary injunction against that company that played a role in its ultimate demise. Had either of these cases continued, the Ninth Circuit Court of Appeals would have had the chance to consider the legaility of aggregation and deep linking. However, both cases were resolved before appeal. The linking question thus has remained an open one in this jurisdiction and others. (To appreciate the global scope of this debate, pay a visit to Stefan Bechtold's Link Controversy Page.)

Recently, the Ninth Circuit has helped clarify at least the copyright portion of the analysis. In its February 6, 2002 Kelly v. Arriba Soft Corporation decision, the Court considered whether the Ditto.com visual search engine - which displays results as images - infringed the copyrights of Leslie Kelly, who exhibits California gold country photographs throughout his web site. As a visual search engine Ditto displayed two types of images - thumbnails, and, when the thumbnails were clicked, full-sized images - by inline linking to their original location. In other words, Ditto did not download images to its own servers, but imported them directly from other sites. The Court concluded that Ditto's thumbnail links were a fair use under U.S. copyright law, but that displaying the full-sized images was not, and instead constituted copyright infringement.

The Court's analysis turned on the four "fair use" factors identified by the Supreme Court in Campbell v. Acuff-Rose Music, Inc., 510 U.S. 569, 579 (1974), and applied those factors to the types of images that Ditto was displaying. Concerning the thumbnails, Ditto fell within the fair use doctrine because the use was "unrelated to any esthetic purpose," and instead functioned "as a tool to help index and improve access to images on the internet and their related web sites." Ditto's purpose in displaying the thumbnail links was not "artistic expression" - in contrast to Kelly's use of the pictures on his site to illustrate and add to the attractiveness of his presentation. The thumbnail image links did not "supplant the need for the originals," but rather benefitted the public "by enhancing information gathering techniques on the internet." The thumbnail links also did no harm to the market or value of the images as used on Kelly's site; in fact, they had just the opposite effect: "By showing the thumbnails on its results page ... the search engine would guide users to Kelly's web site rather than away from it. Even if users were more interested in the image itself rather than the information on the page, they would still have to go to Kelly's site to see the full-sized image."

Ditto's use of full-sized image links was a different story, however, and did not fall within the fair use doctrine. Providing full-sized images did not increase the functionality of the search engine, and could - in contrast to the thumbnail links - discourage users from visiting the originating site. As the Court observed, "any user who is solely searching for images would not need to do so," since the search engine itself provided what the user was after.

The Ninth Circuit thus has struck a reasonable balance in its Kelly decision by respecting copyrights while also acknowledging that links to copyrighted material can serve the selfsame goals. As the Court observed, "The Copyright Act was intended to promote creativity, thereby benefitting the artist and the public alike." By finding Ditto's thumbnail linking to be a fair use, the Court helped ensure "the potential future use of artistic works for purposes of teaching, reasearch, criticism and news reporting," as contemplated by the overall framework of the copyright laws.

Presumably as the result of the decision, the Ditto.com search engine no longer provides search result links in full-sized image format. (And, presumably because Ditto no longer wants to promote the site of someone who sued it, Ditto produces no results at all for "Leslie Kelly" or his "ShowMeTheGold" domain).

Word/Works Compatibility: So, my dad the writer/fisherman has been known to disappear into the mountains for weeks on end, and last year bought a stripped-down e-Machine for his home away from home. He was a bit surprised to learn that the Works documents generated there won't open in Word when he gets back to the ranch. ("Whaddya mean they're not compatible? It's all Microsoft, right?" "Yeah Dad, lemme tell ya a thing or two about Microsoft...") Microsoft, of course, has no patch for the "older" versions of Word, but the folks at the Buffalo State University of New York were kind enough to step into the breach: their Works to Word converter does the trick nicely (supplements Word '97 and 2000 to cause Works docs to be automatically converted when launched). I love that people make such useful tools available for free (don't get me started on YACCS - how neat is that? And we mustn't forget Blogger...), and that Google lets you find them in two clicks -

Hooray for the YACCS comment feature, now appearing here.

Ok, I really owe one to Gary Turner over at Blogstickers for ratting me out about my new co-counsel and trusted confidante, Teddy. Not sure what sort of retribution will follow, but it should be swift and severe.