Australian Full Federal Court Upholds Myriad Gene Patent

an image of the Federal CourtToday, in D’Arcy v Myriad Genetics Inc [2014] FCAFC 115, the Full Court of the Federal Court of Australia upheld the validity of Myriad Genetics’s Australian patent on methods and materials relating to the human  gene known as BRCA1.

THE BRCA1 GENE. Certain mutant alleles of the BRCA1 gene cause a predisposition to breast and ovarian cancer. Among other things, Myriad’s patent affords Myriad exclusive rights over a molecular diagnostic test that it developed to detect the presence of the BRCA1 gene and thereby to indicate whether an individual has an increased susceptibility to cancer.

an image of the DNA double helix

ISOLATED DNA. Claim 1 of the Myriad patent applies to “isolated” nucleic acid sequences corresponding to the relevant BRCA1 DNA mutations and polymorphisms. An “isolated” DNA sequence is one that has been removed from its normal cellular environment. Isolation is typically performed by cell lysis–bursting of the cell membrane or the nuclear membrane in order to release the DNA and RNA from inside–followed by chemical treatment to separate proteins from nucleic acids, centrifugation, and the application of enzymes to break down RNA and leave only purified DNA. The isolation process does not alter the sequence of nucleic acids; each strand contains both the protein-encoding “exons” and the non-coding “introns” as they existed in the cell prior to isolation. In this respect, DNA that has been isolated by extraction from a cell differs from synthetically-produced cDNA, which contains only exons and whose exact sequences are not found in nature.

ARGUMENTS AGAINST VALIDITY OF THE PATENTThe Myriad patent’s opponents, cancer survivor Yvonne D’Arcy and the group Cancer Voices Australia, contended that isolated nucleic acid is not materially different from cellular nucleic acid and that naturally occurring DNA and RNA, even in isolated form, are products of nature that cannot form the bases of a valid patent. The Full Court rejected this reasoning. In particular, the Full Court found inapposite a 2013 decision of the U.S. Supreme Court, which invalidated certain claims of a closely related U.S. patent owned by Myriad on the ground that isolated nucleic acid is a “product of nature” and thus is not patentable subject matter under U.S. patent law. See US Supreme Ct: Naturally Occurring DNA is Unpatentable Product of Nature, SullivanLawNet (13 June 2013).

AN “ARTIFICIALLY CREATED STATE OF AFFAIRS.” Observing that the Australian patent legislation differs from the U.S. Patent Act, the Australian court opined that it is unhelpful under the Australian legal regime to employ terms such as “the work of nature” or “the laws of nature” as a basis for denying a patent. “In Australia,” the court observed, “there is no statutory or jurisprudential limitation of patentability to exclude ‘products of nature.'” Instead, the court explained, the patentability analysis “should focus on differences in structure and function effected by the intervention of man and not on the similarities.” According to the Full Court, the key inquiry “is whether it consists of an artificially created state of affairs, not whether it produces or fails to produce an artificial effect.” The court concluded that the isolated nucleotide sequences claimed by Myriad did constitute such a state of affairs and as such were patentable. It wrote:

The isolated nucleic acid … has resulted in an artificially created state of affairs for economic benefit. The claimed product is properly the subject of letters patent. The claim is to an invention within the meaning of s 18(1) of the Act.

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Guatemalan Congress Repeals Plant Variety Rights Law

Guatemala's Congress of the Republic in Session on September 4, 2014Today the Congress of the Republic of Guatemala voted to repeal in its entirety the Law for the Protection of Plant Variety Rights that it approved less than three months ago. Congreso de la República aprueba de urgencia nacional derogatoria del Decreto 19-2014, Congreso de la Republica (4 Sept. 2014)

When Guatemala became a signatory to the Central America-Dominican Republic Free Trade Agreement, it agreed to accede to or ratify the 1991 Act of the International Convention for the Protection of Plant Varieties (the UPOV Convention). The UPOV Convention requires member states to grant plant variety rights (also known as plant breeders’ rights or plant variety protection)–a special form of intellectual property rights–to persons who breed new varieties of plants that are distinct, uniform, and stable.

The Law for the Protection of Plant Varieties, enacted with 82 votes on June 10, 2014, represented Guatemala’s effort to enact UPOV-compliant legislation. The law granted plant breeders exclusive rights–for 25 years in the case of trees and vines and 20 years for other plant species–regarding the marketing, sale, and other commercial acts relating to seeds of novel plant varieties registered with the government.

Legislators  passed the plant variety rights law without a prior public debate. At the time, national attention was focused on the 2014 World Cup, which was underway in Brazil. However, shortly after the law was enacted, lawmakers came under intense pressure to reform or repeal the measure.  A variety of labor unions, indigenous community organizations, and other critics opposed to the law expressed fears that it would lead to the privatization of the national seed supply, concentration of agricultural production in the hands of multinational companies, erosion of food sovereignty, and the disruption of traditional and indigenous farming practices. Campesinos guatemaltecos lograron derogación de ley Monsanto, Telesur (4 Sept. 2014). In protests against the legislation earlier this week, demonstrators closed sections of the Pan-American Highway, one of the country’s central transportation arteries. Guatemalan Protesters Demand Repeal of Plant Variety Rights Law, SullivanLawNet (2 Sept. 2014).

A press release posted on the official website of the Congress characterized the decision of the 117 congressmen and congresswomen who voted to repeal the law as an action for “the common good of the Guatemalan population.” According to one news source, Congressman Flavio José Yojcom García voted in favor of the law in June but supported its repeal today, explaining that “To err is human.” Presión social obliga al Congreso a derogar Ley de Vegetales, Prensa Libre (4 Sept. 2014).

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Guatemalan Protesters Demand Repeal of Plant Variety Rights Law

Guatemalan National FlagIn demonstrations today in Guatemala City, Guatemala, public officials and thousands of residents of indigenous communities demanded that the national legislature repeal the recently-enacted Plant Variety Rights Law. See Diputados se comprometen a derogar Ley Monsanto, Prensa Libre (2 Sept. 2014).. Although some members of congress opined publicly that passage of the legislation had been a mistake, lawmakers failed to reach the quorum necessary to reconsider the new law. Apparently many legislators were impeded from reaching the Congress because opponents of the law also blocked portions of the Pan-American Highway as part of their demonstration. Pobladores bloquean ruta para exigir derogación de Ley Monsanto, Prensa Libre (2 Sept. 2014). Late in the afternoon, Arístides Crespo, president of the Congreso de la República, promised to convene lawmakers tomorrow afternoon to consider repealing the law. 

"Anonymous" LogoToday the international network of Internet “hacktivists” claimed that, in support of the protest against what critics call the “Monsanto law,” it had shut down the official websites of Guatemala’s agriculture ministry, its constitutional court, and the national civilian police. Anonymous Guatemala se atribuye ataques a páginas oficiales, Prensa Libre (2 Sept. 2014).

Map of CAFTA-DR ParticipantsIn enacting the Plant Variety Rights Law earlier this year, Guatemala was following through on a commitment it made nine years ago in the Dominican Republic-Central America-United States Free Trade Agreement, to ratify or accede to the International Convention for the Protection of New Varieties of Plants (1991) (UPOV Convention 1991). The UPOV Convention establishes an international framework in which member states agree to grant patent-like rights to persons who breed new varieties of plants that are distinct, uniform, and stable. The Plant Variety Rights Law was scheduled to enter into effect later this month. However, on August 26, 2014, the Guatemalan Constitutional Court temporarily suspended the law’s effective date while it considers a constitutional challenge brought by a group of labor unions and farmers. See Expediente 3952-2014 (28-Ago-2014).

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Increased Fines for Violations of North Carolina Seed Law

North Carolina Map 3d ShapeIn 2013, the North Carolina legislature increased the maximum fine for violations of the state’s seed law from $500 to $10,000 per violation. See N.C. Session Law 2013-345, Senate Bill 455, An act to increase penalties for violation of the seed law. An article in neighboring South Carolina’s The State examines the primary reason for passage of the tough new law–unauthorized planting and sales of proprietary plant varieties. Martha Quillin, In North Carolina, a 20-fold increase in fines for seed piracy, The State (May 18, 2014).

As explained in an interview with North Carolina State University peanut breeder Dr. Tom Image of peanuts against background of fieldIsleib, even state universities depend heavily upon licensing revenues from crop varieties they develop, because public funds do not cover the high costs of research and development required to develop successful varieties. The federal Plant Variety Protection Act (PVPA) provides intellectual property protection for registered, proprietary plant varieties that are new, distinct, and uniform.  However, until last year, North Carolina’s state seed law did little to deter so-called “brown bagging”–unlawful sales of proprietary seed. The maximum fine available under the seed law was $500 per violation.

In 2012, it was discovered that a  North Carolina peanut seed distributor was selling large quantities of seed saved from his harvests, in unknowing violation of the law. Recognizing that the state law was ineffective to capture the attention of would-be brown bag sellers, the  North Carolina Seedsmen’s Association and state agricultural officials pushed for the harsher penalties. In addition to increasing applicable fines, the newly amended law also provides that in cases involving unlawful sales of seed protected under the PVPA, a court “shall order the payment of restitution to any injured party for any losses incurred as a result of the unlawful sale.”

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Unintended Consequences of Open Access Publishing Policies

Open Access PublishingRick Anderson at The Scholarly Kitchen has a thought-provoking article regarding the pressure on authors to publish their academic articles under the most permissive open access licenses available. See Rick Anderson, CC-BY, Copyright, and Stolen Advocacy, The Scholarly Kitchen (Mar. 31, 2014).  Generally, this means the Creative Commons Attribution (CC-BY) license. The CC-BY license grants the world the right to do essentially anything with the copyrighted work–including sell, translate, edit, or rewrite it–without obtaining further permission from the copyright owner, so long as the original author is given attribution. As Anderson notes, this exceptionally broad advance grant of permission can have unintended consequences, including uses of the author’s creative work in ways diametrically opposed to the intention of the author. For the most fervent advocates of open access, it is worth considering whether the absence of any restrictions on use of copyrighted content is always the ideal outcome and whether insisting on the CC-BY license may cause injustice to the author.

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“Twilight” Trademark Infringement Claims Cleared for Trial

Trademark Infringement, Likelihood of ConfusionThe U.S. District Court for the Southern District of New York ruled that the entertainment company responsible for the “Twilight” film series is entitled to a trial on claims that its trademarks were infringed by a cosmetics company’s use of the marks TWILIGHT WOODS and TWILIGHT CRUSH. Bath & Body Works Brand Management, Inc. v. Summit Entertainment, LLC, No. 11 Civ. 1594 (S.D. N.Y. Mar. 21, 2014).

Bath and Body Works (BBW) is a cosmetics retailer that operates more than 1,500 stores in the United States. In 2011, BBW filed a lawsuit seeking a declaration that its scented products bearing the word “twilight” do not infringe trademarks owned by Summit Entertainment. Summit is a film studio and a subsidiary of Lions Gate Entertainment that produced and distributed the “Twilight” movies based upon the novels of best-selling author Stephanie Meyer. When BBW filed the declaratory judgment action, Summit asserted trademark infringement counterclaims against BBW. After a period of discovery, BBW filed a motion for summary judgment, contending that Summit’s counterclaims lacked merit as a matter of law. In a March 21, 2014 decision, the court denied BBW’s motion, clearing the way for Summit to present its counterclaims to a jury.

As explained by the court, Summit owns 40 U.S. trademark registrations for “Twilight.” Some of the registrations apply to the production and distribution of motion pictures. However, due to the commercial success of the films, Summit has also produced or licensed several lines of merchandise for which it owns trademark registrations, including clothing, candles, and purses and other bags; nail polish; and cosmetics (specifically for products called “Luna Twilight” and “Twilight Venom”).

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In order to establish a case of trademark infringement, the mark owner must prove that its trademark is valid and that the defendant’s use of a similar mark presents a likelihood of confusion. According to the court, a “likelihood of confusion” means that “numerous ordinary prudent purchasers are likely to be misled or confused as to the source of the product in question because of the entrance in the marketplace of defendant’s mark.” The court made the following observations in light of factors identified by the U.S. Court of Appeals for the Second Circuit as relevant in determining whether there is a likelihood of confusion:



The strength of the plaintiff’s mark;
The similarity of the defendant’s mark to plaintiffs’s mark;
The proximity of the products sold under defendant’s mark to plaintiff’s products;
Where the products are different, the likelihood that plaintiff will “bridge the gap” by selling products being sold by defendant;
The existence of actual confusion among consumers;
Whether defendant acted in bad faith in adopting the mark;
The quality of the defendant’s products; and
The sophistication of the consumers.






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DC Circuit Upholds USDA Country-of-Origin Rule for Meat Labels

Country-of-Origin RuleIn American Meat Institute, Inc. v. United States Department of Agriculture, No. 13-5281 (D.C. Cir. Mar. 28, 2014), the U.S. Court of Appeals for the District of Columbia Circuit rejected industry challenges to a U.S. Department of Agriculture rule that in most cases requires retailers of “muscle cuts” of meat (meat that is not ground) to list the countries of origin and production steps—born, raised or slaughtered—that occurred in each country. The rule also discontinued a prior USDA practice that permitted the use of identical labels on commingled cuts from animals of different origins that were processed on the same day.

Country-of-Origin RuleAmong other things, the DC Circuit acknowledged that the USDA rule implicated the retailers’ constitutionally protected right to engage in commercial speech. However, the court characterized the U.S. Supreme Court’s decision in Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985), as holding that “commercial speech warrants protection mainly due to its information-producing function,” and thus “a commercial actor has only a ‘minimal’ First Amendment interest in not providing purely factual information with which the actor does not disagree.” For this reason, the Supreme Court held that mandatory disclosures do not violate an advertiser’s First Amendment rights, “as long as disclosure requirements are reasonably related to the State’s interest in preventing deception of consumers.”

Applying the standard set forth in Zauderer, the DC Circuit found that the federal government had a legitimate interest in imposing the country-of-origin rule, and thus the rule did not infringe the industry’s First Amendment rights. The court reasoned that–

What then are the government interests here? AMI argues that the rule merely satisfies consumers’ curiosity. But we can see non-frivolous values advanced by the information. Obviously it enables a consumer to apply patriotic or protectionist criteria in the choice of meat. And it enables one who believes that United States practices and regulation are better at assuring food safety than those of other countries, or indeed the reverse, to act on that premise…. We cannot declare these goals so trivial or misguided as to fall below the threshold needed to justify the “minimal” intrusion on AMI’s First Amendment interests.

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Spanish Trademark Office: “Paella Catalana” too Generic to Register as Mark

Trademark, Genericness, DescriptivenessOn September 10, 2013, Barcelona chef Quim Marqués applied to the Spanish Patent and Trademark Office for registration of the trademark PAELLA CATALANA–the name of a wildly popular dish of rice, chicken, and seafood created by Marqués at the restaurant El Suquet de l’Almirall. See Application No. M3090401 (Oficina Española de Patentes y Marcas). Although many people outside Spain view paella as a national dish of Spain, it originated in Valencia and is strongly associated with that Mediterranean region of the country. Marqués’s recipe for Paella Catalana adapts the traditional Valencian meal to the unique tastes of the autonomous community of Catalonia in the east of Spain by substituting calamari, crayfish, peas, and plums from different locales within the region.

However distinctive the taste of Paella Catalana may be, according to various news reports, the Trademark Office recently determined that its name–translated as “paella from Catalonia”–is too generic or simply too descriptive of the product to be registered as a trademark. See La patente de la ‘paella catalana’ vulnera la Ley de Marcas, (27 Mar. 2014); La Ley de Marcas frustra el registro de la denominación ‘paella catalana’, (26 Mar. 2014).

Article 5(1)(b) of Spain’s Trademark Law 17/2001 explicitly prohibits the registration of marks that lack distinctive character. Subsection (c) of the same provision further declares ineligible for registration marks–

… which consist exclusively of signs or indications that may serve in trade to designate the kind, quality, quantity, intended purpose, value, geographical origin, the time of production of goods or of rendering of the service or other characteristics of the product or service.

It is perhaps not surprising that these provisions forbidding the registration of purely descriptive terms seem to have frustrated Marqués’s attempt to claim exclusive rights in the name of his signature recipe. However, even without the added legal boost of a registered trademark, the mouthwatering qualities of the dish–featured in the short video below–appear more than strong enough to ensure its success in the marketplace.

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South Africa Advertising Body Says GM Crops Ad “Unsubstantiated”

GM Crops in South Africa
South Africa

On March 17, 2014, the Advertising Standards Authority (ASA) of South Africa–a non-governmental, self-regulatory body established by the marketing communication industry–declared that a radio advertisement that touted several benefits of genetically engineered crops violated the ASA’s Code of Advertising Practice. Mariam Mayet on behalf of The African Center for Biosafety v. Monsanto South Africa (Pty) Ltd, No. 22576 (S.A. Advertising Stds. Authority 17 Mar. 2014). The advertisement in question, run by Monsanto South Africa, contained the following statements:

GM crops enable us to produce more food sustainably whilst using fewer resources. GM crops and food are strictly regulated and have been extensively researched and tested for safety. GM crops provide a healthier environment by saving on pesticides and decreasing greenhouse gas emissions whilst increasing crop yields substantially.

The African Centre for Biosafety (ACB)–an advocacy organization that campaigns against transgenic crops and commercial agriculture–complained to the ASA that the claims in Monsanto’s commercial were unsubstantiated. Although Monsanto responded to the ACB’s complaint by citing scientific studies in support of its claims for the benefits of genetically modified crops, the ASA did not take those studies into consideration. The ASA explained that it “is not a technical expert, and would not be able to interpret scientific data and information to appropriately extrapolate findings.” For this reason, the ASA expects advertisers “to present unequivocal confirmation from an independent and credible expert in the relevant field to support the exact claims made in the advertising.” Acccordingly, the ASA deemed the statements in Monsanto’s commercial to be unsubstantiated because Monsanto did not submit evidence from “an independent and credible expert to confirm that the various studies relied on and referred to on its website are applicable to the respondent’s product, or that they support the advertising claims.”

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Brazilian Court Annuls Approval to Commercialize Transgenic Corn

Transgenic Corn in BrazilA federal appellate court in Porto Alegre, Brazil nullified a government commission’s approval for commercial release of the transgenic corn (maize) product known as LibertyLink. See Processo 5000629-66.2012.404.7000 (Tribunal Regional Federal da 4ª Região 13 Mar. 2014).

Transgenic CornAPPROVAL OF RELEASE LEADS TO LITIGATION. In 2007, the South American country’s National Technical Committee on Biosafety (CTNBio) approved the importation and use of LibertyLink, a herbicide-resistant, genetically modified variety developed by Bayer Cropscience. See Technical Opinion No.987/2007 – Commercial Release of Genetically Modified Corn, LibertyLink (Corn T25). However, a group of environmental, consumer, and small farmer organizations filed a judicial action to set aside CTNBio’s decision on the grounds of alleged environmental and health concerns and the purported failure of CTNBio adequately to evaluate the risks associated with transgenic corn.

Transgenic Corn in BrazilTHE APPELLATE COURT’S RULING. After inconclusive litigation in the lower court, on March 13, 2014, the Fourth Regional Federal Court invalidated CTNBio’s approval of LibertyLink due to its failure to conduct studies in the north and northeastern regions of Brazil. The court’s written summary of its decision began by urging policy makers to exercise “caution and humility” when dealing with matters that change the natural order. The court further opined that,

As human beings, we have limits, yet often our science and technology make us believe that we can always overcome them. The truth is that sometimes we make mistakes, and our mistakes can be very costly to the environment, to [other] species living on the planet, and to us in the present and our children in the future.

Transgenic Corn in Brazil, GMOs
General Biome Map of Brazil by Oak Ridge National Laboratory

COMMITTEE MUST CONSIDER ALL RELEVANT BIOMES IN PERFORMING RISK ASSESSMENT. The court observed that Article 14(4) of the national Biosafety Law (Lei nº 11.105, de 24 de Março de 2005), CTNBio’s decisions should take into account the particularities of different regions of the country. According to the court, when CTNBio performed its risk assessment for LibertyLink, it should have considered potential effects in all relevant regions (biomes) of the country. Such a broad consideration was necessary, the court stated, because of the vast territory of Brazil, the fact that pollen from corn plants can travel great distances, and the multiplicity of environments that could be affected. This does not mean that CTNBio should have conducted studies in all of Brazil’s states, but the court declared that the committee should at least have considered all biomes where the transgenic corn could be marketed if commercially released.

CALL FOR GREATER TRANSPARENCY IN DECISION MAKING. The court also quoted Principle 10 of the Rio Declaration on Environment and Development–which encourages public participation and widespread consultation by public bodies making decisions affecting the environment–as a reason for CTNBio to become more transparent in its decisions on applications for release of transgenic crops.

 by Shawn N. Sullivan, March 27, 2014.

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