Over the past several years, there has been a growing cry from the business sector about a menacing plague rising in the form of patent litigation originated by non-practicing entities, more commonly referred to as “patent trolls.” Big business, academicians, practitioners and politicians alike are demanding that our patent system be reformed to address this parasite to American capitalism.  Lately, it appears that there has been an all-out attack on this professed scourge of the business world, from the White House, to the halls of Congress, to the United States Supreme Court, and even to various State Houses and Attorneys General across the country.  Now we have to ask: Has the patent troll seen its time come and go?

Since passage of the America Invents Act, there have been no less than 12 bills presented in Congress directed at curbing perceived abuses of the U.S. patent system, particularly in enforcement of patent rights. Several changes to the Patent Act, including discovery reform, heightened pleading requirements and amending the Patent Act’s fee shifting provisions to a loser-pays system, are all on the table. Even a cursory view of the proposed amendments show they are principally directed at curbing perceived abuses by patent trolls.

In addition, at least nine states including Vermont, Oregon, Wisconsin, Georgia, Virginia and Missouri, have either passed or are considering legislation directed at curbing the rise in mass mailing demands from trolls for patent license payments.  Generally, these legislative enactments make it a crime to send patent licensing demands that contain false or misleading information.  Wisconsin, for example now requires any notification seeking enforcement of a patent to include comprehensive patent information including detailed facts forming the basis for the infringement allegations and an identification of any pending court or administrative proceeding related to each asserted patent.  In addition, states are empowering their attorneys general to enforce the provisions of their anti-troll laws with both civil and criminal action. Continue Reading Are We Witnessing the Beginning of the End of the Patent Troll?

In arguments before the Supreme Court earlier this week, Coca-Cola asserted that its label for Minute Maid “Pomegranate Blueberry” juice, which contained a “flavored blend of 5 juices” complies with FDA rules and therefore, Coca-Cola could not be sued by a competitor for using an allegedly “misleading” label under the Lanham Act.  Years ago, the juice market was dominated by apple and orange juices – until POM Wonderful introduced pomegranate based drinks trumpeting the health benefits of pomegranate juice.  POM Wonderful fairly aggressively challenges drink makers that offer beverages with small amounts of pomegranate, while still boasting of the health benefits associated with the juice.

Pom Wonderful sued Coca-Cola under the Lanham Act on the ground that Coca-Cola’s product misleads consumers because purchasers would have no way of telling that the total amount of pomegranate and blueberry in the juice amounts to “a teaspoon in a half gallon.”  Coca-Cola’s defense rested on the ground that the FDA’s right to regulate and approve labels preempts POM Wonderful’s false advertising claims.

During oral arguments, Chief Justice John Roberts seemingly disagreed with Coca-Cola’s defense:  “I don’t know why it’s impossible to have a label that fully complies with the FDA regulations and also happens to be misleading on the entirely different question of commercial competition, consumer confusion that has nothing to do with health.”  Similarly, Justice Anthony Kennedy seemed skeptical of Coca-Cola’s assertion that consumers are sophisticated enough to know that other juices would be in the bottle because the food label contained the word “flavored”.  Justice Kennedy wryly stated:  “Don’t make me feel bad because I thought that was pomegranate juice.”  Justice Ruth Bader Ginsburg also seemed nonplussed by Coca-Cola’s argument, stating “But maybe the two acts are serving different purposes.”

A favorable decision on behalf of POM Wonderful could give rise to an increase in consumer and competitor suits over labelling and advertising claims.  A decision in the case is expected in June.

From the 1980s, scientists from around the world started to search for specific genes that were associated with increased hereditary risk for breast cancer.  By 1990, two genes, BRCA1 and BRCA2, were discovered that if they had specific mutations/alleles would impart an increased risk for breast cancer in women.

In 1994, Myriad Genetics announced that they had sequenced the mutant alleles of BRCA1 and in the subsequent year, they sequenced the mutant alleles for BRCA2.  Right away, Myriad sought and obtained two different kinds of composition patents covering the genetic material of the BRCA genes.  First, they patented the isolated DNA molecules of BRCA1 and BRCA2.  Second, they obtained patents to “complementary DNA” (cDNA) associated with each of the BRCA genes.  cDNA contains only the coding sequences of the gene.  Unlike DNA, it normally does not exist in the body.

With these composition patents, Myriad started to offer exclusive screening of the BRCA genes to women wanting to know their hereditary cancer risk.  However, in 1996, the Genetic Diagnostic Laboratory (“GDL”) at the University of Pennsylvania also started to offer diagnostic screening for the BRCA genes.  Myriad then sent a series of cease-and-desist letters notifying GDL to stop offering BRCA screening to which GDL complied.  At around the same time, Myriad filed several patent infringement suits against other parties that were offering BRCA testing.  The suits were dismissed when these other parties ended their BRCA testing.

A few years later, numerous parties, including doctors at GDL, initiated legal action in the Southern District of New York seeking a declaratory judgment that Myriad’s BRCA patents were invalid.  The District Court granted summary judgment in favor of the plaintiffs, declaring that Myriad’s composition claims for both isolated DNA and cDNA were not patentable under the “products of nature” exception.  In making the ruling, the District Court relied on the decision by the U.S. Supreme Court in Chakrabarty, 447 U.S. 303 (1980) that required a patentable composition of matter to include “markedly different characteristics” from a product of nature.  Thus, the District Court was unconvinced that simply isolating a DNA molecule would make it “markedly different” in a legally significant manner.  Further, the District Court considered the coding sequences of cDNA to be identical to portions of naturally occurring DNA, and accordingly, the District Court deemed the cDNA was also not patentable under the “products of nature” exception.

Continue Reading DNA Composition Claim in the U.S.

Genetic testing continues to play an increasingly important role in the selection of animals for beef cattle production. Recently, the United States Supreme Court determined that the discovery of the location of a gene on a chromosome is not eligible for patent protection. This ruling will significantly alter the playing field for cattle genomics companies that seek to patent genes in relation to tests for traits like marbling, tenderness, or milk production.

In Association for Molecular Pathology v. Myriad Genetics, Inc.,[1] the Supreme Court held that the location of genes and the order of nucleotides in a gene are “products of nature” that do not meet the Patent Act’s invention requirement. At issue in Myriad were patents directed to two DNA markers that identified the BRCA1 and BRCA2 genes as well as the normal sequence of nucleotides within those genes.  Women with certain mutations in these genes have an extraordinarily high risk of developing breast or ovarian cancer. Myriad’s patent claimed the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes and the sequence of the nucleotides within those genes. As a result, no other laboratories could perform tests for mutations of these genes because isolating the genes and their DNA sequence in any individual would infringe Myriad’s patent.

Continue Reading Supreme Court Invalidates Patents on DNA Markers, Beneficial to Cattle Producers

The U.S. Supreme Court recently granted certiorari to hear an appeal filed by POM Wonderful LLC in connection with its suit against The Coca-Cola Company under the Lanham Act alleging that Coca-Cola’s  “Pomegranate  Blueberry” juice labels are misleading. POM Wonderful asserts these labels are misleading due to the fact that, despite the name, the product contains very little pomegranate  or blueberry juice. Instead, the juice contains approximately  99 percent grape and apple juice, and only 0.3 percent pomegranate  juice and 0.2 percent blueberry juice.

Coca-Cola argues that the product label has images of all five fruits contained in the beverage and that the name “Pomegranate  Blueberry – flavored blend of 5 juices” clearly informs consumers that the product is a blend of fruits and tastes like pomegranate  and blueberry juice. In essence, Coca-Cola asserted that its labels are technically in compliance with Food and Drug Administration  (FDA) regulations.

The Ninth Circuit affirmed the district court’s grant of summary judgment to Coca-Cola on the ground that POM Wonderful does not have the right to challenge FDA regulations that allow Coca-Cola to label the beverage as Pomegranate  Blueberry juice. The Ninth Circuit asserted that the Food, Drug and Cosmetic Act (FDCA) wholly regulates food and beverage labeling and as such, a plaintiff cannot sue under the Lanham Act to enforce the FDCA or its regulations or to interpret ambiguous FDA regulations. In other words, according to the Ninth Circuit, the FDCA expressly preempts product labeling claims, thus leaving no room for a company to challenge a competitor’s label under the Lanham Act.

Continue Reading High Court to Weigh In on Labeling Dispute Between Competing Beverage Companies