[T]he Guidelines’ assumption that many types of pharmaceutical inventions are inherently obvious and undeserving of patent protection is incorrect and based on an oversimplified view of how these inventions come about. This Article provides an evidence-based response to the Guidelines that refutes, or at least qualifies, some of the significant conclusions and recommendations set forth by its author.
by Drake T. Land
J.D. Candidate, 2015, Indiana University Robert H. McKinney School of Law
Indiana International & Comparative Law Review: Executive Articles Development Editor
B.S., 2007, Ball State University; Muncie, Indiana
Editor’s note: Mr. Land’s article was selected from submissions in the Indiana Law Review‘s first writing competition.
Following the introduction of Genetically Modified Organisms (“GMOs”) into the food market in 1994,  consumer groups and multiple legislative bodies have fought to restrict their sale and label GMOs differently than traditionally developed foods. . This push to restrict the sale, or label, of GMOs is born of the fear that GMOs will have unforeseen consequences to human health and/or the environment. . These fears have been shown to be unrealized after twenty years of market availability  and, although restrictions on the sale of GMOs and mandatory labeling is the law in most European countries,  labeling initiatives have not achieved the same success in the United States’ federal and state governments. . The European Union “has probably the strictest GMO regulations in the world though these derive rather from political considerations, rather than being based upon scientific principles.” . Unlike the European Union (“the EU”), the United States Constitution explicitly “promote[s] the progress of science,”  and under this framework the United States has provided more protection to the development and retail of GMOs.
All currently grown crops have been developed through genetic modification. . “By selectively breeding plants and animals with the most desirable traits, our predecessors transformed organisms’ genomes, turning a scraggly grass into plump-kerneled corn, for example.” . Following Mendel’s discovery of the inheritance of genetic traits, farmers and scientists alike have been using selective breeding and hybridization to alter food crops to make them more reliable and marketable. . “Today, there are virtually no food products in supermarkets that have not been improved in some manner by selective breeding.” .
Keyword advertising is not a new phenomenon. Some believe that various forms of keyword advertising have been around since as early as 1996. . Generally defined as a “form of advertising on the Internet in which a business pays to have an advertisement [for] a website appear on [a consumer’s] computer screen when [the consumer] uses a particular word or phrase to search for information on the internet,”  keyword advertisements play a very important role in the marketing and advertising of many businesses.
Section 285 of the Patent Act allows a prevailing party to recover attorneys’ fees in “exceptional” cases. . In Octane Fitness, LLC v. Icon Health & Fitness, Inc.,  and Highmark Inc. v. Allcare Health Management Systems, Inc.,  the Supreme Court relaxed the requirements for proving an “exceptional” case in three significant ways: (1) now a party who files a section 285 motion need only prove that a case is “exceptional” by a preponderance of the evidence;  (2) the movant no longer has to prove bad faith and objective baselessness,  but instead must prove that, under the “totality of the circumstances,”  the case “stands out from others,” considering numerous factors, such as “frivolousness, motivation, objective unreasonableness (both in the factual and legal components of the case) and the need . . . to advance considerations of compensation and deterrence;”  and (3) the appellate standard of review under section 285 is now a deferential abuse-of-discretion standard. .
Intellectual property litigators must be aware of these changes and also how various district courts are applying them. This article analyzes the dozens of cases that have applied Octane Fitness and Highmark, with a particular focus on district court opinions,  and identifies helpful trends and insights for patent litigators.