High Standards for Patentable Diagnostic Tests in the Era of Personalized Medicine
Staff Writer
On March 20, 2012, the U.S. Supreme Court unanimously held that Prometheus Laboratory Inc.’s (“Prometheus”) diagnostic process to determine the appropriate level of thiopurine drugs for a patient is not patentable. Thiopurine drugs are used to treat autoimmune diseases. Because each person metabolizes thiopurine at different rates, physicians struggle to determine an appropriate therapeutic dose for a particular patient. Doses that are too high will cause toxic side effects, while doses that are too low will not be therapeutically effective. Prometheus patented a test for determining the precise correlations between how a patient metabolizes thiopruine and what is the appropriate dose for that patient. Although Mayo Clinic Rochester and Mayo Collaborative Services (“Mayo”) had previously used Prometheus’ test, in 2004 it announced an intention to use and sell its own test, which would be similar to the Prometheus test, but with higher metabolite levels. Prometheus sued Mayo for patent infringement. (more…)
The Bill of Rights, Version 2.0: White House Releases “Consumer Privacy Bill of Rights”
On February 23, 2012, the White House issued a press release on its plan to protect consumer privacy on the Internet through a “Consumer Privacy Bill of Rights.” This proposal is part of a larger goal to adopt comprehensive consumer data privacy in the Internet age, as well as bring the United States into conformity with similar privacy principles that are currently enforced throughout the world. This new “Bill of Rights” would increase the protection of individual privacy rights, give users more control over how their information is handled, and allow for new legal tools to protect against misuse of information.
The Consumer Privacy Bill of Rights would apply to all “personal data,” meaning “any data, including aggregations of data, that is linkable to a specific individual.” The newly developed rights include the right to control how personal data is used, the right to avoid having information collected in one context and then used for an unrelated purpose, the right to have information held securely, and the right to know who is accountable for the use or misuse of an individual’s personal data.
The Consumer Privacy Bill of Rights adopts seven general guiding principles for future rule-making and legislation: (more…)
The Washington Journal of Law, Technology & Arts is pleased to announce Kerra J. Melvin as its 2012-13 editor in chief.
Kerra, Class of 2013, is a Butte, Montana native. After graduating from Montana Tech of The University of Montana with a degree in Accounting, Kerra moved to Washington, D.C., where she served first as an intern and a full-time staffer for the United States Senate Finance Committee. Kerra’s interest in law and policy and desire to live and practice in Seattle brought her to The University of Washington School of Law, where her studies focus primarily on corporate and tax law. She looks forward to working with the 2013 Editorial Board and Faculty Adviser Professor Robert Gomulkiewicz to build upon the LTA Journal’s strengths and to make it an even more accessible and useful resource for practitioners.
Kerra will begin her editor duties during Spring quarter.
Texas Jury Finds that Eolas Technologies Does Not Own the World Wide Web
On February 8, 2012, an eight-member federal jury, comprised of laypersons from the Eastern District of Texas, invalidated two internet patents. In the suit filed by co-plaintiffs Eolas Technologies (“Eolas”) and the University of California (“UC”), the plaintiffs alleged that co-defendants, including some of the world’s largest internet-based companies, infringed the two patents in question. This decision has many parties that operate over internet-based technologies and public-domain advocates breathing a sigh of relief. The invalidation of the two patents mitigates potential future liability of infringement for parties that operate interactive websites.
Eolas, which biologist and company founder Michael Doyle named after the Gaelic term for knowledge, is a patent holding and licensing company that has successfully obtained royalty payments from large parties operating over the internet, including Microsoft in a famous 2007 case (for an undisclosed settlement amount reported to be in excess of $100 M USD). In recent years, Eolas relocated its headquarters from Chicago to the small town of Tyler, Texas, which houses the federal courthouse where many patent infringement cases are tried. Many plaintiffs choose the Eastern District of Texas for patent infringement cases because patent holders believe that the jury pool found in and around Tyler is extremely patentee friendly. Because of these actions, many commentators and parties participating in internet-based business transactions have characterized Eolas as a “Patent Troll.” (more…)
Europe Paves the way for Enhanced Online Privacy Protection
Last month, the European Commission proposed a new directive to enhance Internet privacy rights by regulating the access, collection, and use of personal data online. The proposed regulation would require Internet-based companies to obtain consumers’ express consent before using their personal data, and would also require those companies to delete user data upon request. The new directive would protect information ranging from e-mail and IP addresses to bank records and posts on social networking sites.
Notably, the proposed directive will not exempt American-based companies doing business in the European Union. Rather, the new regulation would require companies that offer services to EU citizens to provide the same protections for personal data handled outside the EU. This could be a potential blow – or at least an administrative hurdle – for global companies like Facebook, which has already been subject to multiple lawsuits involving users’ privacy rights in the United States.
While U.S. legislators may eventually follow the EU’s lead and enact statutes to broaden the right to online privacy, the United States has historically lagged behind Europe when it comes to privacy protection. In fact, the EU Charter of Fundamental Rights expressly guarantees the right to “protection of personal data.” Still, if the new EU regulation passes parliament this year, American Internet giants like Amazon and Facebook may have to revise their privacy policies for European Union consumers. This should at least prompt Congress to consider whether American Internet users deserve the same protections.
Twitter to Begin Balancing Free Expression with Legal Compliance
On January 26, Twitter announced that it will remove Tweets on a country-by-country basis. Recognizing that freedom of expression is a “human right,” Twitter also acknowledged the “responsibilities” and “limits” that accompany such a right, especially in countries such as France or Germany, where pro-Nazi content is banned by law. Previously, Twitter could only implement global bans – no matter where the Tweet was posted, no one in the world could see the Tweet if it was taken down. Now, only persons from the originating country will be blocked, while the rest of the world can still see an offending Tweet. This country-by-country policy would help Twitter comply with laws that vary by country. The New York Times observed that the majority of Twitter’s 100 million users live overseas, and that Twitter was confronting the complexities of being both a free speech tool and commercial venture.
Unsurprisingly, the revised policy has sparked considerable controversy, resulting in an immediate “Twitter Blackout” on January 28. But others have remarked that Twitter is balancing the values behind free speech with necessary compliance with foreign and local laws. One commentator remarked how Twitter was the only company to fight the United States government over the Wikileaks case, and Twitter informed users when it lost. The policy has also been praised for its transparency, as users are notified when infringing Tweets are removed, and Twitter will post updates relating to notices on the “Chilling Effects” website, http://chillingeffects.org/twitter. (more…)
Supreme Court Upholds Fourth Amendment Rights In GPS Tracking Case
On Monday, the Supreme Court released its highly anticipated decision in the Fourth Amendment case Unites States v. Jones. The decision, unanimous in favor of respondent Jones, upheld the D.C. Circuit’s reversal of his drug-related convictions.
Jones came under suspicion of trafficking in narcotics in 2004. He was made a target of an investigation that included attaching a GPS tracking device to the car he frequently used. As implemented by law enforcement, the use of this tracking device fell outside the scope of any warrant police had obtained. The device was used to track the vehicle’s location for 28 days and collected more than 2,000 pages of data.
The Supreme Court agreed with the D.C. Circuit that this investigative behavior, outside the scope of a search warrant, was a violation of Jones’ Fourth Amendment right to be secure in his effects against unreasonable searches. The majority position, written by Justice Antonin Scalia, stated that the Court had “no doubt that such a physical intrusion would have been considered a ‘search’ within the meaning of the Fourth Amendment when it was adopted,” citing to, among other authorities, an English case from 1765. (more…)
Second Chance for Blogger Rights
In December, the U.S. District Court for the District of Oregon declined blogger Crystal Cox the protection of an Oregon reporter shield law and First Amendment case law, holding that both applied only to institutional media. See Obsidian Finance Group v. Cox, 2011 WL 5999334, CV-11-57-HZ (D. Or. Nov. 30, 2011). Now she might get a second chance to challenge the defamation claim against her. Cox filed a motion for a new trial Jan. 4, this time with the aid of two attorneys, one of them First Amendment scholar Eugene Volokh – a stark contrast to her previous pro se representation.
The Seattle Weekly provides a concise background of the case, but the gist is that Cox was sued for defamation by investment firm Obsidian Finance Group after writing several blog posts that were critical of the firm and its co-founder. Allegations regarding all but one post were dismissed. Cox admitted that the final post at issue was factual in nature, declining her ability to argue it was protected opinion. But she refused to name the source of the information, claiming Oregon’s Shield Law, Or. Rev. Stat. §44.510 et seq., offered her protection. Cox further asserted that the plaintiff failed to prove negligence or actual malice under the Gertz standard for defamation. See Obsidian Finance, 2011 WL 5999334 at *5 (citing Gertz v. Robert Welch, Inc., 418 U.S. 323, 347 (1974)). While Cox claimed to be an investigative journalist, U.S. District Judge Marco A. Hernandez found her not to be a “journalist” within the parameters of the statute, declining to offer her its protection. He also deemed that Gertz, which requires a showing of negligence when a private speaker is defamed, only applied to journalists, not bloggers. Without these defenses, a jury imposed a $2.5 million verdict against her. (more…)
Isolated Transcription Errors and Tax Preparation Software
Last September, the LTA blog discussed a line of Tax Court cases in which taxpayers unsuccessfully attempted to defend themselves from I.R.S. penalties by arguing that their reliance on tax preparation software amounted to reasonable cause and good faith. After this line of consistent taxpayer defeats, the Tax Court recently ruled in favor of a taxpayer who used tax preparation software to self-prepare his tax return and mistakenly omitted a large amount of trust fund income from his taxable income. See Olsen v. Commissioner. T.C. Summ. Op. 2011-131. While Olsen is notable because a taxpayer who relied on a tax return preparation program was able to assert a successful defense against I.R.S. penalties, it is especially interesting because the successful taxpayer argument in this case was more nuanced than those in previous cases.
Generally, when a taxpayer substantially understates his tax liability by more than $5,000, the I.R.S. asserts a substantial omission penalty against the taxpayer. I.R.C. §6662(b)(2), I.R.C. §6662(d). When faced with this substantial omission penalty, a taxpayer may argue that he qualifies for an exception to the penalty because he had a reasonable cause for the understatement and he acted with good faith. I.R.C. §6664(c). In determining whether a taxpayer acted with reasonable cause and good faith, a court will look at all the pertinent facts and circumstances. Treas. Reg. § 1.6664-1(b)(1).
In the past, taxpayers who relied on software programs to help them prepare their tax returns had a hard time proving reasonable cause and good faith and the Tax Court upheld the penalty, reasoning that tax return preparation software is only as good as the information a taxpayer puts into it. See e.g. Bunney v. Commissioner, 114 T.C. 259, 267 (2000), Lam v. Commissioner, T.C. Memo 2010-82, Anyika v. Commissioner, T.C. Memo 2011-69.
Carrier IQ Litigation: Does Data Gathering on Phones violate Federal Wiretapping Laws?
Recently, Carrier IQ has come under scrutiny for the vast amounts of data it gathers from cell phone users. A cell phone analytics company, Carrier IQ claims it’s software is installed on over 141 million devices. Apparently, the software is mostly on phones from AT&T, Sprint, and T-Mobile. This software has the ability to gather vast amounts of data from users, including logging keystrokes, user location, and telephone calls. For example, the software can track what websites a person visits, as well as the usernames and passwords used on those sites. Since this information is tracked directly from the phone or mobile device, it does not matter if the device is used over wi-fi networks or cellular networks, or if the website itself is encrypted. The potential for invasion of privacy is enormous.
Carrier IQ has responded, saying “While we look at many aspects of a device’s performance, we are counting and summarizing performance, not recording keystrokes or providing tracking tools.” (more…)









leave a comment