The Patent Prosecution Highway: Is Life in the ‘Fast Lane’ Worth the Cost?

Search queries may reveal quite sensitive information about the querier. Even though many queries are not directly associated with a particular person, it has been argued that the IP addresses and cookies of the users can often be sufficient to figure out who the querier is, especially if tied to information from ISPs regarding IP address assignments at the time of the relevant query. Given that the queries have been subject to discovery both by various governments and third parties, there has been great concern for how to keep such queries private. A typical approach to such privacy legislation, especially in Europe, has been to require either destruction of the data so that it is no longer available for discovery, or anonymization so that it cannot be associated with a particular person. This solution has never been proposed for personal data such as medical information used by doctors or financial information used by credit agencies. Instead, there seems to be an assumption about these types of data that their long-term storage is necessary and/or beneficial to the individual associated with them, or at least to society at large. The framework for maintaining the privacy of these data turns on safeguards where it is being held, user control of its retention and accuracy, and strict legal limitations regarding its discovery. This article briefly reviews a few legal frameworks for data protection both in the U.S. and in Europe. It presents several arguments that the deletion or anonymization of search query data is problematic, and describes a framework similar to the way we handle health data that is more beneficial to all stakeholders. Such an approach would lead to a more uniform solution to data protection in which maintaining search query privacy would not sacrifice the benefits of long term, confidential storage of the data.

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Of Babies and Bathwater – The Impact of In Re Bilski on Life Science Patents

Tension between the broad language of 35 U.S.C. § 101 and limitations of its scope is an emerging issue in recent court decisions attempting to resolve the issue of whether patent claims preempt a natural phenomenon. These decisions significantly impact the patentability of personalized medicine inventions that rely on discovery of correlations between biomarkers and the safety and efficacy of therapeutic treatment in an individual. While a “business methods” case, the Federal Circuit’s In re Bilski decision may have a profound impact on medical diagnostics and personalized medicine patents by altering the ability of personalized medicine companies to protect the technology behind their products. A patent law that identifies the unique specificities of a particular industry will better serve the advancement of biotechnology and personalized medicine.

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A Better Carrot Incentivizing Patent Reexamination

Patent reexamination provides a potentially powerful alternative to full invalidity litigation, but it has been underutilized because of deficiencies in the patent reexamination system. The system’s appeal as an alternative to invalidity litigation is greatly diminished by constraints on forms of evidence and grounds for invalidity, the limited potential for challengers to participate in the process, and the significant risk a challenger takes in pursuing patent reexamination. While reforms have been proposed, most have focused on enlarging the procedure within the context originally established by Congress. Although such reforms may be important, they do not address the central obstacle to third party challenges. This note discusses an incentive structure that may encourage third parties to overcome the perverse motivation to practice willful blindness, and encourage active reading of issued patents.

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Exceeding the Scope of the Patent: Solving the Reverse Payment Settlement Problem Through Antitrust Enforcement and Regulatory Reform

Reverse payment settlements in pharmaceutical patent litigation, also known as “pay for delay” settlements, are almost universally anticompetitive. Nonetheless, because of the current regulatory framework and a failure of courts to address the definition of patent scope, many of these settlements are upheld as legal, falling under a patent “exception” to antitrust liability. The patent “exception”, however, does not apply to pay-for-delay settlements, because paying to protect a patent is inherently beyond the scope of that patent. This note addresses the problem of reverse payment settlements and proposes a new comprehensive solution.

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KSR Fallout: Questions of Law Based on Findings of Fact and the Continuing Problem of Hindsight Bias

KSR v. Teleflex marked the Supreme Court’s first significant return to the question of patent “obviousness”—which is used to ensure patents are not improvidently granted to inevitable inventions—in over four decades.  If a jury finds an invention would have been obvious to one of ordinary skill in the art at the time the invention was made, the court is likely to find the patent invalid.  The changes mandated by KSR to non-obviousness determinations provide the opportunity to adjust jury instructions in order to address existing problems in non-obviousness law. Continue reading