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

Is Intellectual Property a Hurdle for Transferring Technology to Developing Countries? If so, How High of a Hurdle?

It might appear that intellectual property protection has a positive impact on a country’s economic development. According to Professor François Dessemontet, “there is a strong correlation between the rate of patents sought by enterprise and the general level of economic developments.” However, it would be arrogant to presume that a one-size-fits-all approach toward intellectual property protection would work for developing countries. In fact, as noted by Sir Hugh Laddie, “[f]or too long intellectual property rights have been regarded as food for the rich countries and poison for poor countries . . . Poor countries may find them useful provided they are accommodated to suit local palates. The . . . appropriate diet for each developing country needs to be decided on the basis of what is best for its development, and that the international community and governments in all countries should take decisions with that in mind.” This essay explores whether intellectual property rights serve as a hurdle for the transfer of technology to developing countries, or whether there are other, subtler influences at work. This essay also explores whether other mechanisms can be employed to encourage the transfer of technology to developing countries.

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Reach-Through Rights and the Patentability, Enforcement, and Licensing of Patents on Drug Discovery Tools

A novel, nonobvious Discovery Tool and its use can be the subject of valid patent claims, but patent claims that reach through to cover as-of-yet-undiscovered drug products generally fail to meet the written description and enablement requirements of 35 U.S.C. § 112. Notwithstanding the Supreme Court’s broad reading of the scope of the statutory exemption to infringement—under 35 U.S.C. § 271(e)(1)—in Merck v. Integra, and the occasionally misapplied common law experimental use exception, valid claims to Discovery Tools and their use are enforceable against unauthorized users. This article analyzes the legality of one form of compensation occasionally sought by Discovery Tool inventors as consideration for the grant of a license to the use of their patented tools: the “reach-through” royalty paid on the sale of a product that is identified by a licensee using a patented Discovery Tool, but is not itself covered by the inventor’s tool patent. In addition, this article reviews judicial remedies in patent infringement cases that reach through the infringed patent to burden products and activities of the infringer that are not covered by the infringed patent—remedies that are analogous to a negotiated contractual reach-through royalty obligation. The article concludes that reach-through royalty arrangements between willing licensors and licensees are permissible under U.S. Supreme Court precedent, despite potential patent misuse challenges, and represent a viable method by which the free market for patented Discovery Tools may adequately reward the tool inventor.

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