In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge Newman wrote a dissenting opinion warning against the chilling effect that antitrust liability could have on a citizen’s right to communicate with the FDA on matters relating to drug safety and efficacy. Continue reading this entry
As announced on the “USPTO Locations” page of its website, the USPTO has implemented a new policy for members of the public visiting the USPTO relating to the REAL ID Act. Under the REAL ID Act, the USPTO may no longer accept driver’s licenses from certain states and instead will require an Enhanced Driver’s License or Federal-issued identification to grant access to secured areas of the USPTO. This means that members of the public visiting the USPTO for an examiner interview or board hearing may need to bring their passports with them. Continue reading this entry
With thanks to my colleague Dr. Christopher Swift for his expert advice on the intersections of US and international law.
The “Myriad-Mayo” patent subject matter eligibility guidance issued March 4, 2014 reflects the USPTO’s interpretation of Supreme Court cases interpreting and applying 35 USC § 101 to claims involving laws of nature, natural phenomena, and natural products, but the USPTO appears to have issued the Guidance without considering whether it comports with the United States’ obligations under international treaties, such as the Uruguay Round Agreements Act (URAA) and the Trade-Related Aspects of Intellectual Property (TRIPS). Here, I highlight how the Guidance is inconsistent with both the requirements of TRIPS in particular and U.S. trade policy in general. Continue reading this entry
This week brings the July 31, 2014 deadline for submitting written comments on two USPTO patent subject matter eligibility guidance documents: The “Myriad-Mayo” Guidance issued March 4, 2014 (for claims involving laws of nature, natural phenomena, and natural products) and the “Alice Corp. v. CLS Bank” Guidance issued June 24, 2014 (for claims involving abstract ideas). These guidance documents make clear that patent applications in all technology areas could be subject to scrutiny under 35 USC § 101, so stakeholders may not want to miss this opportunity to weigh in on how the USPTO should interpret and apply the Supreme Court decisions in Mayo, Myriad and Alice Corp.
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In Align Technology, Inc. v. International Trade Commission, the Federal Circuit held that ITC action that violated ITC’s own regulations warranted vacatur under the Administrative Procedures Act. While the case addresses specific ITC regulations, the same principles apply to other agencies, including the USPTO. Thus, the USPTO should take note of this decision, and take care to follow its own regulations, including those relating to the new patent trial proceedings conducted by the Patent Trial and Appeal Board.