Now that the Supreme Court has issued its decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.), people are wondering what the decision means for the Myriad patents and BRCA1/BRCA2 genetic testing. If you missed it, this article provides an overview of the Supreme Court Myriad decision. Here, I review the claims of the seven patents that were at issue, and highlight how they may or may not be affected by the Supreme Court decision. My comments are provided for discussion purposes only, and do not constitute any legal determinations of validity, invalidity, or freedom to operate.
On June 13, 2013, the Supreme Court issued its long-awaited decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.). In a unanimous opinion authored by Justice Thomas, the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”Continue reading this entry
In Organic Seed Growers and Trade Association v. Monsanto Co., the Federal Circuit dismissed the plaintiffs’ declaratory judgment action against Monsanto, but in so doing held that Monsanto would be judicially estopped from asserting its patents against these farmers for inadvertent infringement that results in the production, use, or sale of only trace amounts of infringing seed.
On June 4, 2013, the White House issued a press release announcing its “Task Force on High-Tech Patent Issues.” The press release outlined five executive actions and seven legislative recommendations “designed to protect innovators from frivolous litigation and ensure the highest-quality patents in our system.” The target of these initiatives are so-called “patent trolls,” whom the White House asserts are responsible for 62 percent of all patent infringement suits in the United States.Continue reading this entry
As I wrote previously, Congressman Goodlatte (R-Va.) released “a discussion draft” of patent reform legislation on May 23, 2013. Although the stated purpose of the draft legislation is to “address the ever increasing problem of abusive patent litigation,” it also includes other significant proposed changes, including provisions that would eliminate Section 145 actions and eliminate Exelixis I-type Patent Term Adjustment (PTA), as I summarized in this article. Here, I look at the provisions that would codify the doctrine of obviousness-type double patenting (OTDP). Continue reading this entry
As reported on the House Judiciary Committee website, on May 23, 2013, Congressman Goodlatte (R-Va.) released “a discussion draft of legislation designed to address the ever increasing problem of abusive patent litigation.” This draft legislation comes on the heels of the Patent Abuse Reduction Act of 2013 (S. 1013), which was introduced in the Senate by Senator Cornyn (R-Tx.) on May 22, 2013. While much attention has been focused on the patent litigation provisions of these bills, the Goodlatte proposal also would, among other things, eliminate Section 145 actions and eliminate Exelixis I-type Patent Term Adjustment (PTA). While this bill has not been introduced in the House, it is supported by Senator Leahy (D-Vt.) who may introduce similar legislation in the Senate. Continue reading this entry
In Dey, L.P. v. Sunovion Pharmaceuticals, Inc., the Federal Circuit vacated the district court’s grant of summary judgment in favor of Sunovion, and remanded for further consideration of whether Sunovion’s clinical trial constituted a “public use” of the formulation claimed in Dey’s patents. As noted by the court, this case is interesting because most pharmaceutical ”public use” cases involve the patent holder’s own clinical trial, while this one involves that of the alleged infringer.Continue reading this entry
While U.S. patent practitioners have been focusing on the changes to U.S. patent law embodied in the Leahy-Smith America Invents Act (AIA), Congress has taken additional steps to harmonize and streamline patent application procedures in accordance with an international treaty, the Patent Law Treaty of 2000 (PLT). The Patent Law Treaties Implementation Act of 2012 (PLTIA) was enacted on December 18, 2012, with a one-year effective date of December 18, 2013. The USPTO has published proposed rules to implement the PLT provisions, and will consider written comments received by June 10, 2013. Stakeholders will be interested to see the changes that relax the requirements for securing an application filing date, provide some flexibility in making a priority claim after the priority term has expires, and eliminate the “unavoidable” standard for reviving abandoned applications and obtaining acceptance of delayed fee payments.
In Uship Intellectual Properties, LLC v. United States, the Federal Circuit upheld the claim construction applied by the Court of Federal Claims when it held that the United States and IBM Corporation did not infringe the claims at issue. Coming on the heels of the Biogen case, this decision provides another warning that any statements made during prosecution can give rise to prosecution history disclaimer.
In a Federal Register Notice published on May 17, 2013, the USPTO announced After Final Consideration Pilot Program 2.0 (AFCP 2.0) as part of its ongoing efforts to “reduce pendency by reducing the number of Requests for Continued Examination (RCE) and encouraging increased collaboration between the applicant and the examiner to effectively advance the prosecution of the application.” The program is set to commence May 19, 2013 (yesterday!), and will run run through September 30, 2013. Continue reading this entry