In a recent decision of the CAFC entitled Millennium Pharmaceuticals, Inc. v. Sandoz Inc., et al, a consolidated appeal of cases 2015-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1109, 2016-1110, 2016-1283, and 2016-1762, decided July 17, 2017, Judge Newman writing the opinion for a unanimous panel reversed a decision of the District Court for the District of Delaware holding the patent (US 6,713,446) on the cancer drug Velcade® invalid for obviousness. That drug had been used clinically to successfully treat multiple myeloma and mantle cell myeloma. The active moiety in Velcade® was the compound D-mannitol N-(2-Pyrazine)carbonyl-L-phenylalanine-L-leucine boronate. That compound arose as a result of a yearlong quest to solve the instability problem with solutions of the non-sugar containing bortezomib compound. When the inventor of the ‘446 patent (a scientist at the NCI and the University of Kansas) lyophilized bortezomib in the presence of mannitol he obtained the aforesaid boronate which had covalently incorporated the mannitol producing a new compound. This compound proved to be not only stabile on storage and in solution but also when administered to a subject functioned as a prodrug for bortezomib. No prior art was presented that taught or suggested a compound whose structure presented a basis for an...
Tagged: Patent Prosecution
Recently, the UK Minister of State for Intellectual Property, Baroness Neville-Rolfe, announced that the UK will implement the Unitary Patent (UP) and Unified Patent Court (UPC). In the announcement, Neville-Rolfe both praised the UP/UPC system as “provid[ing] an option for businesses that need to protect their inventions across Europe” and cautioned that the UK’s decision to implement the UP/UPC system “should not be seen as preempting the UK’s objectives or position in the forthcoming negotiations with the EU.”
In a recent decision, the Supreme Court affirmed the Federal Circuit’s ruling that the Patent Trial and Appeal Board (PTAB) was within its authority to give a patent claim “its broadest reasonable construction” during an inter partes review (IPR) proceeding. The Court found that the PTAB was authorized to apply this standard because 35 U. S. C. §316(a)(4) granted the Patent Office authority to issue “regulations . . . establishing and governing inter partes review under this chapter.”
On Sunday, The Washington Post published an interesting article explaining how the long lost Wright brothers’ patent file for the “Flying Machine” was finally found in March. The government had been searching for this file for the last 16 years. The file, which was last seen in 1980, was thought to be stored in a vault at the National Archives. But, in 2000, when an official commemoration was being planned, they realized it was missing. Ultimately, they were able to locate it in a limestone storage cave in Lenexa, Kansas. Although there was concern that the important record was stolen, the conclusion now is that it was probably just misfiled. The article indicates that the National Archives was able to identify this file as a part of a larger effort to locate missing documents.
Last month, the U.S. Supreme Court granted certiorari in Cuzzo Speed Techs., LLC v. Lee, in which it will review the first Inter Partes Review (IPR) decision from the Patent Trial and Appeal Board (PTAB) created under the America Invents Act. Last month, the U.S. Supreme Court granted certiorari in Cuzzo Speed Techs., LLC v. Lee, in which it will review the first Inter Partes Review (IPR) decision from the Patent Trial and Appeal Board (PTAB) created under the America Invents Act. The Court will specifically review: Whether the Federal Circuit erred in holding that, in an IPR proceeding, the PTAB may construe claims in an issued patent according to their “broadest reasonable interpretation” (“BRI”) rather than their “plain and ordinary meaning;” and Even if the Board exceeded its statutory authority in instituting an IPR proceeding, whether the Federal Circuit erred in holding that the PTAB’s decision to institute an IPR proceeding is judicially non-reviewable.
The Gibbons Institute of Law, Science & Technology recently hosted a program to explore significant changes underway for the European patent landscape. At this program, Dr. Christoph Cordes, Partner at the German law firm Esche Schümann Commichau, presented an overview of the new European Unitary Patent and Unified Patent Court, and was joined by several panelists in a discussion about the anticipated impact of this new European patent regime.
The United States Patent and Trademark Office (“USPTO”) has published a request for comments in the Federal Register for a proposed pilot program which would allow for a single Administrative Patent Judge (APJ) to determine whether to institute an inter partes review (IPR), with two additional APJs being assigned to the IPR if a trial were instituted.
On March 16, 2013, with the enactment of certain provisions of the America Invents Act (AIA), the United States’ patent system moved from being a first to invent patent system (first-to-invent) to a first inventor to file patent system (first-to-file) and retired the use of interference proceedings to determine priority of invention. Prior to and after the initiation of first-to-file system, there has been much debate as to the virtues of both systems. One aspect of this debate was that inventors with less resources and universities benefited more from the first-to-invent patent system rather than the first-to-file where resources can impact the ability to file quickly. It was in this atmosphere and as forecasted, that there was a surge in pre-March 16 application by inventors who sought to have their application reviewed under the first-to-invent system.
Federal Circuit Issues Contentious Order Not to Review En Banc PTAB’s Claim Construction Standard For IPR Proceedings
On Wednesday, July 8, 2015, the Federal Circuit in a contentious 6-5 vote denied en banc review of its first opinion in connection with PTAB decision in an IPR proceeding, In re Cuozzo Speed Technologies, LLC. As previously discussed, Cuozzo appealed the PTAB’s invalidation of three claims of U.S. Patent No. 6,778,074 on the grounds that the PTAB in its IPR decision improperly applied the “broadest reasonable interpretation” standard on claim construction, a standard that is traditionally applied to patent prosecution. A 2-1 panel for the Federal Circuit affirmed the application of this standard in view of the fact that the USPTO has been using this standard for more than a century and the majority’s conclusion “that Congress implicitly adopted the broadest reasonable interpretation standard in enacting the AIA.” The court also found that this was further supported by the statute giving the PTO Director the ability to establish the standards for establishing and governing inter partes review.
On June 15, 2015, the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office (“USPTO”) introduced a new pilot program, beginning on June 19, 2015, that will allow appellants with multiple ex parte appeals pending before the PTAB to obtain an expedited review of one appeal in return for withdrawing another appeal. The stated goals of this program are to allow appellants with multiple ex parte appeals pending to have greater control over the priority with which their appeals are decided and reduce the backlog of appeals before the PTAB.