February 27, 2019
In a precedential opinion issued on February 26, 2019, the Federal Circuit affirmed the District Court's finding of patent ineligibility for a claim "directed to the abstract idea of "collecting, analyzing, manipulating, and displaying data."" University of Florida Research Foundation Inc. v General Electric Company et al (Fed. Cir. 2019).... Read more
February 24, 2019
The USPTO argues that a petitioner who has received a favorable final written decision in an IPR is estopped from reusing the same winning argument in a district court. If the Federal Circuit in BTG International Ltd. v. Amneal Pharmaceuticals LLC, agrees with the PTO, an ANDA sponsor would not take the risk of "winning" at the PTAB and would rather present the best argument in a district court.... Read more
February 11, 2019
In the recent decision, Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc., the Federal Circuit affirmed the PTAB's finding that Claims 8 to 13 of U.S. Reissue Patent 38,551 ("the '551 patent") owned by Research Corporation Technologies, Inc. ("RCT") are not unpatentable.... Read more
January 28, 2019
Since the Federal Circuit’s decision in Wyeth v. Kappos, 591 F.3d 1364, 93 U.S.P.Q. 2d 1257 (Fed. Cir. 2010), aff’g, Wyeth v. Dudas, 580 F. Supp. 2d 138, 88 U.S.P.Q.2d 1538 (D.D.C. 2008), which held that the USPTO was improperly reducing patent term adjustment (PTA) by improperly calculating “overlapping” days of agency delay under 35 U.S.C. §154, the courts have been asked on numerous occasions to look at how the USPTO is calculating PTA. Not every case has been decided in favor of the challenger, but a fair amount has. In addition, the USPTO has identified several internal errors including not accounting for the IDS safe harbor under 37 C.F.R. §1.704(d). As such, patentees should be very mindful of this evolving and important provision of law.<... Read more
January 2, 2019
The USPTO has recently announced extension of Patents 4 Patients, also called as the Cancer Immunotherapy Pilot Program, until June 30, 2020. This pilot program was started on June 29, 2016, to provide a fast-track examination for an application related to cancer immunotherapy. The PTO’s goal is to issue a final decision within a year of the entry of the program. <... Read more
December 12, 2018
In Roche Diagnostics the Federal Circuit continued its failure to recognize that diagnostic claims were not patent ineligible because they used a natural law. Roche involved claims detecting the Mycobacterium tuberculosis strains (MTB) quickly and accurately. Prior to the invention delays often occurred in diagnosing tuberculosis because of the time necessary to detect its presence involved a three to eight week cell culture. Roche discovered that the MTB strains could be quickly identified by identifying the presence of specific nucleotide sequence which functioned as a signature for the MTB. The technique used to identify the presence or absence of the signature nucleotide was conventional PCR analysis. The Federal Circuit affirmed a finding the diagnostic claims to be patent ineligible because the PCR technique was conventional and nucleotides naturally occurring.... Read more
December 12, 2018
Since the Supreme Court's decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), there has been significant discussion on SAS's expected effect on estoppel for IPRs. Essentially universal opinion holds that estoppel will apply to all grounds raised in the IPR petition due to the all-or-nothing institution standard applied by the Patent Trial and Appeal Board ("PTAB") in response to SAS. Post-SAS, final written decisions in IPRs will address all grounds raised in the petition if at least one ground meets the standard for institution, thus making estoppel applicable to all petition grounds as grounds "that the petitioner raised … during that inter partes review" under 35 U.S.C. § 315(e).... Read more
December 10, 2018
In a November 26, 2018 order, the U.S. District Court for the District of Delaware ordered the Wisconsin Alumni Research Fund (WARF) to pay The Washington University – St. Louis (Wash. U.) $31.6 million for breach of contract (The Washington University v. Wisconsin Alumni Research Foundation, Civ. No. 13-2091-JFB). The case originated when Wash. U. filed suit against WARF for breach of contract, breach of fiduciary duty, breach of the implied covenant of good faith and fair dealing, and equitable accounting, relating to a 1995 agreement between the parties entitled "Inter-Institutional Agreement for Prevention of Hyperphosphatemia in Kidney Disorder Patients" (the "IIA"), and particularly relating to the drug paracalcitol. The IIA covered certain patent rights for US Patent 5,597,815, jointly owned by Wash. U. and WARF.... Read more
December 6, 2018
In IPR2018-00673, Paper No. 27, the Patent Trial and Appeal Board ("Board") refused to grant patent owner Wi-Lan's motion to dismiss despite its disclaimer of the only claims for which the Board had found petitioner LG as having a reasonable likelihood of success. LG filed an IPR petition seeking to invalidate claims 1-4 and 6-9 of U.S. Patent No. 9,497,743 ("the '743 patent"). The Board's institution decision found that LG had established a reasonable likelihood that LG would prevail in showing the unpatentability of claims 1-4 of the '743 patent, but not for claims 6-9. Pursuant to SAS, however, the Board instituted trial on claims 1-4 as well as claims 6-9.... Read more
December 3, 2018
Yeda Research and Development Co., Ltd. ("Yeda") is the assignee of three "Copaxone patents" that describe and claim COPAXONE® 40mg/mL (glatiramer acetate ("GA")), a treatment for relapsing-remitting multiple sclerosis ("RRMS"). For analyzing the obviousness of the Copaxone patents, a key limitation of the claims is the administration of a 40mg GA dose in three subcutaneous injections over seven days. The Patent and Trademark Appeal Board ("the Board") found (and the district court affirmed) that the prior art described all limitations of the claims except for the administration of 40mg GA 3x/week for seven days. However, the Board and the district court concluded that the claimed dosage regiment would have been obvious to a parson of skill in the art (POSITA). Yeda appealed both decisions.... Read more