Patents 4 Patients Extended Until June 30, 2020

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

The Federal Circuit Still Doesn't Get Diagnostic Claims

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

After SAS, Will Estoppel Also Apply to Grounds not Included in Petitions for Inter Partes Review and Post-Grant Review?

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

WASHINGTON U. v. WARF – An Implied Covenant Wins the Day

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

SAS Affects Use of Disclaimer to Obtain Motion to Dismiss

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

Obviousness of a Dosage Regimen: Yeda Research and Development Co., Ltd. v. Mylan Pharmaceuticals Inc. Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.

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

Hedge Your Bets in TC 1600 PGRs

November 30, 2018

Post grant reviews (PGRs) have proven to be more popular in the biotechnology space (TC 1600) than any other art unit, with 42—or 28.1%—of the PGRs filed to date classified as TC 1600 patents.[1] By way of comparison, TC 1600 makes up just 10.1% of all IPRs filed to date.  Perhaps not surprisingly, PGRs are appealing for challengers of biotechnology patents because written description, enablement, and indefiniteness can all be raised, and these § 112 hurdles tend to be more challenging in the unpredictable arts of TC 1600. <... Read more

The Internet of Medical Things (IoMT) in the World of Medical Devices

November 20, 2018

The Internet of Medical Things (IoMT) is a hot topic in the world of medical devices. This summer, at the MedTech conference in Philadelphia, IoMT was the word on everyone's lips. No wonder, as a recent report by Allied Market Research predicts that IoMT will be a $136.8 billion market by 2021.... Read more

Assignor Estoppel and IPR's: Possible Impact of Arista v. Cisco on Employment Agreements and Assignment Agreements

November 16, 2018

In a November 9, 2018 decision (copy of decision linked below), the U.S. Court of Appeals for the Federal Circuit ruled that the doctrine of assignor estoppel does not apply in the inter partes review (IPR) context (see Arista Networks, Inc. v. Cisco Systems, Inc., (Fed. Cir. 2018)).... Read more

USPTO Releases Interim Procedure for Requesting Recalculation of Patent Term Adjustment Related to the IDS Safe Harbor

November 9, 2018

On Friday, November 2, 2018, the USPTO released its interim procedure for patentees to request recalculation of the patent term adjustment with respect to information disclosure statements accompanied by a proper safe harbor statement under 37 CFR. 1.704(d) (83 Fed. Reg. 55102 (Nov. 2, 2018); see text at: https://www.gpo.gov/fdsys/pkg/FR-2018-11-02/pdf/2018-24004.pdf).  The interim procedure is effective from the date of the notice until the USPTO can update the patent term adjustment computer program and provide notice to the public that the program is updated.<... Read more