Biologic Patent Transparency Act - New Bill Aimed at Biologics

March 12, 2019

A bipartisan group of senators sponsored a bill this week—the Biologic Patent Transparency Act, S. 659—aimed at making patent information associated with biologics easier to identify and easing the approval process for biosimilar manufacturers encountering patent roadblocks.... Read more

Motions to Amend: Is the PTAB's Lectrosonics Order Just of Western Digital?

March 11, 2019

Spring gardening season has begun and the USPTO is once again planting its Motion to Amend ("MTA") seeds. In a substantial redux of Western Digital Corporation v. Spex Technologies, IPR2018-00082,-00084, paper 13, the PTAB this past week designated paper 15 of Lectrosonics v. Zaxcom, IPR2018-01129, 01130("Lectrosonics Order") as an informative decision.... Read more

Onyx v. Cipla: Companies Beware - What Your Patent Agent Tells You May Not Be Privileged

March 4, 2019

In an order last month, the Delaware district court ruled that some communications involving Onyx's patent agent were not privileged and must be produced to Cipla. The court's order highlights potential pitfalls when relying upon advice solely from patent agents.... Read more

The Federal Circuit Stays the Course in Patent Ineligibility for an Abstract Idea

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

No More IPRs From Generic Drug Makers?

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

Bioisosterism, by Itself, May Not be Sufficient Motivation to Modify a Lead Compound

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

USPTO's Patent Term Adjustment Policies Reigned in Yet Again

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

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