What You Say Can Hurt You

Attorney: Richard D. Kelly
May 21, 2019

Often in writing applications there is a tendency to denigrate prior art techniques. This is not risk free as the patentee in Nuvo Pharmaceuticals (Ireland) v. Dr. Reddy's Laboratories, Inc. (Fed. Cir. May 15, 2019) discovered.... Read more


Category: Patent Eligibility

The Proper Application of the Supreme Court's Alice Standard is an Evolving and Sometimes Hazy Area of Law

Attorney: Daniel J. Pereira, Ph.D.
April 29, 2019

Marijuana, for medical purposes and recreational purposes, is an area of great political, social and legal interest. By some accounts (https://www.forbes.com/sites/thomaspellechia/2018/03/01/double-digit-billions-puts-north-america-in-the-worldwide-cannabis-market-lead/#6d925dd76510), the industry is rapidly growing leaps and bounds. Not surprisingly, patents and disputes centered on patents for this industry are increasing in numbers.... Read more

Federal Circuit Reiterates That Naturally-Occurring Nucleotide Sequences Are Not Patent Eligible Under 35 U.S.C. § 101

Attorney: Matthew E. Barnet, Ph.D.
October 12, 2018

On October 9, 2018, in Roche Molecular Systems, Inc. v. Cepheid, the Federal Circuit upheld a district court decision that claims reciting nucleotide primers in U.S. Patent No. 5,643,723 (“the ‘723 patent”) were invalid under 35 U.S.C. § 101.<... Read more

A Different Lesson from Vanda v. West-Ward

Attorney: Stephen G. Baxter, Ph.D.
August 20, 2018

Last week the Federal Circuit denied West-Ward's petition for rehearing en banc. At the time of the original Federal Circuit decision (Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the case generated substantial commentary in regard to its patent eligibility context. West-Ward's petition focused on the question of whether "adjusting a dose of an old drug based on a patient's genetic risk of poorly metabolizing it" is patent eligible subject matter, so the pro-patent crowd will no doubt be pleased. There is another aspect of the case, however, which is worthy of consideration.... Read more

Is Real and Positive Change Coming for Patent Owners?

Attorney: Vincent K. Shier, Ph.D.
June 11, 2018

New USPTO Director Andrei Iancu provided the Intellectual Property Track plenary lecture at the 2018 BIO International Convention last week. As has been a common theme since being sworn in to office in February, Director Iancu's focus was on changes to provide greater certainty and quality for applicants and patent owners. Yes, we have heard this before, but the time is ripe for real change that positively impacts applicants and patent owners.... Read more

Ex Parte Jadran Bandic – Patent Eligibility Analysis After Berkheimer

Attorney: Marina I. Miller, Ph.D.
June 4, 2018

In Ex Parte Bandic, the PTAB ("the Board") has given an insight into how the Office intends to examine patent eligibility under the two-step Alice test, considering the Memorandum published by the USPTO on April 19, 2018 explaining "Changes in Examination Procedure Pertaining to Subject Matter Eligibility" in view of Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).... Read more

USPTO Issues Memorandum and Publishes Fed Reg Notice for Comment Regarding 101 Eligibility

Attorney: Daniel J. Pereira, Ph.D.
April 23, 2018

On April 20, 2018, the USPTO published (https://www.gpo.gov/fdsys/pkg/FR-2018-04-20/pdf/2018-08428.pdf) in the Federal Register a "Request for Comments on Determining Whether a Claim Element is Well-Understood, Routine, Conventional for Purposes of Subject Matter eligibility" that references a memorandum to the Examiner Corps the day before pertaining to examination procedure regarding Subject Matter Eligibility (https://www.uspto.gov/sites/default/files/documents/memo-berkheimer-20180419.PDF). The public comment period ends on August 20, 2018.... Read more

Federal Circuit Rules in Favor of Patent Eligibility

Attorney: Richard D. Kelly
April 16, 2018

On April 13 the Federal Circuit affirmed the lower court decision in Vanda Pharm. Inc. v. West-Ward Pharm. Int'l. Ltd., appeal Nos. 2016-2707 and 2016-2708. The opinion addresses a number of concerns in ANDA litigation including whether jurisdiction exists under 35 U.S.C. § 271(e)(2) for a "late listed" Orange Book patent (it does), the availability of an injunction to prevent inducement of infringement by a label (it is available), and the patent eligibility of a claim to using a drug based upon the results of a diagnostic technique. It is this latter point which is of significant importance. Claim 1 of the patent (USP 8,586,610 (‘610)):... Read more

In Re Urvashi Bhagat: One More Decision Denying Patent Eligibility of Nature-Based Product Claims

Attorney: Marina I. Miller, Ph.D.
March 29, 2018

Urvashi Bhagat appealed the decision of the PTAB ("the Board") affirming the examiner's anticipation rejections and the rejection under Section 101 of multiple claims in application 12/426,034. The Federal Circuit affirmed the Board's decision in the recent In re Urvashi Bhagat nonprecedential opinion. The claims of this application were directed to lipid-containing formulations comprising omega-6 and omega-3 fatty acids. The '034 application stated that dietary deficiency or imbalance of these fatty acids might lead to a variety of illnesses, and that omega-6 and omega-3 fatty acids are naturally occurring in oils, butters, nuts, and seeds. The '034 application claimed ranges and ratios of the fatty acids and other limitations.... Read more

The Trials and Tribulations of Patent Eligibility of Natural Products at the PTAB

Attorney: Daniel J. Pereira, Ph.D.
March 8, 2018

As patent prosecution practitioners, we often look for direction from the judges at the PTAB, particularly when agreement cannot be reached at the examining level. This is very evident when there is imprecise guidance as to what constitutes patent eligible subject matter for inventions including natural products following the Supreme Court's decision in Myriad as well as the various iterations of PTO guidance and training materials. Here is a tale of two cases with two different panels (yet each panel interestingly includes one common APJ (New)) and each panel renders very different decisions.... Read more