Federal Circuit Reverses Novartis Gilyena Negative Limitation Decision

Attorney: Richard D. Kelly
June 22, 2022

On June 21, 2022, the Federal Circuit acting on a request for panel rehearing in the decision by the Federal Circuit in Novartis v. Accord Health Care, Inc., 21 F.4th 1362 (Fed. Cir. 2022), affirming the district court’s decision of infringement and validity of the Novartis patent on Gilenya, U.S.P. 9,187,405, granted the request and proceeded to reverse the original decision and hold the asserted claim invalid for failing to comply with the written description of 35 U.S.C. § 112(a).<... Read more

Written Description and Creating Ranges from Examples

Attorney: Richard D. Kelly
April 7, 2022

At the close of last year, the Federal Circuit affirmed a decision by the PTAB in IPR2019-00329 that a claimed range created from examples was not patentable because it lacked written description in the application as filed. In its decision the PTAB “second guessed” an examiner’s ex Parte decision that the claimed range had written description in the application as filed.  Written description was at issue because the patent challenged, U.S. Patent 9,687,454 (‘454), filed January 6, 2016, needed benefit of its parent application serial number 12/537,571 published on February 10, 2011, as 2011/0033541 (‘541), to avoid ‘541 from being prior art otherwise, most of the ‘454 claims were anticipated by ‘541. The ‘454 claim 1 is directed to a mucoadhesive film comprising about 40 wt.% to about 60 wt.% of a water-soluble polymeric matrix and claim 7 to a range of from about 48.2 wt.% to about 58.6 wt.%. Neither range was found in the ‘454 patent as filed; the claims were added during prosecution. The ‘454 describes the film as “may contain any desired level of self-supporting film forming polymer”; in “one embodiment, the film forming composition” may be at least 25 weight per cent of the composition; alternatively, at least 50 weight per cent of the composition. No upper limit was described.<... Read more

Patent Invalidation Under Section102(b)'s On-Sale Bar Based on a Letter Including Commercial Terms Sent Before the Critical Date

Attorney: Marina I. Miller, Ph.D.
March 28, 2022

Mr. Junker, the named inventor of U.S. Design Patent No. D450,839, sued Medical Components, Inc. and Martech Medical Products, Inc. (“MedComp”) for infringement of the D’839 patent. The parties filed cross-motions for summary judgment, debating whether a letter sent before the critical date was a commercial offer for sale of the claimed design, rendering the claim invalid under the on-sale bar, 35 U.S.C. § 102(b). The district court granted Mr. Junker’s motion for summary judgment of no invalidity under the on-sale bar. MedComp appeals the district court’s summary judgment of no invalidity under the on-sale bar, the judgment of infringement, and the damages award.<... Read more

ModernaTx, Inc. v. Arbutus Biopharma Corp.: Sublicense Not Enough to Show Standing

Attorney: Elissa Sanford
December 13, 2021

On Dec. 1, 2021, the Federal Circuit held that Moderna lacked standing in an appeal from a Patent Trial and Appeal Board (“PTAB”) decision against rival Arbutus where the PTAB determined U.S. Patent No. 9,364,435 (“the ’435 patent”) was not unpatentable as obvious.[1] The ’435 patent concerns vaccine delivery technology, particularly a lipid nanoparticle delivery system used to protect nucleic acids delivered to cells as utilized in vaccines including Moderna’s COVID-19 vaccine.<... Read more

Biogen v. Mylan Written Description - What Does The Federal Circuit's Decision Really Mean?

Attorney: Jeffrey B. McIntyre
December 8, 2021

Following up on my post last week (Dec 1.), I have read commentary about how the Federal Circuit’s decision in Biogen v. Mylan was incorrect. Is it really the case that the decision was wrong and that the Federal Circuit needs to address it en banc (or that the Supreme Court needs to address it)? <... Read more

Biogen v. Mylan: Make Sure Your Patent Applications Cover Your Current R&D

Attorney: Jeffrey B. McIntyre
December 1, 2021

Yesterday, in Biogen v. Mylan, the Federal Circuit ruled that claims in Biogen’s U.S. patent 8,399,514 (the ’514 patent) were invalid under 35 U.S.C. §112 for failing to satisfy the written description requirement. The Federal Circuit upheld the district court’s previous invalidity determination.<... Read more

Increased Burden in Drafting "Surviving" and "Useful" Utility Patents in the Life Sciences Industry Extends to Design Patents

Attorney: Grace Kim
October 15, 2021

Patents are undoubtedly essential to many industries, and in recent years, the decisions regarding patent eligibility, written description, and enablement have certainly shaken up the life sciences industry in particular. There is an increasing burden on patent applicants and patentees to provide complex, lengthy, thoroughly written disclosures to satisfy the rising standards for written description and enablement, as well as the added pressure to draft multiple claims of varying scope.<... Read more

THE RECENT HHS' PLAN FOR GREATER FDA – USPTO COLLABORATION TO LOWER DRUG PRICES: WHY PHARMA PATENT COUNSEL NEEDS TO REVIEW FDA SUBMISSIONS

Attorney: J. Derek Mason, Ph.D., CLP
September 22, 2021

In a purported effort to lower drug prices, the Department of Health and Human Services (HHS) recently released a proposed plan calling for the US Food and Drug Administration (FDA) to work with the US Patent and Trademark Office (USPTO), suggesting that such collaboration would “facilitate greater awareness of their complementary work and introduce efficiency into their respective workstreams.” This is only one part of the proposed plan, the other parts of which are not the focus of this post.<... Read more

Claims to a Spread-Spectrum Method For Sending Data Over a Communications Channel Are Patent Ineligible under Section 101

Attorney: Marina I. Miller, Ph.D.
August 23, 2021

Plaintiff Zyrcuits IP LLC has sued Defendants Acuity Brands, Inc. and Universal Electronics Inc. for infringement of claim 4 of U.S. Patent No. 6,671,307 (the ‘307 patent). Defendants argued that Zyrcuits's complaints should be dismissed because the ‘307 patent is invalid under 35 U.S.C. § 101 for failing to claim patentable subject matter. Applying the two-step framework from Alice, the court found that the ‘307 patent was invalid under § 101, as the claims of the ‘307 patent are directed to the abstract idea of grouping data together with a single code and do not contain any inventive concept.... Read more

The Week That Was In Skinny Labels

Attorney: Richard D. Kelly
August 9, 2021

This week saw two cases reported with possible implications for skinny labels. The first was a recommendation be Magistrate Judge Hall, District of Delaware, that Hikma Pharmaceuticals could not dodge Amarin’s lawsuit claiming Hikma induced infringement of Amarin’s patents on the use of its heart drug Vascepa® . The patents in suit are U.S. Patent Nos. 9,700,537 (the ’537 patent), 8,642,077 (the ’077 patent), and 10,568,861 (the ’861 patent) under 35 U.S.C. § 271(b). In an interesting twist, Amarin also sued Health Net, an insurance provider, for also inducing infringement of the same patents. The suit against Health Net appears to be a first where an insurance company was sued for inducing infringement of method of using a drug.<... Read more