Federal Circuit Reverses PTAB Finding Tarceva® Method of Treatment Claims Invalid for Lack of Reasonable Expectation of Success Based on over 99.5% Failure Rate among Treatment Candidates
October 15, 2019 | Blog | By Peter Cuomo, Joe Rutkowski
In a precedential opinion on October 4, 2019, the United States Court of Appeals for the Federal Circuit, in OSI Pharmaceuticals v. Apotex, No. 2018-1925, reversed the Board’s Final Written Decision in an inter partes review (“IPR”) finding that claims of United States Patent No. 6,900,221 (the “‘221 patent”) were invalid as obvious.
October 10, 2019 | Blog | By Adam Samansky, Peter Cuomo, Nana Liu
Recently, in Sanofi-Aventis v. Mylan, 2:17-cv-09105-SRC-CLW, Judge Stanley Chesler of the United States District Court, District of New Jersey, denied a motion by defendant Mylan for summary judgment of invalidity of asserted patent claims that were found to be obvious by the Patent Trial and Appeal Board (“PTAB”).
September 23, 2019 | Blog | By Michael Renaud, Aarti Shah, Andrew DeVoogd, Matthew Karambelas, Nana Liu
Recently, Chief Administrative Law Judge (“CALJ”) Bullock of the U.S. International Trade Commission (“ITC”), in Certain Carburetors and Products Containing Such Carburetors, Inv. No. 337-TA-1123, Order No. 77, suggested that “significant” or “substantial” domestic industry investments must amount to greater than 5% of domestic industry product sales in the United States.
International Trade Commission ALJ Holds that Relying on Pre-Suit Testing Waives Privilege Protection
September 10, 2019 | Blog | By Andrew DeVoogd, Kara E. Grogan
A recent order from International Trade Commission Administrative Law Judge Elliott provides helpful guidance regarding a common ITC discovery dispute: whether a party may withhold from discovery as work product pre-suit test results and methods where those results and methods were relied upon in forming the pleaded allegations of the complaint or to support a party’s contentions.
September 3, 2019 | Blog | By Aarti Shah, Kara E. Grogan
In a recent initial determination, Administrative Law Judge (“ALJ”) Cheney of the U.S. International Trade Commission (“ITC”) held that domestic industry products do not need to be commercially available to satisfy section 337’s domestic industry requirement.
Patent Prosecution and FDA Compliance Expenses May Help Satisfy the ITC’s Domestic Industry Requirement
September 3, 2019 | Blog | By Aarti Shah, Kara E. Grogan
In a recent initial determination, Administrative Law Judge (“ALJ”) Cheney of the U.S. International Trade Commission (“ITC”) provided useful guidance for patentees by reaffirming that there is no categorical rule that patent prosecution expenses cannot be included in the domestic industry analysis at the ITC, and also finding that complainants may rely upon expenses relating to FDA compliance to satisfy the domestic industry requirement.
August 23, 2019 | Blog | By Andrew DeVoogd, Serge Subach
A recent decision from the Northern District of New York provides a detailed outline for analyzing venue in patent infringement cases, and may provide facts that companies with equipment installed in other districts should understand.
ANDA Applicant Dismissed for Lack of Venue Under § 1400(b) as District of New Jersey Departs from its own and the District of Delaware’s Prior Rulings
August 21, 2019 | Blog | By Adam Samansky, Peter Cuomo, Joe Rutkowski
On August 13, 2019, the United States District Court for the District of New Jersey, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 18-cv-14305, held that venue was not proper in New Jersey over Mylan in a patent infringement action arising from Mylan’s submission of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of the drug, Jublia®.
Federal Circuit Cautions Against Rigid Approach to Prosecution History Estoppel in Fourth Appeal from ALIMTA® Litigations
August 19, 2019 | Blog | By Adam Samansky, Peter Cuomo, Nana Liu
On August 9, 2019, the United States Court of Appeals for the Federal Circuit, in Eli Lilly & Co. v. Hospira, Inc., Nos. 2018-2126, 2127, 2128, reversed in-part and affirmed in-part a district court’s determination of infringement. The Federal Circuit reversed the district court’s finding of literal infringement but ultimately affirmed judgments of infringement based on the doctrine of equivalents.
PTAB Confirms (Again) that the AIA’s “Enhanced Estoppel” Provision Applies to Concurrent IPR Proceedings
August 12, 2019 | Blog | By Andrew DeVoogd, Tiffany Knapp
In a decision from the Patent Trial and Appeal Board (“the Board”) issued last week, the Board confirmed that the “enhanced estoppel” provision of 35 U.S.C. § 315(e)(1) applies to co-pending inter partes review (“IPR”) proceedings when a final written decision issues in a first IPR. The panel flatly rejected a Petitioner’s attempt to apply the Federal Circuit’s decision in Shaw Indus. Group, Inc. v. Automated Creel Sys., Inc., 817 F.3d 1293 (Fed. Cir. 2016) to those circumstances.
July 1, 2019 | Blog | By Michael Renaud, James Wodarski, Aarti Shah, Matthew Galica, Tiffany Knapp
Calculating royalty rates as part of a patent dispute often becomes a hotly-disputed issue, where opposing economic theories from expert witnesses are pinned against one another. As a litigant, care must be taken when deciding which economic theory to advance—and what facts to rely on—in support of a particular royalty rate. Given the varying and unique nature of disputes, a singular economic approach to determining a royalty rate is impractical and, oftentimes, inappropriate.
June 27, 2019 | Blog | By Kathleen Carr, Joe Rutkowski
On June 17, 2019, the United States District Court for the District of Delaware, in Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., et al., No. 18-cv-01043, held that venue was not proper in Delaware over Mylan Pharmaceuticals Inc. (“MPI”) in connection with Novartis’s Hatch-Waxman patent infringement claim arising from MPI’s submission of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of the drug, Gilenya® (fingolimod).
Supreme Court Declines to Address the Question of Article III Standing to Appeal a Final Written Decision from the PTAB
June 20, 2019 | Blog | By Daniel Weinger, Tiffany Knapp
This week, the Supreme Court left open the question of Article III standing with regards to appealing a final written decision from the Patent Trial and Appeals Board (“PTAB”) that is favorable to the patent owner. On Monday, the Supreme Court denied two petitions for certiorari that sought to appeal final written decisions (“FWD”) adverse to the petitioner in an inter partes review proceeding, in that the PTAB declines to cancel all claims under review.
Criminal Statute for Organized Crime Now Available to Combat Trade Secret Theft – But What is an Act of Trade Secret Theft under Civil RICO?
June 18, 2019 | Blog | By Michael Renaud, Nicholas Armington
The DTSA standing alone provides significant recourse for trade secret owners who have fallen victim to trade secret theft. Apart from the protection provided by the DTSA itself, however, the statute also allows trade secret owners to leverage the Racketeer Influence and Corrupt Organizations Act (RICO), a statute passed to address organized crime, to combat trade secret misappropriation. The DTSA does this by making trade secret theft qualify as a predicate act sufficient to show racketeering activity under RICO. This fairly new tool gives trade secret owners another potent option when confronting trade secret theft.
June 10, 2019 | Blog | By Michael Renaud, Asa Kling, Marguerite McConihe, Derek Constantine
The intersection of artificial intelligence (AI) and intellectual property invokes fascinating theoretical questions. With these questions, however, come significant practical issues that businesses, legal practitioners, and governments need to address proactively. Israel is embracing the challenge.
Score This One in Favor of Standard-Essential Patent Owners: Recent Decision Makes Satisfying FRAND Obligations Easier
June 5, 2019 | Blog | By Michael Renaud, James Wodarski, Aarti Shah, Matthew Galica
A recent decision in the Eastern District of Texas should provide standard-essential patent (“SEP”) owners with more clarity and optimism when negotiating SEP licenses. Coming on the heels of Judge Koh’s decision in the FTC’s dispute with Qualcomm, Judge Gilstrap found Ericsson to have satisfied its fair, reasonable and non-discriminatory (“FRAND”) obligations when negotiating with HTC due in large part to a finding that it had negotiated in good faith.
June 3, 2019 | Blog | By Aarti Shah, Kara E. Grogan
On April 26, 2019, Administrative Law Judge (“ALJ”) Lord clearly stated in Certain Intraoral Scanner and Related Hardware and Software that the International Trade Commission’s (“ITC”) jurisdictional authority extends to accused infringers whose activities have “some nexus” to an element of section 337. ALJ Lord found that involvement in training and supporting resellers, distributors and end users in the infringing goods in the United States was sufficient to put that respondent under the broad reach of section 337, even if they did not import or directly sell the products.
May 30, 2019 | Blog | By Aarti Shah, Rithika Kulathila
In Amarin Pharma, Inc. v. Int’l Trade Comm’n (18-1247), the Federal Circuit affirmed the International Trade Commission’s (“ITC”) finding that Amarin’s false advertising claim under § 43(a) of the Lanham Act was precluded by the Federal Food, Drug, and Cosmetic Act (“FDCA”) because these claims require the FDA’s guidance on whether possible non-compliance of the provision is a violation of the FDCA. The court also found that the Commission may decline to institute an investigation where there is no cognizable claim under § 337.
Claim Construction of “Customary and Ordinary” Meaning Does Not Justify Amendment of Noninfringement and Invalidity Contentions
May 29, 2019 | Blog | By Andrew DeVoogd, Courtney Herndon
Recently, in a patent infringement action pending in the Eastern District of Michigan, Webasto Thermo & Comfort N. Am., Inc. v. BesTop, Inc., No. 2:16-cv-13456, Order No. 209 (E.D. Mich. May 20, 2019) (Borman, J.), the court overruled defendant BesTop’s objections to the Special Master’s recommendation to grant plaintiff, Webasto’s, motion to strike BesTop’s second amended noninfringement and invalidity contentions.
May 24, 2019 | Blog | By Michael Renaud, Bruce Sokler, Rich Gervase, Harold Laidlaw
Just when observers thought Qualcomm could celebrate its successful litigation with Apple another decision has come down which could have major implications for Qualcomm’s business going forward.
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