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HHS HIV Drug Lawsuit: Setting Precedent for Other High Priced Medications or Government Collaborations?
December 9, 2019 | Blog
On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences in Delaware federal court regarding Gilead’s popular HIV drugs, Truvada® and Descovy®.
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Counterproductive and Cost-Increasing Litigation Tactics Are Objectively Unreasonable in Section 285 Attorney Fee Award Analysis
November 20, 2019 | Blog | By Andrew DeVoogd
Nearly six years ago, the Supreme Court in Octane Fitness v. ICON Health & Fitness promulgated a “totality of the circumstances test” for awarding reasonable attorney fees to the prevailing party in exceptional cases under 35 U.S.C. §285. As lower courts have applied this standard, it has become clear that the motivation and conduct of the losing party is a focal point of the exceptionality analysis. However, two recent decisions emphasize that bad faith arguments and litigation tactics—by both parties and in all stages of litigation—are critical to the exceptionality analysis in Section 285 attorney fee awards.
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Key Considerations for Global SEP Litigation - Part 2
November 5, 2019 | Blog | By Michael Renaud, James Wodarski, Matthew Galica
The adoption of multiple, standardized technologies looms on the horizon. This presents the challenge of balancing innovator’s intellectual property rights with implementer’s desire for fair access to technology. As more implementers adopt efficient infringement to circumvent this equilibrium altogether, standard-essential patent (“SEP”) licensing disputes have increased.
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Can Infringement Contentions be Amended to Add New Claims Resulting from an Ex Parte Reexam Filed after IPRs Invalidated Some but Not All Claims?
November 5, 2019 | Blog | By Brad M Scheller
Judge Gilliam of the Northern District of California recently answered this question and provided helpful guidance on the interplay of IPRs, reexaminations and district court litigation. In IXI Mobile (R&D) Ltd., et al., v. Samsung Elec. Co. Ltd. and IXI Mobile (R&D) Ltd., et al. v. Apple Inc., Judge Gilliam denied plaintiffs’ (“IXI”) motion for leave to amend their infringement contentions and asserted claims because IXI was not diligent in identifying new contentions or new accused products.
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ITC rejects minimum threshold requirement for domestic industry economic prong and emphasizes the importance of contextual evidence and case-by-case analyses
November 4, 2019 | Blog | By Michael Renaud, Andrew DeVoogd, Matthew Karambelas, Nana Liu
In a recent decision clarifying the legal standards of the International Trade Commission’s domestic industry requirement, the Commission has upheld, with modified reasoning, Chief Administrative Law Judge Bullock’s initial determination (“ID”), finding no domestic industry in Certain Carburetors and Products Containing Such Carburetors, Inv. No. 337-TA-1123, Comm’n Op. (Oct. 28, 2019).
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Key Considerations for Global SEP Litigation - Part 1
October 30, 2019 | Blog | By Michael Renaud, James Wodarski, Matthew Galica
Litigation involving standard-essential patents (“SEPs”) is on the rise. The now longstanding and disturbing impact of efficient infringement by recalcitrant implementers is the predominant cause of the increase.
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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.
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Collateral estoppel does not attach to PTAB invalidity determination pending appeal
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”).
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ITC suggests 5% Threshold for Domestic Industry Assessment; order may impact tech companies
September 23, 2019 | Blog | By Michael Renaud, 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.
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International Trade Commission ALJ Holds that Relying on Pre-Suit Testing Waives Privilege Protection
September 10, 2019 | Blog | By Andrew DeVoogd
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.
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Patent Prosecution and FDA Compliance Expenses May Help Satisfy the ITC’s Domestic Industry Requirement
September 3, 2019 | Blog
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.
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ITC Domestic Industry Products Do Not Need to Be Commercially Available
September 3, 2019 | Blog
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.
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Alexa: What is venue?
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.
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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®.
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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.
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PTAB Confirms (Again) that the AIA’s “Enhanced Estoppel” Provision Applies to Concurrent IPR Proceedings
August 12, 2019 | Blog | By Andrew DeVoogd
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.
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One Size Does Not Fit All When It Comes to Economic Theories Used to Determine Royalty Rates
July 1, 2019 | Blog | By Michael Renaud, James Wodarski, Matthew Galica
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.
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District of Delaware Dismisses ANDA Applicant for Lack of Venue under TC Heartland and In re Cray
June 27, 2019 | Blog | By 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).
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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
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.
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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.
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