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On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion for new trial, in Amgen Inc. v. Hospira, Inc., Nos. 2019-1067, 2019-1102.  
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On December 5, 2019, Judge David C. Godbey of the Northern District of Texas denied the defendant Diebold Nixdorf, Inc.’s (“Diebold”) motion to dismiss under Rule 12(b)(6), in Nautilus Hyosung Inc. v. Diebold, Inc. et al., 3-16-cv-00364 (N.D. Tex.).  Diebold filed the motion after the Federal Circuit reversed the International Trade Commission’s (“ITC”) finding of infringement in a parallel Section 337 investigation.  Instead, the Federal Circuit held that the one patent in the suit was invalid due to indefiniteness. 
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In its recent decision, Fiber, LLC. v. Ciena Corp., No. 2019-1005 (Fed. Cir. Nov. 21, 2019), the Court of Appeals for the Federal Circuit (Federal Circuit) issued a reminder that the structure necessary to satisfy the definiteness requirement for a means-plus-function in a claim cannot normally be found in material incorporated by reference.
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On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”).  The USMCA, if ratified by each respective country, would replace the North American Free Trade Agreement (“NAFTA”), which has been in effect since January 1, 1994. 
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On December 11, 2019, the U.S. Supreme Court struck down the U.S. Patent and Trademark Office’s (USPTO) controversial policy of shifting attorneys’ fees in Peter v. NantKwest, Case No. 18-801. The Court ruled that the USPTO policy ran counter to the long-accepted “American Rule,” which says “[e]ach litigant pays his own attorney’s fees, win or lose, unless a statute or contract provides otherwise.”
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To amend challenged claims during an Inter Partes Review (IPR), the patent owner must show that the proposed amendment responds to a ground of unpatentability at issue in the IPR trial. 
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The Court of Appeals for the Federal Circuit (CAFC) has recently reminded the Patent Trial and Appeal Board (the Board) that it may not rely on evidence and arguments that fall outside the scope of the instituted grounds during Inter Partes Review (IPR) proceedings. In re IPR Licensing, Inc., No. 2018-1805 (Fed. Cir. Nov. 22, 2019). 
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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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When former President Barack Obama signed the Leahy–Smith America Invents Act into law on Sept. 16, 2011, the patent system in the United States underwent one of its most sweeping and significant overhauls. The AIA replaced the then-existing post-grant review proceeding of inter partes reexamination with several new proceedings known as inter partes review, post grant review and covered business method patent review. Congress implemented AIA reviews to streamline disputes over patent validity, with the goal of reducing costs for all involved. In October 2017, the U.S. Court of Appeals for the Federal Circuit in Aqua Products Inc. v. Matal shifted the burden by putting it back on the challenger to prove unpatentability.
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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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On October 30, 2019, the Federal Circuit held that evidence of copying may be used to rebut an obviousness challenge, even if that evidence does not relate to the copying of a specific product.  (Liqwd, Inc. v. L’Oreal USA, Inc.; appeal from PGR2017-00012).
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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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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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In a decision with potential far-reaching implications, Arthrex, Inc. v. Smith & Nephew, Inc., the Federal Circuit held Thursday that appointments of Administrative Patent Judges of the Patent Trial and Appeal Board violated the Appointments Clause of the U.S. Constitution.
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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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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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Earlier this week, the United States Patent and Trademark Office (“USPTO”) proposed rule changes for amending patents in AIA proceedings.  The proposed rule changes would apply to inter partes review (“IPR”), post-grant review (“PGR”), and covered business method patent review (“CBM”) (collectively, “post-grant trial”) proceedings before the Patent Trial and Appeal Board (“PTAB”) to make explicit that a patent challenger bears the burden of persuasion regarding motions to amend filed during these proceedings.
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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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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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During patent prosecution, Examiners often liberally apply the broadest reasonable interpretation standard in rejecting claims.  When responding to these rejections, it is important to remember that there are limits to an Examiner’s broadest reasonable interpretation. 
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