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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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Viewpoint General
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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Viewpoint General
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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Viewpoint
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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Viewpoint
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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Viewpoint
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 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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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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Practice Hero Patent Opinions Mintz
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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Viewpoint
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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Viewpoint
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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Viewpoint General
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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Viewpoint
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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Practice Hero Artificial-Intelligence Mintz
Artificial Intelligence (AI) inventions have aided development in nearly every industry, but perhaps none more so than synthetic biology. For synthetic biology researchers, AI has developed into a vital tool to create cutting edge applications.
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Viewpoint
On August 29, 2019, the Patent Trial and Appeal Board (PTAB) designated as precedential its January 31, 2019 decision in Cisco Systems, Inc. v. Chrimar Systems, Inc.  In Cisco, the PTAB held that 35 U.S.C. § 315(a)(1) bars institution of IPR if the petitioner filed an earlier civil action, even if such action was voluntarily dismissed by the petitioner without prejudice.    
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Viewpoint
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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Viewpoint
Artificial Intelligence (AI) is increasingly becoming important across a diverse spectrum of technologies and businesses. As AI grows in importance in business and technology, so too grows the number of patent applications and the potential for uncertainty. Therefore, the U.S. Patent and Trademark Office (USPTO) must continue to ensure the appropriate balance in the administration of our IP system.
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Viewpoint
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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Viewpoint
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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Viewpoint
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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