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Intellectual Property Rights - News Letter                   Issue No:2020--080

February 2020 Issue

1. NZNP Finance Ltd. v. Actavis Laboratories UT, Inc. (Fed. Cir. 2020)

Federal Circuit issued a per curiam Order in NZNP Finance Ltd. v. Actavis Laboratories UT, Inc., denying a petition for rehearing en banc filed by Plaintiffs-Appellants HZNP Finance Ltd. and Horizon Therapeutics USA, Inc. The Court also denied Plaintiffs-Appellants a panel rehearing.Circuit Judge Lourie, joined by Circuit Judges Newman, O'Malley, and Stoll, dissented from the denial of the petition for rehearing en banc, arguing that the panel majority had "erroneously misconstrued the 'consisting essentially of' language in evaluating the definiteness requirement of 35 U.S.C. § 112." At issue was claim 49 of U.S. Patent

No. 8,252,838. More

2. 2019 ’ s biggest patent case has nothing to do w i th patent s

In a report published by IAM, Unified’s Chief Patent Counsel Jonathan Stroud explains that the US Supreme Court’s biggest patent law case of the yea r may in fact have nothing to do with patents. Most patent lawyers have probably never heard of Kisor v. Wilkie (argued in March 2019), a sleepy veteran’s appeal that—at first blush—appears to have  little relation to patent law. More

 3. IP Litigation In 2019: Key Developments From 2018 And Predictions For The New Year

2018 was another eventful year for intellectual property litigation. In addition to developments in AIA post-grant trials before the PTAB, the Supreme Court and Federal Circuit issued several landmark decisions affecting both IP owners and accused infringers. By all indications, 2019 promises even more changes, as the Supreme Court already is hearing oral arguments in cases involving patents and copyrights.in this webinar, Brooks Kushman’s expert IP litigators discuss the developments from 2018 that have had the biggest impact on enforcement of IP rights and preview the issues that the Supreme Court and Federal Circuit likely will consider in 2019. More

 4.     The Year in Patents: The Top 10 Patent Stories of 2019

As we prepare to enter a new year—and a new decade—it is time once again to look back on the year behind us to assess its impact for the IP world. All in all, it was very much a year of “almosts.” While the Supreme Court is still considering some cases that could herald massive change for patent law, its most notable move this year has largely been to keep its head planted firmly in the sand, particularly when it comes to Section 101 and patent eligibility, signaling that it seems to either believe everything is fine, or that Congress or the Federal Circuit will fix the problem they initially created. Similarly, Congress has been perhaps more active than ever before on IP issues across the board, but has thus far failed to enact or move forward on meaningful legislation at any level. At the U.S. Patent and Trademark Office (USPTO), Andrei Iancu made some heroic changes in examiner guidance on Section 101 that promised to clear up the massive confusion that has developed over the last decade, but the courts refused to acknowledge the USPTO’s authority on the matter, thereby making the changes virtually useless. More

 5.     The Most Important U.S. Patent Cases of 2019 Thus Far

Thus far 2019 has been an eventful year for patent law in the United States. Over the past seven months, the U.S. Supreme Court and the Court of Appeals for the Federal Circuit (the

U.S. appellate court tasked with reviewing all district court patent decisions) have issued several significant rulings that may affect the rights of patent owners. This article reviews the most important of these rulings. More  

6.     BENCHMARKING IP LITIGATION 2019

The Morrison & Foerster Study of IP Legal Decision-Makers (“MoFo Study”) shows asignificant shift in the nature of IP litigation matters that large companies face.Annual spend on IP litigation matters continues to increase, growing fro $1.7 billion in 2005 to $3.3 billion 2019; growth rates have recently slowed, butcontinue at double-digit ratesWhile spending has increased, the number of matters that companies are managing isdown 27%, from 15 matters on average in 2015 to 11 matters on average in 2019. More

7.     Pillsbury, Womble Help Drive Hyundai's $5M Trademark WiPillsbury Winthrop                                                                          

Shaw Pittman and Womble Bond Dickinson have steered Hyundai Motor Co. to a $5 million consent judgment against a Miami-based company accused of distributing gray market auto parts.Direct Technologies International Inc. stipulated to willful trademark infringement, false designation of origin and other causes of action before U.S. District Judge Max Cogburn Jr. of the Western District of North Carolina. Cogburn entered an injunction that blocks DTI from misrepresenting, importing or distributing non-genuine Hyundai parts. Hyundai will recover $5 million in damages and attorneys fees under the agreement. More

8. VirnetX patents worth more than $1 billion in district court lost at PTAB

Recently, we raised the question as to whether or not 90 percent of patents which are being challenged at the Patent Trial and Appeal Board (PTAB) are being found defective once trial proceedings have concluded. There are those individuals who vigorously defend the workings of the PTAB as an administrative body, pointing towards statistics on denial of institution or trial settlements in order to deflect any viewpoint that the PTAB is mowing down patents at an unusually high rate. There is also a pervasive viewpoint that the patents being challenged are weak patents that deserve to be declared invalid. More

 9. Arctic Cat Inc. v. Bombardier Recreational Products Inc. (Fed. Cir. 2020)

The patent marking statute, codified at 35 U.S.C. § 287(a) appears straightforward:Patentees, and persons making, offering for sale, or selling within the United States any patented article for or under them, or importing any patented article into the United States, may give notice to the public that the same is patented, either by fixing thereon the word "patent" or the abbreviation "pat.", together with the number of the patent. More

10. Fresenius Loses 'Unduly Speculative' Generic Drug Row

A New Jersey federal judge on Tuesday tossed Fresenius Kabi's antitrust suit against Par Pharmaceuticals, which alleged that the drug ingredient maker blocked it from marketing a generic version of an antidiuretic drug.How Companies Can Extract Value from Expired Drug Patents. In pharmaceuticals, companies can learn about compounds and delivery methods others have developed through their patents and patent applications. Expired and lapsed patents (those for which maintenance fees have not been paid, but which have not run their 20- year patent term) can offer tremendous intelligence about competitors, and also about what has not been developed and disclosed through patents. More

 11. Abbott Laboratories v. Edwards Lifesciences Corp.

A Federal Patent at Issue: U.S. Patent No. 6,719,767, ″Device and a method for treatment of atrioventricular regurgitation," describes a less invasive based mitral-valve clip method for treating "mitral insufficiency" instead of traditional open-heart surgery. Petitioner requests institution of IPR, seeking cancellation of claims 1-3, 5, and 14 of the ′767 patent as unpatentable under 35 U.S.C. §§ 102 and 103. More

12. Glaxosmithkline Consumer Healthcare Holdings (US) LLC v. Cipla Ltd.

Patent at Issue: U.S. Patent No. 8,163,723, "Combination of azelastine and steroids," is directed at a pharmaceutical product comprising azelastine and a steroid, in a form suitable for nasal or ocular administration. The '723 patent provides a method of prophylaxis or treatment in a mammal where anti-histamines and/or one or more steroids is indicated. Petitioner challenges claims 1-218 of the ′723 patent as unpatentable under 35 U.S.C. § 103. More

 13. Mylan Laboratories Ltd. v. Janssen Pharmaceutica NV

U.S. Patent No. 9,439,906, "Dosing regimen associated with long acting injectable paliperidone esters," is directed at a method of treating patients in need of treatment with long acting injectable paliperidone palmitate formulations. Petitioner challenges claims 1-21 of the '906 patent as unpatentable under 35 U.S.C. § 103. More

 14. NanoCellect Biomedical, Inc. v. Cytonome/ST, LLC

U.S. Patent No. 10,029,263, "Method and apparatus for sorting particles," is directed at a method and apparatus for the sorting of particles in a suspension, where the input flow path of a sorting module can be split into several output channels. The claims are further directed at a particle sorting system in which a plurality of sorting modules are interconnected to increase particle throughput. NanoCellect challenges claims 1, 5-6, 8, 15, and 16 as obvious under 35

U.S.C. § 103. More 

15. CVC Files Motion in Opposition to Broad's Substantive Motion No. 4

On January 9th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its motion in opposition to Senior Party the Broad Institute (joined by Harvard University and MIT) Substantive Motion No. 4 asking the Patent Trial and Appeal Board (PTAB) for priority to U.S. Provisional Application No.

61/736,527 to Zhang (termed "Zhang B1" in the motion), pursuant to 37 C.F.R. § 41.121(a)(1)(ii) and § 41.208(a)(3) and Standing Order ¶ 208.4.1. More

16.   FDA Continues to App rove Biosimilars

The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has not reduced biologic drug prices that was the hope and justification for its enactment. More

 17. Amgen Inc. v. Amneal Pharmaceuticals LLC (Fed. Cir. 2020)

Transitional terms in patent law (conventionally, "comprising," "consisting of," and the more arcane "consisting essentially of") have their own provenance and meaning, denoting limitations that are "open" (comprising) or "closed" (consisting).  But how should a court construe instances where these terms seem to be at odds with one another? The Federal Circuit provided an answer, at least with regard to the interplay between "comprising" and Markush group language ("selected from the group consisting of") in one of its first opinions of the New Year, Amgen Inc. v. Amneal Pharmaceuticals LLC. More

 18. A Step-by-Step Approach to Patent Subject Matter Eligibility Reform

There is a belief in some quarters that the most significant barrier to patent subject matter eligibility reform is an implacable opposition by companies in the high tech sector because those companies are convinced that the recent Supreme Court precedent (Bilski/Mayo/Alice) as interpreted by the Federal Circuit has resulted in a diminution in lawsuits by so-called "patent trolls," non-practicing entities who accumulate patents to be asserted against these companies. More

 19. Motorola Wins $765 Million Over Theft by Chinese Radio Rival

Motorola Solutions Inc. won a $764.6 million verdict after a federal jury in Chicago said Chinese rival Hytera Communications Corp. stole the company’s critical trade secrets for two-way radio technology. Hytera pledged to appeal.The jury awarded $345.8 million in compensatory damages and $418.8 million in punitive damages -- the full amount sought by Motorola. More

 20. Relypsa, Inc. v. Alkem Laboratories Ltd.

Relypsa asserts infringement of the '873, '824, '476, and '212 patents. Relypsa is the holder of approved NDA No. 205739 for patiromer sorbitex calcium powder for oral suspension sold under the trade name VELTASSA®, a potassium binder indicated for the treatment of hyperkalemia. Relypsa submitted ANDA No. 214075 seeking approval to engage in commercial manufacture, use, offer for sale, sale, and/or importation of patiromer sorbitex as generic versions of VELTASSA®. More

 21. Janssen Products, LP v. Zydus Pharmaceuticals (USA) Inc.

Jassen Products asserts infringement of the '015, '408, '645, and '987 patents. Jassen is the holder of approved NDA 21-976 for PREZISTA® for the treatment of HIV. Zydus submitted ANDA No. 214085 seeking approval to make substantial and meaningful preparations to import into the United States and/or offer to sell, and/or use generic versions of PREZISTA®. More

 22.   HVLPO2, LLC v. Oxygen Frog, LLC (Fed. Cir. 2020)

Expert witness testimony is a frequent (almost ubiquitous) feature of patent litigation, if only because questions of the state of the art or the understanding of one having ordinary skill in the art are almost always at issue for claim construction, infringement, and invalidity issues. In HVLPO2, LLC v. Oxygen Frog, LLC, the Federal Circuit addressed whether opinion testimony from a witness not qualified as an expert is admissible, deciding that it is not. More

 23. Novartis Pharmaceuticals Corp. v. Alembic Pharmaceuticals, Ltd.

Novartis asserts infringement of the '659, '331, '938, and '134 patents. Novartis is the holder of New Drug Application No. 207620 for the commercial manufacturing, marketing, sale, and use of ENTRESTO® (sacubitril and valsartan) tablets, to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction, and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Actavis submitted ANDA No. 213682, seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of sacubitril/valsartan tablets, generic versions of Novartis’s ENTRESTO® tablets. More

 24.   Broad Files Opposition to CVC's Motion No. 1 for Priority Benefit

One of the briefs filed on January 9th in Interference No. 106,115 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") was the Broad's Opposition to CVC's Motion No. 1 to be accorded benefit to three priority applications for Count No. 1 in the interference as declared by the U.S. PTO. More

25. iLife Technologies, Inc. v. Nintendo of America, Inc. (N.D. Tex. 2020)

First, through clever drafting, the applicant must convince a U.S. Patent and Trademark Office (USPTO) examiner to not raise a § 101 rejection during prosecution. If one is raised, the applicant has to persuade the examiner, through amendment or argument, to withdraw it. If the examiner remains unpersuaded, an appeal to the USPTO's Patent Trial and Appeal Board (PTAB) must serve that function. Failing that, appeals to the Federal Circuit (which applies a highly-unpredictable eligibility analysis) and even the Supreme Court (which has not found a patent eligible since 1981) are possible. To be fair, it is unlikely that the high Court will grant certiorari on a § 101 issue these days. More