Gibbons Law Alert

Gibbons Law Alert

Category: Licensing

USPTO Final Rule Limits a Reduction of Patent Term Adjustment to the Period the Applicant Failed to Undertake Reasonable Prosecution Efforts

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Posted in Licensing / Patent / USPTO

On June 26, 2020

On June 16, 2020, the United States Patent and Trademark Office (USPTO) published a final rule revising patent term adjustment under 35 U.S.C. 154(b) in view of Supernus Pharm., Inc. v. Iancu. In Supernus, the Federal Circuit held that a reduction of patent term adjustment must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. The USPTO thus cannot deduct an amount of time beyond the period during which the applicant failed to undertake reasonable efforts to conclude prosecution. The USPTO revised relevant provisions pertaining to reduction of patent term adjustment, aligning the provisions with Federal Circuit law. Section 154(b)(2)(C) of the Patent Act authorizes the USPTO to reduce the total amount of patent term adjustment for certain delays by deducting the number of days equal to the period of time that “the applicant failed to engage in reasonable efforts to conclude prosecution of the application.” The USPTO implemented this section with 37 CFR § 1.704. In 2006, Supernus Pharmaceuticals filed patent applications in both the United States and Europe covering an osmotic drug delivery system. In February 2011, Supernus filed a Request for Continued Examination (RCE) in the U.S. application after a final rejection. Supernus’s European application was granted later...

Supreme Court Invalidates Ban on Immoral or Scandalous Trademarks

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Posted in Licensing / Trademarks

On July 8, 2019

In a long-awaited decision, Iancu v. Brunetti, the Supreme Court held – in a 6-3 opinion delivered by Justice Kagan – that the Lanham Act’s prohibition on registration of “immoral or scandalous” trademarks violates the First Amendment. The decision completes a trilogy of cases that, in recent years, stirred up significant interest on the interplay between freedom of speech and certain Lanham Act trademark prohibitions. Initially, the constitutionality of the bar against registration of disparaging marks was brought to nationwide media attention through the Redskins case (Blackhorse v. Pro-Football, Inc), previously reported on by Gibbons, which culminated the legal effort by Native American tribes to delineate the term “redskin” as an offensive and disparaging racial slur, resulting in the initial cancellation of the eponymous mark owned by the Washington Redskins. Pending review by the Supreme Court, the Blackhorse case was cut short by another case, Matal v. Tam. In that 2017 decision, the Court struck down a Lanham Act provision that prevented registration for marks that are deemed “disparaging,” thus rendering moot any further review of Blackhorse. Because the Court in Matal had already declared the “disparaging” bar unconstitutional, it comes as no surprise that the Section 2(a) prohibition (15 U.S.C. § 1052(a)) on registration of “immoral or scandalous” matter fared similarly under the scrutiny of...

FDA Will Now Provide More Data on 180-Day Exclusivity in the Orange Book

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Posted in Biotech / Licensing / Patent

On June 21, 2019

In a recent alert, the FDA announced that effective June 18, 2019, the Agency will publish additional data in the Orange Book Paragraph IV Certifications list. To enhance the already published data, the Orange Book will now include (1) the number of potential first applicants; (2) the 180-day decision date; (3) the date of the “first applicant” approval; (4) the date of first commercial marketing by any first applicant; and (5) the expiration date of the last qualifying patent. According to the FDA, the updated data listing comports with the Agency’s commitment under the Drug Competition Action Plan where the FDA “committed to enhancing efficiency of the development and approval of ANDAs, with the ultimate goal of more approvals.” Historically, the Orange Book Paragraph IV Certifications list has contained relevant information related to 180-day eligibility for generic drug products. Until recently, the listings included the name of the drug product, dosage form, dosage strength(s), the reference listed drug, the New Drug Application Number and the date upon which the first substantially complete application containing a Paragraph IV certification was submitted to the Agency. The new data will provide greater clarity to Hatch-Waxman litigants in a variety of ways. More specifically, with respect to the number of first applicants, the data will provide the number of...

District Court Must Consider Whether the Patentee Must be Joined Before Dismissing the Case for Lack of Statutory Standing

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Posted in Licensing / Patent

On June 19, 2019

The question of who must join a patent infringement suit often raises interesting questions of rights, obligations, and control of the litigation. In the global marketplace with increased licensing arrangements, the extent of retaining rights can have a direct impact on the viability of a lawsuit and protecting intellectual property. Recently, the Federal Circuit in Lone Star Silicon Innovations v. Nanya Technology provided further clarification on what meets the standing requirement to bring a patent infringement case, and for dismissing a case for lack of standing. In this patent litigation, the asserted patents (twelve in all) were originally assigned to Advanced Micro Devices (AMD). AMD later executed an agreement purporting to transfer “all right, title and interest” in the patents to Lone Star. The transfer agreement, however, imposes several limitations on Lone Star. For example, Lone Star may only assert the patents against “Unlicensed Third Party Entit[ies]” specifically listed in the agreement. To add new entities, Lone Star and AMD both must agree. If Lone Star sues an unlisted entity, AMD has the right, without Lone Star’s approval, to sublicense the patents to the unlisted entity. Further, AMD can prevent Lone Star from assigning the patents, and AMD and its customers can continue to practice the patents. Finally, AMD shares in any revenue Lone Star...

Reversing the First Circuit, the Supreme Court Holds That Rejection of an Executory Trademark License Does Not Bar the Licensee From Continuing to Use the Mark

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Posted in Licensing / Trademarks

On May 29, 2019

In Mission Product Holdings v. Tempnology, the Supreme Court, in an 8-1 opinion delivered by Justice Kagan, held that a debtor’s rejection of a trademark license under Section 365 of the Bankruptcy Code does not terminate the licensee’s rights to use the trademark under the agreement. Tempnology made clothing and accessories designed to stay cool during exercise, and marketed those products under the brand name “Coolcore.” In 2012, Tempnology gave Mission Product Holdings an exclusive license to distribute certain Coolcore products in the United States and granted Mission a non-exclusive global license to use the Coolcore trademarks. The agreement was set to expire in July 2016. In September 2015, however, Tempnology filed for relief under Chapter 11 of the Bankruptcy Code, and rejected the license agreement under Section 365(a). The Bankruptcy Court held that Tempnology’s rejection of the agreement revoked Mission’s right to use the marks. The Bankruptcy Appellate Panel reversed. The First Circuit rejected the Bankruptcy Appellate Panel’s view and reinstated the Bankruptcy Court’s decision. The First Circuit reasoned that Congress, in enacting Section 365(n) in 1988, “expressly listed six kinds of intellectual property,” but not trademarks. The First Circuit thus held that trademark licenses are categorically unprotected from court-approved rejection. The Supreme Court granted certiorari, and reversed the First Circuit. Section 365(a) of...

Incentivizing Global Monetization of U.S. Based IP Rights – The Carrot and the Stick of the 2017 Tax Act

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Posted in Licensing / Patent

On June 12, 2018

The 2017 Tax Act, signed into law on December 22, 2017, encompasses the most significant and wide-ranging changes to the U.S. Internal Revenue Code (“IRC”) since 1986. This article addresses both the new taxation of global intangible low-taxed income (“GILTI”) and a new deduction for foreign-derived intangible income (“FDII”), as they relate to patent rights. GILTI and FDII will significantly affect the tax strategies of multinational corporations, particularly those with valuable intellectual property rights held abroad. The new tax laws do not define intangible property through a list of specific types of assets, including intellectual property like patents. Rather, intangible property under the new laws encompasses anything not strictly considered a tangible asset. This expanded definition applies when determining the GILTI and FDII amounts. GILTI New IRC Section 951A effectively imposes a minimum tax on U.S. shareholders who own at least 10% of controlled foreign corporations (“CFCs”) to the extent the CFCs have “global intangible low-taxed income.” The Tax Act provides a formula for calculating GILTI, which exempts the deemed returns on tangible assets. The GILTI amount is calculated by subtracting the “net deemed tangible income return” from the “net CFC tested income.” The remainder is deemed intangible income subject to income tax. Practically, the GILTI base is determined by subtracting a normal return for the...

Federal Circuit Reaffirms its Patent Exhaustion Doctrine Decisions

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Posted in Licensing / Patent

On February 25, 2016

On February 12, 2016, the en banc Federal Circuit, in a 10-2 decision in Lexmark Int’l, Inc. v. Impression Prods., Inc., reaffirmed its long-standing rules that: (1) the exhaustion doctrine does not apply to patented articles sold subject to single-use/no-resale restrictions that were communicated to the buyer at the time of sale; and (2) the exhaustion doctrine does not apply to the sale of patented goods outside of the U.S.

Maximizing Bankruptcy Protection in Software and SaaS Agreements

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Posted in E-Commerce / Licensing

On September 28, 2015

In today’s digital age, cloud computing has lowered the barrier of entry into many marketplaces by providing network access to a shared pool of configurable computing resources. Cloud services allow business to forego upfront capital costs on servers, network infrastructure, and software allowing companies to focus on establishing and differentiating its business instead of worrying about its IT resources. Additionally, it is typically a “pay as you go” service meaning that businesses can scale up or down as needed in real time. However, entrusting a third-party as the sole source of the company’s network, software, and data storage functionality puts the company at risk of losing these services should the provider enter bankruptcy.

Itsy Bitsy Brulotte Climbed Up The Supreme Court Steps and Was Upheld

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Posted in Licensing

On July 16, 2015

We previously reported on the potential impact that the Supreme Court’s decision in the case of Kimble v. Marvel Enterprises, Inc. may have on patent licensing terms. On June 22, 2015, the Supreme Court, basing its decision on stare decisis, upheld Brulotte which had barred royalty payments on post patent expiration activities. Kimble et al. v. Marvel Ent., LLC, 576 U.S. __ (2015). The Supreme Court, referencing the Brulotte court’s opinion, found that such post expiration royalty provisions “conflict with patent law’s policy of establishing a ‘post expiration . . . public domain’ in which every person can make free use of a formerly patented product” Kimble, 576 U.S. at _ (slip op., at 5) (quoting Brulotte v. Thys Co., 379 U.S. 29, 33 (1964). In upholding that ruling, the Supreme Court reasoned that “stare decisis carries enhanced force when a decision . . . interprets a statute. Then, unlike in a constitutional case, critics of our ruling can take their objections across the street, and Congress can correct any mistake its sees.” Id. at _ (slip op., at 8).

Waiting For Brulotte’s Fate

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Posted in Licensing

On June 11, 2015

As licensing professionals await the decision of the Supreme Court in the case of Kimble v. Marvel Enterprises, Inc., which is widely believed to determine the future viability of the fifty year old decision of the Court in Brulotte v. Thys Co., it may be useful to consider the practical impact such a decision may have. The Brulotte decision held that use of the monopoly power of a patent to exact royalty payments on post expiration activities was a per se violation of the anti-trust laws. The reasoning was based on an analogy of the Court’s earlier prohibitions against tie-in arrangements where the use of a patented article required the purchase of an unpatented article. The patented invention was considered to be in the public domain upon expiration and thus free to use by all.

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