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Reminder of Annual Reporting and IRS Filing for ISO Exercises and ESPP Stock Transfers

This is a reminder for sponsors of equity incentive plans and tax-qualified “employee stock purchase plans” (“ESPPs”) of their year-end information reporting requirements under Section 6039 of the Internal Revenue Code with respect to stock issued to employees or former employees upon the exercise of “incentive stock options” (“ISO”) or transferred under an ESPP. The IRS has issued two forms that companies must use to satisfy the return and information statement requirements: (i) Form 3921, which is required when an employee (or former employee) exercises an ISO, and (ii) Form 3922, which is required when a company records the first transfer of legal title of shares acquired under an ESPP when either (a) the purchase price of the shares was less than the stock’s fair market value on the date of grant or (b) the purchase price of the shares was not fixed or determinable on the date of grant.… Continue Reading

“Consisting Essentially Of” Claims Nixed at Federal Circuit

Michael Tobin Associate Haynes and Boone, LLP In HZNP Medicines LLC v. Actavis Laboratories UT, Inc. (Fed. Cir. 2019)[1], the Federal Circuit affirmed the district court’s holding that the transitional phrase “consisting essentially of” was indefinite as used in several claims of patents owned by HZNP Medicines LLC and Horizon Pharma USA, Inc. (“Horizon”).[2]  Slip Op. at 2, 33.  Horizon’s patents cover its PENNSAID® 2% product, which is a Non-Steroidal Anti-Inflammatory Drug (NSAID) and the first FDA-approved twice-daily topical diclofenac sodium formulation for the treatment of pain of osteoarthritis of the knees.  Claim 49 of U.S. Patent No. 8,252,838 (the “‘838 patent”) is illustrative of Horizon’s formulation patents and recites: A topical formulation consisting essentially of: 1–2% w/w diclofenac sodium; 40–50% w/w DMSO; 23–29% w/w ethanol; 10–12% w/w propylene glycol; hydroxypropyl cellulose; and water to make 100% w/w, wherein the topical formulation has a viscosity of 500–5000 centipoise. Prior to… Continue Reading

DOL Issues Proposed Regulations for Electronic Delivery of ERISA-Required Retirement Plan Disclosures

The DOL recently issued proposed regulations which provide a “Notice-and-Access” safe harbor for the electronic delivery of ERISA-required disclosures. Under the proposed regulations, plan administrators can fulfill their obligation to provide these disclosures by making the information accessible online and by sending a notice of Internet availability (“Internet Availability Notice”) of the disclosures to participants’ e-mail addresses. The Internet Availability Notice must include a brief description of the document being posted online, a website address where the document is posted, and instructions for requesting a free paper copy of the disclosures or electing paper delivery of such disclosures in the future. Although the Internet Availability Notice must generally be sent each time a disclosure is posted online, the proposed regulations would allow a plan administrator to combine such notices in certain circumstances. The proposed regulations only apply to retirement plans, not health and welfare plans, and a plan administrator must… Continue Reading

Did the Federal Circuit Just Raise the Evidentiary Bar for Establishing Obviousness?

According to the panel in OSI Pharmaceauticals, LLC v. Apotex, Inc., Slip Op. No. 2018-1925 (Fed. Cir. Oct. 4, 2019), the answer to the question posed in this article’s title is a solid no.  But considering the opinion’s precedential nature and the facts in the case, the Federal Circuit may have just given patentees extra ammunition to defeat an obviousness challenge on evidentiary grounds.  The Federal Circuit analyzed whether certain pharmaceutical method claims related to a treatment for lung cancer were obvious and concluded that the lack of efficacy data in asserted prior art showed a person of ordinary skill would not have a reasonable expectation of success in applying their teachings.  This holding reversed an obviousness determination by the PTAB in a preceding IPR of the patent at issue, and shows that for challengers mounting an obviousness challenge, prior art containing data-based evidence may be needed to be successful,… Continue Reading

Agency FAQs Provide Additional Guidance under Mental Health Parity and Addiction Equity Act

Recently, the federal Departments of Labor, Treasury, and Health and Human Services (collectively, the “Agencies”) jointly issued a set of frequently asked questions and responses (the “FAQs”) that (i) provide additional examples of applying the Mental Health Parity and Addiction Equity Act, as amended (“MHPAEA”), to various fact patterns and (ii) finalize previous guidance issued by the Agencies in 2018 (see our prior blog post on that guidance here). The MHPAEA generally prohibits group health plans and issuers from imposing financial requirements (such as coinsurance or copays) or treatment limitations (such as visit limits or other “non-quantitative” limitations) on “mental health benefits” and “substance use disorder benefits” (collectively, “MH/SUD Benefits”) that are more restrictive than the predominant financial requirements and treatment limitations that apply to substantially all medical and surgical benefits (collectively, “Med/Surg Benefits”). The fact situations addressed in the FAQs include the following: • A group health plan’s imposition… Continue Reading

California Requires Employee Notice Regarding Flexible Spending Accounts

A new California state law requires an employer to notify its employees who participate in a flexible spending account (including health, dependent care, or adoption assistance flexible spending accounts) of any deadline to withdraw their funds before the end of the plan year. The employer must provide such notice in at least two of the following five forms, only one of which may be electronic: (i) email, (ii) telephone, (iii) text message, (iv) postal mail, or (v) in-person. Given that many flexible spending accounts have run-out periods that extend after a plan year ends, it appears that this notice requirement would apply when there is a termination of employment or other loss of coverage that requires submission of claims before the end of the plan year. However, the legislative history indicates that the statute is concerned with the “use it or lose it” rule for flexible spending accounts. Guidance under… Continue Reading

4th Annual Texas Insurance Academy

Registration now open! Insurance professionals and counsel are invited to attend our 4th Annual Texas Insurance Academy Conference on October 24, 2019, at the Haynes and Boone office in Dallas, Texas. Attendees can expect to learn from risk managers, coverage counsel and brokers about important insurance issues affecting businesses from a broad range of industries. Our experienced panels will share their knowledge on how to navigate through a hard market, including: • State of Play: Hardening Insurance Markets • Factors Driving the Hardening Market • Top 10 “Don’ts” When Negotiating Your Policy • Important Developments in Texas Insurance Law • Strategies for Dealing with the Hardening Market • A Look at Future Risks Date: Thursday, October 24, 2019Time: 7:45 a.m. – 4:30 p.m.Location: Haynes and Boone, LLP, 2323 Victory Avenue, Suite 700, Dallas, TX 75219 Register HereAgenda For more event information please email Patricia Kirven. About the Texas Insurance Academy: The… Continue Reading

Chevron Deference and the USPTO’s Determination of Applicant Delay in the Calculation of Patent Term Adjustment

Angela Oliver, Associate, Haynes and Boone, LLP With administrative law principles becoming increasingly important in patent law, a recent decision from the Federal Circuit highlights the relevance of those principles in patent prosecution.  In Intra-Cellular Therapies, Inc. v. Iancu,[1] the Federal Circuit extended Chevron deference to the USPTO’s determination that an applicant’s failure to submit a proper reply to a final Office action constituted “fail[ure] to engage in reasonable efforts to conclude prosecution of the application” under 35 U.S.C. § 154(b)(2)(C)(i), thus resulting in the accrual of applicant delay for patent term adjustment purposes.  Congress set forth the framework for calculating patent term adjustment (“PTA”) in 35 U.S.C. § 154(b) (“the PTA statute”).  Section 154(b)(1) enumerates the types of Patent Office delay that will lead to PTA accrual, while § 154(b)(2) provides that PTA may be reduced for delays caused by an applicant.  The dispute in Intra-Cellular Therapies pertained to the calculation of… Continue Reading

October 15 Deadline to Provide Medicare Part D Notice of Creditable Coverage

Health plans that offer prescription drug coverage must distribute the Annual Medicare Part D Notice of Creditable Coverage (the “Notice”) prior to October 15, 2019. The Notice informs participants whether the plan’s prescription drug coverage constitutes creditable or non-creditable coverage. Employers must provide the Notice to all Medicare-eligible participants and dependents. The Centers for Medicare and Medicaid Services has posted forms and instructions for providing this Notice, which are available here.

Court Penalizes Employer $41,140 for Failure to Timely Provide Plan Documents

In Kinsinger, a federal district court in North Carolina significantly penalized a plan administrator that failed to timely respond to employees’ request for plan documents related to an employer-sponsored group health plan subject to ERISA. The documents were not provided until 748 days after the ERISA required 30-day period to provide documents had expired, and then only in response to a lawsuit claiming an ERISA fiduciary breach for misappropriating employee contributions. The federal district court assessed a penalty of $55 per day (half of the statutory maximum of $110 dollars per day) for the failure to provide the required documents—a penalty determined by the court to reflect “both the egregiousness of the [plan administrator’s] misconduct as well as the extraordinary length of delay.” This opinion serves as a cautionary warning to ERISA plan administrators to not ignore document requests; however, not all documents requested by plaintiff’s attorneys are required to… Continue Reading

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