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

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

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

Section 112 Indefiniteness Is Still a “Lofty” Invalidity Attack

Jason Whitney, Counsel, Haynes and Boone, LLP After the U.S. Supreme Court tightened the requirements of 35 U.S.C. Section 112 in Nautilus, Inc. v. Biosig Instruments, Inc. by holding that claims must describe “the scope of the invention with reasonable certainty,”[1] some envisioned the possibility of a reinvigorated indefiniteness standard standing as a bulwark against overly broad or vaguely drafted patent claims. Indeed, just months after Nautilus, the Court of Appeals for the Federal Circuit hinted at such a future with Interval Licensing LLC v. AOL, Inc., which established the rule that terms of degree “must provide objective boundaries” for claimed inventions.[2] But as the Federal Circuit has continued to define the contours of Nautilus over the following years, indefiniteness attacks have met uneven success and produced inconsistent application of Section 112. The Federal Circuit’s recent opinion in Guangdong Alison Hi-Tech Co. v. ITC,[3] which examined the term of degree… Continue Reading

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