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“Bank For Your Buck” – The Legal Implications of Banksy’s Destruction of “Girl with Balloon”

For centuries, artists have been celebrated for pushing boundaries and shaping how society should view art. As members of the audience, we rely on artists to expose us to these unique dimensions of thought and we return the favor by placing value on their creations. For the past twenty years, one anonymous artist has continuously thrilled his audience by publicly displaying his work throughout the streets of major cities. Banksy, as the public knows him, has once again shocked his audience, this time at the Sotheby’s auction of one of his most famous graffiti pieces, “Girl with Balloon.”

However, the $1,037,000 record breaking bid price was not the cause for headlines after the sale. In pure avant-garde fashion, immediately upon the sounding of the auctioneer’s hammer, the frame securing the piece proceeded to shred the bottom half of, “Girl with Balloon.” The bidder, who remains anonymous, said that she is planning to keep the shredded piece, and “realized that [she] would end up with [her] own piece of art history.”[1] However, what if the owner had not had such an optimistic outlook on the prank, could she have legally deemed the sale void?

Under the Uniform Commercial Code (“UCC”), “a sale by auction is complete when the auctioneer so announces by the fall of the hammer or in other customary manner.”[2] While the sounding of the hammer indicates the transfer of ownership, this does not necessarily also indicate a transfer of liability. The UCC and Sotheby’s terms of sales state that the “risk of loss passes to the buyer upon her receipt of the property or on tender of delivery.”[3] In sum, liability is imposed on the party who has physical possession of the artwork. If the buyer receives the goods in a condition that does not conform to the condition the buyer reasonably believed the goods to be in at the time of the sale, under the UCC, a buyer may revoke her acceptance of the goods.[4]

As applied to, “Girl with Balloon” once the hammer struck, the ownership of the piece transferred from the hands of Banksy’s agent, Sotheby’s, to the anonymous bidder. However, since the piece immediately shred upon finalization of the sale, there was no actual physical transfer of the artwork. Between the time of the sale and the shredding, the piece was still mounted at the Sotheby’s auction house, therefore under the company’s liability. Since the art work was damaged while under the possession of Sotheby’s, under the UCC, it is likely that the anonymous buyer could have canceled the sale.

Moreover, there is also the issue of the price appraisal of the artwork. Buyers rely on auction houses like Sotheby’s to provide them with a guideline of establishing the value of pieces of art, in particular their reserve price (the minimum bid price for a piece). Sotheby’s set the reserve price for “Girl with Balloon” to reflect the piece in its original creation and it is unclear how the piece will be valuated post alteration. However, members of the art world seem to believe that this was not a destruction but rather a reincarnation of the piece. One art broker, Joey Syer, believes that Banksy’s prank contributed to art history, adding a “minimum 50% to its value.”[5]

If Syer’s estimates are true, could Sotheby’s in return bring a claim against Banksy for transforming his piece without their knowledge, thus manipulating the reserve price? Banksy admits to orchestrating the prank, and even recently revealed that his initial intention was to shred the whole work, but a mechanical error stopped the shredder at the bottom half of the piece.[6] It is unclear if, when Sotheby’s inspected the piece, they were aware of the shredder within the frame and if that was incorporated in their valuation of the piece. It is quite likely that Banksy did not disclose the shredder to Sotheby’s, who could potentially bring an action against Banksy for fraudulent concealment. Sotheby’s could make the claim that, by not disclosing the shredder, they misevaluated the piece and set the reserve price lower than its worth. Thus, had they set the reserve price higher, the piece could have sold for more, guaranteeing a greater commission for the auction house.

As of now, the parties and fans around the world view this as a positive occurrence. Sotheby’s head of contemporary art, Alex Branczik does not seem worried about the trick and views this as, “the first artwork in history to have been created live during an auction.”[7] Once again, Banksy has played with his audience’s conception of art, and the future valuation of the newly named, “Love in in the Bin,” will reveal whether the joke is actually on us.

[1] https://www.bbc.com/news/uk-england-bristol-45829853

[2] Uniform Commercial Code § 2-328

[3] Uniform Commercial Code § 2-509

[4] Uniform Commercial Code § 2-512

[5] https://www.telegraph.co.uk/news/2018/10/06/banksy-shreds-girl-balloon-p…

[6] https://www.cnn.com/style/article/banksy-video-girl-with-balloon/index.html

[7] https://www.bbc.com/news/uk-england-bristol-45829853

Copyright © 2018, Sheppard Mullin Richter & Hampton LLP.

Nurse Staffing Ratios May Be Coming to a Hospital Near You

On November 6, 2018, when Massachusetts voters go to the polls to select a new Governor and other key elected officers, they will also consider Ballot Question 1, which will mandate rigid registered nurse staffing ratios for hospitals across the Commonwealth effective as of January 1, 2019. This proposal would make Massachusetts the second state in the United States to have specific staffing ratios mandated in all units. This initiative follows only California, which passed a less comprehensive law through the legislative process in 1999 and provided over five (5) years for hospitals to implement by 2004.[1] The Massachusetts ballot initiative process, like that of some other states, allows the voters to write entirely new law into books. Question 1 appears to be the most heavily-fought ballot initiative in Massachusetts in recent memory. While Massachusetts seems to be the only state this year with a nurse staffing ratio as a referendum ballot initiative,[2] unions nationally will focus on the results of this year’s effort.

What is Question 1?

Question 1, if passed, would mandate highly-prescriptive and specific nurse-to-patient ratios based on the type of patients/units in hospitals, regardless of market, acuity of the patient, physician orders, or nursing judgement. Hospitals are required to implement a written plan detailing the maximum number of patients to be assigned to a registered nurse by unit at all times, while also “concurrently detailing the facility’s plans to ensure that it will implement such limits without diminishing the staffing levels of its health care workforce.”

Hospitals would also be required to develop a “patient acuity tool” for each unit to be used to determine whether the maximum number of patients that may be assigned should be lower than the assignment limits in the law. Notices regarding the patient assignment limits must be posted in conspicuous places, including each unit, patient room, and waiting area.

What are the Ratios?

The specific ratios mandated are summarized as follows (nurse:patient):

  • Step-down/intermediate care 1:3
  • Post anesthesia care (PACU) 1:1; PACU post-anesthesia 1:2
  • All units with operating room (OR) patients 1:1; OR patients post-anesthesia 1:2
  • Emergency Services Department: 1:1, 1:2,1:3, or 1:5 depending on the emergent or urgent nature of a patient which often changes by the minute
  • Maternal child care patients:
    • Active labor, intermittent auscultation for fetal assessment, and patients with medical or obstetrical complications 1:1
    • During birth and for up to two hours immediately postpartum 1:1 for mother and baby; when the condition of the mother and baby are determined to be stable and the critical elements are met, 1 nurse may care for both the mother and the baby(ies)
    • During postpartum for uncomplicated mothers or babies 1:6 (either 6 mothers or babies, 3 couplets of mothers and babies, or, in the case of multiple babies, not more than a total of 6 patients
    • Intermediate care or continuing care babies is 1:2 for babies
    • Well-babies 1:6
  • Pediatric 1:4
  • Psychiatric 1:5
  • Medical, surgical and telemetry patients 1:4
  • Observation/outpatient treatment 1:4
  • Rehabilitation units 1:5
  • All others 1:4

How Would the New Law be Enforced?

Question 1 also requires the state’s Health Policy Commission (HPC) (as opposed to the Department of Public Health, which is the state authority to license and regulate hospitals and other health care providers) to promulgate regulations and conduct inspections governing the implementation of the initiative.  The HPC is a six year old independent state agency charged with monitoring health care spending growth, it does not have the staff or infrastructure to conduct routine hospital surveys to monitor internal facility management and operations. It is also important to note that the proposed ballot would restrict the HPC by preventing it from issuing any delays, temporary or permanent waivers, or modifications of the ratios. Thus, even if the HPC believed that the January 1st  implementation date was unfeasible, it may be prohibited from offering waivers.

The HPC may report violations to the State Attorney General, who could file suit to obtain injunctions as well as civil penalties of up to $25,000 per violation and up to $25,000/day for continued violations.

The Impact if Question 1 Passes

Coalitions have lined up on both sides of Question 1.  Each side has painted dramatically-different pictures of a future for the industry with mandated nurse staffing ratios. The supportive nursing union has cast the initiative as being relatively small dollars for the industry, costing only $47 Million for all hospitals in the state in total according to their study.[3],[4]  The Massachusetts Health and Hospital Association and a broad-based coalition of health care providers and other nursing organizations opposed to the initiative point to studies estimating that the cost will be in excess of $1 Billion to the industry.[5]  Increased costs are based on the need to recruit new nurses, as well as the across-the-board increases in pay. There will be a need to hire 5,911 registered nurses within 37 business days to comply with January 1st  deadline and this is in a state that already has a shortage of approximately 1,200 registered nurses.[6]  Individual community hospitals are reporting projected additional expenditures that amount to more than the $30 Million per year, with teaching hospitals anticipating increased expenditures higher than that.[7]

On October 4, 2018, the HPC issued its independent report on the estimated costs of Question 1, essentially validating the opposition’s concerns, and projecting annual increased costs of $676 Million to $949 Million, and noted that the projections were “conservative.” The HPC study undercounted costs as it only looked at increased costs in certain units, and excluded costs associated with increased staffing in emergency departments, observation units, outpatient departments, or any costs for implementation or to non-acute hospitals.[8]  Wage increases of 4 – 6% are predicted in the HPC study, based on the California experience with across-the-board staffing requirements in place, and estimated increases of total health expenditures in Massachusetts of 1.1 – 1.6%, with increases of 2.4 – 3.5% for hospital spending alone, again, based on a conservative and partial analysis. Thus, it appears that the industry fears of greater than $1Billion in annual increased expenses are valid.

Ancillary adverse impacts anticipated by the HPC included reduced access to emergency care, increased wait times, decreased patient flow, increased “boarding,” and more ambulance diversions.

The HPC also compared Massachusetts to California hospitals and concluded that there was “no systematic improvement in patient outcomes post-implementation of ratios.”

What Should Hospitals be Doing Now?

Question 1, if passed, would only apply to Massachusetts licensed hospitals.  But hospitals and health systems in other jurisdictions should be prepared for similar efforts in their states. The following are some initial steps hospitals should be considering

Access Management.  Access problems will be common starting in January if Question 1 passes. Elective procedures, non-emergent appointments and other services may need to be curtailed effective January 1, 2019.  Hospitals will need to meet staffing levels on that day with respect to then-current inpatients and outpatients.  Avoiding new admissions in December may be necessary to assure the hospital is not in instant violation on New Year’s Day. Early patient contact to warn about the possibility of rescheduling procedures will prudent.

Payer Contract “Reopeners.”  Payer contracting “reopeners” should be added to managed care contracts now. The hospital community has been watching the interest of the unions in pushing nurse staffing ratios in Massachusetts and other states for a number of years. Health systems and hospitals negotiating long-term contracts with payers have often included “reopeners” to permit the hospital to revisit contract rates even during the term of an agreement if certain extreme events come to pass.  Hospitals in all jurisdictions are encouraged to consider adding such reopeners to their agreements today.

Massachusetts hospitals should review their payer contracts now to confirm if they have the right to a mid-term reopening and, if so, provide notice immediately upon passage to their payers that the hospital will need to renegotiate rates to address the increased costs. Charge masters will also need to be reviewed immediately.

Union status? Based on their efforts to rally public support around Question 1, the Massachusetts Nurses Association is trying to do an end-run around the collective bargaining table where their past efforts on the issue of staffing ratios have failed.  Health systems and hospitals should review their collective bargaining agreements to determine whether they are in a position to trigger a reopener during the term of the contract to address the numerous monetary and non-monetary consequences of rigid staffing ratios contemplated by Question 1.

Unit Closure Plans.  If passed, hospitals in Massachusetts will likely need to immediately assess whether and how they could comply with these new ratios. Units that already operate at a loss, or for which meeting the staffing requirements is impossible, should be closed or reduced to the smallest possible patient compliment.  Closure plans and negotiations will need to commence immediately.

Massive Recruitment Efforts.  While there are believed to be a few hospitals that may already meet these staffing levels (at some times), most hospitals will need to recruit many more registered nurses, as well as have additional nurses standing by for fluctuations in patient loads on various units on a daily basis.  As noted above, the law will require hiring nearly 6,000 RNs in the fourth quarter of this year.[9]

Conclusion

If Question 1 passes, conservative projections estimate extreme new costs will be incurred by Massachusetts hospitals, which will result in both reductions in levels of service, and increased costs to payers and patients.  It is important to note that the dire circumstances of the ballot has led to an increasing large number of nursing organizations and physician groups in Massachusetts to all oppose Question 1. While Massachusetts hospitals are making plans akin to natural disaster preparedness, hospitals in other states should watch carefully these events to be ready should similar initiatives arise locally.

———————————

[1] A few other states have limited ratios in certain special types units (like intensive care units), but Question 1 applies to all hospital units.

[2] See http://www.ncsl.org/research/elections-and-campaigns/ballot-measures-database.aspx(June 6, 2018); downloaded on October 8, 2018.

[3] See https://www.massnurses.org/news-and-events/p/openItem/11083

[4] See https://safepatientlimits.org/wp-content/uploads/Shindul-Rothschild-Esti…

[5] See https://www.protectpatientsafety.com/get-the-facts/

[6]  See Mass Insight Global Partnership, Protecting the Best Patient Care in the Country, Local Choices v Statewide Mandates in Massachusetts (April, 2018)  http://www.bwresearch.com/reports/bwresearch_mha-nlr-report_2018Apr.pdf (“Mass Insight Study”)

[7] See Financial impact of nurses ballot question? Depends who’s counting, Priyanka Dayal McCluskey, Boston Globe (Sept. 17, 2018).  https://www.bostonglobe.com/metro/2018/09/17/financial-impact-nurses-ballot-question-depends-who-counting/mlS4yZa5IB8hcDaFZ7ojXM/story.html

[8] See Analysis of Potential Cost Impact of Mandated Nurse-to-Patient Staffing Ratios, October 3, 2018, https://www.mass.gov/doc/presentation-analysis-of-potential-cost-impact-…

[9] Mass Insight Study.

 

© 2018 Foley & Lardner LLP
This post was written by Lawrence W. Vernaglia and Donald W. Schroeder of  Foley & Lardner LLP.

USCIS Will Begin Accepting Cap-Subject H-1B Petitions for Fiscal Year 2020 on April 1, 2019

U.S. Citizenship and Immigration Services (USCIS) will accept new H-1B petitions subject to the annual quota for fiscal year 2020 (FY 2020) starting April 1, 2019. Employers should identify any current or future employees who may require new H-1B visas to work in the United States. Individuals currently holding F-1 student visas, individuals seeking to change to H-1B status from another visa status (such as L-1, TN, O-1, or E-3), and individuals outside the United States likely will require cap-subject H-1B petitions to be filed on their behalf.

Overview of the H-1B Visa Program

The H-1B visa program permits U.S. companies to employ foreign nationals in specialty occupations. A “specialty occupation” is a position that requires the theoretical or practical application of a body of highly specialized knowledge, such as that of an engineer, economist, or scientist. The specialty occupation must require a bachelor’s degree or higher (or its foreign equivalent) in a specific field.

The number of new H-1B visas available on an annual basis is subject to limitations for each fiscal year. Currently, the annual limit is 65,000 visa numbers per year with an additional 20,000 available to H-1B applicants who possess advanced degrees from U.S. academic institutions. Of the 65,000 available H-1B visas, 6,800 are reserved for citizens of Chile and Singapore. Due to the cap, employers will want to plan far in advance and file their cap-subject petitions as early as possible to help ensure they have the best chance to secure H-1B status for the next fiscal year.

When USCIS receives more cap-subject H-1B petitions than the annual fiscal year limitation, USCIS conducts a computer-generated random lottery selection process. The first lottery is limited to individuals who possess advanced degrees from U.S. academic institutions. If a qualifying advanced degree holder is not selected in this first lottery, his or her petition will be rolled into a second lottery for the regular H-1B cap.

Cap-subject petitions that have not been selected in the lottery will be returned with the U.S. government filing fees. Once the number of available H-1B visas has been fulfilled, USCIS will not accept or approve any additional cap-subject H-1B petitions until the filing period for the next fiscal year opens.

Cap-Exempt Petitions

Some H-1B petitions are exempt from the annual fiscal year limitation, including (1) H-1B petitions that are filed to extend or amend H-1B employment for foreign workers who are already in H-1B status and (2) petitions filed on behalf of new workers to be employed in H-1B status by institutions of higher education or related nonprofit entities, nonprofit research organizations, or government research organizations.

How to Prepare for the FY 2020 H-1B Cap

The annual fiscal year cap for H-1B visas is typically reached within the first week of filing. Because the number of cap-subject H-1B petitions that will be filed by employers for FY 2020 is uncertain, employers will want to mail all cap-subject H-1B petitions early within the filing window. The first day to mail FY 2020 cap-subject petitions will be March 29, 2019, for delivery to USCIS on April 1, 2019, which is the first day of the filing period. Employers should immediately begin identifying individuals for whom H-1B sponsorship will be needed to allow sufficient time for H-1B petition preparation.

In preparing FY 2020 H-1B petitions, employers should keep in mind the time required to file and receive certification of a Labor Condition Application (LCA). The LCA is a prerequisite to a properly filed H-1B petition. As part of the LCA, employers must attest that they will pay the H-1B worker the higher of the prevailing wage or actual wage for the position in the geographic area of intended employment. The LCA is then submitted to the U.S. Department of Labor, which can take up to 10 days to certify the application. Employers should keep this processing time in mind to ensure timely approval of an LCA. Timely filing and approval of an LCA will help ensure that an employer is best positioned to mail the H-1B cap-subject petition on March 29, 2019, for delivery to USCIS on April 1, 2019.

Employers can take action now to initiate cap-subject H-1B petitions.

 

© 2018, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.

The Evolution of the Health Club as a Tenant in Retail and Mixed-Use Developments; Pros and Cons

A health club used to be an unwelcome tenant in any retail shopping center.  The traditional thinking was that health club patrons occupied the parking areas at peak shopping times and for extended periods, and then left without shopping at the other retail stores in the center. The number of people with a membership to a fitness center or health club continues to grow, with 60.87 million in 2017, up from 32.8 in 2000, approximately an 85% increase (see more here). As personal fitness has become the rage, the health club has become not only mainstream, but the anchor store and a requirement in both retail shopping centers and mixed-use and residential developments.

The move for more fitness centers has coincided with the transformation of the shopping center with traditional big box retail anchors into destination centers with restaurants, green open space, retail stores, and of course health clubs and health related uses focused on personal fitness and group related activities – all things one cannot do on the internet.  Circuit City has been replaced by Life Time Fitness, Equinox, or other fitness centers.

While this may have saved the retail shopping center, as a neighbor the health club can be hard to take.  The parking problem continues to be a challenge.  Absent a distinct and separate building, the noise and vibration emanating from a fitness center can deprive neighboring stores (next to, above and below the health club) of the quiet enjoyment of their space.  The slamming of heavy weights, vibrations and blaring music, all typical in health clubs, can create major disruptions to retail, office, and residential tenants alike.  Imagine doing eye exams while the walls and floors shake from the dropping of heavy weights, and as heavy bass vibrates through the walls from the cycling class.  Will you be seeing eye to eye with the health club?

Landlords must consider the location of the health club – preferably a separate pad site otherwise on grade or below, away from residences and professional (particularly medical) offices.  The onus should be on the health club to insulate the sound and vibration or discontinue the offending use.  Upgrading of walls and/or reinforcement or padding of floors and soundproofing the ceiling may be required.  The building structure generally must be considered.

The attraction of a health club as a tenant in a high end residential or mixed-use building cannot, however, be denied. Landlords looking to add a fitness center tenant to their roster should contact their attorney to ensure their lease covers their unique needs of these tenants.

 

© 2018 SHERIN AND LODGEN LLP
This post was written by Gary D. Buchman of Sherin and Lodgen LLP.

Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”).  Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule that would require pharmaceutical manufacturers to disclose the list price of their pharmaceutical products in direct-to-consumer (“DTC”) television ads (the “Proposed Rule”).  This comes only a week after the President signed legislation prohibiting “gag clauses” in pharmacy agreements and allowing pharmacists to tell patients that they can obtain a product for less by paying the cash price instead of their insurance company’s negotiated rates.

This recent Proposed Rule is relatively straightforward: any prescription drug or biologic with a list price of more than $35 that may be directly or indirectly covered by Medicare or Medicaid must include the following statement in DTC television ads:

  • “The list price for a [30-day supply of] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.”

CMS proposes that the “list price” in the above statement should be the product’s Wholesale Acquisition Cost (“WAC”); however, CMS is seeking comment on whether WAC best reflects the “list price.”  WAC is the published price that pharmaceutical manufacturers charge wholesalers for their products.  WAC does not include any prompt pay or other discounts, rebates or reductions in price. It is also different from the usual and customary price that a cash paying patient pays at the pharmacy.

CMS further proposes that the only “enforcement mechanism” under the Proposed Rule would be the annual publication of a list of manufacturers that have not complied with the disclosure requirements.  CMS believes violations of the regulation would be enforced as unfair and deceptive marketing through the Lanham Act, which allows competitors to bring causes of action against each other.  In other words, CMS is anticipating that the industry will self-police compliance with the regulation.  However, CMS is also seeking comment on other approaches to enforce compliance with the Proposed Rule.

Notwithstanding the straightforward nature of the Proposed Rule, it is clear that CMS is bracing itself for legal challenges.  CMS spends a significant portion of the preamble defending its rationale for requiring list price to be disclosed and its authority to issue this Proposed Rule, as well as attempting to preempt potential First Amendment challenges.

The stated purpose of the Proposed Rule is to reduce the price “that consumers pay for prescription drugs and biological products.”  CMS’ rationale is that by providing beneficiaries with “relevant information about the costs of prescription drugs and biological products,” beneficiaries can make informed decisions that minimize their out-of-pocket costs and reduce costs to Medicare and Medicaid.  CMS believes that requiring pricing information in ads allows beneficiaries to “price shop,” so that the prescription drug market can be similar to other commodities.  CMS points to market research among other commodities finding that when pricing information is available, competition increases resulting in price reductions.  One interesting note is that out-of-pocket costs only impact non-dual-eligible Medicare beneficiaries.  States can only charge Medicaid beneficiaries a nominal prescription drug copay that is identified in the Medicaid State Plan or in regulation.  Dual-eligible beneficiaries have a copayment that ranges from $0 to $8.35, regardless of the drug’s WAC.

CMS states that it has legal authority to promulgate this Proposed Rule because the Social Security Act requires that the Secretary administer the Medicare and Medicaid programs in a manner that minimizes unreasonable expenditures.  Further, it explains that Congress explicitly directs HHS to operate the Medicare and Medicaid programs efficiently.  CMS argues that promoting pricing transparency promotes efficient markets and can reduce unnecessary expenditures.  It is interesting to note the Administration determined that this rule should be issued by CMS, rather than FDA or Federal Trade Commission, which otherwise regulate the advertisement of prescription drugs and market competition, respectively.  Statements from Secretary Azar and HHS officials indicate that HHS did not use FDA’s authority because such authority is limited to drug claims and side effects.

Additionally, CMS tries to preempt any First Amendment challenges against its proposal, stating that this price disclosure “consists of purely factual and uncontroversial information about a firm’s own product.”  CMS argues that prescription drug price disclosure is no different from requiring the disclosure of calories on menus or an insurer’s financial interest in PBMs, which have been upheld by either the United States Supreme Court or circuit courts.

CMS will accept comments on this rule for 60 days following its publication to the Federal Register.  Given the speed in which the Administration is tackling the proposals in its Blueprint, we will continue to track developments.

 

©1994-2018 Mintz All Rights Reserved.
This post was written by Lauren M. Moldawer of Mintz.

Federal Circuit Concurring Opinion Recommends En Banc Review of Prior Ineligible Subject Matter Decision

On October 9, 2018, the United States Court of Appeals for the Federal Circuit affirmed a grant of summary judgment of invalidity due to patent-ineligible subject matter in Roche Molecular Systems, Inc. v. Cepheid, No. 2017-1690, applying its prior holding concerning claims directed to similar technology in In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755, 760 (Fed. Cir. 2014).  In a concurring opinion, Judge O’Malley recommended that the full court revisit the holding in BRCA1.  If the full court decides to revisit BRCA1, this could strengthen patent protection for other biotech inventions.

Background

Roche’s U.S. Pat. No. 5,643,723 includes claims directed to a method for detecting a pathogenic bacterium using a short, single-stranded nucleotide sequence known as a “primer” and other claims directed to the primers themselves.

Roche accused Cepheid of infringing the ‘723 patent and Cepheid filed a motion for summary judgment of invalidity under 35 U.S.C. § 101. The U.S. District Court for the Northern District of California granted the motion, relying on the Federal Circuit’s holding in BRCA1 relating to primers.  Specifically, the district court held that the claims were unpatentable under § 101 because “the primer claims in this case, which have genetic sequences identical to those found in nature, are indistinguishable from those held to be directed to nonpatentable subject matter in In Re BRCA1.”

Majority Opinion

The Federal Circuit affirmed the summary judgment of patent ineligibility based on its prior holding in BRCA1.  Specifically, the majority noted that the primers of the ‘723 patent have identical nucleotide sequences as naturally occurring DNA, just like the primers in BRCA1.  The majority rejected Roche’s argument that its synthetic primers differed from those in the naturally-occurring gene based on the presence of a 3-prime end and 3-prime hydroxyl group, noting that the “same argument was made in BRCA1.”

Concurring Opinion

Although Judge O’Malley agreed with the majority that BRCA1 compelled the conclusion that the claims of the ‘723 patent are not patent-eligible subject matter, she wrote separately to express her further view that the Federal Circuit should revisit en banc the holding in BRCA1 at least with respect to Roche’s primer claims.  BRCA1 involved an appeal from the denial of a preliminary injunction motion brought early in that case.  Judge O’Malley noted that the record in BRCA1 was underdeveloped and the Federal Circuit in BRCA1 did not have the benefit of certain arguments and evidence, such as those presented by Roche, which could support a finding that the primer claims are patent eligible.  For example, Roche demonstrated the ways in which the claimed primers may differ structurally from anything that occurs in nature.

Judge O’Malley also distinguished the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).  In particular, unlike the claims in Myriad, which were neither “expressed in terms of chemical composition, nor” reliant “in any way on the chemical changes that result from the isolation of a particular section of DNA,” the primer claims in the ’723 patent are expressed in terms of chemical composition and are reliant on the presence of a 3-prime end and a 3-prime hydroxyl group at a nonnaturally occurring location.

Takeaway

Some of the alleged modifications that Judge O’Malley suggests might render Roche’s primers patent eligible and could save other patent claims directed to synthetic DNA.  If the full court agrees with Judge O’Malley’s suggestion to revisit BRCA1, this may strengthen patent protection for other biotech inventions.

 

© Copyright 2018 Brinks, Gilson & Lione

New Federal Overtime Rule Expected in Early 2019

It doesn’t seem that long ago that employers were busily preparing for the new overtime rule that would have doubled the minimum salary level for the “white collar” exemptions from $23,660 to nearly $48,000.  That new rule—finalized in May 2016 and set to take effect on December 1 of that year—was struck down by a Texas federal court in late November 2016.

President Trump took office in January 2017, and the DOL—with less interest in so aggressively raising wages as the predecessor administration—pushed the pause button on revisions to the overtime rule.  In public comments, however, Labor Secretary Alexander Acosta, who assumed the post in late April 2017, repeatedly indicated that he favors some increase in the minimum salary threshold for exemption, which was last raised in 2004 (and before that, in 1975).

In July 2017, the DOL began seeing public comment on a revised overtime rule, publishing a Request for Information in the Federal Register.  The comment period closed in September 2017.

In its Spring 2018 Regulatory Agenda, the Trump Administration formally announced its intention to issue a Notice of Proposed Rulemaking (NPRM) in January 2019 “to determine what the salary level for exemption of executive, administrative, and professional employees should be.”

So what should employers expect in a new overtime rule?  Likely an increase in the minimum salary for exemption to something in the low-to-mid $30,000s.  This would be consistent with Secretary Acosta’s comments on the issue, but still considerably lower than the level proposed by the Obama Administration.  It would also be significant lower than some state law minimum salaries for exemption (consider New York’s minimum for exempt executive and administrative employees, which will climb to $58,500 at the end of 2018).

Another thing we could see in a new overtime rule are more modern examples of how the various exemptions might apply in today’s workplaces.  The DOL included a number of new examples in its sweeping revisions to the overtime exemption rules in 2004.  It would make sense to revisit those examples, and to consider additional examples, given how the workplace has evolved in the last 15 years.

It’s also possible the DOL will depart from a one-size-fits-all salary minimum and propose different tests for smaller or non-profit employers.  Small businesses, non-profits, and educational institutions were among the loudest voices in opposition to the 2016 overtime rule changes, and would be among the hardest hit by any increase in the minimum salary levels.

What I don’t expect from a new overtime rule are automatic future increases (which were part of the 2016 rule) or a change from a qualitative to a quantitative (e.g., California-style) primary duties test.

I also don’t expect any new overtime rule to take effect before 2020.  Even assuming the DOL meets its expected deadline of proposing a new rule in January 2019, it will likely receive (and have to review) hundreds of thousands of public comments.  (The DOL received more than 270,000 comments in response to the proposed overtime rule that was finalized in 2016.)  In all likelihood, the DOL will give employers plenty of lead time to plan and prepare for any increases in the minimum salary for exemption.  So for employers who are not subject to more stringent state rules around exemption, it’s likely you have at least a year and a few months before you’d have to implement any changes.

 

© 2018 Proskauer Rose LLP.
This post was written by Allan Bloom of Proskauer Rose LLP
Learn more labor and employment news on the National Law Reviews Labor & Employment page.

Proposed Immigration Rule – Inadmissibility on Public Charge Grounds

USCIS has proposed rules that could deny entry to non-immigrants seeking admission to the United States and adjustment of status to permanent residence to immigrants if they rely on public benefits for food, housing or medical care, and other forms of public assistance. The proposed rule – “Inadmissibility on Public Charge Grounds” – is published in the Federal Register. The public may comment on the proposed rule during the 60-day comment period ending on Dec. 10, 2018. USCIS will review comments to the proposed rule and then revise and issue a final public charge rule that will include an effective date. In the interim, and until a final rule is in effect, USCIS will continue to apply the current public charge policy.

Pursuant to Section 212(a)(4) of the Immigration and Nationality Act (INA), an individual seeking admission to the United States or seeking to adjust status to permanent resident (obtaining a green card) is inadmissible if the individual “at the time of application for admission or adjustment of status, is likely at any time to become a public charge.”

Under 8 U.S.C. § 1601 (PDF)(1), “Self-sufficiency has been a basic principle of United States immigration law since this country’s earliest immigration statutes.”

Further under 8 U.S.C. § 1601 (PDF)(2)(A), “It continues to be the immigration policy of the United States that aliens within the Nation’s borders not depend on public resources to meet their needs, but rather rely on their own capabilities and the resources of their families, their sponsors, and private organizations.”

While self-sufficiency has been the guiding principle of U.S. immigration law, as indicated in the above federal regulations, “public charge” has not been defined in statute or regulations. According to USCIS, there has been insufficient guidance on how to determine if an alien who is applying for a visa, admission, or adjustment of status is likely at any time to become a public charge. In determining inadmissibility USCIS has used the definition of “public charge” as an individual who is likely to become “primarily dependent on the government for subsistence, as demonstrated by either the receipt of public cash assistance for income maintenance, or institutionalization for long-term care at government expense.” (See, “Field Guidance on Deportability and Inadmissibility on Public Charge Grounds,” 64 FR 28689 (May 26, 1999). In determining whether an alien meets this definition for public charge inadmissibility, USCIS considers several factors, including age, health, family status, assets, resources, financial status, education, and skills. No single factor will determine whether an individual is a public charge.

The proposed rule will apply to foreign nationals seeking admission to the United States on non-immigrant and immigrant visas, as well as those non-immigrants who have availed themselves of public benefits within the United States and are seeking to seeking to either extend their stay or change their status. Under the proposed rule, USCIS would only consider the direct receipt of benefits by the individual alien applicant. Receipt of benefits by dependents and other household members would not be considered in determining whether the alien applicant is likely to become a public charge.

Factors that would generally weigh heavily in favor of a finding that an individual is likely to become a public charge include the following:

  • The individual is not a full-time student and is authorized to work, but cannot demonstrate current employment, has no employment history, or no reasonable prospect of future employment;
  • The individual is currently receiving or is currently certified or approved to receive one or more of the designated public benefits above the threshold;
  • The individual has received one or more of the designated public benefits above the threshold within the 36 months immediately preceding the alien’s application for a visa, admission, or adjustment of status;
  • The individual has been diagnosed with a medical condition that is likely to require extensive medical treatment or institutionalization or that will interfere with the alien’s ability to support himself or herself, attend school, or work, and the alien is uninsured and has no prospect of obtaining private health insurance; or
  • The individual has previously been found inadmissible or deportable based on public charge.

Alternately, factors that would weigh strongly against a finding that a foreign national is likely to become a public charge include:

  • The individual has financial assets, resources, and support of at least 250 percent of the Federal Poverty Guidelines for a household of the alien’s household size; or
  • The individual is authorized to work and is currently employed with an annual income of at least 250 percent of the Federal Poverty Guidelines for a household of the alien’s household size.

This proposed rule could have wide-reaching effects on legal immigration to the United States. The rule proposes not only to define “public charge” and the factors to be considered in making current and prospective public charge determinations, but also to add requirements for “public charge bonds” for certain applicants who are more likely to become a public charge. It is important for interested parties to comment on this proposed rule by the Dec. 10, 2018 deadline.

 

©2018 Greenberg Traurig, LLP. All rights reserved.
This post was written by Anita E. J. Ninan of Greenberg Traurig, LLP.

Permanent Injunctions for Non-Practicing Entities in Patent Cases

Many patent practitioners assume that non-practicing entities cannot obtain permanent injunctions in patent cases.  This is attributed to the belief that NPEs fail the four-factor test set out by the Supreme Court in eBay.  Given that belief, it is surprising for some to learn that a recent decision from the Northern District of California resurrected decade old case law indicating that non-practicing entities can get injunctive relief.  Practitioners having cases involving NPEs would do well to study this line of reasoning to be prepared for arguments surrounding permanent injunctions.

The four-factor test identified by the Supreme Court in eBay for determining whether to award permanent injunctive relief to a prevailing plaintiff requires the plaintiff to demonstrate: (1) that it has suffered an irreparable injury; (2) that remedies available at law are inadequate to compensate for that injury; (3) that considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.  eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391, 126 S. Ct. 1837, 1839 (2006).  After the eBay decision in 2006, it has been extremely rare for NPEs to be awarded permanent injunctions, but a recent district court decision has resurfaced the issue.

On July 3, 2018, Judge Chen from the Northern District of California denied a defendant’s motion to dismiss or strike a plaintiff’s prayer for injunctive relief where the defendant had argued for the dismissal given the plaintiff’s status as an NPE.  Software Research, Inc. v. Dynatrace LLC, No. 18-cv-00232-EMC, 2018 U.S. Dist. LEXIS 111468, at *49-50 (N.D. Cal. July 3, 2018).  The decision first questioned whether there was any proof that the plaintiff was in fact an NPE, but then indicated that even if the plaintiff were an NPE, the court could not find as a matter of law on a motion to dismiss that the plaintiff would fail to satisfy the eBay criteria.  Id.  The court then made the striking statement that “non-practicing entities have successfully managed to get injunctive relief post-eBay where they have shown potential injury to its licensing program.”  Id. at *50.

As support for that statement, the court pointed to the decade old decisions of Commonwealth Sci. & Indus. Research Organisation v. Buffalo Tech. Inc., 492 F. Supp. 2d 600 (E.D. Tex. 2007) and Acticon Techs. v. Heisei Elecs. Co., 2007 U.S. Dist. LEXIS 100081 (S.D.N.Y. Aug. 1, 2007).  Id. at *50 n.4.  The citation to Acticon Techs. was surprising because as the court noted, even though an injunction was entered following a default judgment in that case, there were few facts in the magistrate judge’s report and recommendation to indicate that the plaintiff in that case was an NPE.  Id.  Judge Chen apparently took the initiative to review Acticon Technologies’ website, and then stated that “[b]ased on a review of plaintiff Acticon Technologies’ website, it appears that Acticon is involved solely in licensing its intellectual property and does not practice its patents.”  Id.

The Commonwealth Scientific decision cited by the court was the subject of many articles back in 2007 speculating about its implications for permanent injunctions for NPEs, but has largely been forgotten over the intervening years.  In that case, a research institution involved in licensing programs was granted a permanent injunction after the four-factor eBay test was found to have been met.  Commonwealth Sci., 492 F. Supp. 2d at 604-07.  Regarding the first factor to show irreparable harm, the plaintiff’s harm was explained to be not merely financial because its reputation was an important element in recruiting the top scientists in the world, and having its patents challenged via the courts not only impugned its reputation as a leading scientific research entity but also forced it to divert millions of dollars away from research and into litigation costs.  Id. at 604.  The harm of lost opportunities to start other research projects due to litigation costs was found to be irreparable because they could not be regained with future money as any opportunity that was lost would already belong to someone else.  Id.

Regarding the second factor to show inadequate remedies at law, the plaintiff’s harm was found to be no less important than other recognized forms of harm a competitor might suffer to its brand name or sales position in the market, because its reputation as a research institution was found to be impugned just as another company’s brand recognition or good will may be damaged.  Id. at 605.  For the third factor, the balance of hardships was found to favor the plaintiff’s motion for permanent injunction because the harm that continued infringement would likely cause plaintiff’s research and development projects outweighed the harm that an injunction would cause the defendant in being excluded from competing in the market.  Id. at 606-07.  Finally, regarding the fourth factor, the public interest was explained as being advanced by encouraging investment by research organizations into future technologies, which served to promote the progress of science and the useful arts.  Id. at 607.

The recalling of the long dormant Commonwealth Scientific decision by the court in Software Research breathes life again into the issue of permanent injunctions for non-practicing entities.  It remains to be seen whether this is an isolated occurrence, or if this recent decision could spark a renewed interest by NPEs in permanent injunctions.  Patent practitioners representing NPEs may see the potential for strengthened judgments, while those opposing NPEs should be prepared to respond to attempts for permanent injunctions.

 

© 2018 Foley & Lardner LLP
This post was written by Justin M. Sobaje of Foley & Lardner LLP.
Read more Intellectual Property News on our Intellectual Property Type of Law Page.

Do Your Employees Use Cell Phones for Work While Driving?

Many employers have policies regarding the use of cell phones while driving, including the requirement to use the car’s hands-free, Bluetooth phone system, and abide by all applicable laws. But what happens when an employee still abides by the employer’s policy, is involved in a car accident, and causes injuries to a third party? Can the employer be held liable under the theory of respondeat superior?

Well, it depends on the facts and circumstances of the case. By way of background, respondeat superior means that an employer is vicariously liable for the torts of its employees when these employees commit the wrongful acts within the scope of their employment. California courts have held that the determination of whether an employee has acted within the scope of employment is a question of fact, but it also can be a question of law in circumstances where the facts cannot be disputed and there can be no conflicting inferences possible.

The California Court of Appeal in Ayon v. Esquire Deposition Solutions (decided on Sept. 21, 2018) was faced with this issue and held that under the facts presented the employer was not liable for the actions of its employee because there was no evidence that the employee in question was acting within the scope of her employment at the time of the accident.

In Ayon, the plaintiff’s car was struck by Brittini Zuppardo (“Zuppardo”), the scheduling manager of defendant Esquire Deposition Solutions (“Esquire”) while Zuppardo was driving. At the time of the accident, Zuppardo was on the phone with one of Esquire’s court reporters using her car’s hands-free Bluetooth phone system. This phone call (and hence the accident) occurred after normal business hours.

The plaintiff filed suit against Esquire and Zuppardo for personal injuries.  Esquire filed a motion for summary judgment on the ground that the plaintiff could not establish Esquire was vicariously liable for any damages its employee caused. The trial court agreed with Esquire, and the plaintiff appealed.

On appeal, the Court found that, based on the evidence presented, Zuppardo was not acting within the course and scope of her employment, particularly since (a) the phone call in question was after-hours, (b) Zuppardo was not on a work errand, but rather was coming home from a social engagement, and (c) although the phone call was with one of Esquire’s court reporters, Zuppardo and the court reporter were also friends and the conversation was not about work matters, but rather personal in nature. In sum, the trial court concluded that there was no evidence that Zuppardo talked about work matters at the time of the accident.

In Ayon, the Court found convincing the testimony of the Esquire employees who denied that they were discussing anything concerning work. And, their testimony was supported by undisputed evidence that (a) Zuppardo only made after-hours work calls on rare occasions, (b) it was not within her usual job duties, and (c) the two were friends. Accordingly, the Court of Appeal agreed with the trial court’s findings in favor of Esquire.

While it is unclear from Ayon whether the employee’s use of her cell phone (albeit hands-free) was a contributing factor to the accident, the employer was successful in avoiding liability in this case. Nevertheless, the outcome of this case may have been different if the employee was not using a hands-free device at the time of the accident. As such, enforcing policies can reduce the risk of claims.

 

©2018 Drinker Biddle & Reath LLP. All Rights Reserved.
This post was written by Pascal Benyamini of Drinker Biddle & Reath LLP.