Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the login-customizer domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /home1/natiopq9/public_html/wp-includes/functions.php on line 6131

Deprecated: Function WP_Dependencies->add_data() was called with an argument that is deprecated since version 6.9.0! IE conditional comments are ignored by all supported browsers. in /home1/natiopq9/public_html/wp-includes/functions.php on line 6131

Deprecated: Function WP_Dependencies->add_data() was called with an argument that is deprecated since version 6.9.0! IE conditional comments are ignored by all supported browsers. in /home1/natiopq9/public_html/wp-includes/functions.php on line 6131
The National Law Forum - Page 531 of 753 - Legal Updates. Legislative Analysis. Litigation News.

Hostile Work Environment Case Gets Additional Fourth Circuit Scrutiny

Poyner Spruill Law firm

​The Fourth Circuit Court of Appeals has agreed to an en banc rehearing (in which all judges on the court will hear the case) of Boyer-Liberto v. Fountainebleau Corp. after a three-judge panel of the court ruled in May 2014 that the factual allegations in the case did not rise to the level of a hostile work environment. The three-judge panel ruled that because a racial slur used inh the workplace was limited to two occasions arising from a single incident, the plaintiff had not been subjected to a hostile work environment based on her race.

Ms. Boyer-Liberto based her EEOC Charge of Discrimination and subsequent lawsuit against her former employer on two conversations she had with a coworker about an incident that occurred on September 14, 2010. During those conversations, which were on two consecutive days, the coworker twice directed a racial slur at Ms. Boyer-Liberto. One week after the incident, Ms. Boyer-Liberto was terminated from her job. The United States District Court for the District of Maryland granted summary judgment to the former employer, holding the offensive conduct was too isolated to support the plaintiff’s claims for discrimination and retaliation, and the three-judge panel of the Fourth Circuit affirmed that decision. Although the appeals court agreed the term used was “derogatory and highly offensive,” it held “a co-worker’s use of that term twice in a period of two days in discussions about a single incident was not, as a matter of law, so severe or pervasive as to change the terms and conditions of Liberto’s employment so as to be legally discriminatory.”

The Fourth Circuit has agreed to rehear the case, but it is not clear Ms. Boyer-Liberto will fare better on the rehearing although she argued in her petition for rehearing that the three-judge panel’s decision was inconsistent with other court rulings. That panel had specifically addressed the other cases Ms. Boyer-Liberto argued supported her claim and distinguished each as involving a greater number of incidents occurring over a longer time period or involving conduct having long-term, ongoing consequences.

As the panel noted in this case, a hostile work environment exists when “the workplace is permeated with discriminatory intimidation, ridicule, and insult that is sufficiently severe or pervasive to alter the conditions of the victim’s employment and create an abusive working environment.” The Fourth Circuit’s upcoming decision in this case bears watching to see if the court takes the opportunity to expand what has been a relatively narrow definition of hostile work environment. Regardless, employers should promptly investigate any claims of harassment or discrimination, document those investigations, and act quickly to address any harassment or discrimination uncovered in the investigations.

Article By:

Of:

Department of State Releases August 2014 Visa Bulletin

Morgan Lewis logo

The bulletin shows minor advancement in the EB-2 category for applicants chargeable to India and China as well as significant advancement in the EB-3 category for applicants chargeable to China and the Philippines, minor advancement for applicants chargeable to India, and no change for applicants chargeable to Mexico or the Rest of the World.

The U.S. Department of State (DOS) has released its August 2014 Visa Bulletin. The Visa Bulletin sets out per country priority date cutoffs that regulate the flow of adjustment of status (AOS) and consular immigrant visa applications. Foreign nationals may file applications to adjust their statuses to that of permanent residents or to obtain approval of immigrant visas at a U.S. embassy or consulate abroad, provided that their priority dates are prior to the respective cutoff dates specified by the DOS.

What Does the August 2014 Visa Bulletin Say?

In August, the cutoff date for applicants in the EB-2 India category will advance by a little more than four months, while the cutoff date for applicants in the EB-2 China category will advance by a little more than three months. Meanwhile, the cutoff date in the EB-3 China category will advance by slightly more than two years, while the cutoff date in the EB-3 Philippines category will advance by 17 months. The EB-3 India category will advance by one week, while the cutoff date for EB-3 Mexico and the Rest of the World will remain unchanged. The cutoff date in the F2A category for applicants from all countries will also remain unchanged.

EB-1: All EB-1 categories will remain current.

EB-2: The cutoff date for applicants in the EB-2 category chargeable to India will advance by a little more than four months to January 22, 2009. The cutoff date for applicants in the EB-2 category chargeable to China will advance by slightly more than three months to October 8, 2009. The EB-2 category for all other countries will remain current.

EB-3: The cutoff date for applicants in the EB-3 category chargeable to India will advance by one week to November 8, 2003. The cutoff date for applicants in the EB-3 category chargeable to China will advance by a little more than two years to November 1, 2008. The cutoff date for applicants in the EB-3 category chargeable to the Philippines will advance by one year and five months to June 1, 2010. The cutoff date for applicants chargeable to Mexico and all other countries will remain unchanged at April 1, 2011.

The relevant priority date cutoffs for foreign nationals in the EB-3 category are as follows:

China: November 1, 2008 (forward movement of two years and one month)
India: November 8, 2003 (forward movement of one week)
Mexico: April 1, 2011 (no movement)
Philippines: June 1, 2010 (forward movement of one year and five months)
Rest of the World: April 1, 2011 (no movement)

Developments Affecting the EB-2 Employment-Based Category

Mexico, the Philippines, and the Rest of the World

The EB-2 category for applicants chargeable to all countries other than China and India has been current since November 2012. The August Visa Bulletin indicates no change, meaning that applicants in the EB-2 category chargeable to all countries other than China and India may continue to file AOS applications or have applications approved through August 2014.

China

The July Visa Bulletin indicated a cutoff date of July 1, 2009 for EB-2 applicants chargeable to China. The August Visa Bulletin indicates a cutoff date of October 8, 2009, reflecting forward movement of three months and one week. This means that applicants in the EB-2 category chargeable to China with a priority date prior to October 8, 2009 may file AOS applications or have applications approved in August 2014.

India

In December 2013, the cutoff date for EB-2 applicants chargeable to India retrogressed significantly to November 15, 2004 because of unprecedented demand in this category. This cutoff date remained constant through June. There was significant movement forward of nearly four years in the July Visa Bulletin. The August Visa Bulletin indicates a cutoff date of January 22, 2009, reflecting forward movement of another four months and three weeks. This means that applicants in the EB-2 category chargeable to India with a priority date prior to January 22, 2009 may file AOS applications or have applications approved in August 2014.

Developments Affecting the EB-3 Employment-Based Category

China

In late 2013 and early 2014, the cutoff date for EB-3 applicants chargeable to China advanced significantly to generate demand in this category. In June, to regulate demand, this cutoff date retrogressed by six years to October 1, 2006 and remained the same for July. The August Visa Bulletin indicates a cutoff date of November 1, 2008, reflecting forward movement of two years and one month. This means that only applicants in the EB-3 category chargeable to China with a priority date prior to November 1, 2008 may continue to file AOS applications or have applications approved in August 2014.

India

The July Visa Bulletin indicated a cutoff date of November 1, 2003 for EB-3 applicants chargeable to India. The August Visa Bulletin indicates a cutoff date of November 8, 2003, reflecting forward movement of one week. This means that only EB-3 applicants chargeable to India with a priority date prior to November 8, 2003 may file AOS applications or have applications approved in August 2014.

Rest of the World

From September 2013 through April 2014, the cutoff date for EB-3 applicants in the worldwide category advanced by 3.75 years. In June, to regulate high demand, the cutoff date in this category retrogressed by 549 days to April 1, 2011. The August Visa Bulletin indicates no change to this cutoff date. This means that only applicants in the EB-3 category chargeable to the Rest of the World with a priority date prior to April 1, 2011 may file AOS applications or have applications approved in August 2014.

Developments Affecting the F2A Family-Sponsored Category

In March, as a result of heavy demand in the F2A category from applicants chargeable to Mexico, the cutoff date in this category retrogressed significantly to April 15, 2012. In June, this cutoff date retrogressed again to March 15, 2011 and remained the same in July. The August Visa Bulletin indicates no change to this cutoff date. This means that only those applicants from Mexico with a priority date prior toMarch 15, 2011 will be able to file AOS applications or have applications approved in August 2014.

During fiscal year 2013, in an effort to generate demand in the F2A category from applicants from all countries other than Mexico, the cutoff date in this category advanced significantly. This advance resulted in a dramatic increase in demand, followed in June by a further retrogression of the cutoff date to May 1, 2012. The August Visa Bulletin indicates no change to this cutoff date. This means that only those F2A applicants from countries other than Mexico with a priority date prior to May 1, 2012will be able to file AOS applications or have applications approved in August 2014. Further retrogression of the worldwide F2A category should not be ruled out.

How This Affects You

Priority date cutoffs are assessed on a monthly basis by the DOS, based on anticipated demand. Cutoff dates can move forward or backward or remain static. Employers and employees should take the immigrant visa backlogs into account in their long-term planning and take measures to mitigate their effects. To see the August 2014 Visa Bulletin in its entirety, please visit the DOS website.

Article By:

Of:

Due Process Requires Proper Service: Federal Rules of Civil Procedure

RaymondBannerMED

Among the Federal Rules of Civil Procedure is Rule 12(b)(5) which permits a defendant to file a motion to dismiss a case for insufficient service of process.  Most states have a similar rule for their own courts.

This rule arises from Constitutional requirements of due process.  To commence a lawsuit and change the legal position of parties, due process requires that proper notice be given.  This is a fundamental proposition and failure to serve notice violates due process.  Even actual notice of a lawuit may not suffice if service of process requirements have not been met.  Typically, this involves service by a sheriff, constable, marshal or other person duly appointed to serve process, who then makes a proper affidavit of service.

Recently, a case has become notorious because the Plaintiff’s attorney opted to name the Tor Project as a defendant simply because an offending website used Tor.  Tor is a system by which anonymous internet use is facilitated; it can be used for good and for ill.  The Tor Project likely enjoys complete immunity under Section 230 of the Communications Decency Act.  However, I observed another flaw.

The chief defendant, a website, has faced litigation from this attorney before.  As an obvious joke, they listed a colleague of his as the attorney to whom complaints should be addressed.  Yet, the Plaintiff’s attorney chose to attempt to effect service on the defendant website at his colleague’s office.  I observed that due process would not be met and the service defective.  Moreover, it might constitute a fraud on the court since the attorney apparently knowingly attested to the court that service upon the colleague would be good service.

Techdirt, which is an online magazine addressing interesting technological developments, cited to my comments approvingly in a follow-up piece.  Even if the purpose of the litigation is good, one should not violate a defendant’s right to due process to accomplish those ends.

Article By:

Of:

SEC Settles Civil Foreign Corrupt Practices Act (FCPA) Action Against Two Former Oil Services Executives

Katten Muchin

On the eve of a trial which was scheduled to begin this week, the Securities and Exchange Commission settled a civil Foreign Corrupt Practices Act (FCPA) case it brought against two former oil services executives. The case was an outgrowth of anindustry-wide investigation the SEC had initially commenced beginning in 2010.

In February 2012, the SEC filed a complaint against Mark A. Jackson, who was the former CEO and CFO of Noble Corporation, and James J. Ruehlen, former Director and Division Manager of Noble’s Nigerian subsidiary, alleging that they authorized the payment of bribes to customs officials to process false paperwork that purported to show the export and re-import of oil rigs, which was necessary under the requirements of Nigerian law. In fact, the rigs had never been moved. The SEC alleged that the scheme was part of a design to save Noble from losing business and incurring costs associated with exporting rigs from Nigeria and re-importing them under new permits. The complaint asserted violations of the anti-bribery and books and records provisions of the FCPA. The complaint also detailed the fact that Jackson had refused to cooperate during Noble’s internal investigation of the matter and had asserted his Fifth Amendment rights and refused to testify during the SEC investigation.

The settlement with Jackson and Ruehlen was the last in a lengthy saga of FCPA actions against Noble and its former employees. Noble was initially charged with FCPA violations in a civil action in 2010. The company settled, agreeing to pay more than $8 million in fees. The SEC filed charges against Jackson and Ruehlen in 2012 following the corporate settlement and also filed charges against Thomas F. O’Rourke, the former controller and head of internal audit at Noble. O’Rourke quickly settled and agreed to pay a penalty.

Despite pursuing the action for more than two years and alleging serious wrongdoing by the defendants, including responsibility for an extensive bribery scheme, the SEC agreed to settle with Jackson and Ruehlen just two days before their trial was to commence with an injunction against violating the books and records provision of the FCPA. Although Noble had settled its own case for a hefty penalty, neither Jackson nor Ruehlen were required to pay a fine, concede a violation of the bribery provisions of the FCPA nor agree to restrictions on employment.

SEC v. Jackson et al., No. 4:12-c-00563 (S.D. Tex. Jul. 7, 2014).  

Article By:

Of:

Proposed Legislation Introduced to Override Hobby Lobby Ruling

Barnes Burgandy Logo

On July 9th, Senator Democrats introduced proposed legislation known at the Protect Women’s Health from Corporate Interference Act (Act) in an effort override the U.S. Supreme Court’s Hobby Lobby decision, which was previously discussed in our June 30th Alert.

The Act would reinstate the Affordable Care Act’s contraceptive coverage obligations imposed on employers, requiring employers to provide such health insurance. The Act specifically is targeted at the Supreme Court’s 5-4 Hobby Lobby decision, which held closely-held companies (those that are family-owned or have a limited number of shareholders) can exercise their freedom of religion protections to avoid paying for such contraceptive coverage.  Senator Tom Harkin (D-Iowa), one of the three Senators who introduced this legislation, explained that houses of worship and religious non-profits would remain exempt from providing contraceptive coverage under the Act.

The introduction of this legislation in the Senate follows the announcement by two House Democrats last week, indicating they would introduce similar bills in response to the Hobby Lobby decision. If the legislation were to pass the Senate, many experts anticipate it will fail in the Republican-controlled House.

Article By:

Of:

Serve Up a Strategic Marketing Approach

KLA Marketing Logo

Here it is more than halfway through the year and a lot of you who began 2014 committed to changing your marketing approach now realize “wow, nothing has changed.”

Below are ten steps to be more strategic in this year’s marketing planning:

1. Having good intentions in January is not the same as making marketing a priority.In other words, you jotted down some ideas, threw them in a drawer and went about your business. Marketing is often an afterthought.  If you do not make building and growing your practice a priority by scheduling it into your daily calendar and then “live and breathe” the concepts, how do you expect progress to be made, by you and other team members?

2. Develop cash flow budgets and projections are imperative so that you would have something to measure progress by. Businesses run with numbers. Law firms are no different. When creating a marketing plan, be as specific as possible. Set concrete goals as such as below:

  • Increase employment law cases by privately-held businesses cases by 15%
  • Acquire at least one new client each quarter with billings of at least $90k per quarter.
  • Increase revenue per existing top five clients by 20 percent

3. Creating metrics to measure the success or failure of your plans and activities against projections developed in number 2 is an ideal way to track your marketing initiatives by results achieved. Items such as response rates, average new billings per new clients, average billings from repeat work of existing clients…etc.  Do you have any written metrics and do you constantly monitor them? If not, this is a critical component for measuring success.

4. Assemble the right team.  Get the right people “on the bus and the wrong people” off the bus.  If your firm is full of worker bees, you will be challenged to produce marketing results.  However, if you support and empower those lawyers who are motivated to become a producer, a rainmaker, you are more likely to have a stronger marketing focus and better marketing results.

5. Retain professional training.While many lawyers “think” they know what to do, and they may, most do not know “how” to engage in high impact business development endeavors successfully. Effectively marketing and promoting a law practice ain’t what it used to be. Gone are the days when deals are just a handshake away and a matter of spending the afternoon on the golf course.

Seeking outside support to fully learn, from soup to nuts, the sales process, how to efficiently fill your pipeline AND persistently track your sales (i.e. new client engagements) are things that do not materialize from amorphous. Retain a professional trainer/coach and you will never go back.

6. Set a clear and powerful direction.  It is a powerful exercise to have regular meetings with your team to cultivate a marketing culture within a firm and to outline the marketing expectations.  Team meetings can serve multiple purposes of parlaying business opportunities, sharing knowledge, and achieving positive marketing results.

7. Turn up the focus dial. Most likely, if you do not focus like a laser on identifying targeted clients, markets and niche areas of practice, you will likely become discouraged and ease up on your marketing commitment. Thus, it is imperative to narrow down exact targets so you know who you are looking for. An example of this for a construction litigation practice may be commercial developers on the East Coast with revenues between $50-150 million a year. That description will narrow the companies you are looking for and are simple to find with basic online market research.

8. Assemble the marketing tools. Having the right tools is essential to ensuring you derive the most out of your marketing strategies. Tools are no longer limited to printed brochures, email and promotional items. Video, social media networking, SMS texting, webinars, podcasts, and creative interactive websites can also be highly effective, depending upon your marketing goals and objectives. The increase in marketing tools equates to greater options in your toolbox. It also means that selecting the right tools is more important than ever.

9.Invest in the right things.  Decadent offices, random acts of lunch, and token “shotgun” expenditures in the name of marketing do not attract new clients. Invest instead in strengthening relationships with key clients, communicating to existing clients and prospective clients how you are improving their businesses and/or personal lives.

10. Action, Action, Action. One of themost impactful ways you can be more strategic in your marketing planning is simply to execute on the plan. Marketing must be an integral part of your business, not a “set it and forget it” aspect of your business. In order to ensure that your marketing plan succeeds, you must be actively engaged in working that plan.

The means by which to instill a more strategic approach to your marketing are vast. Reiterating my mantra that marketing success comes with “consistent, persistent massive amounts of action over a prolonged period of time”, all the strategic marketing spokes (Internet marketing; communications program; reputation management, etc.) must be moving forward at the same concurrently. Anything less and the wheels just spin.

Of:

Chicken Restaurant Case Serves Up A Bucket of Sound Contract Principles for Commercial Leases

vonBriesen

 

In Tufail v. Midwest Hospitality LLC, 2013 WI 62, the Wisconsin Supreme Courthighlighted the importance of including precise language in commercial leases, especially if the lease includes an integration clause. The court confirmed that when dealing with a fully integrated lease, it is guided by the terms of the lease as written rather than by extrinsic evidence or unwritten understandings between the parties. While this may seem obvious, this case serves as a good reminder for those who negotiate commercial leases to always include all specific business and legal terms.

Tufail (“Landlord”) and Midwest Hospitality LLC (“Tenant”) entered into a lease for commercial property that was then being used by Landlord as a “New York Chicken” restaurant. Tenant leased this property with the intent of operating a “Church’s Chicken” restaurant. However, during build-out, Tenant discovered that a special use permit would be required to operate its fast food restaurant with a drive-through. While Tenant was able to obtain the permit it needed, the permit was conditioned upon the restaurant being closed by 9 p.m. (as opposed to the 4 a.m. close time allowed for the prior restaurant).

Tenant terminated the Lease and notified Landlord that it would stop paying rent due to the adverse effect the earlier closing time would have on its profitability. Tenant argued that the permit requirement was contrary to Landlord’s representation that Tenant would not be prevented from using the premises for the permitted uses set forth in the lease. The lease contained the following use clause: “[t]enant may use and occupy the Premises for any lawful purposes, including, but not limited to, the retail sales, consumption, and delivery of food and beverages which shall include, but not be limited to, Chicken products, Fish products, bread products, salads, sandwiches, dessert items, promotional items, and any other items sold by any Church’s Chicken store.”

After reviewing the lease’s integration clause and finding it to be complete, the court rejected Tenant’s argument that the general reference to “Church’s Chicken” in the use clause required that a fast food restaurant with a drive-through be allowed because the understanding between the parties was that Church’s Chicken restaurants were in fact drive-through fast food restaurants. The court concluded that the lease did not include a false representation and also limited its review to the specific language used in the use and representation clauses of the lease due to its conclusion that the lease was fully integrated.

The court also concluded that the terms of the representation clause as written required simply that Tenant not be prevented from using the property for the purposes set forth in the use clause. The court stated that there was nothing that prevented Tenant from specifically addressing hours of operation, the requirement that a drive-through be allowed, or other specific requirements it considered to be vital to the successful operation of its restaurant in the lease. However, the court was bound to interpret only the contract to which the parties actually agreed, and these requirements were not included therein.

While this is a misrepresentation case on its face, the case ultimately turned on basic contract principles and is an important reminder of the effects of integration clauses. Not only can these “boilerplate” clauses intensify the scrutiny of the specific language chosen by the parties, but, as shown in this case, they can be used to support the theory that even the smallest of deal points should have been included in the agreement if they were important to the parties. This case demonstrates that it is extremely important to include precise, unambiguous language in leases and to double check that even the seemingly minor deal points are included in the lease if they are necessary to make the deal viable.

Article By:

Paid Sick Leave: Connecticut Tweaks and Newark Speaks

Jackson Lewis Logo

The Connecticut Paid Sick Leave Law has been tweaked in three respects: (1) to allow employers to determine the 50-employee applicability threshold in the same manner as under the state’s Family and Medical Leave Act, i.e., by determining whether the employer has at least 50 employees on its payroll for the week containing October 1; (2) to allow accrual of paid sick leave hours on any annual basis, not just a calendar year, and (3) to add one additional job title—radiologic technologists—to the list of “service worker” titles that are eligible for paid sick leave. The law adopting the tweaks— An Act Creating Parity between Paid Sick Leave Benefits and Other Employer-Provided Benefits (Public Act 14-128)—is effective January 1, 2015.

Newark, N,J. whose  Paid Sick Leave Ordinance became effective on June 21, 2014, has issued FAQs about the ordinance. There are 24 FAQs–a dozen directed to employers and a dozen directed to employees. The FAQs address a myriad of questions on topics such as employee eligibility, accrual of paid sick leave, employer notice obligations, appropriate uses of paid sick leave and the law’s integration with collective bargaining agreements.

Also on the paid sick leave issue, the Massachusetts Secretary of State announced last week that voters in November will be asked whether to approve a mandatory earned sick time law. If the issue passes, Massachusetts would become the second state and ninth jurisdiction to adopt a paid sick time law.

Article By:

Of:

European Commission Discusses Big Data

Morgan Lewis logo

The European Commission (the Commission) recently issued a press release recognizing the potential of data collection and exploitation (or “big data”) and urging governments to embrace the positive aspects of big data.

The Commission summarized four main problems that have been identified in public consultations on big data:

  • Lack of cross-border coordination
  • Insufficient infrastructure and funding opportunities
  • A shortage of data experts and related skills
  • A fragmented and overly complex legal environment

To address these issues, the Commission proposed the following:

  • A public-private partnership to fund big data initiatives
  • An open big data incubator program
  • New rules on data ownership and liability for data provision
  • Mapping of data standards
  • A series of educational programs to increase the number of skilled data workers
  • A network of data processing facilities in different member states

The Commission stated that, in order to help EU citizens and businesses more quickly reap the full potential of data, it will work with the European Parliament and the European Council to successfully complete the reform of the EU’s data protection rules. The Commission will also work toward the final adoption of the directive on network and information security to ensure the high level of trust that is fundamental for a thriving data-driven economy.

Of:

 

First Written Decision Pertaining to Pharmaceuticals

ArmstrongTeasdale logo

Practitioners monitoring the use of inter partes review (IPR) proceedings to challenge pharmaceutical patents may want to note what appears to be a pair of first-time events.  The Patent Trial and Appeal Board (PTAB) recently issued the first Final Written Decision in an IPR proceeding involving a pharmaceutical-related patent. In addition, the first petition for covered business method review challenging an Orange Book-listed patent for a marketed drug was recently filed.

On June 20, 2014, the PTAB issued Final Written Decisions in four related IPR proceedings (IPR2013-00116IPR2013-00117IPR2013-118; and IPR2013-00119)  involving U.S. Patent Nos.  5,997,915; 6,011,040; 6,673,381; and 7,172,778, respectively. The patents generally disclose compositions for supplementing dietary folate and the challenged claims were directed to compositions comprising natural isomers of reduced folates and corresponding methods of using such compositions.  Petitioner Gnosis SpA initiated the IPR proceedings after it was sued for infringement of the patents by a group of plaintiffs including Merck KGaA (licensee of three of the patents) and Merck & Cie (owner of the remaining patent).  The decision to challenge the patents in an IPR proceeding was a successful one for Gnosis as the PTAB found all of the challenged claims to be unpatentable, holding that certain claims were anticipated and the remaining claims were obvious.

Several days later, on June 24, 2014, Amneal Pharmaceuticals, LLCPar Pharmaceutical, Inc., and Roxane Laboratories, Inc. (Petitioners) filed a petition for covered business method of a patent listed in the Food and Drug Administration’s Orange Book for the prescription drug product Xyrem®, which is marketed by Jazz Pharmaceuticals, Inc. The patent, U.S. Patent No. 7,895,059, generally discloses methods for controlling the distribution of, and access to, hazardous or abuse-prone drugs and the challenged claims are directed to “[a] computerized method of distributing a prescription drug under the exclusive control of an exclusive central pharmacy.”

Each of the Petitioners had previously filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval of a generic version of Xylem and been sued by Jazz for infringement of several Orange Book-listed patents including U.S. Patent No. 7,895,059. In their petition for covered business method review, the Petitioners asserted that the challenged method claims involve the verification of an insurance payment for the drug and therefore are related to a “financial product or service” (a requirement for covered business method review). Should the PTAB accept this argument and grant the petition, that determination could potentially encourage others to file petitions for covered business method review of additional Orange Book-listed patents containing similar “Risk Evaluation and Mitigation Strategies (REMS)”-type claims.

Article By:

Of: