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The National Law Forum - Page 477 of 753 - Legal Updates. Legislative Analysis. Litigation News.

The Supreme Court Closes the Books on Civil False Claims Act Cases and Takes Issue with the First to File Rule

In a unanimous decision, the Supreme Court in Kellogg Brown & Root v. United States ex rel. Carter reversed the Fourth Circuit in part and affirmed in part, holding that the Wartime Suspension of Limitations Act (WSLA) only applies to criminal offenses, and that the popular colloquialism known as the “first to file rule” only prohibits qui tam actions when a similar suit is currently pending. Based on the text of the legislation alone, these holdings are glaringly obvious, but somehow both of these decisions manage to upset generally accepted Government contracts assumptions.

In 2005, a whistleblower filed a qui tam action against Kellogg Brown & Root Services Inc. (KBR) and Halliburton Co. (subsidiaries and the relator’s former employers) alleging that they had submitted a false claim to the Government. The relator alleged that KBR billed the Department of Defense under a water purification services contract for services that were either not performed or not properly performed. Water purification service contracts in Iraq have been a popular area for litigation with the U.S. Army, partly because of the enormity of the operation and expense required to supply deployed soldiers with a steady supply of clean water in an arid environment.  Unique to this case, the allegation of fraud was brought as a qui tam action that allows the relator to recover up to 30% of the Government’s total recovery.

The statute of limitations for qui tam actions is within six years of a violation or within three years of the date by which the United States should have known about a violation, but under no circumstances can it be brought more than 10 years after the date of the violation. The Solicitor General argued that the Wartime Suspension of Limitations Act (WSLA) indefinitely suspends any statute of limitations for “any offense” involving fraud against the Government during “hostilities” and therefore also suspended the statute of limitations for qui tam actions. On its face, the WSLA appears broad enough to encompass both civil and criminal accusations of fraud, especially if the reader has an expansive view of the word “offense.” From a practical perspective, this has been very difficult for defense contractors to stomach. As a nation that has been in uninterrupted war for 14 years, Government contractors could be called to disprove an allegation in a qui tam suit stemming from events that transpired more than a decade ago. These liabilities remain on their books and can factor into insurance coverage for dealing with these types of claims. These risks and liabilities inherent in doing business with the Government are often passed on to the Government in the form of less competitive bid proposals and higher costs. Many Government contracts attorneys understood that the Government’s use of WSLA in civil cases was questionable as the WSLA statute is codified in Title 18 “Crimes and Criminal Procedure.” The Supreme Court focused on this location of the WSLA text and the definition in place at that time defining “offenses” as crimes. In the end, the Supreme Court reversed the Fourth Circuit on this point and held that the WSLA does not apply to civil actions involving fraud. While this would seem to be a straightforward result, as noted in the Solicitor General’s brief, “every court of appeals to consider the questions has held that the WSLA applies in civil fraud cases.” The list includes cases in the Ninth and Sixth Circuits as well as the former Court of Claims, so this decision while reasonably anticipated still constitutes considerable reversal.

The Supreme Court’s second holding in this case was similarly obvious from a textualist perspective, but it manages to awaken long dormant liabilities for those contractors that applauded the first part of the Supreme Court’s opinion. This case took an unusual route to get to the Supreme Court. It was filed four separate times after the each of the previous filings was dismissed because similar qui tam cases were pending in other jurisdictions. The False Claims Act, which provides the rules for filing a qui tam states that “no person other than the Government may intervene or bring a related action based on the facts underlying the pending action.” This is popularly referred to as the “first to file rule.” Unfortunately, that shorthand is so prevalent within the industry that the term “first to file,” which does not appear in the text, took on a meaning of its own when combined with decisions on notice and original source requirements. It was generally accepted that Congress’s intent was to prohibit copycat filings where a business would have to deal with the same qui tam allegations of fraud over and over from different relators. It was thought that the public disclosure required in unsealing a qui tam action should prohibit a future relator from using some of that same information in his own qui tam suit filed immediately upon the dismissal of the first suit. The National Whistleblower Center argued in its brief that if the “first to file rule” precluded future filings on the same issue a “wholly uninformed whistleblower could file a vexatious, frivolous, overbroad, and all-encompassing lawsuit. The Government would be left uninformed of the fraud as it was prior to the filing of the suit, and other well-informed whistleblowers would have no incentive or ability to come forward.” The Supreme Court agreed that there was no support in the text of the statute to interpret “pending” as anything more than “not yet decided” and affirmed this portion of the Fourth Circuit’s judgment. This means that qui tam filers must merely wait until similar cases are dismissed before filing their claims.

This doesn’t mean that qui tam filers will simply be able to adopt the accusations and evidence from the previous case, but it remains to be seen what advantages this approach might have for secondary filers who have had the benefit of observing the first qui tam. There is another pending petition at the Supreme Court, Purdue Pharma v. United States ex rel. May, that provide additional clarity on “whether the False Claims Act’s pre-2010 ‘public-disclosure bar,’ 31 U.S.C. § 3730(e)(4) (2009), prohibits claims that are ‘substantially similar’ to prior public disclosures, or instead bars a claim only if the plaintiff’s knowledge ‘actually derives’ from prior disclosures.”

For now, Government contractors need to be aware that qui tam filings are not necessarily prohibited just because someone previously filed a qui tam on the same issue. Defense contractors who supported military efforts in Iraq or Afghanistan can rely on the normal statute of limitations for civil claims involving fraud, but need to be aware that criminal acts of fraud are still prosecutable years after the cessation of hostilities.

ARTICLE BY Dana M. Collins of Odin, Feldman & Pittleman, P.C.
© 2015 Odin, Feldman & Pittleman, P.C.

FDA Issues Draft Guidance on Mandatory Food Recalls Under the Food Safety Modernization Act

The Food and Drug Administration (FDA) recently issued a draft guidance titled, “Questions and Answers Regarding Mandatory Food Recalls.” FDA was given general mandatory food recall authority by the Food Safety Modernization Act (FSMA). The guidance is notable for its brevity, coming in at a total of seven pages including the cover. Although much of the content will be familiar to those with experience in food recalls, the guidance does discuss the procedure for FDA to order a mandatory food recall and the assessment of user fees for those subject to such a recall.

With respect to the procedure, the guidance states after FDA finds that the criteria for a mandatory recall have been met, it must first provide the responsible party with an opportunity to perform a voluntary recall of the food. FDA will provide this opportunity in writing using an expeditious method. If the responsible party does not voluntarily cease distribution and recall the food within the time and manner prescribed by FDA, FDA may order the responsible party to cease distributing the article of food, order the responsible party to give notice to certain other persons to cease distributing the article of food, and give the responsible party an opportunity for an informal hearing. After these steps are completed, FDA may order a recall if it determines that the removal of the food from commerce is necessary. Only the FDA Commissioner has the authority to order a recall.

As to user fees, the guidance observes that the FDA has the authority to collect fees from a responsible party for a domestic facility and an importer who does not comply with a food recall order. The fees would cover time spent by FDA conducting food recall activities, including technical assistance, follow-up effectiveness checks, and public notifications. FDA defines noncompliance to include (1) not initiating a recall as ordered by FDA, (2) not conducting the recall in the manner specified by FDA in the recall order, or (3) not providing FDA with requested information regarding the recall, as ordered by FDA. FDA publishes a Federal Register notice of fees for non-compliance with a Recall Order no later than 60 days before the start of each fiscal year.

Given that most parties will voluntarily recall food when the statutory conditions are satisfied to avoid a public relations disaster and harsh FDA action, it seems unlikely that FDA will have to resort often to the exercise of its mandatory recall authority or assessment of fees. The fact that FDA has this authority, however, helps ensure FDA will not have to exercise it.

A copy of the draft guidance document can be found here.

ARTICLE BY Hae Park-Suk & Lynn C. Tyler, M.S. of Barnes & Thornburg LLP
© 2015 BARNES & THORNBURG LLP

Time to Exclude the IMD Exclusion – Institutions for Mental Disease

Some rules are borne out of the best of intentions, and the Institutions for Mental Disease Exclusion (“IMD exclusion”) bears the hallmarks of such a beginning. The IMD exclusion bars federal funding for care of patients between the ages of 21 and 65 who receive inpatient treatment in an IMD, a hospital, nursing facility or other institution with more than 16 beds that primarily treats those with mental illness. This provision came into being in 1965, primarily as a way to prevent dubious institutions from stocking up on mentally ill patients for the purposes of collecting federal funds en masse, but also to put the onus on states, rather than the federal government, to care for the mentally ill.

IMD Exclusion, Institutions for Mental Disease

In modern times, however, the IMD exclusion is arguably one of the larger impediments to expansion of mental and behavioral health treatment, particularly in the area of substance abuse disorders, where a brewing epidemic of opioid addiction demands a proportional institutional response. Not only does this exclusion apply to standard mental health institutions, a Center for Medicare & Medicaid Services (“CMS”) interpretation applies the exclusion to other facilities such as substance abuse treatment center. The irony is that states which have accepted the Medicaid expansion to cover a wide range of newly-eligible patients for mental and behavioral health disorders such as substance abuse find themselves stymied by a lack of appropriate facilities in which to treat them. The Mental Health Parity and Addiction Equity Act of 2008 (“MHPAEA”) provides that covered individuals receive the same coverage for mental and behavioral health as for other medical and surgical benefits, yet medical and surgical facilities are not limited to a maximum of 16 beds, rendering much of the benefit of this law illusory.

The Medicaid expansion provides mental and behavioral health providers with a steady new flow of patients in dire need of assistance – so long as that inpatient treatment is provided in increments of 16. Substance abuse victims now have the coverage to receive the services they desperately need, and behavioral health providers now have more tools than ever to combat the problem. The obstacle in care comes in the limitation of the facilities.

Even an exception for behavioral health provider facilities for substance abuse treatment would provide significant relief, and CMS went so far as to allow eight states to include IMD benefits under Medicaid managed care programs for a period of ten years. Although this exception hasn’t been allowed recently, it at least provides a ray of hope that CMS can adapt regulatory policies to reflect a growing problem, understanding that it may be standing in the way of progress with draconian measures.

True parity can only be attained when mental and behavioral health facilities are free from the limitations imposed by the IMD exclusion. Until then, rather than protecting patients from unscrupulous institutions, this policy will only continue to hurt those who need real care.

ARTICLE BY Molly Nicol Lewis of McBrayer, McGinnis, Leslie and Kirkland, PLLC

© 2015 by McBrayer, McGinnis, Leslie & Kirkland, PLLC. All rights reserved.

UPDATE: Ice Cream Recall Begets First Lawsuit

In April 2015, Blue Bell Creameries announced a full, nationwide recall of all its products.  It didn’t take long for a lawsuit to be filed.

On Tuesday, the first lawsuit seeking to hold Blue Bell liable for illness caused by listeria-contaminated ice cream was filed in the United States District Court, Western District of Texas. Plaintiff David Philip Shockley seeks unspecified damages in a negligence lawsuit. Shockley says that while living in Houston, Texas, in October 2013, he was hospitalized for respiratory failure and septic shock. Doctors diagnosed him with listeria meningitis with encephalitis and Shockley suffered brain damage. Shockley alleges he regularly ate single serving Blue Bell ice cream, provided by his employer.  In 2013, Mr. Shockley was 31 years old and was employed as a director and administrator at a nursing home/retirement community.

Blue Bell recently laid off or furloughed 37% of its workforce, as it grapples with the fallout from the recall and the challenges of getting its plants back into production. While this is the first lawsuit to come from the Blue Bell recall, it is unlikely to be the last. Judge Lee Yeakel is presiding over this suit.

ARTICLE BY Mishan Wroe of Schiff Hardin LLP
© 2015 Schiff Hardin LLP

Three Steps to Leverage LinkedIn for Your Law Firm

I have yet to find an attorney who could not benefit from having their profile on LinkedIn. It’s the number one online network for white-collar professionals.

Whether you want to connect with non-competing attorneys, non-legal professionals, or potential clients, the demographics on LinkedIn speak for themselves:

  • The average age range of a LinkedIn user is 30 to 49

  • 44% of LinkedIn users report an annual income of more than $100,000

  • 50% of members have a college degree

  • 28% have a graduate degree

LinkedIn members are highly educated and affluent. Is this a demographic you would like to reach? For most attorneys, the answer is obvious.

The first step to using LinkedIn is to create a comprehensive profile. Use your entire bio in your profile and be sure to include your keywords in it. In other words, use the exact keywords that you believe prospects or potential referral sources would use to find an attorney with your skill sets.

For example, if you are a business attorney in Omaha it might sound like this:

“John Doe is a Omaha business attorney who works with small business owners and CEOs of mid-sized companies to create comprehensive operating agreements, buy-sell agreements and employment agreements. His Omaha business clients appreciate the fact that John is an attorney who has a strong business background, having owned and operated two different companies, including a high tech company with 25 employees.”

Next, go to the See Who You Already Know on LinkedIn page and import your email contact list. This makes it super simple to connect with people you already know who are also on LinkedIn. In addition, based on your contacts, LinkedIn will suggest relevant contacts for you to connect with on the site.

Then search LinkedIn Groups and join those where your clients and prospects are. Create content — blog posts, free reports, articles, etc. — that will attract their attention. You can also start your own group and invite contacts to join.

The key to utilizing LinkedIn effectively is to be involved and be consistent. You need to commit to investing at least 30-45 minutes every week to log in, post an update or a link to your blog, reach out to your contacts, answer any questions that are sent to you, and make yourself visible. Simply setting up a profile on LinkedIn will not lead to more referrals any more than a having a business card will automatically get you new business.

ARTICLE BY Stephen Fairley of The Rainmaker Institute
© The Rainmaker Institute, All Rights Reserved

Shaking Down the Thunder From the Sky: Notre Dame’s Challenge to the Contraception Mandate

For the second time in as many years, the Seventh Circuit has declined to grant Notre Dame’s request for an injunction exempting the university from the contraception requirements of the Affordable Care Act. 

As was true back in 2014, the court remained skeptical of the link between Notre Dame’s actions (filling out a form noting its religious objections to contraceptives and sending the form to its insurance administrator) and the resulting actions (the administrator then providing the contraceptives directly to the insured). Consequently, the court ruled that Notre Dame did not meet its burden of showing that its religious beliefs were substantially burdened by the contraceptive mandate. Judge Posner wrote the majority opinion, which Judge Hamilton joined while writing a separate concurrence.

The case was back before the Seventh Circuit following the Supreme Court’s vacating of the Seventh Circuit’s 2014 opinion with directions to review the case in light of the Court’s Hobby Lobby opinion. (Odd, then, that the Seventh Circuit’s decision does not begin discussing Hobby Lobby until page 18 and discusses the case for little more than a page in a 25-page opinion.) The court concluded in short order that Hobby Lobby had virtually no application in Notre Dame’s case: In Hobby Lobby, a private sector employer wanted to receive the accommodation afforded to religious organizations, whereas Notre Dame argued that the accommodation itself was insufficient to protect its religious beliefs.

As in the original opinion, Judge Flaum strongly dissented. He once again argued that the majority was inappropriately judging the sincerity of Notre Dame’s beliefs, something he believes was foreclosed by the Hobby Lobby decision.

Perhaps most noteworthy about this opinion is that—nearly 18 months after Notre Dame filed suit—the decision simply affirmed the denial of a preliminary injunction. As both Judge Posner’s majority opinion and Judge Hamilton’s concurrence note, the record is still barren of the kinds of facts that a trial will bring out—and that could allow Notre Dame to introduce more evidence of the religious burden the contraceptive provisions of the Affordable Care Act place on the school. Yet it seems likely that before that trial occurs, Notre Dame will again petition the Supreme Court to review the Seventh Circuit’s opinion. And given the Court’s willingness to weigh in on these issues, the thunderstorm shows no signs of letting up.

ARTICLE BY Ryan N. Parsons of Foley & Lardner LLP
© 2015 Foley & Lardner LLP

Shaking Down the Thunder From the Sky: Notre Dame's Challenge to the Contraception Mandate

For the second time in as many years, the Seventh Circuit has declined to grant Notre Dame’s request for an injunction exempting the university from the contraception requirements of the Affordable Care Act. 

As was true back in 2014, the court remained skeptical of the link between Notre Dame’s actions (filling out a form noting its religious objections to contraceptives and sending the form to its insurance administrator) and the resulting actions (the administrator then providing the contraceptives directly to the insured). Consequently, the court ruled that Notre Dame did not meet its burden of showing that its religious beliefs were substantially burdened by the contraceptive mandate. Judge Posner wrote the majority opinion, which Judge Hamilton joined while writing a separate concurrence.

The case was back before the Seventh Circuit following the Supreme Court’s vacating of the Seventh Circuit’s 2014 opinion with directions to review the case in light of the Court’s Hobby Lobby opinion. (Odd, then, that the Seventh Circuit’s decision does not begin discussing Hobby Lobby until page 18 and discusses the case for little more than a page in a 25-page opinion.) The court concluded in short order that Hobby Lobby had virtually no application in Notre Dame’s case: In Hobby Lobby, a private sector employer wanted to receive the accommodation afforded to religious organizations, whereas Notre Dame argued that the accommodation itself was insufficient to protect its religious beliefs.

As in the original opinion, Judge Flaum strongly dissented. He once again argued that the majority was inappropriately judging the sincerity of Notre Dame’s beliefs, something he believes was foreclosed by the Hobby Lobby decision.

Perhaps most noteworthy about this opinion is that—nearly 18 months after Notre Dame filed suit—the decision simply affirmed the denial of a preliminary injunction. As both Judge Posner’s majority opinion and Judge Hamilton’s concurrence note, the record is still barren of the kinds of facts that a trial will bring out—and that could allow Notre Dame to introduce more evidence of the religious burden the contraceptive provisions of the Affordable Care Act place on the school. Yet it seems likely that before that trial occurs, Notre Dame will again petition the Supreme Court to review the Seventh Circuit’s opinion. And given the Court’s willingness to weigh in on these issues, the thunderstorm shows no signs of letting up.

ARTICLE BY Ryan N. Parsons of Foley & Lardner LLP
© 2015 Foley & Lardner LLP

New Chicago Affordable Housing Ordinance Means Greater Costs for Developers

chicago_skyline

The Chicago City Council recently passed an amendment to the existing Affordable Requirements Ordinance (the 2015 ARO), which will increase the cost to develop most affordable housing projects in Chicago.  With the passage of the 2015 ARO, developers must now provide on-site or off-site affordable housing in addition to the in lieu fees which makes it impossible for developers to circumvent the purpose of the affordable housing requirements mandated by the ordinance.  In addition, the 2015 ARO significantly increases the in lieu fees that developers must pay in order to satisfy the requirements of the ordinance.

The Affordable Requirements Ordinance was enacted in 2003 and revised in 2007 to expand access to housing for low-income and moderate-income households and to preserve the long-term affordability of such housing in the Chicago.  Housing is considered “affordable” if the sales price or rent for the housing unit does not total more than a certain percentage of a family’s household income.  To qualify for affordable housing, the household must make at or below a certain percentage of an area’s median income as established by the Department of Housing and Urban Development.

Before the 2015 ARO, developers could pay an “in lieu fee” in the amount of $100,000.00 for every affordable unit they elected not to include in their projects to completely satisfy the affordable housing requirements.

You can click here for a complete summary of the 2015 ARO.  It is a quick reference guide for anyone considering the development of residential projects in Chicago.

Application

The 2015 ARO applies to residential projects that contain ten (10) or more residential units and satisfy one of the following requirements:

  • The project receives a zoning change that permits a higher floor area ratio, changes the use from non-residential to residential or permits residential uses on ground floors where that use was not previously allowed;

  • The project includes land that was purchased from the City of Chicago;

  • The project received financial assistance from the City of Chicago; or

  • The project is part of a planned development in a downtown zoning district.

Minimum Percentages of Affordable Housing

While there are certain exemptions, the 2015 ARO creates minimum percentages for affordable units in projects as follows:

  • Rezoning – In the case of a rezoned property, the developer is required to designate 10% of the units in the project as affordable housing (or 20% if the developer receives financial assistance from the City of Chicago).  Financial assistance from the City of Chicago includes grants, direct or indirect loans or allocation of tax credits to the development.

  • City Land Sales – Where the City of Chicago sells property to a developer and such property is subsequently developed for residential purposes or is incorporated into a residential housing project site in order to satisfy City of Chicago Municipal Code requirements, the developer must designate no less than 10% of the units in the project as affordable housing (or 20% if the developer receives financial assistance from the City of Chicago).

  • Existing Buildings | Zoning Change – Where there is an existing building that contains housing units at the time of an approved zoning change or an existing building that contains a mixed-use occupancy with use being residential at the time of an approved zoning change, only the additional housing units permitted under the rezoning are subject to the affordable housing requirements of the ordinance.  However, in the event the developer has received financial assistance from the City of Chicago, then the entire building is subject to the affordable housing requirements of the ordinance.

Additional Considerations for Affordable Housing Units by Project Location

Compliance with the ordinance will depend on the area where the project is located:

1.  Low-Moderate Income Areas 

  • For low-moderate income areas (designated by the City of Chicago Department of Planning and Development), a developer must provide at least 25% of the required affordable units on-site.

  • For the remaining 75% of the required affordable housing units, the developer has the option of satisfying the requirements of the ordinance by (a) establishing additional on-site affordable housing units; (b) paying an in lieu fee in the amount of $50,000.00 per unit; or (c) any combination of (a) and (b).

2.  Higher Income Areas 

  • In higher income areas (those areas that are not designated as low-moderate income areas), the developer must provide at least 25% of the required affordable units on-site or off-site.

  • For the remaining 75% of the required affordable housing units, the developer has the option of satisfying the requirements of the ordinance by (a) establishing additional on-site or off-site affordable units; (b) paying an in lieu fee in the amount of $125,000.00 per unit; or (c) any combination of (a) and (b).

  • All off-site units must be located within a two (2) mile radius of the residential housing project at issue and in the same or a higher income area or in a district zoned “D” (downtown district) under the City of Chicago Zoning Ordinance.

3.  Rental Units in Downtown Districts

  • In downtown districts and planned developments in a downtown district (zoned “D”), a developer of rental units must provide at least 25% of the required affordable rental units on-site or off-site.

  • For the remaining 75% of the required affordable housing units, the developer has the option of satisfying the requirements of the ordinance by (a) establishing additional on-site or off-site affordable units; (b) paying an in lieu fee; or (c) any combination of (a) and (b).

  • The in lieu fee is $140,000.00 per unit through and including the first anniversary of the publication date of the ordinance in the Journal of the Proceedings of the City Council of the City of Chicago.  The in lieu fee is increased to $175,000.00 thereafter.

  • All off-site units must be located within a two (2) mile radius of the residential housing project at issue and in the same or a higher income area or in a district zoned “D” (downtown district) under the City of Chicago Zoning Ordinance.

4.  Owner-Occupied Units in Downtown Districts 

  • In downtown districts and planned developments in a downtown district (zoned “D”), a developer of owner-occupied units (i.e., condominiums) may establish affordable housing in the following ways: (a) establishing affordable owner-occupied units as part of the residential housing project; (b) establishing off-site affordable owner-occupied units; (c) paying an in lieu fee; or (d) any combination of (a), (b) and/or (c).

  • The in lieu fees are the same as rental units in downtown districts; however, in the event the developer elects not to provide a minimum of 25% of the required affordable owner-occupied units either on-site or off-site, the in lieu fee shall be increased to $160,000.00 per unit through and including the first anniversary of the publication date and $225,000.00 per unit thereafter.

  • Off-site affordable owner-occupied units may be located anywhere in the City of Chicago, subject to the Department of Planning and Development’s approval.

In summary, the 2015 ARO has significantly increased a developer’s cost to develop residential units in the City of Chicago.  It also mandates that affordable housing units be built even if it is off-site.  It remains to be seen if these new laws will in fact inhibit developers from constructing residential projects in the City of Chicago.  To learn more about 2015 ARO and its implications for your business, contact a member of the Much Shelist Real Estate practice group.

ARTICLE BY

Harold S. Dembo & Kristin A. Nordman of Much Shelist, P.C.
© 2015 Much Shelist, P.C.

Patent Safe Harbor Applies To Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for patent infringement when the activities generated information that was submitted to the FDA to support a supplemental New Drug Application andCitizen’s Petition. However, the Federal Circuit remanded the case to the district court to determine whether other allegedly infringing activities, such as using the information to file a patent application, also were shielded by the statute.

The Claims At Issue

The patent at issue was Classen’s U.S. 6,584,472, directed to a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and then commercializing the new use. Claim 36 (which depends from claim 33, which was canceled during reexamination) is representative of the asserted method claims, and claim 59 is representative of the asserted kit claims:

33. A method for creating and using data associated with a commercially available product, wherein the method comprises the steps of:
accessing at least one data source, comprising together or separately, adverse event data associated with exposure to or use of the product and commercial data regarding marketing, sales, profitability or related information pertaining to the product;
analyzing the accessed data to identify (i) at least one new adverse event associated with exposure to or use of the product, (ii) at leastone new use for the product responsive to identification of the at least one new adverse event, and (iii) the potential commercial value of the at least one new use for the product; and
commercializing the newly identified product information based upon the analyzed data.

36.  The method of claim 33, wherein the commercializing step comprises formatting the data relating to at least one new adverse event associated with exposure to, or use of the product, or documenting same, such that a manufacturer or distributor of the product must inform consumers, users or individuals responsible for the user, physicians or prescribers about at least one new adverse event associated with exposure to or use of the product.

59.  A proprietary kit comprising (i) product and (ii) documentation notifying a user of the product of at least one new adverse event relating to the product, wherein determination of the new adverse event is based upon the data provided by the method of claim 36.

Footnote 1 of the Federal Circuit decision states, “Because issues of validity are not before us in this appeal, we express no opinion as to whether the asserted claims cover patent ineligible subject matter in light of the Supreme Court’s decision in Alice Corp. v. CLS Bank International, 573 U.S. __, 134 S. Ct. 2347 (2014).”

Procedural Background

Classen asserted U.S. Patent No. 6,584,472 against Elan, alleging that Elan infringed the patent by (i) studying the effect of food on the bioavailability of the FDA-approved muscle relaxant Skelaxin, (ii) using the clinical data to identify a new use for the drug, and (iii) commercializing the new use. In particular, after Skelaxin was approved, Elan conducted clinical studies on the effect of the drug when administered with or without food, and then submitted the results to the FDA when seeking approval of a supplemental New Drug Application (“sNDA”) to revise the labeling for Skelaxin and in a Citizen’s Petition proposing changes to the approval requirements for generic versions of Skelaxin. Additionally, Elan filed patent applications based on the new clinical data and sold kits with the revised label containing information derived from the data.

The U.S. District Court for the District of Maryland granted Elan’s motion for summary judgment of non-infringement, finding that Elan’s activities were “reasonably related to the submission of information” under the Federal Food, Drug, and Cosmetic Act (FDCA), and were therefore protected by the safe harbor provision of 35 U.S.C. § 271(e)(1). Classen appealed to the Federal Circuit.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Lourie and joined by Chief Judge Prost and District Judge Gilstrap (of the Eastern District of Texas) sitting by designation.

On appeal, Classen argued that Elan’s activities are not exempt under the safe harbor because they involved merely “routine” post-approval reporting to the FDA, which the Federal Circuit held in its 2011 decision in Classen Immunotherapies, Inc. v. Biogen IDEC lies outside the scope of the § 271(e)(1) safe harbor.

This statute provides in relevant part:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . . .

In Classen v. Biogen, the court indicated that the safe harbor applies only to pre-marketing activities, and held that the safe harbor “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.” However, a year later in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., the Federal Circuit held that the safe harbor can shield post-approval activities from giving rise to liability for patent infringement where the information submitted to the FDA “is necessary both to the continued approval of the ANDA and to the ability to market the … drug.” Thus, it is not surprising that in this case the Federal Circuit noted that the statutory language does not “categorically exclude post-approval activities from the ambit of the safe harbor.”

Turning to the activities at issue, the Federal Circuit found that post-approval studies conducted to support an sNDA “serve similar purposes as pre-approval studies in ensuring the safety and efficacy of approved drugs.” Thus, the court reasoned, “As an integral part of the regulatory approval process, those activities are ‘reasonably related to the development and submission of information’ under the FDCA, 35 U.S.C. § 271(e)(1), and are therefore exempt from infringement liability.” The court  therefore concluded that the post-approval clinical trials, sNDA and Citizen’s Petition “clearly fall within the scope of the safe harbor.”

Although the Federal Circuit remanded to the district court to determine whether Elan’s activities related to “reanalyzing the clinical data to identify patentable information and filing patent applications are commercial activities outside the scope of the safe harbor,” and whether “selling Skelaxin with the revised label that contained the information derived from the clinical study” infringed the Classen kit claims, the court took it upon itself to “assist the district court in its analysis of infringement . . . [by] mak[ing] the following observations of the record:”

  • Filing a patent application is generally not an infringement of a patent

  • Filing a patent application is not commercialization of an invention, and so a method claim requiring commercialization is likely not infringed by Elan’s actions

  • Placing information submitted to the FDA on a product label generally cannot be an act of infringement.

Given these “observations,” it seems unlikely that the district court will find that Elan infringed the claims at issue.

The Wide Mouth of the Safe Harbor

This decision is one of many Federal Circuit decisions that broadly construe the safe harbor of § 271(e)(1). Indeed, less than one year after the court seemed to draw a bright line around the scope of the safe harbor that excluded post-approval activities, the court blurred that line in Momenta and now it has erased it further in this case.

The Commercial Value of Patent Applications

Although the Federal Circuit’s “observation” that filing a patent application generally is not an act of infringement may be correct, we question its suggestion that filing a patent application is not a commercial activity. To the contrary, filing a patent application can be an essential step of a commercialization plan, and can increase the commercial value of the invention. On the other hand, we would agree that it is unusual that a patent could be infringed by “commercializing … information,” as recited in the Classen patent.

U.S. Supreme Court’s Wynne Decision Calls New York’s Statutory Resident Scheme into Question

On May 18, the U.S. Supreme Court issued its decision inComptroller of the Treasury of Maryland v. Wynne. In short, the Court, in a five-to-four decision written by Justice Alito, handed the taxpayer a victory by holding that the county income tax portion of Maryland’s personal income tax scheme violated the dormant U.S. Constitution’s Commerce Clause.

Specifically, the Court concluded that the county income tax imposed under Maryland law failed the internal consistency test under the dormant Commerce Clause, because it is imposed on both residents and non-residents with Maryland residents not getting a credit against that Maryland local tax for income taxes paid to other jurisdictions (residents are given a credit against the Maryland state income tax for taxes paid to other jurisdictions).

The Supreme Court emphatically held (as emphatically as the Court can be in a five-to-four decision) that the dormant Commerce Clause’s internal consistency test applies to individual income taxes. The Court’s holding does create a perilous situation for any state or local income taxes that either do not provide a credit for taxes paid to other jurisdictions or limit the scope of such a credit in some way.

The internal consistency test—one of the methods used by the Supreme Court to examine whether a state tax imposition discriminates against interstate commerce in violation of the dormant Commerce Clause—starts by assuming that every state has the same tax structure as the state with the tax at issue. If that hypothetical scenario places interstate commerce at a disadvantage compared to intrastate commerce by imposing a risk of multiple taxation, then the tax fails the internal consistency test and is unconstitutional.

Although the Wynne decision does not address the validity of other taxes beyond the Maryland county personal income tax, the decision does create significant doubt as to the validity of certain other state and local taxes such as the New York State personal income tax in the way it defines “resident.” New York State imposes its income tax on residents on all of their income and on non-residents on their income earned in the state; this is similar to the Maryland county income tax at issue in Wynne.

“Resident” is defined as either a domiciliary of New York or a person who is not a domiciliary of New York but has a permanent place of abode in New York and spends more than 183 days in New York during the tax year. N.Y. Tax Law § 605. (New York City has a comparable definition of resident.) N.Y.C. Administrative Code § 11-1705. Thus a person may be taxed as a statutory resident solely because they maintain living quarters in the state and spend more than 183 days in the state, even if those days have absolutely nothing to do with the living quarters; this category of non-domiciliary resident is commonly referred to a “statutory resident.” As such, under New York’s tax scheme, a person can be a resident of two states—where domiciled and where a statutory resident—and thus be subject to taxation on all of their income in both states.

Although New York State grants a credit to residents for taxes paid to another jurisdiction, that credit is only for taxes paid “upon income derived” from those other jurisdictions. N.Y. Tax Law § 620. As such, New York State does not grant a credit for taxes paid to another jurisdiction on income earned from intangible property, such as stocks, because income earned from intangible property is not ‘derived from’ any specific  jurisdiction.

To illustrate using an example, suppose an investment banker is unquestionably a domiciliary of New Jersey and has an apartment, i.e., permanent place of abode, in New York that he uses only occasionally. Further, suppose that the investment banker spends more than 183 days in New York during a tax year by going to his office in New York on most workdays. In such a case, the investment banker is a resident of both New Jersey and New York and subject to tax as a resident in both states on his entire worldwide income. New York does not give a credit for taxes paid to New Jersey on income derived from intangible property, and thus the investment banker pays tax on this income twice, once to New Jersey and once to New York, clearly disadvantaging interstate commerce and resulting in double taxation.

This is not some hypothetical example. This is actually the fact pattern in In the Matter of John Tamagni v. Tax Appeals Tribunal of the State of New York, 91 N.Y.2d 530 (1998). In that case, the New York Court of Appeals (New York State’s highest court) held that New York State’s taxing scheme did not violate the dormant Commerce Clause and did not fail the internal consistency test. The validity of the Court of Appeals’ decision is seriously called into question under the Wynne case.

The Court of Appeals, relying upon Goldberg v. Sweet, held that the dormant Commerce Clause did not apply to residency-based taxes because those taxes were not taxing commerce, but rather a person’s status as a resident. However, the U.S. Supreme Court’s decision in Wynne not only repudiates the very dicta from Goldberg v. Sweet cited by the New York Court of Appeals in Tamagni, but the U.S. Supreme Court also determined that even if a state has the power to impose tax on the full amount of a resident’s income, “the fact that a State has the jurisdictional power to impose a tax [under the Due Process clause of the Constitution] says nothing about whether that tax violates the Commerce Clause.” After Wynne, it is clear that the dormant Commerce Clause applies to residency-based personal income taxes.

The second reason that the vitality of the Tamagni decision is in question is its application of the internal consistency test. The Court of Appeals held that even if the dormant Commerce Clause applied, the internal consistency test was not violated because the tax at issue was imposed upon a purely local activity and thus could not violate the Complete Auto tests. However, as discussed above, New York State’s lack of a credit for taxes paid to other jurisdictions mirrors the lack of a credit under Maryland’s county income tax scheme.

New York State taxpayers should be cognizant of the Wynnedecision and should consider filing refund claims if they have paid— or will pay—tax to New York State as a statutory resident (i.e., not as a New York domiciliary). One would expect the New York State Department of Taxation and Finance to be quite resistant to granting such refunds and likely to vigorously defend the existing taxing scheme.

It may be worthwhile to note that this problem of double taxation was acknowledged and addressed in an agreement executed in October 1996 by the heads of the revenue agencies of Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Vermont. Under that agreement, the “statutory resident” state would provide a credit for the taxes paid by the individual on his or her investment income to his/her state of domicile. Unfortunately, that agreement was never implemented through legislation— maybe now is the time for that to be done.

Finally, a word about New York City: New York City imposes a personal income tax on residents, allowing no credit for taxes paid to other jurisdictions. However, New York City does not impose a tax on non-residents, making its personal income tax different than the Maryland county income tax. Thus, the constitutionality of the New York City personal income tax is not specifically addressed by the U.S. Supreme Court’s decision. However, similar to the New York State definition of resident, a person can be a resident in two different jurisdictions under the New York City definition of resident. As such, New York City’s personal income tax could be imposed twice on a person if the person is a domiciliary of one state and a statutory resident in another. Thus, the tax potentially fails the internal consistency test.

ARTICLE BY

Arthur R. Rosen & Mark Yopp of McDermott Will & Emery
© 2015 McDermott Will & Emery