Consumer Financial Services Basics – ABA Conference

The National Law Review is pleased to bring you information regarding the upcoming Consumer Financial Services Basics Conference sponsored by the ABA:

When

October 08 – 09, 2012

Where

American University

Washington College of Law

Washington, DC

Program Description

Facing the most comprehensive revision of federal consumer financial services (CFS) law in 75 years, even experienced consumer finance lawyers might feel it is time to get back in the classroom. This live meeting is designed to expose practitioners to key areas of consumer financial services law, whether you need a primer or a refresher.It is time to take a step back and think through some of these complex issues with a faculty that combines decades of practical experience with law school analysis. The classroom approach is used to review the background, assess the current policy factors, step into the shoes of regulators, and develop an approach that can be used to interpret and evaluate the scores of laws and regulations that affect your clients.Program FocusThis program will explain each of the major sources of regulation of consumer financial products in the context of the regulatory techniques and policies that are the common threads in a complex pattern, including:

  • Price regulation and federal preemption of state price limitations
  • Truth in lending and disclosure requirements
  • Marketing, advertising and unfair or deceptive conduct
  • Account servicing and collections
  • Regulating the “fairness” of financial institution conduct
  • Data security, fraud prevention and identity protection
  • Consumer reporting: FCRA & FACT Act
  • Fair lending and fair access to financial services
  • Remedies: regulators and private plaintiffs
  • Regulatory and legislative priorities for 2012 and beyond

Who Should Attend…The learning curve for private practitioners, in-house lawyers and government attorneys to understand the basics and changes to CFS law is very steep. This program is a great way to jump up that curve for:

  • Private practitioners with 1-10 years of experience who focus on CFS products or providers
  • In-house counsel at financial institutions and non-bank lenders
  • Government attorneys, in financial practices regulatory agencies
  • Compliance officers (who may be, but need not be, attorneys)

Club Membership Deposits in Bankruptcy

The National Law Review recently featured an article by the Hotels, Resorts & Clubs Group of Greenberg Traurig, LLP regarding Club Memberships and Bankruptcy:

GT Law

As noted in our “Club Membership Deposits — From Gold to Paper” posted on August 4, 2011,  many membership deposit clubs have resorted to bankruptcy to restructure their membership deposit debt liability.  Below are descriptions of how the membership deposits have been restructured in four bankruptcies.

Dominion Club. Members will receive in full satisfaction of their membership deposit claims, distributions pro rata from an escrow account to be funded in part from future new membership sales proceeds and certain contributions from a club owner affiliate. Each member had the option to receive in lieu of distributions from the escrow account an upfront payment equal to 11% of the member’s membership deposit.

Amelia Island. The purchaser of the multiple golf course club and resort entered into a lease/purchase agreement with a club member entity with respect to one golf course and clubhouse.  Members received in satisfaction of their membership deposit claims membership rights in the member owned club.  Under the new Membership Plan, a golf member who converted to equity membership by paying $2,000 was to receive a refund of 30% of the membership deposit after resignation from available funds, increasing to 80% over a seven year period.  Golf members who did not convert to equity membership were to receive a refund of 30% of their membership deposit after resignation from available funds.

Palmas del Mar. A government affiliated entity that acquired the club established a fund to pay, first, administrative claims and a tax claim, and then, if any amount remained, members would receive a pro rata share of the balance based on the present value of their membership deposit liability. It was expected that club members would be paid a very small percentage of their membership deposits.

PGA West.  Membership deposits payable after resignation and reissuance will be paid at 50% of the total membership deposit; starting two years after the date of the reorganization plan, the refund percentage will increase by 5% each year.  Members retain their right to 100% of their membership deposits at the end of 30 years and after death subject to annual caps on the total amount of payments under such provisions.

The individual circumstances for each club impacted the final provision governing the membership deposit restructure.

Membership deposits must be restructured so that members as a class of creditors vote in favor of the reorganization plan or the bankruptcy court determines that the reorganization plan does not unfairly discriminate and is fair and equitable.  The club governing documents and the economics of the restructure must be carefully reviewed.

©2012 Greenberg Traurig, LLP

Consumer Financial Services Basics – ABA Conference

The National Law Review is pleased to bring you information regarding the upcoming Consumer Financial Services Basics Conference sponsored by the ABA:

When

October 08 – 09, 2012

Where

American University

Washington College of Law

Washington, DC

Program Description

Facing the most comprehensive revision of federal consumer financial services (CFS) law in 75 years, even experienced consumer finance lawyers might feel it is time to get back in the classroom. This live meeting is designed to expose practitioners to key areas of consumer financial services law, whether you need a primer or a refresher.It is time to take a step back and think through some of these complex issues with a faculty that combines decades of practical experience with law school analysis. The classroom approach is used to review the background, assess the current policy factors, step into the shoes of regulators, and develop an approach that can be used to interpret and evaluate the scores of laws and regulations that affect your clients.Program FocusThis program will explain each of the major sources of regulation of consumer financial products in the context of the regulatory techniques and policies that are the common threads in a complex pattern, including:

  • Price regulation and federal preemption of state price limitations
  • Truth in lending and disclosure requirements
  • Marketing, advertising and unfair or deceptive conduct
  • Account servicing and collections
  • Regulating the “fairness” of financial institution conduct
  • Data security, fraud prevention and identity protection
  • Consumer reporting: FCRA & FACT Act
  • Fair lending and fair access to financial services
  • Remedies: regulators and private plaintiffs
  • Regulatory and legislative priorities for 2012 and beyond

Who Should Attend…The learning curve for private practitioners, in-house lawyers and government attorneys to understand the basics and changes to CFS law is very steep. This program is a great way to jump up that curve for:

  • Private practitioners with 1-10 years of experience who focus on CFS products or providers
  • In-house counsel at financial institutions and non-bank lenders
  • Government attorneys, in financial practices regulatory agencies
  • Compliance officers (who may be, but need not be, attorneys)

Consumer Financial Services Basics – ABA Conference

The National Law Review is pleased to bring you information regarding the upcoming Consumer Financial Services Basics Conference sponsored by the ABA:

When

October 08 – 09, 2012

Where

American University

Washington College of Law

Washington, DC

Program Description

Facing the most comprehensive revision of federal consumer financial services (CFS) law in 75 years, even experienced consumer finance lawyers might feel it is time to get back in the classroom. This live meeting is designed to expose practitioners to key areas of consumer financial services law, whether you need a primer or a refresher.It is time to take a step back and think through some of these complex issues with a faculty that combines decades of practical experience with law school analysis. The classroom approach is used to review the background, assess the current policy factors, step into the shoes of regulators, and develop an approach that can be used to interpret and evaluate the scores of laws and regulations that affect your clients.Program FocusThis program will explain each of the major sources of regulation of consumer financial products in the context of the regulatory techniques and policies that are the common threads in a complex pattern, including:

  • Price regulation and federal preemption of state price limitations
  • Truth in lending and disclosure requirements
  • Marketing, advertising and unfair or deceptive conduct
  • Account servicing and collections
  • Regulating the “fairness” of financial institution conduct
  • Data security, fraud prevention and identity protection
  • Consumer reporting: FCRA & FACT Act
  • Fair lending and fair access to financial services
  • Remedies: regulators and private plaintiffs
  • Regulatory and legislative priorities for 2012 and beyond

Who Should Attend…The learning curve for private practitioners, in-house lawyers and government attorneys to understand the basics and changes to CFS law is very steep. This program is a great way to jump up that curve for:

  • Private practitioners with 1-10 years of experience who focus on CFS products or providers
  • In-house counsel at financial institutions and non-bank lenders
  • Government attorneys, in financial practices regulatory agencies
  • Compliance officers (who may be, but need not be, attorneys)

A New ‘Must-Do’ for Children’s Products Importers and Domestic Manufacturers: A CPSC-Compliant Product Testing and Certification Program

The National Law Review recently featured an article, A New ‘Must-Do’ for Children’s Products Importers and Domestic Manufacturers: A CPSC-Compliant Product Testing and Certification Program, by Ruth A. Bahe-JachnaDavid P. CalletFrancis A. CiteraVictoria Davis Lockard, and Gretchen N. Miller of Greenberg Traurig, LLP:

GT Law

Since the 2008 passage of the Consumer Product Safety Improvement Act,importers and domestic manufacturers of children’s products (a consumer product designed or intended primarily for children 12 or under) have been required to issue a certificate of compliance (known as a “General Conformity Certificate” or “GCC”) stating that the product is compliant with all U.S. Consumer Product Safety Commission (“CPSC”) mandated product safety rules. Now, however, children’s products importers and domestic manufacturers will be required to do more. Last year the CPSC issued regulations that require importers and domestic manufacturers to also develop and implement by February 8, 2013 their own Product Testing and Certification Program.

This new Product Testing and Certification Program, previously called a “Reasonable Testing Program,” must include specified elements, the implementation of which will, according to the CPSC’s regulations, provide the issuer of a new type of GCC (a “Children’s Product Certificate”) a “high degree of assurance” that all of its children’s products, not just the products that were tested, are compliant with applicable CPSC product safety rules.

The good news is that developing and implementing the new Product Testing and Certification Program will increase the likelihood that a company’s children’s products are in compliance with applicable CPSC product safety rules. Thus, it will help to protect the company’s brands from adverse publicity and avoid commercial disruption from goods being detained at a port or recalled by the CPSC.

A Company’s CPSC-Compliant Product Testing and Certification Program Must Include and/or Address:

  • Initial product certification which is to be based upon third-party lab testing of “sufficient samples” of the children’s products to provide the company a “high degree of assurance” that all of its children’s products meet applicable product safety rules.
  • A Periodic Testing Plan, which addresses the tests to be conducted, the intervals between tests, the number of samples to be tested and the methods that ensure that the tested samples are “representative” of the entire production population, so that the company can continue to have a “high degree of assurance” that its products remain compliant with all applicable product safety rules.
  • Material change in the product design or manufacturing process, including the sourcing of component parts, which could affect the children’s products’ ability to comply with applicable product safety rules.
  • Procedures to safeguard against a company using undue influence over third-party labs.
  • Records of all Children’s Product Certificates, third-party test results, Periodic Testing Plans, and material change and undue influence policy documents must be maintained for five years and made available to the CPSC on request.

A CPSC-Compliant Product Testing and Certification Program May Include and/or Address:

  • Component part certification and/or testing which a company may rely upon if it has exercised “due care” to ensure that reliance on that component part certificate and/or test was justified.
  • A Production Testing Plan which describes the production management techniques and tests that will be performed to provide the company a “high degree of assurance” that its children’s products continue to comply with applicable product safety rules after issuance of an Initial Product Certification. Although not required, a Production Testing Plan can extend the company’s mandatory third party testing from a minimum of once a year to once every two years.

©2012 Greenberg Traurig, LLP

LinkedIn Password Theft Results in Class Action Lawsuit: Privacy and Security Law Matters

The National Law Review recently published an article by Kevin M. McGinty of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. regarding The Recent Hacking of LinkedIn:

Nearly as predictable as the sun coming up in the morning, the recent theft of 6.5 million LinkedIn user passwords has resulted in the filing of a class action lawsuit in a California federal court.  In her complaint, a LinkedIn premium subscriber asserts claims on behalf of all LinkedIn users for breach of implied and express contractual obligations, negligence and violation of California’s Unfair Competition Law, Cal. Bus. & Prof. Code § 17200.

Although the attack affected the passwords of just over 5% of LinkedIn’s approximately 120 million users, plaintiff purports to assert claims on behalf of all LinkedIn users.  Although plaintiff alleges classwide damages in excess of $5,000,000 (the jurisdictional threshold for federal court jurisdiction over the state law claims advanced in the complaint) it is unclear what damages plaintiff alleges that the class actually sustained by reason of merely losing passwords.  Some commentators have hypothesized that the propensity to use a single password for multiple online accounts could result in losses where non-LinkedIn accounts are accessed using an individual’s LinkedIn password.

Proving that such losses have occurred, however, would require highly individualized showings that would likely preclude adjudicating plaintiff’s claims as a class action.  Even less clear is what conceivable damages were allegedly sustained by LinkedIn users whose passwords were not stolen.  Thus, as with most privacy class actions, damages issues appear to pose the greatest obstacle to the success of the claims against LinkedIn.

©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Abbott’s $1.6 Billion Settlement Stands as Cautionary Tale to Pharma Companies

The National Law Review recently published an article by David Deitch of Ifrah Law regarding Abbott’s Recent Settlement:

A recent settlement by global pharmaceutical giant Abbott Laboratories over its promotion of the drug Depakote shows that federal regulators remain prepared to pursue drug manufacturers for promoting unapproved uses of their products. Abbott has agreed to pay federal and state governments a total of $1.6 billion in criminal and civil fines and to plead guilty to a criminal misdemeanor violation of the Food and Drug Act to resolve allegations against it. This makes the case the second-largest in a series of multi-million dollar settlements of enforcement actions by the U.S. Department of Justice and state regulators against drug makers. Abbott will be subject to monitoring and reporting requirements as a condition of its plea.

When the Food and Drug Administration approves a drug as “safe and effective” for sale to the public, it specifies that the approval is for one or more defined medical purposes. It is a common practice among doctors, however, to prescribe drugs for other uses based on their understanding of other effects of use of the drug, and such “off label” prescriptions are not illegal.It is illegal, however, for drug manufacturers to promote off-label use of their products.

In the Abbott case, federal and state regulators and law enforcement agencies alleged that the company had promoted off-label use of Depakote, which the FDA has approved to treat epileptic seizures, migraines and the manic episodes suffered by people with bipolar disorder. As part of its settlement, Abbott has admitted that, beginning in 1998, it trained a portion of its sales force to promote Depakote to nursing home personnel as a way to control agitation and aggression in elderly patients suffering from dementia. Abbott continued to do so through 2006 even after it was forced to discontinue clinical trial testing in 1999 of the use of Depakote to treat patients with dementia because the drug caused increased drowsiness, dehydration and anorexia in the elderly test subjects.

The use of Depakote by nursing homes for the off-label use promoted by Abbott was attractive because, as Abbott’s sales force highlighted, Depakote was not covered by the Omnibus Budget Reconciliation Act of 1987 (OBRA) and its implementing regulations designed to prevent the use of unnecessary medications in nursing homes. Thus, use of the drug for this purpose could help nursing homes avoid the administrative costs and other burdens of complying with that law.

In some ways, the Abbott settlement is simply another reminder that pharmaceutical manufacturers that “misbrand” drugs by promoting off-label use will face scrutiny and enforcement from federal and state governments. On the other hand, the Abbott case is particularly egregious given the allegations that, after tests showed poor effectiveness and possible problems with the off-label use of Depakote, Abbott failed to disclose to its sales force the results of those studies. In highly regulated industries such as pharmaceutical manufacturing, the case is a reminder that companies that fail to adhere closely to legal and regulatory requirements do so at great risk.

© 2012 Ifrah PLLC

The CFPB’s Consumer Complaint System: Key Points of Concern for Financial Services Companies

The National Law Review recently published an article by Stephanie L. Sanders and Richard Q. Lafferty of Poyner Spruill LLP regarding CFPB’s Consumer Complaint System:

The Dodd-Frank Act requires the Consumer Financial Protection Bureau (CFPB) to collect, investigate and respond to consumer complaints as part of its work in protecting consumers of financial products and services.  Over the past year, CFPB’s Consumer Response team has gradually begun taking complaints on credit cards, mortgages, private student loans, other consumer loans, and other bank products and services.  Because the complaint process could result in investigation or enforcement actions, financial services companies should be sure they understand the system and are prepared to respond promptly to complaints.  Below is a list of recommendations for financial service companies to deal with the complaint system.

Know How to Use the Complaint System

CFPB’s website now prominently includes a “Submit a Complaint” portal.  Consumers wishing to make a complaint in one of the above categories can simply click on the “Submit a Complaint” icon and follow the directions provided.  In addition, CFPB accepts complaints by telephone, mail, email, and fax.  The portal is the primary means of communication between CFPB and financial service companies, so companies should be familiar with the portal and establish procedures for fielding any complaints in a timely manner.  CFPB has provided aCompany Portal Manual explaining how the portal and the complaint process works.

Once a complaint is submitted, CFPB screens it to determine whether it falls within the agency’s primary enforcement authority, whether it is complete, and whether it is a duplicate submission.  If the complaint passes these tests, it is then forwarded to the company for response.  The company is notified of the complaint and can log into the portal to view all active cases.  Upon receipt of the complaint, the company must communicate with the consumer to determine the appropriate response.  The company’s response is submitted via the portal, and the consumer is invited to review the response.  The consumer can log onto the secure portal or call a toll-free number to receive status updates and review responses.  The consumer is then given an opportunity to dispute the response.

Be Prepared to Respond Quickly

CFPB requests that companies respond to complaints within 15 calendar days and resolve complaints within 60 days.  Failure to provide a timely response may trigger an investigation of the complaint by CFPB.  Since a complete response requires that the company correspond with the complaining consumer, companies should pursue a response quickly to ensure they meet CFPB deadlines.

Understand that Complaints May Result in Investigations or Enforcement Actions by CFPB

The Consumer Response Team prioritizes review and investigation of complaints where a consumer disputes the response or the company fails to provide a timely response.  In addition, the team analyzes groups of complaints to identify issue-specific trends.  In some cases, complaints are referred to CFPB’s Division of Supervision, Enforcement, and Fair Lending and Equal Opportunity for further action.  Financial services companies should thus be vigilant on the same matters, paying greater attention to disputed responses, ensuring that responses are timely, and monitoring for trends in the complaints received so that underlying problems are addressed before they are raised by the agency.

Understand that cCmplaints May Also Result in Investigations By Other Agencies

If a complaint is outside CFPB’s jurisdiction, it may be forwarded to the appropriate regulator (for example, while CFPB handles complaints on private student loans, it forwards complaints received about federal student loans to the Department of Education).

In addition, the Dodd-Frank Act requires CFPB to share consumer complaint information with the Federal Trade Commission (FTC) and other state and federal agencies.  For example, if CFPB receives a complaint about identity theft, it may share that with the FTC, which is the agency that has historically investigated such complaints.  As a result, financial services companies may need to anticipate receiving questions from the FTC about the effectiveness of their Red Flags program, which companies should have fully implemented in response to applicable FTC and other federal agency rules.  In addition, CFPB currently shares its complaints with the FTC’s Consumer Sentinel system, an online database of consumer complaints maintained by the FTC that is accessible by law enforcement.

Be Prepared for an Increase in the Volume of Complaints

Consumer use of the complaint system is off to a strong start.  CFPB recently issued a Consumer Response Annual Report summarizing the use of the complaint system from its launch in July 2011 through December 31, 2011.  The report indicates that CFPB received 13,210 consumer complaints during that time, including 9,307 credit card complaints and 2,326 mortgage complaints.  The most common credit card complaints involved billing disputes, identity theft, and APR or interest rates.  The most common mortgage complaints involved situations in which the consumer was unable to pay (loan modification, collection, foreclosure).  The complaint systems for bank products and services, private student loans, and other consumer loans only began in 2012, so the report did not cover those categories.  By the end of 2012, the CFPB expects that the complaint system will cover all consumer financial products and services.

Financial services companies should monitor these trends to identify issues that may affect their business.  They also should anticipate a significant increase in complaint volume as CFPB adds additional products to the complaint system and more consumers become aware of it.  By comparison, the FTC Consumer Sentinel fielded 1.8 million complaints in 2011.

© 2012 Poyner Spruill LLP

Kansas Supreme Court Decision Declares Resale Price Maintenance Per Se Illegal Under State Antitrust Statute

The National Law Review recently published an article by Lawrence I. FoxMegan Morley, and Joseph F. Winterscheid of McDermott Will & Emery regarding Resale Price Maintenance in Kansas:

The Kansas Supreme Court recently determined resale price maintenance isper se illegal under state law, becoming the latest state to reject the rule of reason standard mandated by the Supreme Court of the United States.  The decision serves as a reminder that although a supplier’s pricing policies may be permissible under federal law, they may nevertheless be subject to per se condemnation under certain state statutes.

On May 4, 2012, the Kansas Supreme Court announced that resale price maintenance (RPM) is per se illegal under Kansas law in O’Brien v. Leegin Creative Leather Products, Inc.  With this ruling, Kansas joined a growing number of states—including Maryland, New York and California—that have refused to follow the Supreme Court of the United State’s 2007 holding in Leegin Creative Leather Products, Inc. v. PSKS, Inc. that the legality of RPM should be assessed under the rule of reason.  The O’Brien decision therefore serves as yet another sobering reminder that suppliers need to be mindful that although RPM may be subject to rule of reason analysis at the federal level, it remains subject to per secondemnation at the state level in many states under state antitrust statutes

In O’Brien, the plaintiff, a purchaser of accessories, filed a class action litigation against Leegin Creative Leather Products, a manufacturer and retailer of Brighton fashion accessories and luggage (Brighton)—the same defendant involved in the U.S. Supreme Court’s landmark 2007 eponymous decision—alleging Brighton’s pricing practices violated the Kansas Restraint of Trade Act (KRTA).  These practices included calling for retailers to sell Brighton products at a “keystone” price determined by Brighton and for certain “heart store” retailers to sell Brighton products at a “suggested price every day, 365 days a year.”  Brighton did admit to investigating reports it received regarding alleged violations of the policy and, although not occurring in Kansas, it acknowledged refusing to deal with retailers that intentionally violated the policy.

Upon motion for summary judgment, the trial court held the plaintiff’s RPM claims should be evaluated under the rule of reason.  To determine that a rule of reason analysis is appropriate, the court invoked language from Heckard v. Park, 188 P.2d 926, 931 (1948), and Okerberg v. Crable, 341 P.2d 966, 971 (1959): “The real question is never whether there is any restraint of trade but always whether the restraint is reasonable in view of all the facts and circumstances and whether it is inimical to the public welfare.”  Using this standard, the court refused to grant summary judgment because it believed there was a genuine issue of material fact as to the reasonableness of Brighton’s pricing policies.  The trial court, however, still granted Brighton’s summary judgment motion after ruling the plaintiff would be unable to prove antitrust injury.

On the plaintiff’s appeal, the Kansas Supreme Court overturned the ruling of the trial court and declared that horizontal and vertical restraints of trade, including RPM, are per se illegal.  In reaching this decision, the Kansas Supreme Court examined the plain language of KRTA, federal antitrust rulings and past Kansas precedent.

First, the court looked at the statutory language of KRTA.  Section 50-101(d) provides “[a]ny such combinations are declared to be against public policy, unlawful and void.”  Section 50-112 states “[a]ll arrangements, contracts, agreements, trusts, or combinations … designed or which tend to advance, reduce, or control the price … to the consumer … are hereby declared to be against public policy, unlawful, and void.”  Because these statutes do not mention reasonableness, the court believed that this “clear statutory language draws a bright line” against the use of a rule of reason standard.

Second, the court briefly addressed and then dismissed the notion that federal antitrust rulings, such as Leegin, compelled a rule of reason analysis.  Citing a string of Kansas decisions, the court determined “that federal precedents interpreting, construing, and applying federal statutes have little or no precedential weight when the task is interpretation and application of a clear and dissimilar Kansas statute.”

Third, the Kansas Supreme Court looked at prior state cases to assess whether a reasonableness standard should be read into KRTA.  Three of these cases were decided under Kansas’s General Statutes of 1915 and Revised Statutes of 1923, which the court described as the “legislative ancestor[s]” of KRTA and which contained similar language to the present day statute.  In each of these cases, the Kansas Supreme Court held the vertical price-fixing agreements at issue were unenforceable and per se illegal.

In 1937, however, the state legislature enacted the Kansas Fair Trade Act (KFTA).  This statute both permitted contracts controlling resale prices and authorized private actions to punish deviations from these contracts.  Although the legislature repealed this statute in 1963, the Kansas Supreme Court examined whether the per se rule adopted in these pre-KFTA cases had been overruled while KFTA was in effect.  The only relevant cases decided during this period were the aforementioned decisions in Heckard and Okerberg, which did indeed adopt a reasonableness standard.

Analyzing these KFTA-era cases, however, the Kansas Supreme Court determined that this “reasonableness rubric” did not apply to alleged price-fixing agreements.  The restraints of trade at issue in those cases—non-compete covenants and requirements contracts—were “factually and legally distinct from vertical and horizontal price-fixing.”  Moreover, the court went on to state it would have to read unwritten elements into the unambiguous statutory language of KRTA to impose a rule of reason in price-fixing cases, which would require the court to impermissibly encroach on the legislative function.  The court concluded that if Heckard andOkerberg were before it today, it would not impose a reasonableness standard because the clear statutory language does not require it.  The Kansas Supreme Court therefore overruled the reasonableness standard adopted in Heckard andOkerberg and held that price-fixing violations are per se illegal under KRTA.

With the decision in O’Brien, Kansas is the latest state to reject the rule of reason standard mandated by Leegin for federal RPM cases when applying state antitrust statutes.  This decision serves as a reminder to suppliers that although their pricing policies may be permissible under federal law, these same policies may nevertheless be subject to per se condemnation under certain state statutes.  Any programs directed at affecting downstream resale prices must therefore be crafted carefully to ensure they are legally compliant at both the state and federal levels.

© 2012 McDermott Will & Emery

Otsuka v. Sandoz – Motivation Trumps Structure

An article by Warren Woessner of Schwegman, Lundberg & Woessner, P.A. about Otsuka v. Sandoz recently appeared in The National Law Review:

The recent decision of the Fed. Cir. in Otsuka v. SandozApp. No. 2011-1126, -1127 (Fed. Cir. May 7, 2012) continues the courts admirable work in defining obviousness post-KSR. This case revisits the standards involved in making out a prima-facie case of structural obviousness. What is particularly interesting in this decision is the weight – or lack thereof – that the court gave to evidence of therapeutic utility of the closest prior art compound. In fact, the court applied the fairly obscure maxim of patent law articulated forty years ago In re Steminski, 444 F.2d 581 (CCPA 1971). John L. White, in Chemical Patent Practice, summarized the holding of Steminski as part of his discussion of the “Hass-Henze Doctrine”:

“The [CCPA] concluded that because the characteristics normally possessed by members of a homologous series [e.g., differing by only one methylene group] are principally the same, varying gradually from member to member [e.g., methyl, ethyl, propyl, butyl, etc], chemists knowing the properties of one member of a series would in general know what to expect in adjacent members so that a mere difference in degree is not the marked superiority which will ordinarily remove the unpatentability of adjacent homologs of old substances. Contra, where no use for the prior art compound is known [citing Steminski].”

Sandoz was trying to invalidate an anti-schizophrenic drug, aripiprazole, marketed by Otsuka as Abilify. The court abbreviated its structure by referring to it as a 2,3-dichlorophenylbutoxy compound. Sandoz et al. were trying to invalidate the claim to this compound in US Pat No. 5,006,528 over an earlier patent that disclosed the 2,3-dicholorphenylpropoxy analog of Abilify (a butoxy compound). Not only is the prior art compound  a homolog of Abilify, but the prior art patent disclosed a laundry list of utilities, including “antischizophrenia agents”. Many other structurally more remote analogs were disclosed, and three others were discussed in detail in the opinion, but the appellant/defendants must have felt pretty confident, even though the district court ruled that the patent was unobvious.

No such luck! The Fed. Cir. discussed the “lead compound concept” at length and stated that: “Absent a reason or motivation based on such prior art evidence [of pertinent properties], mere structural similarity between a prior art  compound and the claimed compound does not inform the lead compound selection….See KSR [citation omitted] (‘A fact finder should be aware, of course, of the distortion caused by hindsight bias and must be cautious of arguments reliant upon ex post reasoning.’)” Slip op. at 18-19. In other words, structural similarity, taken alone is not sufficient to establish obviousness.

But wasn’t there data beyond the “naked” structure of the 2.3-dichlorophenyl propoxy prior art homolog? Citing Takeda, 492 F.3d at 1357 and Pfizer, 480 F.3d at 1361, the court fell back on the rule that the art worker must be motivated to use the teachings of the reference to achieve the claimed invention and had a reasonable expectation of success. The court focused on the generality of the prior art disclosure of utility and the primitive nature of this area of pharmacology prior to Otsuka’s invention of Abilify: “At the relevant time, there were no carbostyril compounds that were marketed as antipsychotics or were publicly known to have potent antipsychotic activity with minimal side effects.”So reasonable expectation of success probably carried the day (or the lack thereof), and the ‘528 patent remains valid. Apart from the revival of Steminski, I was heartened by the number of times that the court criticized defendants’ use of what the court(s) considered to be hindsight. For instance, defendants tried to argue that Otsuka’s advance involved “a short timeline”. The Fed. Cir. replied:

“The inventor’s own path itself never leads to a conclusion of obviousness; that is hindsight. What matters is the path the [POSA] would have followed, as evidenced by the pertinent prior art…the district court’s careful analysis exposed the Defendants’ obviousness case for what it was—a poster child for impermissible hindsight reasoning.”

Not just pretty words, beautiful ones!

© 2012 Schwegman, Lundberg & Woessner, P.A.