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Your Marketplace is Global – Ensure that Your Patent Protection is Too.
When: Monday, July 15 to Tuesday, July 16, 2013
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Industry Related Article by Inovia posted 05/06/2013
Inovia, the leading foreign filing provider, today announced the release of its annual report, “The 2013 U.S. Global Patent & IP Trends Indicator,” an in-depth look at how the economy has impacted global IP strategy and its influence on future foreign filing plans. inovia announced the annual survey findings at the 135th Annual Meeting of the International Trademark Association taking place May 4-8 in Dallas.
Similar to the findings in previous years, foreign patent filing is on an upswing with large organizations continuing to outsource much of the foreign patent filing process to non-law firm providers as a means to cut costs and gain efficiencies. More than half of those surveyed filed at least 50 percent of their patent applications overseas, reflecting the growing importance of international patent protection among U.S. companies.
Now in its fourth year, the Indicator has become a definitive resource for identifying the trends having the greatest impact on the foreign filing strategies of U.S. patentees. The mood for 2013 was again “Cautiously Optimistic,” with the number of patent families expected to be filed in 2013 in-line with 2012 filings.
The changes brought by U.S. patent reform and key provisions of the America Invents Act going into effect in March 2013 were overwhelmingly cited by respondents as the most important topic for the IP industry in 2012 and into 2013. Other trends anticipated in 2013 include concerns around the rising cost to obtain patent protection, as well as patent enforcement and patent trolls.
Other key findings from the Indicator include:
- International Patent Filing on the Rise: Compared to the 2012 survey results, respondents this year tended to file more broadly with 70 percent filing in four or more countries – an 11 percent increase from the year prior. As in previous surveys, the overwhelming majority (99 percent) of respondents used the Patent Cooperation Treaty (PCT) for their foreign filing in 2012.
- China Becomes Regular Filing Destination vs. Emerging Market: Of those respondents who filed into new countries, only 14 percent started filing into China in 2012, down from 28 percent in 2011. But, when asked to rank the importance of certain jurisdictions in their 10-year foreign filing strategy, Europe, China and Japan rated as the most important countries – indicating that China has become a regular filing destination. Respondents also expressed fewer concerns about enforceability issues in China.
- Applicants Taking Control of Foreign Patenting: As compared to 2012 results, more applicants expect to save on foreign patenting costs in 2013 by bringing steps in-house (91 percent increase from 2012 survey results), negotiating with foreign counsel (74 percent increase) and using non-law firm providers (73 percent increase).
“The theme of Cautious Optimism returns for the third-consecutive year, with budget cuts lessening and large companies moving away from local counsel for foreign patent filing,” said inovia founder and Australian patent attorney Justin Simpson. “As U.S. patent holders continue to struggle with the changes made by the America Invents Act and a desire to contain costs, they are opting to bring steps in-house or outsource to non-law firm providers with deep experience in areas such as foreign filing, annuities and patent translations.”
inovia surveyed companies and universities through an online questionnaire. Organizations spanned industries and ranged from small enterprises filing a single patent family to multinational organizations filing more than 100 patent families in 2012. All survey participants are involved in the IP strategy and patent filing activity of their organization, with job functions ranging from patent manager, to general counsel and up to executive leadership positions. To download a copy of inovia‘s 2013 U.S. Global Patent & IP Trends Indicator, visit: http://www.inovia.com/resources/global-ip-trends-indicator
- See more at: http://www.inovia.com/news/050313-annual-survey-shows-ip-outsourcing-become-commonplace.jsp#sthash.1wcWs9a8.dpuf
Expert Article by Office of Governor Edmund G. Brown Jr.
Governor Edmund G. Brown Jr. today proposed reforms to strengthen and restore the intent of Proposition 65, a three decade old law enacted to protect Californians from harmful chemicals, that has been abused by some unscrupulous lawyers driven by profit rather than public health.
The administration, through the California Environmental Protection Agency, will work closely with the Legislature and stakeholders to revamp Proposition 65 by ending frivolous “shake-down” lawsuits, improving how the public is warned about dangerous chemicals and strengthening the scientific basis for warning levels.
“Proposition 65 is a good law that’s helped many people, but it’s being abused by unscrupulous lawyers,” said Governor Brown. “This is an effort to improve the law so it can do what it was intended to do – protect Californians from harmful chemicals.”The package of reforms will build on legislative efforts already underway, including a proposal to limit frivolous lawsuits.“Proposition 65 serves a vital public interest. It provides the public with information about carcinogens and toxins that may be present in the products we use in our everyday lives. But for Prop 65 to be effective, this information must be clearly stated and we need to work with the Legislature to prevent groups from exploiting or misconstruing this information for their own personal gain,” said California EPA Secretary Matt Rodriquez.
Voters approved Proposition 65 in 1986. The measure requires the Governor to annually publish a list of chemicals known to the state to cause cancer or reproductive toxicity. If a business in California sells a product containing chemicals listed by the state in excess of safe levels, the business must provide a clear warning to the public. Similar provisions apply to California workplaces.
The administration, stakeholders and the Legislature will discuss reforms to:
• Cap or limit attorney’s fees in Proposition 65 cases.
• Require stronger demonstration by plaintiffs that they have information to support claims before litigation begins.
• Require greater disclosure of plaintiff’s information.
• Set limits on the amount of money in an enforcement case that can go into settlement funds in lieu of penalties.
• Provide the State with the ability to adjust the level at which Proposition 65 warnings are needed for chemicals that cause reproductive harm.
• Require more useful information to the public on what they are being exposed to and how they can protect themselves.
While Proposition 65 has motivated businesses to eliminate or reduce toxic chemicals in consumer products, it is also abused by some lawyers, who bring nuisance lawsuits to extract settlements from businesses with little or no benefit to the public or the environment.
Under provisions of Proposition 65, a private attorney can bring a complaint against a business if the business knowingly exposes consumers to state-noticed chemicals.
Since 2008, nearly 2,000 complaints have been filed by these “citizen enforcers.”
In one case, Consumer Defense Group Action brought 45 Proposition 65 notices of violation against banks based on second-hand smoke near bank entrances or ATMs. The group claimed that the banks had failed to post warnings, and alleged that the banks controlled the behavior of smokers in those areas. In responding that there was no basis for the claim and misrepresentations within the notices, the Attorney General warned that the group’s notices could “constitute unlawful business practices.”
Governor Brown’s proposed reform follows a strong record of pursuing regulatory changes to improve the state’s business climate. Since taking office in 2011, the Governor has approved legislation to improve the workers’ compensation system, the regulatory and fee structure for the timber industry, Americans with Disabilities Act (ADA) compliance requirements and the facility inspection process for the life sciences industry. In addition to these legislative actions, Brown has established the Governor’s Office of Business and Economic Development (GO-Biz) to help companies deal with regulatory “red tape.”
Master the litigation strategies that your company needs to successfully scale the legal intricacies of this next crag of the patent cliff
When: Tuesday, May 07 to Wednesday, May 08, 2013
Where: Crowne Plaza Times Square Manhattan, New York, NY
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Industry Related News
Industry related article from patentdocs.org, by Kevin E. Noonan, posted on 04/01/13:
Supreme Court Oral Argument in FTC v. Actavis
The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy Solicitor General Malcolm Stewart arguing for the government and Jeffrey Weinberger arguing for Respondents. Justice Alito recused himself from any involvement with this case, raising the possibility that the Court could not render a decision that would resolve the circuit split between the 11th Circuit decision at issue here and the K-Dur case in the Third Circuit (In re K-Dur Antitrust Litigation).
To briefly recap, the case involved a reverse payment settlement between NDA holder Solvay Pharmaceuticals and ANDA filers Watson Pharmaceuticals and Paddock Pharmaceuticals over AndroGel, a prescription testosterone formulation prescribed for treating hypogonadism. Unimed (acquired by Solvay and later acquired by Abbott) and Besins Healthcare S.A. held the NDA, as well as Orange Book-listed U.S. Patent No. 6,503,894 directed to the formulation; this patent will expire in August 2020. Watson and Paddock filed separate ANDAs having Paragraph IV certifications that the ’894 patent was invalid or unenforceable, and Unimed/Besins timely filed suit pursuant to 35 U.S.C. §271(e)(2) in the U.S. District Court for the Northern District of Georgia. The lawsuit was pending longer than the statutory 30-month stay, and the FDA approved Watson’s ANDA, but neither Watson nor Paddock launched “at risk” (i.e., before the lawsuit had been decided). As part of the suit, both Watson and Paddock did not contest that their products would infringe the ’894 patent, but rather that the patent was invalid or unenforceable. However, before the District Court could rule on defendants’ summary judgment motions after aMarkman hearing, the parties settled; the Court entered a Stipulation of Dismissal against Watson and a permanent injunction against Paddock.
The case on appeal arose pursuant to an investigation by the FTC of these settlement agreements under 21 U.S.C. § 355 (2003). The FTC alleged violations of Section 5a of the Federal Trade Commission Act under 15 U.S.C. § 45(a)(1). The suit was transferred from the Central District of California to the Northern District of Georgia, where the District Court granted defendants’ motion to dismiss pursuant to Fed. R. Civ. Pro. 12(b)(6) (failure to state a claim). In doing so, the District Court rejected the FTC’s contentions in its complaint “(1) that the settlement agreement between Solvay and Watson is an unfair method of competition; (2) that the settlement agreement among Solvay, Paddock, and Par is an unfair method of competition; and (3) that Solvay engaged in unfair methods of competition by eliminating the threat of generic competition to AndroGel and thereby monopolizing the market.” The basis for the District Court’s action was that, in the 11th Circuit, reverse payments did not constitute anticompetitive behavior “so long as the terms of the settlement remain within the scope of the exclusionary potential of the patent, i.e., do not provide for exclusion going beyond the patent’s term or operate to exclude clearly non-infringing products, regardless of whether consideration flowed to the alleged infringer.”
The 11th Circuit affirmed, and the FTC convinced the Court to review this decision rather than the Third Circuit’s K-Dur decision (see “FTC Asks Supreme Court to Play Favorites in Reverse Payment Settlement Agreement Cases“).
At oral argument, the government began with its strongest statement of its argument: “a payment from one business to another in exchange for the recipient’s agreement not to compete is an paradigmatic antitrust trust violation.” The question before the Court, according to the government, is whether the same payments arising in settlement of patent infringement (ANDA) lawsuits should be permitted, thus pandering to the Court’s displeasure with patents, patent law, and “special rules” for patents.
The government’s grounds for its position is that such settlements “subvert the competitive process by giving generic manufacturers an incentive to accept a share of their rival’s monopoly profits as a substitute for actual competition in the [marketplace].” This assertion was met by a question from Justice Scalia, who asked “how is a payment different from a geographic division of a market via an exclusive license?” The government’s first response, that exclusive licenses are contemplated by the Patent Act, was not convincing (Justice Scalia said it “doesn’t impress”), so the government enunciated a second rationale (which would resonate with the Justices later in the argument), that a license “doesn’t give the . . . infringement defendant anything that it couldn’t hope to achieve by prevailing in the lawsuit.” Justice Scalia said that this is just another way to say that the defendant would get to make money, and asked why the patentee could not “short circuit” the process and just give the defendant the money to make them “go away.” The government responded that the difference is that the payment is “a substitute for earning profits in a competitive marketplace,” reflecting the FTC’s preference for “competition.”
The government seemed to assert a refinement of its position (which, it should be recalled, began with the proposition that reverse payment settlement agreements in ANDA litigation should be a per se violation of the Sherman Act), now arguing that the “logical subject of compromise” should be that the generic drug maker would be able to enter the marketplace at some time before it would have if the branded patentee had won the underlying ANDA lawsuit and after the time it could have entered the marketplace if the generic drug maker won. “That’s an actual subject of compromise and we don’t have a problem with that,” according to Mr. Stewart.
Justice Scalia asked for a case where the patentee has been held liable under the antitrust laws for doing something within the scope of the patent, and the government said yes, provided that you define “scope of the patent” the way it characterized the Respondents’ position, that “the goods that are being restricted are arguably encompassed by the patent and the restriction doesn’t extend past the date when the patent expires.” The government also analogized reverse payment settlement agreements to resale price maintenance agreements (which the Court held to be illegal in the face of patent protection) because “there’s nothing in the Patent Act that says you can pay your competitor not to engage in conduct that you believe to be infringing.” And the government reminded the Court that reverse payment settlement agreements involve (typically) a non-sham allegation of infringement rather than a finding of infringement.
Justice Ginsberg mentioned that this seems to be a change in the government’s position, and Mr. Steward argued that while the FTC hasn’t changed its position, the DOJ had previously “advocated . . . a test that would focus on the strength and scope of the patent[, t]hat is, the likelihood that the brand name would . . . ultimately have prevailed if the suit had been litigated to judgment.” The government’s current position is that these agreements are “presumptively unlawful with the presumption able to be rebutted in various ways.”
Justice Kennedy asked whether one of these ways was assessing the “strength” of the infringement case, something he identified as his “problem,” because the government’s test is “the same for a very weak patent as a very strong patent,” which “doesn’t make a lot of sense.” In response, the government shifted the focus of its argument to be whether there has been a payment “that would tend to skew the parties’ choice of an entry date, that would tend to provide an incentive . . . for the generic to agree to an entry date later than the one that it would otherwise insist on.” Justice Kennedy suggested that the determination — of how much and in what direction the market entry was “skewed” — would “itself reflect the strength or weakness of the patent so that the market forces take that into account.” The government’s response was that “legitimate” agreements would be those where an assessment of the strength of the patent would determine when the generic drug maker entered the marketplace — presumably such agreements would not involve payments. But “the problem with the reverse payment is that it gives the generic an incentive to accept something other than competition as a means of earning money,” Mr. Stewart advocated as a (the?) principle issue the government had with these settlements.
Justice Scalia posited that this issue reflected a problem with the Hatch-Waxman Act (as shown by attempts to “fix” these problems, notably by the Medicare Prescription Drug, Improvement and Modernization Act of 2003), and the government responded that “these types of payments appear to be essentially unknown in other lawsuits and other patent infringement cases” (but Justice Scalia reminded Mr. Stewart that “suits against this kind of payment” also don’t exist outside the Hatch-Waxman context, either). The Justice suggested that Hatch-Waxman “made a mistake by not foreseeing these types of arrangements,” further saying:
And in order to rectify the mistake, the FTC comes in and brings in a new interpretation of antitrust law that did not exist before, just to make up for the mistake that Hatch-Waxman made, even though Congress has tried to cover its tracks in later amendments, right, which . . . deter . . . these payments.
Not surprisingly, the government was not willing to go that far, but Justice Scalia asked why the Court should be willing to “overturn understood antitrust law” to fix Congress’s mistake in Hatch-Waxman?
Turning the argument back to antitrust law, the government argued for a hypothetical where Watson developed a new drug that would compete with AndroGel and Solvay paid them not to market it; this would be a clear antitrust violation, according to the government, “even though Watson’s ultimate ability to market the new drug would depend on FDA approval that might or might not be granted.” The government’s point was that the underlying illegality should not be vitiated by intervening considerations (FDA approval, or in this case patent protection, albeit requiring the Court to ignore the statutory presumption of validity). Mr. Stewart cited Professor Hovenkamp for the proposition that “in the typical market if a patent holder were known to have paid a large sum of money to a competitor who had been making a challenge to the patent, if other competitors knew that that had happened, then they would perceive that to be a sign that the patent was weak and that they would leap in” (which, paradoxically is exactly the argument the 11th Circuit made in deciding that “weak” patents would be more, not less vulnerable if the patentee made too generous settlements or payments). Specifically:
Although a patent holder may be able to escape the jaws of competition by sharing monopoly profits with the first one or two generic challengers, those profits will be eaten away as more and more generic companies enter the waters by filing their own paragraph IV certifications attacking the patent.
Herbert Hovenkamp, “Sensible Antitrust Rules for Pharmaceutical Competition,” 39 U.S.F. L. Rev. 11, 25 (2004).
The government also asserted the “first filer” provisions of the ANDA statute (which is a red herring after the 2003 amendments where a first filer loses its ability to block later filers by entering into a reverse payment settlement agreement), stating that the 180-day exclusivity is “not good in and of itself for consumers” due to the delay in price erosion during that period. Justice Breyer seemed unconvinced (“that’s rather thin”), speaking generally about settled antitrust tools and principles and asking the government’s lawyer why this approach (“Judge, pay attention to the department when it says that these very often can be anticompetitive, and ask the defendant why he’s doing it.”) shouldn’t be used in assessing the legality vel non of reverse payment settlement agreements. According to Justice Breyer, the government asks the Court to “produce some kind of structure — I don’t mean to be pejorative, but it’s rigid — a whole set of complex per se burden of proof rules that I have never seen in other antitrust cases,” and asks the government to provide the antecedents in antitrust law that would support such a regime. After some colloquy regarding other standards like the “quick look” rule of reason, Justice Breyer said:
[W]hy isn’t the government satisfied with an opinion of this Court that says, yes, there can be serious anticompetitive effects. Yes, sometimes there are business justifications, so Judge, keep that in mind. Ask him why he has this agreement, ask him what his justification is, and see if there’s a less restrictive alternative. In other words, it’s up to the district court, as in many complex cases, to structure their case with advice from the attorneys.
Mr. Stewart responded that this would not provide enough guidance, but Justice Breyer rejoined that it is the same guidance as in any other antitrust case with regard to anticompetitiveness. He remarked that he has “32 briefs” supporting the government’s position that the agreements are anticompetitive, and then “four , maybe five” briefs supporting Respondents that say there could be “offsetting justifications.” And for Justice Breyer, district courts can make these distinctions.
The government countered, saying that its “approach accounts for that,” wherein it is the payment that “gives rise to the inference that . . . the delay . . . is longer than the period that would otherwise reflect [the generic's] best assessment of its likelihood . . . of success in the lawsuit.” There are two ways the government proposes that parties to a reverse payment settlement agreement could rebut the presumption of illegality: either by a showing that the payment was not for delay in market entry, or that (unlikely in the government’s view) even if the payment was for delay there is some pro-competitive effect.
Justice Breyer noted that the briefs in support of the Respondents mention at least two other possible rebuttals of the government’s presumption. The hypothetical is significant due to Justice Breyer’s understanding that it is not anticompetitive:
[B]ecause the person’s already in the market thinks that the next year or two or three years is worth $100 million a year, and the person who’s suing thinks it’s worth 30 million a year. And so he says, hey, I have a great idea, I’ll give him the 30 million and keep the 70. And . . . that, I don’t see why that’s anticompetitive if that’s what’s going on.
The other rebuttal perceived by Justice Breyer is when the market is hard to break into, and then the brand is helping the generic enter the market in return for not challenging the patent (which Justice Breyer thought would be procompetitive). But he admitted that parsing this out can be a nightmare.
The government blamed any nightmarish aspects of the agreements on the branded and generic parties who make them so, and stated that Respondents’ position that it would be permissible for the branded to delay entry of the generic until patent expiry upon the payment of sufficient monies “really shows their anticompetitive potential, i.e., that the payment is what skews the decision to agree on a time for generic market entry.
Justice Sotomayor then asked the Deputy SG “why is the rule of reason so bad?,” apparently agreeing with Justice Breyer that the government is asking the Court to erect a completely new structure where traditional antitrust principles should work just fine. She addressed the problem with the government’s position in terms echoing those identified in the Bender White Paper (see “Academic White Paper Rebuts FTC and S. 214“):
I have difficult[y] . . . understanding why the mere existence of a reverse payment . . . presumptively . . . changes the burden from the Plaintiff. It would seem to me that you have to bear the burden . . . of proving that the payment for services or the value given was too high. I don’t know why it has to shift to the other side.
While never providing a direct response, the government raised “administrative” and “conceptual” grounds which did not convince Justice Breyer, who believed that making these types of determinations would take a district court “probably 3 minutes or less.” The government completed the opening portion of its argument by reiterating that the ANDA lawsuit could not have resulted in a reverse payment to the generic company, and thus that the existence of the payment is enough to raise a presumption of anticompetitive behavior and thus to be illegal.
Respondents’ attorney Mr. Weinberger began his argument by answering (in the negative) Justice Scalia’s query regarding whether the Court had ever found an antirust violation resulting from a “patent-based restraint[on trade],” with the only exceptions being in cases where the patentee was acting outside the scope of the patent, such as downstream retail price controls.
Justice Sotomayor asked why this isn’t the case here, because there is no presumption of infringement, so doesn’t the settlement raise the presumption that the parties are acting outside the scope of the patent? Mr. Weinberger said no, because there is no basis for assessing whether there has been an antitrust violation based on whether you could establish in litigation that the patent had been infringed. But Justice Sotomayor opined that the Court should not be asked to “accept” that there had been infringement under circumstances where the patentee has “voluntarily decided not to pursue his rights.” The Justice contrasted the case where the infringer licenses the patent and gets the right to sell upon payment to the patentee, with the situation here where the patentee pays the generic putative infringer not to sell, suggesting to her that the parties are “sharing profits.” She also noted that typical licensing settlements for patent infringement suits don’t involve reverse payments.
Justice Breyer characterized the government’s position to be that reverse payment settlement agreements are not per se unlawful, but that “they want to cut some kind of line between a per se rule and the kitchen sink. And if you look at the brief supporting you, it is the kitchen sink,” asking Mr. Weinberger to define the rule. Mr. Weinberger stated that he didn’t think there was any “intermediary” test, because “you can’t really measure whether there were any anticompetitive effects from such a settlement agreement without determining what would have happened if the case hadn’t settled and it would have been litigated”; if the patentee had won there would not have been any anticompetitive effects. This was the determination of the Second and Federal Circuits in the tamoxifen and Cipro cases, respectively, where those courts applied the antitrust “rule of reason” test and required the government to establish anticompetitive effects, according to Mr. Weinberger.
Justice Kennedy then asked whether the focus should have been on what the generic could have lost rather than what the branded gained, and Mr. Weinberger returned to Respondents’ theme that there would have been no gains if the generics had not prevailed, requiring that patent litigation actually ensued and infringement was found (or not).
Justice Kagan asked for clarification with her own hypothetical, which quickly indicated where her initial inclinations seemed to lie. According to the Justice, what if there is a lawsuit and the defendant says to the patentee, if I win I reduce your profits from $100 million to $10 million, but if I go away you continue to make the $100 million. Thus, if the patentee paid $25 million to the challenger both parties would be better off, but such an arrangement would be anticompetitive and an antitrust violation. If that is the case, asked the Justice, why doesn’t that describe the situation before the Court? She added: “It’s clear what’s going on here is that they’re splitting monopoly profits and the person who’s going to be injured are all the consumers out there” and “I think if we give you the rule that you’re suggesting we give you, that is going to be the outcome because this is going to be the incentive of both the generic and the brand name manufacturer in every single case is to split monopoly profits in this way to the detriment of all consumers.” (In this, the Justice ignored, for the moment, the fact that this hasn’t happened.)
In response, Mr. Weinberger mentioned the lower entry cost to challenge a patent under Hatch-Waxman based on certification alone, because a generic challenger does not need to make the actual investment that a competitor would need to make in other types of patent infringement litigation. “And the FTC’s own studies have shown that it takes a very small chance of winning, something like 4 percent for a drug over $130 billion to justify a generic suing a brand name company” he reminded the Court.
Justice Sotomayor then raised her own concerns with these agreements. “The Second Circuit recognized,” said the Justice, “even though it accepted your scope of the patent [standard], that there was a troubling dynamic in what you’re arguing, which is that the less sound the patent, the more you’re going to hurt consumers because those are the cases where the payoff, the sharing of profits is the greatest inducement for the patent holder.” Mr. Weinberger responded by arguing that this isn’t an issue in practice because of the “so many potential challengers” to the patent, for all of whom “all they have to do is file an ANDA, there are 200 generic companies in this industry, that if you try to adopt that strategy of paying the profits of a generic, there’s going to be a long line of [generics to pay off].”
Justice Kagan disputed this argument based on the first filer/180-day exclusivity provisions (which she called a “glitch” in Hatch-Waxman), saying that “once the 180-day first filer is bought off, nobody else has the incentive to do this” (which may have been the law before 2003 but is not the law now). Respondents argued that this is not correct “either by logic or by reference to actual experience” based on the long lifetimes of the drugs, but Justice Kagan stated she understood that “the huge percentage of the profits [are made] in the exclusivity period.”
Justice Sotomayor then posed the counter question to Mr. Weinberger that she posed to the Deputy SG: “what’s so bad with banning reverse payment settlements?” Mr. Weinberger responded that while the parties could “always just litigate,” there is no incentive for the generic not to litigate instead of settling without some financial recompense, i.e., the reverse payment.
Justice Ginsberg raised the concern that the generic is unjustly enriched, a position in which Justice Kennedy agreed, to the extent that the generic obtained more than what it would have gotten if it won the ANDA litigation. Justice Ginsberg stated her interpretation of the government’s position, that generics were getting a windfall, but Mr. Weinberger noted that the government has not provided any data or examples of such a situation. Justice Kennedy noted that “if the generic wins [the ANDA litigation] the brand companies profits are going to go way, way down right away and generic profits are not going to be that great. . . . [I]f you key your payment to what the brand company will make, it’s just a much higher figure, and a greater danger of unreasonable restraint.” Mr. Weinberger’s response was that while this may be a hypothetical risk, the reality is that “with the number of challenges you have here, which is basically unlimited, that if you put a sign around your neck that says, paying off all generic companies their profits, whoever wants to challenge my patent come do it, there is going to be a long line of people, of companies doing it.” When Justice Kennedy asked whether this wasn’t true in every industry, Mr. Weinberger reminded him of the low barrier to ANDA status: “They have nothing at risk. If they lose, they haven’t lost any damages. They just walk away.”
In the most cogent few minutes of uninterrupted argument, Mr. Weinberger made the case that:
I think that the antitrust rule should not be fashioned to deal with a case on the extreme, which hasn’t been shown to happen, which logically from an economic point of view is highly unlikely to happen. And if for some reason that starts happening empirically, then Congress — and it is a loophole in Hatch-Waxman that is causing that, and there is really no evidence that that extreme example has happened – then Congress can deal with it, just as it dealt with the exclusivity provision.
Justice Sotomayor made the most direct argument against reverse payment settlement agreements from the bench:
I see that as an argument that there is an economic reality in Hatch-Waxman that would require us not to apply any rule we choose or accept here to other situations, only here. That’s the argument that you’re creating for me, that there’s a different economic reality here that requires a different rule [because] in Hatch-Waxman, Congress decided that there was a benefit for generics entering without suffering a potential loss to enter the market more quickly [and] any settlement in these cases deprives consumers of the potential of having the benefit of an earlier entry.
Respondents’ only argument to counter these assertions was that these settlements have not hindered the rise in generic entry over the past 10 years, and that requiring generics to litigate to conclusion could restrict generic entry.
In rebuttal, the government argued that the outcome of patent litigation is irrelevant because antitrust liability comes from the behavior (not the reality) of the parties, and that this approach (essentially ignoring the existence of the patent) avoids the “conundrum” of determining the outcome of patent litigation. No doubt.
From the oral argument, reading how the Justices may be leaning is easier for some of the Justices than others. Justices Sotomayor and Kagan (and to a lesser degree, Justice Ginsberg) appeared most enamored of policy arguments against these agreements and concerned about their negative effects, while the Chief Justice and Justice Thomas’ leanings are incapable of being determined by their silence. Justices Scalia, Breyer, and Kennedy were apparently concerned (to varying extents) with whether agreeing with the government would upset settled antitrust jurisprudence and, paradoxically, itself add another “special” set of rules for patent cases. On balance, the Court clearly understood that this case represented another instance of the interplay between patent, regulatory, and antitrust law, and while individual Justices appeared uncertain about particular provisions and their effects (particularly the 180-day exclusivity period) the Court questioned both the government and Respondents with equivalent intensity. Meaning that there is little prospect of providing any reasonable conjecture on how this case will come out.
The Court is expected to render its decision by the end of its term in June.
Not only does the conference attract a “who’s who” in the products liability space, but the speaking faculty is comprised of in-house counsel, outside counsel, prominent government enforcers, and renowned members of the state and federal bench, providing advice for defeating claims and litigating more efficiently
When: Monday, December 9 to Wednesday, December 11, 2013
Where: Marriott Marquis, New York City
For more information, and to register: click here
ACI’s 17th Annual Drug & Medical Device Litigation conference (December 3-5, 2012)
ACI’s 17th Annual Drug & Medical Device Litigation conference (December 3-5, 2012) was a resounding success, bringing together more than 400 litigators from across the country. We appreciate the support of all of our sponsors and attendees, and look forward to welcoming everyone back in 2013.
Preparations are already underway for the 2013 iteration of Drug & Med, taking place December 9–11, 2013 at the Marriott Marquis in New York City. This conference is the leading forum to network with their peers, and craft strategies to surmount new litigation challenges. Participants at the 2012 iteration of the conference included:Allergan, Bayer, Biomet, Boehringer Ingelheim, Boston Scientific, DePuy Synthes, Eli Lilly, Johnson & Johnson, Medtronic, Merck, Novo Nordisk, Purdue Pharma, Pfizer, Sandoz, Teva, and many more!
Hear for yourself from those who were in attendance:
Employers Beware – An Award of Attorney Fees and Costs to a Successful Workers’ Compensation Appellant is Not Dependent on How Many Claimed Conditions are Approved/Denied
Expert Article by Alexander Kipp
Late last year, in Holmes v. Crawford Machine, Inc., Slip Opinion No. 2012-Ohio-5380, the Ohio Supreme Court held that R.C. 4123.512(F) entitles a successful workers’ compensation claimant to recovery all attorney fees, up to the $4,200 statutory maximum, and all costs, rather than apportioned amounts, when a trial court approves only one of the claimant’s multiple claimed medical conditions. In other words, as long as the trial court approves one claimed condition, R.C. 4123.512(F) entitles a claimant to also recover attorney fees and costs related to specifically disallowed conditions. The Court’s ruling resolved a conflict of decisions between the Third and Tenth District Courts of Appeals.
The case involved a workers’ compensation claim filed by Jeff Holmes for injuries to his hand, arm, shoulder, and back that he alleged were caused when he suffered an electric shock while working for Crawford Machine, Inc. Holmes’s claim was ultimately allowed administratively for: left-shoulder strain; electrical shock; low back strain; left-rotator-cuff tear; left-posterior-shoulder dislocation; and abrasion of right fifth finger. Crawford Machine appealed the administrative order to the Crawford County Court of Common Pleas. Holmes petitioned the court for approval of all of his allowed conditions.
Following a jury trial, the court ruled that Holmes was entitled to participate in the Ohio Workers’ Compensation system for the condition of “abrasion right fifth finger” but was not entitled to participate for any of the other conditions that had been administratively allowed. Holmes then petitioned the court for recovery from Crawford Machine of the legal fees and costs he incurred during the appeal process. Crawford Machine argued that Holmes was not entitled to reimbursement of his attorney fees and costs because he had not incurred any attorney fees or costs in relation to his fifth-finger-abrasion condition. The trial court granted Holmes’s motion and ordered Crawford Machine to pay Holmes $4,200 in attorney fees and $7,551.23 in costs.
Crawford Machine appealed from the judgment granting attorney fees and costs, and Holmes appealed from the judgment allowing one, but not all, of his claimed conditions. The Third District Court of Appeals upheld the judgment allowing only one of Holmes’s claimed conditions, and reversed the judgment awarding attorney fees and costs. The Third District certified that its ruling regarding attorney fees and costs was in conflict with a Tenth District Court of Appeals decision on the same legal issue. The Ohio Supreme Court agreed to review the case to resolve the conflict.
Writing for the majority, Justice McGee Brown wrote, “The plain language of R.C. 4123.512(F) requires a trial judge to order reimbursement to a claimant for costs, including attorney fees up to $4,200, if the claimant’s right to participate in the fund is established or upheld on appeal. In this case, Holmes was adjudicated to be entitled to participate in the fund for a fifth-finger abrasion. Therefore, pursuant to R.C. 4123.512(F), the trial court was required to reimburse him for his costs, including attorney fees, associated with his appeal. Since R.C. 4123.512(F) does not require apportionment of these costs based on the outcome of Holmes’s particular conditions, the trial court did not abuse its discretion when it made no such division of costs”… Therefore, once a claimant’s right to participate in the workers’ compensation fund has been established, a trial court does not abuse its discretion under R.C. 4123.512(F) by awarding the claimant reimbursement for costs related to the conditions for which the trier of fact determined the claimant was ineligible to participate in the fund.”
This case should caution employers to choose wisely when it comes to appealing and contesting workers’ compensation claims beyond the administrative levels. As Crawford Machine found out, when multiple conditions are at issue, it may be wise to forego challenging minor cuts, scrapes, and bruises, rather than end up paying nearly $12,000 for a pinky-finger abrasion that was treated with a Band-Aid.
ACI event related to Employment Law
When: Thursday, March 21 to Friday, March 22, 2013
Where: The Carlton Hotel, New York, NY, USA
For more information, and to register: click here
9th Circuit Court Of Appeals Upholds Reliance Standard Insurance Company’s Denial Of Disability Benefits And Interpretation Of The 24 Month Mental Nervous Limitation
Expert Article by Gregory Michael Dell
Reliance Standard Insurance Company’s decision to terminate a disability claimant’s long term disability benefits as a result of a 24 month “mental nervous limitations “clause has been upheld by the Ninth Circuit Court of Appeals. It is very common to see disability insurance companies denying claims as a result of a 24 month mental nervous limitation. In the recent 9th circuit court of appeals case of Maurer v. Reliance Standard Life Insurance Company, the plaintiff claimed that Reliance Standard abused their discretion by terminating long term disability benefits. The Appellate court stated,
“[Reliance Standard] permissibly interpreted the “mental/nervous” limitation to preclude coverage when, in the absence of a mental or nervous disorder, a beneficiary would be physically capable of working. Defendant’s interpretation is consistent with the Plan’s limitation of coverage for disabilities that are “caused by or contributed to” by mental disorders.”
No Strong Evidence of A Physically Disabling Condition In the Record
The court clarified that the doctrine of contra proferentem does not apply when the fiduciary/ plan administrator has been granted explicit discretion to interpret the plan. This case is very fact specific as three of the claimant’s physicians provided medical records stating that the claimant was disabled by psychological issues despite physical complaints. One of the physicians stated, “without psychiatric elements, the patient would be capable of work activity.” A different treating doctor found that the claimant’s “physical problems caused her mood disorder.” Reliance Standard argued that mental disorder “contributed to” her disability and therefore the claim is limited to 24 months. This is a unique case as based upon the facts provided in the District Court and Appellate Court decisions it appears that the claimant did not have strong medical evidence or documentation to support a primary disabling condition which was physical. If the claimant had an underlying disabling condition which was physical in nature and had psychiatric limits which were secondary, it is highly unlikely that Reliance Standard would have been unable to rely on the 24 month mental nervous limitation.
Psychiatric Complaints Secondary to a Physically Disabling Condition Should not be Subject to Mental Nervous Limitation
As a disability insurance lawyer that has represented thousands of claimants, it is very common to see a psychiatric condition such as depression or cognitive difficulties which are secondary to a physical limitation. It is normal for a claimant to be depressed or anxious over the reality that they have lost their inability to work and enjoyment of life due to a disabling condition. When dealing with a disability insurance claim, claimants with a physical disability must make sure that their doctors are documenting any psychiatric limitations as secondary to the physical. As long as the physical condition on its own is disabling, then the fact that a psychiatric condition is also disabling should not subject a claimant to a 24 month limitation.
More Disability Insurance blog posts from this author can be found here: http://www.diattorney.com/our-blog/
ACI event related to this topic
When: Thursday, January 24 to Friday, January 25, 2013
Where: The Carlton Hotel, New York, NY, USA
For more information, and to register: click here
Michael Walsh is a partner in the Dallas office of Strasburger & Price and leads the firm’s Drug and Device Industry Team and is a regular contributor to the firm’s Food and Drug Law Blog. He is licensed to practice in Texas and New York and devotes most of his practice defending complex litigation matters, as well as representing clients in FDA regulated industries on issues related to labeling and compliance. He is a member of the DRI Drug and Device Committee, ABA Section of Litigation, and the Laws and Regulations Committee of the Association of Food and Drug Officials. Mr. Walsh is a frequent writer and speaker on issues related to off-label promotion, the First Amendment and products liability.
- Admitted, Texas; Northern, Southern, Eastern and Western U.S. District Courts of Texas
- Admitted, New York; Southern and Eastern U.S. District Courts of New York
- Defense Research Institute
- Dallas Bar Association
- New York City Bar Association
- American Bar Association
- Association of Food and Drug Officials, Laws and Regulations Committee
- Case Western Reserve, J.D., 1985
- Berklee College, B.A., 1980
- Off-Label Promotion and the First Amendment: How a $25 Fine and 100 Hours of Community Service Sank the Titanic (December 11, 2012)
Contact Michael Walsh
901 Main Street, Suite 4400
Dallas, TX 75202
Phone: (214) 651-4459
Fax: (214) 659-4085
Be a part of the nation’s premier long term care defense litigation conference and ensure that you stay on the cutting edge of evolving defense strategies and emerging theories of liability
When: Wednesday, January 23 to Thursday, January 24, 2013
Where: The Conrad, Miami, FL, USA
For more information, and to register: click here
Industry related article from Ltlmagazine.com, by The Long-Term Living editors, posted on 11/07/12:
What President Obama’s re-election means for the future of long-term care
The re-election of President Obama and the retention of a Democratic majority in the Senate point toward a continuation of current policies and initiatives pertaining to the long-term care (LTC) industry. But control of the U.S. House of Representatives remains strongly with the Republican Party, adding the factor of party-based conflict among the legislature, much like after the presidential election in 2008.
However, the looming deadlines within the 2010 Affordable Care Act (ACA)—including sequestration and the tax increases of the so-named “fiscal cliff” should Congress fail to act by year’s end—mean lawmakers and the President still must work together on a host of challenges in the next two months.
No one can predict how Congress and the LTC industry players will choose to form their conjoined solutions, or how those solutions will affect skilled nursing facilities and other LTC operations, including the extent of the effects on Medicare. Some of the possible compromises already voiced include certain Medicare reductions and perhaps an increase in the eligibility age for beneficiaries from 65 to 67, among other proposals.
Yet, now that the Presidential election is over, many political entities no longer have reason to campaign heatedly against each other on national healthcare issues, leading to hopes of better bipartisan communication and cooperation down the road. “There is intense pressure in Washington to find a solution,” says Bob Gatty, founder and president of G-Net Strategic Communications, Sykesville, Md., and contributing writer to Long-Term Living. “The early tone of [post-election] comments from President Obama and House Speaker John Boehner indicates that there may be a possibility of compromise between the [Republican-controlled] House of Representatives and the White House.”
Now that the nation’s voters have had their say, it’s time to return to the hard work of working together on the issues troubling the U.S. healthcare system, says American Health Care Association President and CEO Mark Parkinson, in a statement following the elections. “While we know that the President and our newly elected Congress must find ways to reduce federal spending and fund a wide variety of programs, now is the time to take a hard look at meaningful reforms to solve the issues that face both the Medicare and Medicaid programs. Stable Medicare and Medicaid funding will help ensure America’s seniors continue to have access to high quality long term and post-acute care.”
Leading long-term care organizations also are ready to move beyond the election rhetoric and return to reform initiatives already underway. “I think our course is now known,” LeadingAge President and CEO Larry Minnix told Long-Term Living. “We’re now beyond political posturing. We’ve got to get into actual implementation of [the ACA]. There are models that people are working on that will work.”
AS THE ELECTION DUST SETTLES
The LTC industry has long complained that continuing reductions in Medicare are jeopardizing patient care and that increases in funding are needed to overcome the failure of Medicaid to adequately cover the cost of serving those patients. However, given the pressure to deal with the federal budget deficit, it is rather unlikely that such increases will be approved by Congress.
Post-election frustrations abound among some in the LTC industry, a care sector that gets a huge amount of its reimbursements from Medicare. William V. Day, president of St. Barnabas Health System in Gibsonia, Pa., says he’s worried that as many as 50 percent of hospitals and nursing homes will close because of Medicare cuts. “Both parties project that $716 billion will be cut from Medicare to use in Obamacare,” he told Long-Term Living. “I doubt that older Americans realize the impact Obamacare will have on their lives and their health in the future.”
Day views the re-election of President Obama as a great victory for those in favor of increased government control of healthcare: “Regulations and inspections in the healthcare delivery system will be dramatic over the next four years,” he predicts.
The LTC space should prepare for more regulatory activities, agrees Caroline J. Berdzik, Esq., partner, Goldberg Segalla LLP. “We will continue to see more rule-making from the Department of Labor, OSHA and EEOC that will negatively impact nursing homes and result in increased labor costs and additional employment litigation defense costs,” she says.
Berdzik also suggests that “a flurry of regulations under the ACA will be issued to gear up for 2014, and operators will need to pay very close attention, as these regulations will impact areas such as compliance, increased transparency disclosures and background checks of employees. It is highly unlikely that ACA will be repealed now, so operators will have to strategically prepare for these changes and also evaluate, if they have not done so already, how this will affect health insurance offerings to their employees. You may have employers looking to significantly reduce hours of employees to avoid increased health insurance costs. However, any proposed action will need to be analyzed in conjunction with maintaining excellent quality and continuity of care.”
Other LTC industry leaders are cautiously optimistic about Congress’ ability to iron out the healthcare challenges, hoping that efforts can focus on improving quality of care. LeadingAge’s Minnix comments on the LTC industry shift toward quality outcomes: “You’ve heard ‘cash is king?’ Well , now ‘quality is queen,’ and the queen is the boss now,” he says. “So we’re going to work to help people define and measure, and to stand accountable for their quality, because that’s the only thing that will earn the public trust.”
Another key post-election issue is how Congress will choose to deal with the upcoming physician Medicare payment reductions, currently scheduled to take place on January 1. Although another temporary Congressional “doc fix” is possible, it would just add to the overall federal budgetary pressures that Congress is already facing, Gatty notes.
The American Medical Association remains committed to finding a different solution, one that is focused on rewarding physician leadership in the mission of quality outcomes within patient-centric healthcare delivery. “It is time to transition to a plan that will move Medicare away from this broken physician payment system and toward a Medicare program that rewards physicians for providing well-coordinated, efficient, high-quality patient care while reducing health care costs,” the AMA wrote in its response to the election results.
THE ROLE OF THE STATES
The U.S. Congress isn’t the only law-making body that has work to do under the ACA deadlines. Each state has until Nov. 16 to declare which of the three Health Insurance Exchange (HIX) models will be used within the state.
After the June 28 Supreme Court decision that allowed states to choose whether or not to participate in Medicaid expansion, six states—Florida, Georgia, Louisiana, Mississippi, South Carolina and Texas—had vowed not to participate in Medicare expansion. In yesterday’s Presidential election, five of those six states voted Republican, with Florida still undeclared as of this posting.
Yet, nearly all states have been attending policy meetings on forming state exchanges, says Nancy Taylor, JD, co-chair of the Health and FDA Business Practice at Greenberg Traurig, LLC, Washington, D.C. Among the three HIX models, she says, most states are planning state-federal partnership exchanges, while 10-15 states are considering purely state-certified exchanges. One or two states may opt for a federally-facilitated exchange model, where the state exchange will be operated by the federal government for an initial time period, she adds.
DOWN IN THE LTC TRENCHES
Meanwhile, LTC facilities are busy getting ready for 2013 and 2014, regardless of the election. While care coordinators deal with Meaningful Use compliance, therapy caps and Medicaid, LTC facility owners are grappling with their corporate decisions concerning the new employee benefits mandates within the ACA.
“There’s so much going on that it’s almost overwhelming,” Taylor says, although she clarifies that LTC facilities shouldn’t plan on any postponements to current deadlines. “Many nursing homes are pretty up to speed. But we need to get the employer issues stabilized for nursing homes so they have a pathway on how to comply with the law, and then they can deal with all their reimbursement issues. Over the next few months, we’ll see more guidances and regulations, so the long-term care community knows how to comply with the employer requirements.”
When it comes to reimbursements, LTC facilities will have to wait to see how the influx of new beneficiaries affects the fee schedules. “I think with an Obama presidency we can expect that the fee schedules will be revisited to try to neutralize the financial impact of the significantly larger number of people who will be receiving services,” says Eli Pick, president of Post Acute Innovations, Elmhurst, Ill. “[The adjustments] will either be way too low or the reductions won’t be anywhere near enough to account for the expansion of the population, and it’s usually the latter—underestimating the volume of people to be covered. So, the options most likely won’t be able to account for the increased number of people who will receive services.”
THE ROLE OF TECHNOLOGY
Championing the use of technology infrastructures within long-term care—including electronic medical records, ePrescribing and streamlined transitions of care—has long been touted as a pathway to reduced healthcare costs and better care quality. Many of the initiatives begun under the 2009 Health Information Technology for Economic and Clinical Health Act (HITECH) would have been viewed as in dire jeopardy for continued funding had President Obama not won the election, but healthcare technology thought leaders now hope the industry can finish the various initiatives already underway.
“Cuts to long-term and post-acute care providers and the lack of incentives to assist them in upgrading their technology make it difficult to achieve interconnectivity and interoperability in a healthcare system that is to have a person-centric ,electronic, longitudinal-care focus ,” says John Derr, RPh, co-founder of the Long-Term and Post-Acute Care Health Information Technology Collaborative (LTPACHIT) and health information technology strategy consultant to Golden Living. “We need to encourage pro-action, prevention of episodic incidents and higher quality clinical outcomes.”
LeadingAge’s Minnix agrees: “We know that the current approach of [LTC] service delivery is fragmented and isn’t holding its own weight financially,” he says. “So we’re going to be emphasizing integrated models of service in every community—things like housing with services, managed care approaches where our members work with hospitals and doctors and how technology can help with all that.”
THE ATMOSPHERE OF CHANGE
Industry leaders are calling for meaningful reforms to solve the Medicare and Medicaid issues and pledge to work with the President and Congress to find viable solutions. There’s no doubt that many more reform discussions will take place, especially among the new Congress that takes office in 2013, Gatty says.
Meanwhile, most LTC facilities are preparing for moving ahead into a new world of integrated care delivery with acute care, home care, assisted living, and beyond. “We will definitely see a lot of changes,” Tim Dressman, executive director, St. Leonard Franciscan Community, Centerville, Ohio, told Long-Term Living. “I just hope they [the federal entities] don’t cut funding so drastically that the person is taken out of the healing process and healthcare becomes nothing more than an assembly line.”
During the ongoing regulatory and legislative processes, it will be essential for all LTC industry players—from small facilities to large ones—to get involved, notes LeadingAge’s Minnix. “While Medicaid obviously needs to be changed, you can’t do it on the backs of vulnerable people,” he says. “We believe our members will do their part on innovation. A number have done things that show great promise for improving quality and reducing costs, but those things need time to incubate. We believe that over the next four years, we’ve got time to begin to see the fruits of those solutions.”
Bob Gatty, founder and president of G-Net Strategic Communications, Sykesville, Md., contributed to this report
When: Monday, October 29 to Tuesday, October 30, 2012
Where: The Carlton Hotel, New York, NY, USA
ACI’s Forum on International Labor & Employment Law has been specifically designed to provide both in-house and outside counsel for multinational corporations with everything that they need to know to handle the multitude of international labor and employment issues confronting them. Our unparalleled international speaker faculty will provide attendees with key insights for managing and overcoming the most difficult challenges and mastering the nuances inherent in international employment law.
We’ve polled the audience, and below are the 7 top issues that international labor and employment professionals are facing and which will be a focus of the conference:
- Reducing exposure to lawsuits arising from hiring and firing
- Drafting and enforcing cross-border restrictive covenants with confidence
- Protecting data and privacy, including cross-border investigations and employee social media activity
- Conducting successful reductions in force, mergers and acquisitions across borders
- Effectively managing expat assignments, including benefits and tax considerations
- Implementing global corporate social responsibility initiatives without increasing exposure to litigation
- Overcoming the hurdles associated with extraterritorial enforcement of U.S. discrimination and whistleblower laws
This year’s International Labor & Employment Law conference has been tailored to address the needs of in-house and outside employment counsel for multinational corporations. Plus, don’t miss out on an unparalleled international faculty from more than 20 cities world-wide and networking opportunities with in-house counsel from multinational corporations including:
FedEx Corporation, Halliburton, Northrop Grumman, McDonald’s, Toyota Tsusho America, Reed Elsevier, Goldman, Sachs & Co., BNP Paribas
Hill-Rom, ServiceMaster, Marsh & McLennan, Credit Suisse
…and many other companies in the audience as well!
Join us in New York on October 29-30 at the beautiful Carlton Hotel on Madison Avenue. When registering, don’t miss out on the in-depth pre and post-conference workshops.
|Pre-Conference Workshop • Sunday, October 28, 2012 • 3:00p.m. – 5:30p.m.|
|Employment Law Primer on the International Reach of Title VII, ADA, and ADEA|
|Post-Conference Workshop • Tuesday, October 30, 2012 • 2:45p.m. – 5:15p.m.|
|An In-Depth Look at the Hotbed of Continental Europe and the UK|
When: Monday, October 29 to Tuesday, October 30, 2012
Where: New York Marriott Downtown, New York, NY, USA
ERISA defense counsel are facing a growing number of claims from an increasingly sophisticated plaintiffs’ bar. It is essential that defense counsel are prepared for these new and emerging claims and fully up-to-date on which defense strategies are working and which are not.
This October, the country’s leading ERISA litigation attorneys, expert in-house counsel, and renowned federal judges from around the nation will congregate in New York for the 5th National Forum on ERISA Litigation – make sure that you do not miss out!
Registrations are far outpacing all previous iterations of this event and the October conference is on pace to be our largest yet. This is no doubt due in large part to our unparalleled speaker faculty combined with the mounting pressures on defense counsel from an uptick in ERISA claims.
If you haven’t already registered, here are 4 reasons why you must register today:
1. Hear firsthand from 20 renowned judges, representing courts located in 8 circuits
2. Benchmark and network with more than 25 in-house industry experts, from firms including:
Blue Cross/Blue Shield
Crawford & Co.
|Deere & Co.
Kraft Foods Group
|Procter & Gamble
W.R. Grace & Co.
3. Your clients and colleagues have already registered – you do not want to fall behind the curve!
4. Receive up-to-the minute strategic advice and critical insights on key ERISA topics, including:
- PPACA and its impact on ERISA administration and litigation
- Cigna v. Amara revisited: assess the repercussions of this landmark case and its progen
- ERISA fiduciary litigation: new and emerging theories of liability, their impact on defense strategies, minimizing exposure to fiduciary liability, and defending against a DOL investigatio
- Emerging trends in stock drop and ESOP litigation, the 404(c) safe harbor provisions, and new theories of liability relating to investment decisions in defined benefit plan
- 401(k) fee cases: current litigation trends, evolving defense strategies, reaction to Tussey v. ABB, Inc., and new DOL disclosure rule
- Benefits litigation: defeating the latest claims, overcoming evidentiary issues in ‘conflict’ situations, and mor
- Service providers: ensuring adequate communication with service providers and managing litigation that arises between plan sponsors and service provider
- Fiduciary liability insurance: ensuring adequate coverage and assessing its impact on settlement considerations
- Winning the procedural battle in ERISA litigation: new procedural developments and how to use them to your advantage or minimize their negative impact on your case