Category: Antitrust

New Antitrust Suit Takes Aim at NCAA Model

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The NCAA’s amateurism model is once again under fire — this time in an antitrust lawsuit filed by sports labor attorney Jeffrey Kessler. Kessler, on behalf of four named current men’s basketball and football players (Clemson football player Martin Jenkins, Rutgers basketball player Johnathan Moore, Texas El-Paso football player Kevin Perry, and University of California basketball player William Tyndall), alleges the NCAA and the five major conferences (the Atlantic Coast Conference, the Big 12 Conference, the Big Ten Conference, the Pac-12 Conference, and the Southeastern Conference; these conferences currently include 62 member institutions) have entered into “cartel agreements” that unlawfully cap the compensation paid to student-athletes.

The suit seeks to eliminate current NCAA and conference amateurism regulations and  create a market where institutions compete for the services of men’s basketball and football players in a less regulated way. This would be a major shift from the NCAA’s current amateur model to one similar to free agency in professional sports that would permit student-athletes to attend the highest bidding institution.

“We believe that the business has grown so big in Division I men’s basketball and in the football championship series system that we believe that judges, jurors, the public, the media and many in college sports themselves recognize that change has to come,” Kessler told The Wall Street Journal.

Currently, student-athletes are eligible only to receive tuition, room and board, and course-related books from the institutions they attend. The suit refers to these limitations as “an artificial and unlawful ceiling.”

The current restrictions on student-athlete compensation also are characterized in the suit as a “patently unlawful price-fixing and group boycott arrangement.” The suit alleges the NCAA and its member institutions “have lost their way far down the road of commercialism, signing multi-billion dollar contracts wholly disconnected from the interests of ‘student athletes,’ who are barred from receiving the benefits of competitive markets for their services even though their services generate these massive revenues.”

Valuing the current broadcast rights for the NCAA Tournament at $11 billion and the College Football Playoff at $5.64 billion, the suit alleges student-athletes are not sufficiently rewarded for the financial success of men’s basketball and football.

“The main objective is to strike down permanently the restrictions that prevent athletes in Division I basketball and the top tier of college football from being fairly compensated for the billions of dollars in revenues that they help generate,” Kessler told ESPN. “In no other business — and college sports is big business — would it ever be suggested that the people who are providing the essential services work for free. Only in big-time college sports is that line drawn.”

The suit questions why coaches, and not student-athletes, should benefit from the massive, and growing, revenues of college football and men’s basketball. It says that, “flush with cash and unable to compete for athletes on the basis of financial remuneration, colleges have directed their resources and competitive efforts to, among other things, the hiring of head coaches, instead of players.”

The suit seeks to permanently enjoin the alleged antitrust violations and to recover individual damages for the named plaintiffs.

Michael Ackerstein also contributed to this post.

Article by:

Gregg E. Clifton

Of:

Jackson Lewis P.C.

Call Waiting: Department of Justice (DOJ) to Maintain Scrutiny of Wireless Industry Consolidation

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The wireless industry has seen steady consolidation since the late 1980s.  Recently, in late 2013, reports began circulating about a potential merger between Sprint and T-Mobile, the nation’s third and fourth-largest wireless carriers, respectively.  Last week, however, in an interview with the Wall Street Journal, William Baer, the assistant attorney general for the antitrust division at the Department of Justice (DOJ), cautioned that it would be difficult for the Agency to approve a merger between any of the nation’s top four wireless providers.

T-Mobile’s CEO, John Legere, stated that a merger between his company and Sprint “would provide significant scale and capability.”  Baer, on the other hand, warned that “It’s going to be hard for someone to make a persuasive case that reducing four firms to three is actually going to improve competition for the benefit of American consumers,”  As a result, any future consolidation in the wireless industry is likely to face a huge hurdle in the form of DOJ’s careful scrutiny of any proposed transaction.

Much of the DOJ’s interest in the wireless industry stems from the Agency’s successful challenge of a proposed merger between T-Mobile and AT&T in 2011.  Since then, Baer believes consumers have benefitted from “much more favorable competitive conditions.”  In fact, T-Mobile gained 4.4 million customers in 2013, bringing optimism to the company’s financial outlook after years of losses.  In the final two quarters of 2013, T-Mobile’s growth bested that of both Sprint and AT&T.  The low-cost carrier attracted customers and shook up the competition by upending many of the terms consumers had come to expect from wireless carriers, as well as investing in network modernization and spectrum acquisition.  This flurry of activity has pushed the competition to respond with its own deals, resulting in “tangible consumer benefits of antitrust enforcement,” according to Baer.

The DOJ’s antitrust division has kept careful watch over the wireless industry the past few years. That scrutiny will remain, as the Agency persists to advocate that four wireless carriers are required for healthy market competition.  The cards are beginning to play out from the Agency’s decision, and as Baer stated, “competition today is driving enormous benefits in the direction of the American consumer.”

Article by:

Lisa A. Peterson

Of:

McDermott Will & Emery

Federal Court Rules That Patent Infringement Can Violate Antitrust Laws

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Patent infringement can be considered anticompetitive conduct under federal antitrust law, according to a recent ruling issued by the U.S. District Court for the Eastern District of Texas.

This ruling arose out of a dispute between Retractable Technologies, Inc. (Retractable) and Becton, Dickinson and Company (BD),1 in which Retractable alleges, among other claims, that BD’s infringement of Retractable’s patents foreclosed competition and maintained BD’s monopoly power in the hypodermic syringe market, thereby violating Section 2 of the Sherman Act.2

Retractable manufactures patented safety syringes and IV catheters, which protect against needlestick injuries by automatically retracting the needle after injection.  According to Retractable’s complaint, BD is the leading U.S. manufacturer of hypodermic syringes and holds a very large share of the relevant market.  Retractable claims that BD took steps to protect its dominant position after Retractable’s entry into the market, including by introducing an inferior line of safety syringes that infringe on Retractable’s patents.  Retractable contends that these actions, together with other exclusionary conduct including unlawful bundling and loyalty discounts, impeded the adoption of new and novel safety syringes, including those of smaller rivals such as Retractable, substantially lessening competition and maintaining BD’s dominance.  Retractable also alleges false advertising and other unfair competition claims.

To prove a violation of Section 2 of the Sherman Act, a plaintiff must demonstrate that the defendant (1) possesses monopoly power, and (2) acquired, enhanced, or maintained that power by exclusionary or anticompetitive conduct.3 In one of several motions to dismiss, BD asked the court to find that, as a matter of law, patent infringement can never be considered “exclusionary or anticompetitive conduct,” and therefore cannot be the basis of a Section 2 monopolization claim.  BD argued that no court has ever found patent infringement to be an “anticompetitive” act under Section 2 and that Retractable’s claim makes no economic sense, because patent infringement actually increases competition by making more products available to consumers.

On September 9, 2013, U.S. District Court Judge Leonard Davis adopted the recommendations of U.S. Magistrate Judge Roy S. Payne’s August 5 Report and Recommendation and issued an order denying BD’s motion.  Judge Davis agreed with Judge Payne that the only binding precedent offered by BD in support of its arguments held that patent infringement is not an injury recognized under the Sherman Act,4 but this has nothing to do with patent infringement as anticompetitive conduct.  Both judges noted the U.S. Supreme Court’s statement in U.S. v. American Tobacco Co. that the Sherman Act covers “every conceivable act which could possibly come within the spirit or purpose of the prohibitions of the law, without regard to the garb in which such acts were clothed.”5 Judge Payne further explained in his Report that while patent infringement often increases competition and benefits the end consumer despite harming a specific competitor, in this case Retractable alleges that the effect of BD’s patent infringement was to decrease competition by keeping BD’s inferior products on the market and preventing the sale of other, better quality safety syringes.

The complex interactions between intellectual property rights and the antitrust laws have received significant attention recently in various contexts, such as pay-for-delay settlements in pharmaceutical patent cases and abusive enforcement of standard essential patents.  The decision in this case adds an arrow to the quiver of companies with patented technology that are trying to compete in a market with a large and established player.  Companies with high market shares should take note that this ruling may expose them to additional antitrust risks, and should carefully consider whether any of their business practices would support a Section 2 monopolization claim against them.

1 Retractable Technologies, Inc., et al. v. Becton, Dickinson and Co., Case No. 2:08-CV-00016 (E.D. Tex.).

2 15 U.S.C. § 2.

3 United States v. Grinnell Corp., 384 U.S. 563 (1966).

4 A plaintiff must prove antitrust injury in order to recover damages.

5 221 U.S. 106, 181 (1911).

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Supreme Court Holds That Reverse Payment Patent Settlements Are Subject to Antitrust Scrutiny

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For over a decade, the antitrust enforcers at the Federal Trade Commission have challenged the type of patent settlement where a brand-name drug manufacturer pays a prospective generic manufacturer to settle patent challenges, and the generic manufacturer agrees not to bring its generic to market for a specified number of years. The lower federal courts have over the years rejected the challenges. However, on June 17, 2013, the Supreme Court addressed the issue in Federal Trade Commission v. Actavis, and in a 5-3 decision held that such settlements are subject to rule of reason antitrust scrutiny. However, beyond that conclusion, the Court left the questions of how to structure and resolve the rule of reason issue to the lower courts and future cases.

As Justice Breyer’s majority opinion summarized the issue and its holding:

Company A sues Company B for patent infringement. The two companies settle under terms that require (1) Company B, the claimed infringer, not to produce the patented product until the patent’s term expires, and (2) Company A, the patentee, to pay B many millions of dollars. Because the settlement requires the patentee to pay the alleged infringer, rather than the other way around, this kind of settlement agreement is often called a ‘reverse payment’ settlement agreement. And the basic question here is whether such an agreement can sometimes unreasonably diminish competition in violation of the antitrust laws.

In this case, the Eleventh Circuit dismissed a Federal Trade Commission (FTC) complaint claiming that a particular reverse payment settlement agreement violated the antitrust laws. In doing so, the Circuit stated that a reverse payment settlement agreement generally is ‘immune from antitrust attack so long as its anticompetitive effects fall within the scope of the exclusionary potential of the patent.’ And since the alleged infringer’s promise not to enter the patentee’s market expired before the patent’s term ended, the Circuit found the agreement legal and dismissed the FTC complaint. In our view, however, reverse payment settlement such as the agreement alleged in the complaint before us can sometimes violate the antitrust laws. We consequently hold that the Eleventh Circuit should have allowed the FTC’s lawsuit to proceed. (Citations omitted.)

The Court reasoned that even if the settlement agreement’s anticompetitive effects fall within the scope of the exclusionary potential of the patent, that fact or characterization cannot immunize the agreement from antitrust attack. Justice Breyer found that “it would be incongruous to determine antitrust legality by measuring the settlement’s anticompetitive effects solely against patent law policy, rather than by measuring them against procompetitive antitrust policies as well” and that “patent and antitrust policies are both relevant in determining the ‘scope of the patent monopoly’ — and consequently antitrust law immunity — that is conferred by a patent.”

Justice Breyer acknowledged that a conclusion of antitrust immunity would find some degree of support in a general legal policy favoring the settlement of dispute. However, he concludes that this factor should not “determine the result here” but is offset by five sets of considerations:

First, the specific restraint at issue has the potential for genuine adverse effects on competition. To the Court, even though the settlement permitted the challenger to enter the market before the patent expired, the settlement also entrenched the patent holder for the period the challenger agrees to stay out of the market in exchange for a payment, delaying the potential for lower prices. As the Court put it, “The patentee and the challenger gain; the consumer loses.”

Second, these anticompetitive consequences will at least sometimes prove unjustified. To be sure, in some circumstances, the reverse payment may amount to no more than a rough approximation of the litigation expenses saved through the settlement, or compensation for other services the generic has promised to perform. In such circumstances, a patentee is not using its monopoly profits to avoid the risk of patent invalidation or a finding of no infringement. In the antitrust proceeding, the Court concludes, the patentee should have to show that such legitimate justifications are present.

Third, where a reverse payment threatens to inflict unjustified anticompetitive harm, the patentee likely possesses the power to bring that harm about.

Fourth, the majority believes that an antitrust action would be administratively feasible. The majority did not believe that it would be necessary to litigate patent validity to normally answer the antitrust question — an unexplained large reverse payment itself would normally suggest that the patentee has serious doubts about the patent’s survival. “In a word, the size of the unexplained reverse payment can provide a workable surrogate for a patent’s weakness, all without forcing a court to conduct a detailed exploration of the validity of the patent itself.”

Fifth, the fact that a large, unjustified reverse payment risks antitrust liability does not prevent litigating parties from settling in some other way, without the potential to maintain and share patent-generated monopoly profits.

The FTC advocated that the Court adopt a rule that reverse payments are “presumptively unlawful” and that they be analyzed under a “quick look” approach, requiring the patentee to show empirical evidence of procompetitive effects. The Court rejected this position, instead instructing the issue undergo a full rule of reason analysis. In doing so, it left to the lower court the structuring of this and other rule of reason antitrust litigation on the issue.

In practical terms, the decision leaves many difficult issues to be grappled with, and the majority’s apparent confidence that the antitrust question is answerable without getting into the patent issues themselves may prove more aspirational than practical. Chief Justice Roberts’s dissent exposes one flaw:

The majority seems to think that even if the patent is valid, a patent holder violates the antitrust laws merely because the settlement took away some chance that his patent would be declared invalid by a court. …This is flawed for several reasons.

First, a patent is either valid or invalid. The parties of course don’t know the answer with certainty at the outset of litigation; hence the litigation. But the same is true of any hard legal question that is yet to be adjudicated. Just because people don’t know the answer doesn’t mean that there is no answer until a court declares one. Yet the majority would impose antitrust liability based on the parties’ subjective uncertainty about that legal conclusion.

The Court does so on the assumption that offering a ‘large’ sum is reliable evidence that the patent holder has serious doubts about the patent. Not true. A patent holder may be 95% sure about the validity of its patent, but particularly risk averse or litigation averse, and willing to pay a good deal of money to rid itself of the 5% chance of a finding of invalidity. What is actually motivating a patent holder is apparently a question district courts will have to resolve on a case-by-case basis. The task of trying to discern whether a patent holder is motivated by uncertainty about its patent, or other legitimate factors like risk aversion, will be made all the more difficult by the fact that much of the evidence about the party’s motivation may be embedded in legal advice from its attorney, which would presumably be shielded from discovery.

The FTC has hailed the decision:

The Supreme Court’s decision is a significant victory for American consumers, American taxpayers, and free markets. The Court has made it clear that [reverse payment] agreements between brand and generic drug companies are subject to antitrust scrutiny, and it has rejected the attempt by branded and generic companies to effectively immunize these agreements from the antitrust laws. With this finding, the Court has taken a big step toward addressing a problem that has cost Americans $3.5 billion a year in higher drug prices.

The FTC’s “victory lap” is probably premature. To be sure, we now know that blanket antitrust immunity for reverse payment settlements does not exist. However, everything else remains up for grabs. Until there are additional decisions grappling with the actual issue of liability issued, and reviewed, the extent and circumstances of antitrust liability is unclear. The risk-averse patent holder to whom Justice Roberts alluded might well be motivated to avoid utilizing reverse payments in structuring settlements in the future. In addition, the Competition Office of the European Union actively continues to examine reverse payments settlements, and there have been renewed calls for federal legislation banning such settlements.

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FTC v. Actavis, Inc.: Supreme Court Rules That Reverse Patent Settlements May Violate Antitrust Laws

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On April 29, 2013, the Supreme Court declined to review a decision that had created uncertainty as to when a manufacturer’s customer loyalty program may violate antitrust laws. Most circuits considering the issue have found that companies can use loyalty programs or long-term agreements, as long as the rebates do not price the product below cost. The Third Circuit, however, found that a manufacturer’s customer loyalty program amounted to an unlawful “de facto exclusive dealing contract,” despite the above-cost price of the product. The Supreme Court’s decision to allow the Third Circuit opinion to stand raises many questions as to when manufacturers may use incentive programs and which legal standard will be used to analyze these agreements. Regardless of where a company is located, if the company’s products are sold within the Third Circuit (Pennsylvania, New Jersey, Delaware and the U.S. Virgin Islands), then that company may be impacted by this decision.

The case of ZF Meritor, LLC v. Eaton Corp., 696 F.3d 254 (3d Cir. 2012) cert. denied, ___ U.S. __, 2013 WL 673880 (U.S. Apr. 29, 2013), involved two manufacturers of heavy-duty truck transmissions. The defendant, a leading supplier of these transmissions in North America, signed long-term agreements with its customers. Those agreements provided incentives to its customers, offering rebates to those who purchased a specified percentage of their parts from the defendant manufacturer. The plaintiff, a competitor in the heavy-duty transmission market, brought suit, claiming that the defendant’s long-term agreements constituted illegal exclusive dealing contracts. After trial, a jury found that the agreements stifled competition and violated antitrust laws. The defendant sought to overturn the jury verdict, arguing that its agreements were lawful, because it priced its transmissions above cost. The U.S. District Court for the District of Delaware upheld the jury verdict, however, finding that there was sufficient evidence to conclude that defendant’s conduct unlawfully foreclosed competition. Defendant appealed to the Third Circuit.

On appeal, the defendant urged the Third Circuit to follow the First, Second, Sixth, Eighth, and Ninth Circuits, which apply a “price-cost test” when analyzing long-term agreements which offer above-cost rebates. Under the “price-cost test,” a company is not engaging in anticompetitive conduct if it prices its products above cost. Instead, the Third Circuit applied the “rule of reason” test and found that the customer loyalty program constituted a “de facto exclusive dealing arrangement.” Under the rule of reason, “exclusive dealing arrangements can exclude equally efficient (or potentially equally efficient) rivals, and thereby harm competition, irrespective of below-cost pricing.” Therefore, the Third Circuit upheld the District Court jury verdict, stating that defendant’s  “conduct unlawfully foreclosed a substantial share of the HD transmission market, which would otherwise have been available for rivals.” The defendant then appealed to the Supreme Court, which declined to hear the case, allowing the Third Circuit’s decision to stand.

In refusing to consider the Third Circuit’s decision, the Supreme Court has failed to resolve a conflict in the circuits as to how long-term agreements containing rebates or other incentives will be analyzed by the courts. This conflict removes the predictability of a single “price-cost” standard applied across all circuits and creates uncertainty for manufacturers who wish to offer loyalty programs to their customers. In the future, manufacturers hoping to offer such programs may want to ensure that their agreements can withstand both the price-cost test and rule of reason analysis.

Patent Exhaustion Rejected: Patented Seed Purchaser Has No Right to Make Copies

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The Supreme Court in Bowman v. Monsanto Co. ruled unanimously that a farmer’s replanting of harvested seeds constituted making new infringing articles.  While the case is important for agricultural industries, the Supreme Court cautioned that its decision is limited to the facts of the Bowman case and is not a pronouncement regarding all self-replicating products.

In a narrow ruling that reaffirms the scope of patent protection over seeds, and possibly over other self-replicating technologies, the Supreme Court of the United States held that a purchaser of patented seeds may not reproduce them through planting and harvesting without the patent holder’s permission.  Bowman v. Monsanto Co., Case No. 11-796 (Supreme Court May 13, 2013).

In this case, Monsanto had asserted two of its patents that cover genetically modified soybean seeds that are resistant to herbicide (Roundup Ready® seeds).  Monsanto broadly licenses its Roundup Ready® soybean seeds under agreements that specify that the farmer “may not save any of the harvested seeds for replanting, nor may he supply them to anyone else for that purpose.”  Vernon Hugh Bowman is a farmer who purchased soybean seeds from a grain elevator.  Bowman replanted Roundup Ready® seeds in multiple years without Monsanto’s permission.  The district court granted summary judgment of patent infringement against Bowman, and the U.S. Court of Appeals for the Federal Circuit affirmed.  Bowman appealed to the Supreme Court, which granted certiorari.

On appeal, Bowman heavily relied on the “patent exhaustion” doctrine, which provides that the authorized sale of a patented article gives the purchaser or any subsequent owner a right to use or resell that article.  Bowman argued that the authorized sale of the Roundup Ready® seeds exhausted Monsanto’s patent rights in the seeds, because “right to use” in the context of seeds includes planting the seeds and reproducing new seeds.

Patent Implications

Speaking through Justice Kagan, the Supreme Court unanimously affirmed the Federal Circuit’s decision that Bowman’s activities amounted to making new infringing articles.  The Supreme Court held that “the exhaustion doctrine does not enable Bowman to make additional patented soybeans without Monsanto’s permission.”  Specifically, the exhaustion doctrine restricts a patentee’s rights only as to the particular article sold, but “leaves untouched the patentee’s ability to prevent a buyer from making new copies of the patented item.”  The Supreme Court noted that if Bowman’s replanting activities were exempted under the exhaustion doctrine, Monsanto’s patent would provide scant benefit.  After Monsanto sold its first seed, other seed companies could produce the patented seed to compete with Monsanto, and farmers would need to buy seed only once.

In rebuffing Bowman’s argument that he was using the seed he purchased in the manner it was intended to be used, and that therefore exhaustion should apply, the Supreme Court explained that its ruling would not prevent farmers from making appropriate use of the seed they purchase—i.e., to grow a crop of soybeans consistent with the license to do so granted by Monsanto.  However, as the Supreme Court explained “[A]pplying our usual rule in this context . . . will allow farmers to benefit from Roundup Ready, even as it rewards Monsanto for its innovation.”

Tying the Supreme Court’s decision in this case narrowly to seed (as opposed to other self-replicating technologies), Justice Kagan noted that the decision is consistent with the Supreme Court’s 2001 decision in J.E.M. Ag. Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., in which the Supreme Court concluded that seeds (as well as plants) may simultaneously be subject to patent protection and to the narrower protection available under the Plant Variety Protection Act (PVPA).  PVPA protection permits farmers who legally purchase protected seed to save harvested seed for replanting.  However, reconciling the two forms of protection, Justice Kagan explained, “[I]f a sale [i.e., of a patented seed] cut off the right to control a patented seed’s progeny, then (contrary to J.E.M.) the patentee could not prevent the buyer from saving harvested seed.”

Other Self-Replicating Technologies

The Supreme Court’s decision in Monsanto is, of course, important for agricultural industries.  If extended to other self-replicating technologies, it may also prove important for biotechnology companies and others  that rely on self-replicating technologies, including, for example, companies that own patent rights over viral strains, cell lines, and self-replicating DNA or RNA molecules.  If subsequent cases extend the “no exhaustion” holding of Monsanto to these technologies, patent protection would extend to copies made from the “first generation” product that is obtained through an authorized sale.

However, the Supreme Court cautioned that its decision is limited to “the situation before us” and is not an overarching pronouncement regarding all self-replicating products.  The Supreme Court suggested that its “no exhaustion” ruling might not apply where an article’s self-replication “occur[s] outside the purchaser’s control” or is “a necessary but incidental step in using the item for another purpose,” citing computer software (and a provision of the Copyright Act) as a possible example.  As explained by Justice Kagan, “We need not address here whether or how the doctrine of patent exhaustion would apply in such circumstances.”  In this regard, the Supreme Court particularly noted that “Bowman was not a passive observer of his soybeans’ multiplication.”  Instead, Bowman “controlled the reproduction” of seeds by repeated planting and harvesting.  Thus, the Supreme Court suggests that a purchaser’s “control” over the reproduction process likely will be a key inquiry in considering the patent exhaustion doctrine as it relates to other self-replicating technologies.  Of course, it remains to be seen how broadly lower courts will interpret the Supreme Court’s ruling.

Antitrust Implications

By holding that Monsanto’s restriction on replanting was within the scope of its patent rights, the Supreme Court effectively immunized that restriction from antitrust scrutiny.  Other court decisions have called into question other license restrictions viewed as going beyond the scope of patent protection as being potentially susceptible to an antitrust or patent misuse challenge.

The Supreme Court highlighted its application of the exhaustion doctrine last addressed in Quanta, which held that “the initial authorized sale of a patented item terminates all patent rights in that article.”  This boundary line conventionally demarcated the end of a patent’s protection and the beginning of a potential antitrust minefield.  Some commentators may interpret the Monsanto decision to push that line further out.  Importantly, however, the Supreme Court deemed the seeds at issue to be a “new product.”  So construed, Monsanto’s restriction on replanting did not affect the product’s use, as in Quanta and Univis Lens, but rather came within the well-settled principle that “the exhaustion doctrine does not extend to the right to ‘make’ a new product.”

The Supreme Court not only was doctrinally conservative in its Monsanto decision, it was also careful to explain that its holding is a narrow one.  Monsanto never exhausted its patent rights in the “new” seeds; indeed, it never truly “sold” them.  Rather, Bowman created new seed from seeds that Monsanto had sold.  The decision therefore may not portend a more general inclination to construe the scope of patent protection more broadly.  In fact, the Supreme Court went so far as to clarify that it could reach a different outcome were it presented with a different technology.

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3rd Annual International Trade Compliance Conference

The National Law Review is pleased to bring you information about the upcoming Marcus Evans conference – 3rd Annual International Trade Compliance Conference:

3rd Annual International Trade Compliance - April 24-26 2013

 Navigating the Latest Changes in Trade Regulations and Global Controls for Improved Compliance

24-26 Apr 2013
venue to be confirmed – Chicago, IL, United States of America

Building from the success of our 2012 conference, the marcus evans 3rd Annual International Trade Compliance Conference will bring together senior executives looking to improve processes with evolving global markets, trade agreements, technology requirements and compliance. Additionally, this conference will provide attendees with the latest updates in international trade regulations, as well as insights and tools for strengthening internal operations in order to remain compliant with critical requirements on a day-to-day basis.

The 3rd Annual International Trade Compliance Conference features two distinct tracks; allowing attendees to fully customize their agenda.

Track one focuses specifically on advanced import & customs topics, such as identifying the latest changes to the ISA program, discovering advancements in supply chain programs and applying recent FDA regulation updates to your business plan.

Track two is entirely centered on export controls. Featured topics include evaluating the recent updates to the ECR, understanding requirements for OFAC compliance and dissecting US and global technology regulations for secure transfers.

Delegates are able to mix and match sessions from both tracks to create a complete conference experience that covers every area of interest.

Attending this conference will enable you to:

1.)   Identify the latest regulatory changes within emerging markets for seamless trade operations

2.)   Navigate Free Trade Agreements to increase efficiency and decrease corporate costs

3.)   Institute a successful global trade compliance program to improve company procedures

4.)   Conquer import and export classification for more effective business practices

5.)   Tackle the latest regulations and requirements for technology transfers and determine various tactics for remaining compliant

Industry leaders attending this conference will also benefit from a dynamic presentation format consisting of workshops, panel-discussions, and industry-specific case studies that provide accurate, real-world knowledge. Attendees will experience highly interactive conference sessions, 10-15 minutes of Q&A time after each presentation, 4+ hours of networking, and exclusive online access to materials post-event.

Who Should Attend
marcus evans invites Heads, Vice Presidents, In-House Counsel, and government agencies with responsibilities in the following areas:

-Global/International Trade Compliance
-Import/Export Trade Compliance
-Global Customs Compliance
-Import/Export Operations
-Export Controls

Supreme Court Hears Oral Argument in “Pay-for-Delay” Patent Settlement Antitrust Case

The National Law Review recently published an article, Supreme Court Hears Oral Argument in “Pay-for-Delay” Patent Settlement Antitrust Case, written by Jeffrey W. Brennan and Glenn Engelmann with McDermott Will & Emery:

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On March 25, 2013, the Supreme Court of the United States heard argument on the issue of pharmaceutical patent settlement agreements between branded and generic drug companies that contain so-called “pay-for-delay” or “reverse payment” provisions. Federal Trade Commission v. Actavis, Inc., involves the Federal Trade Commission’s (FTC’s) appeal of the U.S. Court of Appeals for the 11th Circuit’s order affirming dismissal of an FTC charge that such an agreement was an unfair method of competition in violation of Section 5 of the Federal Trade Commission Act.  Proof that an agreement between competitors is anticompetitive under Section 5 (which only the FTC may enforce) and under Section 1 of the Sherman Act (for which there is a private right of action) is essentially the same.  The Supreme Court’s ruling in FTC v. Actavis will almost certainly have major implications for the viability of FTC and private suits alleging that pay-for-delay settlements are anticompetitive, and for the level of antitrust risk facing companies that enter into such settlements.

Pay-for-delay challenges arise from settlements of patent infringement suits by branded drug patent holders against generic drug applicants under the Hatch-Waxman framework.  Two provisions must be present for the theory to apply: a restriction on generic entry until a future date (even if the entry precedes patent expiration), and payment of money or other value by the brand to the generic firm.  The payment typically is part of an ancillary agreement, such as a supply or co-promotion arrangement or IP license (coined a reverse payment because the plaintiff pays the defendant to settle).  The FTC argues that this paradigm delays competition because it likely induces the generic to settle for later entry, or would have under exclusivity provisions if it won the lawsuit.  The FTC finds the agreements presumptively unlawful and would put the burden on defendants to prove otherwise.  Defendants counter that the patent conveys a right to exclude and that these settlements promote and accelerate competition, because they enable generic entry prior to patent expiration.  Defendants assert that the burden should remain with the plaintiff to prove an anticompetitive effect.

The facts alleged in the FTC complaint squarely fit this paradigm.  The settlement occurred in 2006.  Solvay marketed branded drug Androgel.  A formulation patent claiming Androgel expires in 2020.  Generic drug firm Watson (now Actavis) had applied to the U.S. Food and Drug Administration for approval to launch a generic version of Androgel and certified that the generic product did not infringe Solvay’s patent and that the patent was invalid.  Solvay sued Watson and another firm for patent infringement, then settled.  The parties agreed that Watson would not launch its generic version of Androgel until 2015—five years prior to patent expiration—and that Watson would promote Androgel to a key customer source, urologists, and be compensated by Solvay for those services.  The agreement thus contains both components of an FTC pay-for-delay paradigm: a time-restriction on generic entry and a reverse payment.

The 11th Circuit followed its own precedent in rejecting the FTC case under the “scope-of-the-patent” test.  (The Second and Federal Circuits apply the same test.)  Under that analysis, if the patent was not obtained by fraud, and the infringement suit is not a sham (i.e., objectively baseless), then a settlement does not violate the antitrust laws if its terms do not expand the exclusionary scope of the patent, such as by prohibiting generic entry even after the patent expires.  Since the Solvay-Watson settlement provided for generic entry five years before patent expiration and did not otherwise allegedly fail the foregoing tests, the 11th Circuit affirmed dismissal of the FTC complaint.  The Supreme Court likely accepted the case because of a circuit split on this issue.  In 2012, in In re K-Dur Antitrust Litigation, in which the FTC was not a party, the Third Circuit reversed a district court and applied a legal analysis that rejects the scope-of-the-patent test and essentially adopts the FTC approach.

In the oral argument, the Justices directed a number of pointed questions and comments to each side.  As noted, the government would put the burden on defendants to show that their agreement is not anticompetitive, arguing that “agreements of this sort should be treated as presumptively unlawful, with the presumption able to be rebutted in various ways” that do not include an assessment of the patent’s validity or of the strength of the infringement claim.  Members of the Supreme Court expressed skepticism about that rule.  Justice Kennedy responded, “[t]hat’s my concern, is your test is the same for a very weak patent as a very strong patent.  That doesn’t make a lot of sense.”  Justice Scalia said that to not evaluate the strength of the patent in assessing competitive effects is to leave out “the elephant in the room.”  Justice Breyer remarked that the government proposes “a whole set of complex per se burden of proof rules that I have never seen in other antitrust cases,” adding, “I’m worried about creating some kind of administrative monster.”

Justices also had pointed comments for the companies’ counsel, particularly on whether it is appropriate to find that the patent has an absolute right to exclude even though it was being tested in court.  The companies’ counsel argued that “the patent gives the patentholder the legal right to exclude” and that unless the patent is legally unenforceable, the patentholder is “entitled to monopoly profits for the whole duration of the patent.”  Justice Sotomayor said “there is no presumption of infringement” by the generic product, “[s]o what you’re arguing is that in fact a settlement of an infringement action is now creating the presumption.”  She added, “I don’t know why we would be required to accept that there has or would be infringement by the product that has voluntarily decided not to pursue its rights.”  Justice Kagan remarked that “[i]t’s clear what’s going on here is that [the brand and generic firms are] splitting monopoly profits and the person who’s going to be injured are all the consumers out there,” and that under the companies’ proposed rule, the brand and generic firm will have the incentive “in every single case . . . to split monopoly profits in this way to the detriment of all consumers.”

The Supreme Court’s term concludes in June 2013, by which time a decision is expected.

© 2013 McDermott Will & Emery

3rd Annual International Trade Compliance Conference

The National Law Review is pleased to bring you information about the upcoming Marcus Evans conference – 3rd Annual International Trade Compliance Conference:

3rd Annual International Trade Compliance - April 24-26 2013

 Navigating the Latest Changes in Trade Regulations and Global Controls for Improved Compliance

24-26 Apr 2013
venue to be confirmed – Chicago, IL, United States of America

Building from the success of our 2012 conference, the marcus evans 3rd Annual International Trade Compliance Conference will bring together senior executives looking to improve processes with evolving global markets, trade agreements, technology requirements and compliance. Additionally, this conference will provide attendees with the latest updates in international trade regulations, as well as insights and tools for strengthening internal operations in order to remain compliant with critical requirements on a day-to-day basis.

The 3rd Annual International Trade Compliance Conference features two distinct tracks; allowing attendees to fully customize their agenda.

Track one focuses specifically on advanced import & customs topics, such as identifying the latest changes to the ISA program, discovering advancements in supply chain programs and applying recent FDA regulation updates to your business plan.

Track two is entirely centered on export controls. Featured topics include evaluating the recent updates to the ECR, understanding requirements for OFAC compliance and dissecting US and global technology regulations for secure transfers.

Delegates are able to mix and match sessions from both tracks to create a complete conference experience that covers every area of interest.

Attending this conference will enable you to:

1.)   Identify the latest regulatory changes within emerging markets for seamless trade operations

2.)   Navigate Free Trade Agreements to increase efficiency and decrease corporate costs

3.)   Institute a successful global trade compliance program to improve company procedures

4.)   Conquer import and export classification for more effective business practices

5.)   Tackle the latest regulations and requirements for technology transfers and determine various tactics for remaining compliant

Industry leaders attending this conference will also benefit from a dynamic presentation format consisting of workshops, panel-discussions, and industry-specific case studies that provide accurate, real-world knowledge. Attendees will experience highly interactive conference sessions, 10-15 minutes of Q&A time after each presentation, 4+ hours of networking, and exclusive online access to materials post-event.

Who Should Attend
marcus evans invites Heads, Vice Presidents, In-House Counsel, and government agencies with responsibilities in the following areas:

-Global/International Trade Compliance
-Import/Export Trade Compliance
-Global Customs Compliance
-Import/Export Operations
-Export Controls

Supreme Court Narrows ‘State Action’ Immunity From Antitrust Laws

GT Law

The U.S. Supreme Court has referred to the federal antitrust laws as “a charter of freedom [having] a generality and adaptability comparable to that found to be desirable in constitutional provisions.” The antitrust laws are generally broadly worded, and they have been subject to various interpretations and reinterpretations over the past century. Certain types of anti-competitive activity, such as horizontal price fixing, have been deemed so obviously harmful to the marketplace as to be declared per se illegal. Others are judged by the so-called “rule of reason” analysis, in which courts weigh the effect on a defined market of the alleged anti-competitive activity.

Click the View Media link to read the full article.