FDA Lawyers Blog

The fight over whether versions of the emergency contraceptives Plan B and Plan B One-Step (collectively "Plan B") should be available without a prescription to all women continued yesterday. Lawyers for FDA appeared before Judge Edward Korman of the Eastern District of New York urging him to stay his April 4 Order requiring the Agency to lift age restrictions on access to emergency contraceptives by May 10. FDA has appealed that ruling to the Second Circuit. The Agency has yet to implement the court's directive, but in late April it approved a supplemental new drug application ("sNDA") that lowers the age at which women can obtain these drugs without a prescription from 17 to 15. Judge Korman expressed skepticism as to the timing of the approval and criticized the Agency for not following his order. A ruling on the stay is expected by the end of this week.

FDA's actions have received mixed reviews. Last week, President Barack Obama reiterated his support of FDA's and the Department of Health and Human Services' ("DHHS's") determination that the age-restriction should be fifteen. He said that he was "very comfortable with the decisions they've made." Others have been more critical. Nancy Northup, President and CEO of the Center for Reproductive Rights, speaking after the Department of Justice's appeal to the Second Circuit said, "We are deeply disappointed that just days after President Obama proclaimed his commitment to women's reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions."

Written by Scot B. Pittman

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The approval of Plan B has a long history. Originally approved in 1999 for prescription-only use, Plan B became the United States' first emergency contraceptive. In February 2001, sixty-six organizations filed a Citizen Petition with FDA urging the Agency to switch Plan B, as well as any other emergency contraceptives, from a prescription-only drug to an over-the-counter ("OTC") drug and remove all age and point-of-sale restrictions. Despite repeated claims that it would address the outstanding petition, the Agency waited over five years to rule--denying the Petition in June 2006. FDA claimed that the petitioners had failed to provide sufficient data or information to meet the statutory and regulatory requirements of an OTC switch to any age group.

Last week, the U.S. Patent and Trademark Office ("USPTO") instituted its first inter partes review of a design patent, U.S. Patent No. D617,465 ("the '465 Patent") assigned to Luv N' Care, Ltd. Petitioners, Munchkin, Inc. and Toys "R" Us, Inc., successfully persuaded the Patent Trial and Appeal Board that "there is a reasonable likelihood that Petitioners would prevail with respect to the sole claim of the '465 Patent."

The claim of the '465 Patent recites "the ornamental design for a drinking cup, as shown and described." The '465 Patent includes five figures of a drinking cup having a vessel, collar, and spout. The Petitioners alleged that the claim of the '465 Patent was obvious over U.S. Published Patent Application No. 2007/0221604 published September 27, 2007 ("Hakim '604") and, separately, obvious over U.S. Patent No. 6,994,225 issued February 7, 2006 ("Hakim '225"). The Petitioners also presented numerous combinations of references to assert that the claim of the '465 Patent was obvious. These additional obviousness arguments were grouped into nine categories according to the primary reference being asserted.

Written by Shelly Fujikawa. Ph.D

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As an initial matter, the Board addressed the effective filing date of the claim of the '465 Patent since several asserted references were intervening prior art, in particular Hakim '604 and Hakim '225. The '465 Patent issued from U.S. Application Serial No. 29/292,909, which was filed on October 31, 2007, as a continuation of U.S. Application Serial No. 10/536,106 ("the '106 Application"), which is the national stage of PCT Patent Application PCT/US03/24400 filed August 5, 2003. The Board concluded that the claims were not entitled to the benefit of the filing date of the '106 Application, because the '106 Application did not have sufficient disclosure to demonstrate that the inventor possessed the claimed subject matter at the time of filing the '106 Application. In particular, the drawings of the '106 Application do not show the same design as the drawing of the '465 Patent.

On April 15, the U.S. Supreme Court heard oral arguments in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. et al., the famous case concerning the patent-eligibility of human gene patents. At issue is the validity of Myriad's patents on the human genes, BRCA1 and BRCA2, but ruling would surely cover the patent eligibility of all animal and plant genes and impact various biotechnology industries. Additional details may be found in previous blogs, for instance here and here.

The Justices appeared skeptical of Myriad's argument that isolated DNA is patent-eligible subject matter. Isolated DNA is DNA that is cut from a chromosome, resulting in an "isolated" piece of DNA that has the same nucleotide sequence as the naturally-occurring genomic DNA.

Written by Dan Constantinescu, Ph.D.

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The Justices compared Myriad's isolated DNA to the discovery of plants with medicinal properties. Justice Breyer commented that it was long-standing patent law that while particular applications of such a plant can be patented, the plant cannot be. If someone discovers a medicinal plant "he gets a patent on the process, on the use of the thing, but not the thing itself." Justice Sotomayor expressed her understanding that to obtain a patent "you had to take something and add to what nature does" and wondered, "how do you add to nature when all you are doing is copying its sequence?"

Over the past months, there has been a lot of speculation (see recent blogs here , here, and here) whether the White House's proposed budget would cause a sequester situation for FDA, resulting in potential layoffs or program cuts, in an era of new user fees for generic drugs and biosimilar biological products. While initial reports and temporary budget fixes (called continuing resolutions) appeared to keep FDA's user fees intact and available for use, FDA's Commissioner, Margaret A. Hamburg, M.D., recently reported to members of a biotechnology trade association, the Massachusetts Biotechnology Council ("MassBio"), that it was not clear what would happen with user fees in the new federal budget.

Released on April 10, the White House's proposed fiscal year 2014 budget is a mixed bag that has been called a "political document rather than a serious piece of legislation" with a "series of bargaining positions" that "would bleed pharma." On the one hand, the plan would appear to confirm that FDA's user fees would not be sequestered, given that it supported the $4.7 billion in total program budget requested by FDA, which included user fees that would help fund over 90 percent of the requested increases. On the other hand, the budget includes a myriad of proposals that would change the way the government pays for medical care and products. For example, Medicare (senior citizens' drug coverage) Part D manufacturer discounts for branded drugs would be increased from 50% to 75% in 2015 (rather than 2020) and low-income individuals would be pushed more to generic drugs by increasing certain copayments for branded drugs and lowering certain copayments for generic drugs.

Written by Brian J. Malkin

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Many of the more controversial proposals were nestled in a document called "Reducing the Deficit in a Smart and Balanced Way". Here, the White House proposes, among other things, several items to purportedly lower drug costs, including: 1) authorizing the Federal Trade Commission to stop companies from entering into certain "pay-for-delay" agreements (see below) and 2) beginning in 2014, to reduce biologic product exclusivity from 12 years to 7 years and prohibit additional periods of exclusivity for minor changes to product formulations. These two items could open up some unanticipated debate regarding the White House's budget.

On March 27, FLH attorneys Brian Malkin and Christopher Gosselin attended the International Trade Commission ("ITC") Trial Lawyer's Association ("ITCTLA") luncheon with administrative law judge ("ALJ") Thomas B. Pender. Judge Pender joined the ITC in October, 2011, and is one of six ALJs at the Commission.

Judge Pender arrived at the luncheon with a number of themes that he wanted to discuss. Chief among them is a concern shared by many other ALJs and district court judges about the scope of electronic discovery in today's litigation. He urged the practitioners in the room not to lose control of the paper, and to reign in the costs and scope of electronic discovery. In Pender's experience, less than 1% of all discovery becomes an exhibit, and less than 5% of those exhibits are ever argued. In addition to paring back discovery, Pender would like to see fewer patents and patent claims being asserted by complainants. Ultimately, Pender would like to see more efforts taken to reduce the cost of litigation at the ITC, and hopes that more streamlined cases will allow him to finish an Initial Determination in a year or less.

Written by Christopher Gosselin

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Judge Pender also suggested, on a related note, that big firms make an effort to send their associates "to the podium," both to give the associates valuable experience, and to reduce the cost of a trial. In his experience, well-prepared associates perform as well or better than partners who had less time to prepare. Pender cautioned parties to think twice before betting an entire case on one witness, and suggested that secondary witnesses could and should be handled by associates.

On March 25, 2013, the U.S. Supreme Court heard oral argument in the Federal Trade Commission's ("FTC's") case challenging the Hatch-Waxman patent settlements Solvay (now owned by Abbot Laboratories) entered into with Watson Pharmaceuticals, Par Pharmaceutical, and Paddock Laboratories resolving their disputes involving Solvay's testosterone-replacement drug AndroGel®. The so-called reverse-payment settlements at issue in FTC v. Actavis, Inc., Sup. Ct. No. 12-416 ("AndroGel") involved the generic manufacturers' agreements to abandon their patent challenges and delay generic entry for nine years. The settlements also involved Solvay making certain payments to the generic manufacturers in return for backup manufacturing and marketing support. For additional background information, please see some of our more recent blogs here, here, and here.

The issue before the Court is whether reverse-payment settlements are per se lawful unless the underlying patent litigation was a sham or the patent was obtained by fraud (as the Eleventh and other circuits have held), or instead are presumptively anticompetitive and unlawful (as the Third Circuit held in K-Dur).

Written by Justine K. Donahue

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Deputy U.S. Solicitor General Malcolm L. Stewart argued on behalf of the FTC that the Court should adopt a "quick look" rule of reason analysis under the antitrust laws whereby reverse-payment settlements will be presumptively anticompetitive unless defendants can show that the payment from the brand to the generic was for a purpose other than delaying generic entry, or the payment offered some pro-competitive benefit. Notably, this quick look approach was adopted by the Third Circuit in K-Dur. Counsel for the respondent drug companies argued that the Court should adopt the "scope of the patent defense" applied by the Second, Eleventh, and Federal Circuits finding these agreements to be lawful absent sham litigation or fraud in obtaining the patent.

The Supreme Court has another chance to clarify the scope of the safe-harbor provisions of 35 U.S.C. § 271(e)(1). Momenta Pharmaceuticals, Inc. and Sandoz Inc. petitioned the Supreme Court to review Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc.. In that case, the Federal Circuit held that 35 U.S.C. § 271(e)(1) protected post-approval studies performed for FDA. Momenta's request comes roughly one month after the Supreme Court declined to grant cert in Classen Immunotherapies, Inc. v. Biogen Idec, another Federal Circuit case involving the scope of 271(e)(1) (blogged on here).

Momenta identifies the issue for the Supreme Court as:

Whether the use of a patented invention in the course of post-approval manufacture of a drug for commercial sale, where the FDA requires that a record of that manufacturing activity be maintained, is exempt from liability for patent infringement under Section 271(e)(1) as "solely for uses reasonably related to the development and submission of information under a Federal law which regulations the manufacture, use, or sale of drugs.

Written by Scot B. Pittman

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The generic-drug company seeks Supreme Court intervention to remedy what it views as inconsistent and incorrect Federal Circuit law. The safe harbor states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention solely for uses reasonably related to the development and submission of information under [federal drug laws]. 21 U.S.C. § 271(e)(1). In Classen, a divided Federal Circuit panel interpreted the provision to be limited to "activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions, before patent expiration." Roughly one year later, another divided Federal Circuit panel, in Momenta, held that "the requirement to maintain records for FDA inspection satisfies the requirement that the uses be reasonably related to the development and submission of information to FDA.

On February 11, the American Medical Association ("AMA") voiced its opinions regarding the U.S. Supreme Court's upcoming review of pharmaceutical patent litigation settlements that include payments to patent challengers, commonly referred to as "pay for delay" settlements.

As explained here, pay-for-delay settlements occur in the context of pharmaceutical litigation under the Hatch-Waxman Act. In a nutshell, they involve payments from a patent holder to a generic manufacturer (who has filed an abbreviated new drug application ("ANDA") relying on the patent holder's brand-name drug product and been sued) in return for an agreement to refrain from selling the generic product for a period of time. These settlement deals have become targets of the antitrust enforcement agencies and, as widely predicted, the High Court has agreed to resolve a circuit split over their presumptive legality.

Written by Rachael P. McClure

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The question presented, from the 11th Circuit case FTC v. Actavis (Docket No. 12-416), is "whether reverse-payment agreements are per se lawful unless the underlying patent litigation was a sham or the patent was obtained by fraud (as the court below held), or instead are presumptively anticompetitive and unlawful (as the Third Circuit has held)." The Eleventh Circuit determined that the U.S. Federal Trade Commission's ("FTC's") assertion that a patent holder was "not likely to prevail" in the underlying infringement action against generic manufacturers did not assert a valid antitrust claim because focus is "on the potential exclusionary effect of the patent, not the likely exclusionary effect," and a settlement that imposes restraints lesser than that full potential effect do not exceed the "scope of the patent." The Third Circuit, conversely, applied a "quick look rule of reason," finding that "any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market [is] prima facie evidence of an unreasonable restraint of trade," rebuttable by a "showing that the payment (1) was for a purpose other than delayed entry or (2) offers some pro-competitive benefit."

On January 24 to a packed house, the Food, Drug and Cosmetic Law Section of the New York State Bar held its annual meeting. This year, the agenda featured presentations on medical devices, a Supreme Court update, an in-house/outside counsel panel to discuss effective relations for FDA/regulatory advice, a discussion of the Federal Sunshine Act, and "A View from the Inside" retrospective of some hot issues at FDA from a recent high-level official at FDA, including the new food and pharmacy initiatives under development.

In the Supreme Court update called "Pivotal Court Cases for FDA Practitioners 2012-2013 Updates", FLH Partner Brian J. Malkin, spoke on two cases to watch in the first quarter of 2013, Mutual Pharm. Co., Inc. v. Bartlett , No. 12-142 (U.S., cert. granted Nov. 30, 2012, argument scheduled Mar. 19, 2013) and Bowman v. Monsanto Co., No. 11-796 (U.S., cert. granted Oct. 5, 2012, argument scheduled Feb. 19, 2013). The question presented in Mutual v. Bartlett is:

Whether the First Circuit erred when it created a circuit split and held--in clear conflict with this Court's decisions in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)--that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.

Written by Brian J. Malkin

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Bowman v. Monsanto is a case that my firm, Frommer Lawrence & Haug LLP, is arguing on behalf of petitioner Bowman, where the question presented is:

Patent exhaustion delimits rights of patent holders by eliminating the right to control or prohibit use of the invention after an authorized sale. In this case, the Federal Circuit refused to find exhaustion where a farmer used seeds purchased in an authorized sale for their natural and foreseeable purpose--namely, for planting. The question presented is: Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?

Mr. Malkin's summaries of these two cases may be found here. His presentation for these two cases, including topics for consideration by the Food, Drug, and Cosmetic Section may be found here.

Frommer Lawrence & Haug LLP Partner Brian J. Malkin will speak on two topics at the 2013 Annual Meeting of the New York State Bar Association, Food, Drug, and Cosmetic Law Section in New York City on January 24, 2013 : 1) Pivotal Cases for FDA Practitioners: 2012-2013 Updates and 2) In-House/Outside Counsel Panel: Effective Communication Regarding FDA/Regulatory Advice. For the Pivotal Cases, Mr. Malkin will be joined by Janet Linn from Eckert Seamans Cherin & Mellott, LLC, and Mr. Malkin's In-House/Outside Counsel Panel includes Geoffrey Levitt, Senior Vice President and Associate General Counsel, Worldwide Regulatory and Policy Law, Pfizer, Inc.; Michael DiBello, Vice President and Associate General Counsel - Regulatory, Aceto Corp.; and Afia Konadu Asamoah, Associate, Covington & Burling LLP. Mr. Malkin hopes the In-House / Outside Counsel panel will be of interest for advancing effective interactions between FDA regulatory affairs professionals.

Earlier this week, the U.S. Supreme Court denied GlaxoSmithKline's certiorari petition in a case that would have helped clarify the scope of 35 U.S.C. § 271(e)'s safe-harbor provision. The issue facing the Court was whether section 271(e)(1) applies to postmarketing activity as well as premarketing activity.

Section 271(e), which states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention "solely for uses reasonably related to the development and submission of information under [federal drug laws]," does not include a time limitation. The question about timing was highlighted in two recent Federal Circuit cases. In Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit explained that "§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration." Last year, however, a different panel of judges in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) held that post-approval studies performed for the FDA fall within § 271(e)(1)'s safe harbor and explained that Classen held that 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained."

Written by Scot B. Pittman

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As previously blogged on here, the Solicitor General had urged the Supreme Court to deny GSK's petition in the Classen case. Despite a belief that the Federal Circuit erred in Classen, United States Solicitor General Donald Verrilli offered the following reasons why the Supreme Court should deny certiorari: (1) the Federal Circuit's Momenta decision sufficiently clarified and narrowed the Classen holding; (2) it was unclear whether the safe harbor applied to the types of patents at issue in the Classen case; and (3) the petitioners were not entitled to the safe harbor protection regardless of the Supreme Court's interpretation of the provision.

On January 16, 2013, FLH Partner Brian J. Malkin was quoted in FDAnews article: "Alabama Supreme Court: Brand Drugmakers Can Be Held Liable for Generic-Drug Labeling". The Alabama Supreme Court recently held that Pfizer Inc. ("Pfizer") could be sued for injury caused by a generic version of its drug. FDAnews asked Mr. Malkin how this could affect branded drug manufacturers makers and whether this decision would contradict federal laws and court rulings. Below is an excerpt from that story:

The Alabama court decision raises the question of whether states or the federal government should have had jurisdiction over the matter, Brian Malkin, a Partner at Frommer Lawrence & Haug told DID.

Written by Brian J. Malkin

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"If it is fraud, it is fraud on a national level so you would think the case should have gone to the FDA," Malkin said. He has noticed a tension between state-specific and FDA authority in this arena and has noted a couple of cases where states seem to be taking on areas that are traditionally in the FDA's realm. The Mutual v. Bartlett generic preemption case set to be heard by the Supreme Court this spring also began at the state court level, Malkin said (DID, Dec. 3, 2012).

This Monday, the U.S. Supreme Court announced that it will not review a challenge to federal funding of human embryonic stem-cell research. By rejecting the petition from a pair of scientists opposing such funding, the Court gave the green light for controversial embryo-based studies to move forward.

Scientists James L. Sherley and Theresa Deisher sued the United States Department of Health and Human Services ("HHS") and the National Institutes of Health ("NIH") in 2009, challenging NIH guidelines related to human-stem cell research promulgated pursuant to Executive Order 13,505. E.O. 13,505 was signed by President Barack Obama in March 2009 with the aim "to expand NIH support for the exploration of human stem cell research." The order loosened limitations imposed by the previous administration on the use of federal tax dollars for embryonic stem cell research and overturned an order barring NIH from conducting research on embryonic stem cells beyond the 60 cell lines then in existence. In addition, it directed NIH to review its guidelines regarding stem-cell research.

Written by Rachael P. McClure

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Sherley and Deisher-both adult stem-cell researchers who do not conduct research on human embryos or embryonic stem cells-challenged the Guidelines on the grounds that: (1) NIH refused to address comments submitted in response to the draft version, in violation of the Administrative Procedure Act and (2) they violate the Dickey-Wicker Amendment. The Dickey-Wicker Amendment is an appropriations rider, included in every HHS appropriations bill since 1996, prohibiting the use of federal funds for "the creation of human embryo or embryos for research purposes" and "research in which human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under [other federal regulations]." The final NIH Guidelines, published on July 7, 2009, authorized federal funding of research using live human embryos that were created "for reproductive purposes" (i.e., in vitro fertilization) but are "no longer needed for [that] purpose."

The Solicitor General has urged the U.S. Supreme Court to deny GlaxoSmithKline's ("GSK's") pending certiorari petition in GlaxoSmithKline v. Classen Immunotherapies, Inc., case number 11-1078 The issue facing the Supreme Court should it grant GSK's petition is whether the Federal Circuit correctly interpreted 35 U.S.C. § 271(e)(1)'s safe harbor as applying to only pre-market approval of generic counterparts. In its amicus brief submitted late last week, the Solicitor General explained that there is no need to clarify the safe harbor provision and voiced concerns that the Classen case would not be the proper vehicle to do so should the Supreme Court feel the need.

The dispute between GSK and Classen involves three patents, U.S. Patent Nos. 6,638,739, 6,420,139, and 5,723,283, which relate to methods of optimizing vaccine immunization schedules to decrease the risk of developing chronic immune-mediated disorders. Classen sued a number of defendants, including GSK, alleging infringement of its patents through various vaccination research projects. GSK's allegedly infringing activities related to its participation in a government study that evaluated a suggested association between the timing of childhood vaccinations and the risk of developing type 1 diabetes. GSK argued, and the district court agreed, that such activity was within section 271(e)(1)'s safe harbor because the information was ultimately submitted to FDA. On appeal, the Federal Circuit reversed, holding that section 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained." Classen Immunotherapies, Inc. v. Biogen Idec at 1070. The Federal Circuit further explained, "§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration." Id. at 1071.

Written by Scot B. Pittman

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In the amicus brief, United States Solicitor General Donald Verrilli expressed his belief that the Federal Circuit's interpretation of § 271(e)(1) in Classen was incorrect. 35 U.S.C. 271(e)(1) reads:

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

On December 7, 2012, the U.S. Supreme Court granted the Federal Trade Commission's ("FTC's") certiorari petition and will address the question of whether settlements of Hatch-Waxman pharmaceutical patent litigation that include so-called "reverse-payments" are per se lawful unless the underlying patent litigation was a sham or the patent was obtained by fraud or, instead, are presumptively anticompetitive and unlawful.

As previously reported here, the FTC has repeatedly attacked reverse payment agreements between branded and generic pharmaceutical companies, alleging that such settlements--which the FTC also refers to as "pay-for-delay"--are a violation of antitrust laws. There is currently a split in the circuits regarding the legality of these agreements. In the decision now being reviewed by the Supreme Court, FTC v. Watson Pharmaceuticals, Inc. (involving the brand-name drug AndroGel), the Eleventh Circuit held that such settlements are legal so long as they fall within the "scope of the patent" and there is not evidence of sham litigation or fraud in obtaining the patent. Other courts have arrived at similar conclusions, including the Second Circuit (In re Tamoxifen Citrate Antitrust Litigation) and the Federal Circuit (In re Ciprofloxacin Hydrochloride Antitrust Litigation). In contrast, the Third Circuit's recent In re K-Dur Antitrust Litigation decision held that these agreements create a rebuttable presumption that the settlement is anticompetitive. Both Merck and Upsher-Smith filed petitions to the Supreme Court to review the Third Circuit's K-Dur decision; however, the Court has not yet announced whether it will grant those requests.

Written by Richard F. Kurz

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In AndroGel, the FTC asks the Supreme Court to adopt the Third Circuit's approach. The FTC argues that the "scope-of-the-patent approach in general, and the decision of the [Eleventh Circuit] in particular, reflect a misapplication of federal competition law." Thus, the FTC advocates for the Third Circuit's "approach, [in which] the restraints embodied in reverse-payment agreements are presumed to be anticompetitive, and the antitrust defendants--who, after all, have settled litigation against each other by agreeing not to compete--bear the burden of advancing some countervailing procompetitive virtue." (Internal quotation omitted).