"Quamquam (...) tecum uiuere amem, tecum obeam lubens." Horácio 3.9
[Apesar de (...) amaria viver contigo, [e] morreria contigo prazerosamente.]
[Apesar de (...) amaria viver contigo, [e] morreria contigo prazerosamente.]
Friday, 15 November 2013
CONIUGI OPTIMAE ET DULCISSIMAE, PARENTIBUS CARISSIMIS
| http://www.archive.org/stream/cu31924021620236/cu31924021620236_djvu.txt |
Friday, 1 November 2013
FTC v. Actavis - rule of reason x rule per se
FTC v. Actavis
On June 17, the Supreme Court ruled that reverse payment settlements between brand name and generic drug manufacturers were not presumptively unlawful, but were subject to scrutiny under the “rule of reason.” This holding overruled the United States Court of Appeals for the Eleventh Circuit’s dismissal of the case, resolving a circuit split.
JD Supra explains the Court’s holding. HealthAffairs describes the background of the industry and the history of the case. FDA Law Blog predicts its implications on future litigation.
Actavis addresses the uncertain legality of “reverse payment settlements.” Such settlements are common when a generic drug manufacturer announces its intention to produce a patented drug and declares that it believes the patent to be invalid in an Abbreviated New Drug Application (“ANDA”) to the FDA, as required by the Hatch-Waxman Act. Actavis, slip op. at 2–4. This declaration constitutes infringement, and the patent owner can immediately sue to prevent the generic drug from entering the market. Id. at 3–4.
In many such cases, the patent owner agrees to pay the potential infringer in exchange for a promise not to produce the patented drug until the expiration of the patent term. Reverse payment settlements allow the parties to avoid potentially costly litigation, at the cost (to everyone else) of allowing invalid drug patents to remain effectively enforced as government-granted monopolies.
Actavis involved Solvay Pharmaceuticals, the manufacturer of a patented drug called AndroGel, and three generic manufacturers — Actavis, Inc. (“Actavis”), Paddock Laboratories (“Paddock”), and Par Pharmaceutical (“Par”). Id. at 5. When Actavis and Paddock filed ANDAs in 2003 seeking approval to market a generic version of AndroGel and claiming that Solvay’s patent was invalid, Solvay sued. Id. In 2006, the parties settled, agreeing that the generic manufacturers would promote AndroGel to urologists and would not market generic versions of AndroGel until 2015, 65 months before the patent’s expiration date. Id. In return, Solvay agreed to pay $12 million to Paddock, $60 million to Par, and up to $30 million annually for nine years to Actavis. Id. at 5–6.
The FTC filed a lawsuit against all parties in 2009, arguing that the purpose of the payments was to compensate the generic manufacturers for their agreement not to compete with Solvay. Id. The District Court and the Eleventh Circuit dismissed the case, holding that “a reverse settlement is immune from antitrust attack so long as its anticompetitive effects fall within the [term] of the patent” because of the inherent anticompetitive goals of the patent system and the policy of encouraging settlement. Id. at 6–7 (quoting FTC v. Watson Pharmaceuticals, Inc., 677 F.3d 1298, 1312 (11th Cir. 2012)). The Court granted certiorari to resolve the split between courts applying this logic and other courts holding reverse payment settlements presumptively unlawful. Id. It heard oral arguments in March 2013 (previously covered by the Digest).
The Court declined to adopt either position of the lower courts, endorsing instead a “rule of reason” test. Id. at 20. The Court first rejected the idea that settlements within the term of the patent were presumptively valid, noting that while valid patents would grant a holder legitimate monopoly rights, “[t]he patent here may or may not be valid, and may or may not be infringed.” Id. at 8. However, it also rejected the FTC’s proposed “quick look” rule, which would have found reverse payment settlements to be presumptively invalid; the “complexities” of the settlements’ consequences merited a case-by-case determination of anticompetitive effects. Id. at 20–21.
The Court held that courts should balance patent and antitrust goals. Settlements “amount[ing] to . . . a rough approximation of the litigation expenses saved” or compensating “for other services that the generic has promised to perform” weighed against a finding of anticompetitive effects, id. at 17; however, “unexpectedly large” reverse payments could show a desire to maintain “supracompetitive prices,” id. at 19. The Court found that the FTC’s case should have been allowed to continue, given the special incentives of Hatch-Waxman, the suspicious characteristics of the settlement, and the potentially unjustified competitive consequences, and remanded the case for further proceedings. Id. at 16–21.
Dissenting, Chief Justice Roberts endorsed the Eleventh Circuit’s test. Id. at 1–3. He argued that the validity and scope of a patent were not antitrust principles but questions for patent law. Id. at 5–6. Roberts further argued that the majority’s rule would disincentivize patent litigation settlements, and therefore invalidity suits, by decreasing their reward. Id. at 11. His dissent also noted that the majority’s decision could discourage patent challenges, and prohibiting litigation of validity disputes constitutes a public harm would undermine the entire idea of patent licensing. Id. at 11, 14, 17–18.
Commentators, such as Patently-O and FDA Law Blog, suggest that the Court’s decision in Actavis will increase uncertainty for parties contemplating reverse-payment settlements, as the opinion offers little guidance to indicate how the “rule of reason” will actually apply to these settlements. Going forward, those looking to enter into such agreements will likely want to be extra cautious of the potential antitrust issues such settlements implicate.
On June 17, the Supreme Court ruled that reverse payment settlements between brand name and generic drug manufacturers were not presumptively unlawful, but were subject to scrutiny under the “rule of reason.” This holding overruled the United States Court of Appeals for the Eleventh Circuit’s dismissal of the case, resolving a circuit split.
JD Supra explains the Court’s holding. HealthAffairs describes the background of the industry and the history of the case. FDA Law Blog predicts its implications on future litigation.
Actavis addresses the uncertain legality of “reverse payment settlements.” Such settlements are common when a generic drug manufacturer announces its intention to produce a patented drug and declares that it believes the patent to be invalid in an Abbreviated New Drug Application (“ANDA”) to the FDA, as required by the Hatch-Waxman Act. Actavis, slip op. at 2–4. This declaration constitutes infringement, and the patent owner can immediately sue to prevent the generic drug from entering the market. Id. at 3–4.
In many such cases, the patent owner agrees to pay the potential infringer in exchange for a promise not to produce the patented drug until the expiration of the patent term. Reverse payment settlements allow the parties to avoid potentially costly litigation, at the cost (to everyone else) of allowing invalid drug patents to remain effectively enforced as government-granted monopolies.
Actavis involved Solvay Pharmaceuticals, the manufacturer of a patented drug called AndroGel, and three generic manufacturers — Actavis, Inc. (“Actavis”), Paddock Laboratories (“Paddock”), and Par Pharmaceutical (“Par”). Id. at 5. When Actavis and Paddock filed ANDAs in 2003 seeking approval to market a generic version of AndroGel and claiming that Solvay’s patent was invalid, Solvay sued. Id. In 2006, the parties settled, agreeing that the generic manufacturers would promote AndroGel to urologists and would not market generic versions of AndroGel until 2015, 65 months before the patent’s expiration date. Id. In return, Solvay agreed to pay $12 million to Paddock, $60 million to Par, and up to $30 million annually for nine years to Actavis. Id. at 5–6.
The FTC filed a lawsuit against all parties in 2009, arguing that the purpose of the payments was to compensate the generic manufacturers for their agreement not to compete with Solvay. Id. The District Court and the Eleventh Circuit dismissed the case, holding that “a reverse settlement is immune from antitrust attack so long as its anticompetitive effects fall within the [term] of the patent” because of the inherent anticompetitive goals of the patent system and the policy of encouraging settlement. Id. at 6–7 (quoting FTC v. Watson Pharmaceuticals, Inc., 677 F.3d 1298, 1312 (11th Cir. 2012)). The Court granted certiorari to resolve the split between courts applying this logic and other courts holding reverse payment settlements presumptively unlawful. Id. It heard oral arguments in March 2013 (previously covered by the Digest).
The Court declined to adopt either position of the lower courts, endorsing instead a “rule of reason” test. Id. at 20. The Court first rejected the idea that settlements within the term of the patent were presumptively valid, noting that while valid patents would grant a holder legitimate monopoly rights, “[t]he patent here may or may not be valid, and may or may not be infringed.” Id. at 8. However, it also rejected the FTC’s proposed “quick look” rule, which would have found reverse payment settlements to be presumptively invalid; the “complexities” of the settlements’ consequences merited a case-by-case determination of anticompetitive effects. Id. at 20–21.
The Court held that courts should balance patent and antitrust goals. Settlements “amount[ing] to . . . a rough approximation of the litigation expenses saved” or compensating “for other services that the generic has promised to perform” weighed against a finding of anticompetitive effects, id. at 17; however, “unexpectedly large” reverse payments could show a desire to maintain “supracompetitive prices,” id. at 19. The Court found that the FTC’s case should have been allowed to continue, given the special incentives of Hatch-Waxman, the suspicious characteristics of the settlement, and the potentially unjustified competitive consequences, and remanded the case for further proceedings. Id. at 16–21.
Dissenting, Chief Justice Roberts endorsed the Eleventh Circuit’s test. Id. at 1–3. He argued that the validity and scope of a patent were not antitrust principles but questions for patent law. Id. at 5–6. Roberts further argued that the majority’s rule would disincentivize patent litigation settlements, and therefore invalidity suits, by decreasing their reward. Id. at 11. His dissent also noted that the majority’s decision could discourage patent challenges, and prohibiting litigation of validity disputes constitutes a public harm would undermine the entire idea of patent licensing. Id. at 11, 14, 17–18.
Commentators, such as Patently-O and FDA Law Blog, suggest that the Court’s decision in Actavis will increase uncertainty for parties contemplating reverse-payment settlements, as the opinion offers little guidance to indicate how the “rule of reason” will actually apply to these settlements. Going forward, those looking to enter into such agreements will likely want to be extra cautious of the potential antitrust issues such settlements implicate.
Universalidade de Fato x Universalidade de Direito
Universalidade de fato
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Universalidade de direito
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É o conjunto de bens singulares que são reunidos pela vontade de seu dono para determinada destinação unitária.
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É o conjunto de relações jurídicas titularizados pela mesma pessoa possuindo valor econômico.
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Art.
90. Constitui universalidade de fato a pluralidade de bens singulares
que, pertinentes à mesma pessoa, tenham destinação unitária.
Parágrafo único. Os bens que formam essa universalidade podem ser objeto de relações jurídicas próprias.
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Art. 91. Constitui universalidade de direito o complexo de relações jurídicas, de uma pessoa, dotadas de valor econômico.
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Ex: biblioteca, rebanho de gado, qualquer coleção, estabelecimento empresarial.
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Ex.: herança, massa falida.
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Universitas juris is a Latin term which means ‘a quantity of things
of all sorts.’ It includes both corporeal and incorporeal things that
are taken together as a whole. In civil law universitas juris is a
collection of rights and duties united by the single circumstance of
their having belonged at one time to one person. The tie that connects a
number of rights of property, rights of way, rights to legacies, duties
of specific performance, debts, obligations, to compensate wrongs which
so connects all these legal privileges and duties together as to
constitute them a universitas juris is the fact of their having attached
to some individual capable of exercising them. A universitas juris is
always governed by the lex loci domicilii.
In Stewart v. B. & O. R. R. Co., 11 Ohio Dec. 232, 235 (Ohio
Misc. 1901), the court held that, a universitas juris occurs when one
man is invested with the legal clothing of another, becoming at the same
moment subject to all his/her liabilities and entitled to all rights.
Universitas facti is a Latin term which means the aggregate. In civil
law it is a plurality of corporeal things of the same kind, regarded as a
whole. For example, a stock of goods. Universitas facti form a group
of things which as a whole has a legal existence.
Diz-se da universalidade de fato o conjunto de coisas materiais
singulares, simples ou compostas reunidas em coletividade pela vontade
da pessoa, tendo distinção comum, ou seja, objetos iguais, de mesma
natureza, como, por exemplo, um rebanho, uma biblioteca, uma frota de
automóveis.
Diz-se da universalidade de direito o conjunto de coisas (matérias ou imateriais) corpóreas ou incorpóreas que tem seu caráter coletivo, mas que a lei atribui caráter unitário, como um patrimônio, uma herança, uma massa falida, bem como direitos e obrigações. Este tipo de universalidade caracteriza-se por ser formada por um complexo de relações jurídicas, por ter seu vínculo resultante exclusivamente de lei e pela indiferença de seus elementos, sejam materiais ou imateriais, simples ou compostos.
Não se confundem, coisas compostas e coisas coletivas (universais), pois na primeira há síntese de partes, formação de uma coisa inteira (considerada em seu todo) por partes diferentes, enquanto que na segunda há reunião, agrupamento de coisas distintas consideradas em sua individualidade.
Diz-se da universalidade de direito o conjunto de coisas (matérias ou imateriais) corpóreas ou incorpóreas que tem seu caráter coletivo, mas que a lei atribui caráter unitário, como um patrimônio, uma herança, uma massa falida, bem como direitos e obrigações. Este tipo de universalidade caracteriza-se por ser formada por um complexo de relações jurídicas, por ter seu vínculo resultante exclusivamente de lei e pela indiferença de seus elementos, sejam materiais ou imateriais, simples ou compostos.
Não se confundem, coisas compostas e coisas coletivas (universais), pois na primeira há síntese de partes, formação de uma coisa inteira (considerada em seu todo) por partes diferentes, enquanto que na segunda há reunião, agrupamento de coisas distintas consideradas em sua individualidade.
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