Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S

Issues

Does the counterclaim provision of the Hatch-Waxman Act authorize a generic drug manufacturer in a patent infringement suit to assert a counterclaim compelling the patent holder to modify an overly broad description of its patent?

 

Petitioner Caraco Pharmaceutical Laboratories, a generic drug manufacturer, sought FDA approval to market the diabetes drug repaglinide. Pursuant to the Hatch-Waxman Act's expedited FDA application process for generic drugs, Caraco certified that its drug label would not conflict with Respondent Novo Nordisk’s patented repaglinide-metformin use combination. Relying on Novo’s description of its patent, the FDA denied the certification. Caraco invoked the Act’s counterclaim provision to compel Novo to revert to a narrower patent description. The United States Court of Appeals for the Federal Circuit found that Caraco could not assert the counterclaim. Caraco argues that the Federal Circuit’s reading of the counterclaim provision is incorrect and that the purpose of the counterclaim provision—to “correct” misleading patent descriptions—supports reversal. Novo asserts that the statute plainly permits a counterclaim only if Novo’s patent does not claim any approved method of use. The Supreme Court’s reading of the counterclaim provision may affect healthcare costs and the generic drug manufacturing industry.

Questions as Framed for the Court by the Parties

When the Food & Drug Administration (FDA) approves a drug for multiple uses, the Hatch-Waxman Act allows generic drug makers to avoid contested patent litigation by marketing generic versions of the drug solely for non-patented uses. The FDA lacks the authority and expertise needed to verify the patent information submitted by name-brand drug companies, however, so it defers to their descriptions of the scope of their patents. Such companies can therefore block the approval of generic drugs by submitting overbroad patent descriptions to the FDA, effectively extending their patents to cover non-infringing uses.

To combat this problem, the Act allows a “counterclaim seeking an order requiring the [patent] holder to correct or delete the patent information submitted by the holder . . . on the ground that the patent does not claim . . . an approved method of using the drug.” 21 U.S.C. §  355(j)(5)(C)(ii)(I). In a 2-1 decision that conflicts with this Court's precedents and recent D.C. Circuit authority, the Federal Circuit held that the counterclaim provision effectively authorizes only “delet[ing]” improperly listed patents, but not “correct[ing]” information that misrepresents the scope of the approved uses claimed by a patent. That ruling expressly invalidates longstanding FDA regulations defining “patent information,” which the FDA deems “essential” to administering the Act, without seeking the agency's views. The question presented is:

Whether this counterclaim provision applies where (1) there is “an approved method of using the drug” that “the patent does not claim,” and (2) the brand submits “patent information” to the FDA that misstates the patent's scope, requiring “correct[ion].”

The Hatch-Waxman Act expedites the process by which generic drug manufacturers can obtain approval from the Food and Drug Administration (“FDA”) to market generic drugs, and allows generic drug manufacturers to produce and market brand-name drugs for FDA-approved uses that are not covered by existing patents. See 21 U.S.C.

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Carachuri-Rosendo v. Holder

Issues

Whether a deportable alien is ineligible to challenge his removal proceedings because he could have been prosecuted for recidivist narcotics possession, an “aggravated felony” for the purposes of federal immigration law, even though the alien was not prosecuted for recidivist possession in state court?

 

Under the Immigration and Nationality Act, a deportable lawful permanent resident is ineligible to petition the Attorney General for cancellation of removal proceedings if he has a conviction for an “aggravated felony.” Congress defines “aggravated felony” as including any felony under the Controlled Substances Act. Under that Act, simple possession of most narcotics is a misdemeanor. However, possession of a controlled substance by an individual who has a prior conviction for possession is a felony. This case will resolve a circuit split in deciding whether a deportable alien who has been twice convicted in state court for non-felony simple possession is ineligible to seek cancellation of removal proceedings on the theory that the alien has been, for the purposes of federal immigration law, convicted of an “aggravated felony” because he could have been prosecuted for felony recidivist-possession under federal law.

Questions as Framed for the Court by the Parties

Under the Immigration and Nationality Act, a lawful permanent resident who has been "convicted" of an "aggravated felony" is ineligible to seek cancellation of removal. 8 U.S.C. § 1229b(a)(3). The courts of appeals have divided 4-2 on the following question presented by this case:

Whether a person convicted under state law for simple drug possession (a federal law misdemeanor) has been "convicted" of an "aggravated felony" on the theory that he could have been prosecuted for recidivist simple possession (a federal law felony), even though there was no charge or finding of a prior conviction in his prosecution for possession.

Petitioner Jose Angel Carachuri-Rosendo (“Carachuri-Rosendo”) came to the United States in 1993 and thereafter became a lawful permanent resident. See Carachuri-Rosendo v. Holder, 570 F.3d 263, 264 (5th Cir.

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Caperton v. A.T. Massey Coal Company, Inc., et al.

Issues

Must a judge recuse himself in a case where a substantial campaign contributor is a party?

 

The judge, aloof in his black robes, sits as the incarnation of the nation's courts and of the ideals those courts are meant to embody: impartiality, fairness, and, above all, justice.  However, judges are also human and liable to err; as such, they are themselves judged by those involved in or reporting on legal proceedings. Consequently, the avoidance of bias, apparent or otherwise, has been a matter of concern for those regulating the courts-chiefly the judges themselves. While a judge may well be able to administer justice even when a personal bias exists, the Supreme Court has held that the Due Process Clause of the Fourteenth Amendment requires judges and tribunals to avoid even the mere appearance of bias. This case concerns an elected justice-that is, a judge sitting on the highest court of a state judicial system-who remained at the bench to administer a case involving a company whose CEO had contributed substantially to that justice's election campaign. Petitioner Hugh M. Caperton argues that this individual, Justice Brent Benjamin, ought to have recused himself and not administered the trial because of the appearance of bias, especially as he was the deciding figure in this case. Conversely, Respondent Massey Coal Co. contends that Justice Benjamin was in compliance with due process and that he stood to gain nothing from the outcome of the trial. This case offers the Supreme Court the opportunity to set the standards by which judges will be required to recuse themselves from cases involving apparent bias.

 

    Questions as Framed for the Court by the Parties

    Justice Brent Benjamin of the Supreme Court of Appeals of West Virginia refused to recuse himself from the appeal of the $50 million jury verdict in this case, even though the CEO of the lead defendant spent $3 million supporting his campaign for a seat on the court--more than 60% of the total amount spent to support Justice Benjamin's campaign-- while preparing to appeal the verdict against his company. After winning election to the court, Justice Benjamin cast the deciding vote in the court's 3-2 decision overturning that verdict. The question presented is whether Justice Benjamin's failure to recuse himself from participation in his principal financial supporter's case violated the Due Process Clause of the Fourteenth Amendment.

    In 1998 the Petitioners, Hugh M. Caperton, Harman Development Corporation, Harman Mining Corporation, and Sovereign Coal Sales, Inc. sued Respondent A.T. Massey Coal Company, Inc. and several affiliated companies to recover damages in the Circuit Court of Boone County, West Virginia. See Caperton v. A.T. Massey Coal Company, Inc., No. 33350, 2008 WL918444 at *4 (W. Va.

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    Camreta v. Greene; Alford v. Greene

    Issues

    1. Prior to questioning a child regarding possible sexual abuse, must law enforcement agents first obtain a warrant, or are they permitted to proceed without a warrant, provided that the public interest in conducting the investigation outweighs any impact that the questioning has on the liberties of the individual?

    2. Is the Supreme Court authorized to review the legal basis of a lower court opinion that objected to the petitioners’ actions, even though the court ultimately decided in favor of the petitioners on qualified immunity grounds?

     

    When the Oregon Department of Human Services received a report of alleged abuse against a nine-year old child, a caseworker and police officer decided to interview the child at school, without parental consent or a warrant. After the charges against the child's father, Mr. Greene, were dropped, the child’s mother, Mrs. Greene, sued the caseworker and officer for violating her daughter's Fourth Amendment right against unreasonable search or seizure, arguing that probable cause is a necessary prerequisite to interviewing children about their alleged sexual abuse because such interviews may cause irreparable harm to the children when the allegations are unfounded. The caseworker and officer argue that reasonableness is the proper standard because it would be difficult to obtain probable cause when the child is often the only witness to the abuse. The Court's decision will likely clarify whether probable cause or reasonableness is the proper standard for interviewing a child who is the alleged victim of abuse without parental consent.

    Questions as Framed for the Court by the Parties

    Camreta

    1. The state received a report that a nine-year-old child was being abused by her father at home. A child protection caseworker and law enforcement officer went to the child's school to interview her. To assess the constitutionality of that interview, the Ninth Circuit applied the traditional warrant/warrant-exception requirements that apply to seizures of suspected criminals. Should the Ninth Circuit, as other circuits have done, instead have applied the balancing standard that this Court has identified as the appropriate standard when a witness is temporarily detained?

    2. The Ninth Circuit addressed the constitutionality of the interview in order to provide "guidance to those charged with the difficult task of protecting child welfare within the confines of the Fourth Amendment[,]" and it thus articulated a rule that will apply to all future child-abuse investigations. Is the Ninth Circuit's constitutional ruling reviewable, notwithstanding that it ruled in petitioner's favor on qualified immunity grounds?

    Alford

    Does the Fourth Amendment require a warrant, a court order, parental consent, or exigent circumstances before law enforcement and child welfare officials may conduct a temporary seizure and interview at a public school of a child whom they reasonably suspect was being sexually abused by her father?

    In 2003, Nimrod Greene was arrested after F.S., a seven-year old child, informed his parents and investigators that Mr. Greene had inappropriately touched him twice. See Greene v. Camreta, 588 F.3d 1011, 1016 (9th Cir. 2009). In connection with the ensuing investigation, F.S.'s mother told investigators that Mr. Greene's wife, Sarah Greene, said that she did not like her daughters, S.G.

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    Campbell-Ewald Co. v. Gomez

    Issues

    1. Does a claim become moot when the plaintiff receives an offer of complete relief; and does the answer change if that plaintiff purports to represent an uncertified class?
    2. Does the doctrine of derivative sovereign immunity extend generally to government contractors acting within the scope of their contract, or is it limited to claims of property damage related to public works projects?

     

    This case presents two issues. First, the Supreme Court will determine whether a case is  moot when a plaintiff receives an offer of complete relief for his claims, even if one of the plaintiff’s claims was made on behalf of an uncertified class of litigants. Petition for Writ of Certiorari, Campbell-Ewald Co. v. Gomez, No. 14-857, 13 (Feb. 19, 2015). If the case is not moot, the Court will consider whether the doctrine of derivative sovereign immunity for government contractors is restricted to claims arising out of property damage caused by public works projects or is applicable in other cases. See Brief for Petitioner, Campbell-Ewald Co. at 36–37, 42. Government contractor Campbell-Ewald argues that an offer of complete relief renders the plaintiff’s individual and class claims moot. See id. at 26–27. But the plaintiff, Jose Gomez, contends that an unaccepted offer does not moot a claim. See Brief for Respondent, Jose Gomez at 37. Additionally, Campbell-Ewald argues that it qualifies for derivative sovereign immunity. See Brief for Petitioner at 36–37, 42. However, Gomez argues that only contractors working on public works projects are entitled to such immunity. See Brief for Respondent at 44. This case may affect the viability of class action  lawsuits,  and may define the scope of derivative sovereign immunity. See Brief of Amicus Curiae Constitutional Accountability Center, in Support of Respondent at 19; Brief of Amicus Curiae KBR, Inc., in Support of Petitioner at 23.

    Questions as Framed for the Court by the Parties

    1. Does a case become moot, and thus beyond the judicial power of Article III, when the plaintiff receives an offer of complete relief on his claim?
    2. Is the answer to the first question any different when the plaintiff has asserted a class claim under Federal Rule of Civil Procedure 23, but receives an offer of complete relief before any class is certified?
    3. Is the doctrine of derivative sovereign immunity recognized in Yearsley v. W.A. Ross Construction Co., 309 U.S. 18 (1940), for government contractors, restricted to claims arising out of property damage caused by public works projects?

    In 2005, the U.S. Navy contracted Campbell-Ewald Co. to provide the Navy advertising services. See Campbell-Ewald v. Gomez, No. 13-55486, at 4 (9th Cir.

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    Burwell v. Hobby Lobby Stores; Conestoga Wood Specialties Corp. v. Sebelius

    Issues

    1. Does the Religious Freedom Restoration Act protect for-profit corporations?
    2. Does the contraceptive-coverage Mandate of the Patient Protection and Affordable Care Act of 2010 violate corporations’ religious exercise rights?

     

    As part of the Affordable Care Act ("ACA"), the Department of Health and Human Services ("HHS") adopted a mandate requiring that employment-based health plans covered by the Employment Retirement Income Security Act ("ERISA") include twenty contraceptive methods. Two corporations, Hobby Lobby and Conestoga Wood, sued, objecting on religious grounds to the inclusion of four of the methods because they prevent the implantation of a fertilized egg. The corporations argue that the Mandate offends their religious rights under the Religious Freedom Restoration Act ("RFRA") and the Free Exercise Clause. The government argues that corporations do not have these rights; and, in any case, the Mandate is statutorily and constitutionally permissible. The Supreme Court will consider whether for-profit corporations can sue under RFRA or the Free Exercise  Clause,  and whether this mandate violates corporations’ right to exercise religion. The Court’s ruling may significantly impact foundational principles of corporate law and the scope of corporations’ First Amendment rights. This case will also impact the Affordable Care Act’s power to mandate health plans.

    Questions as Framed for the Court by the Parties

    Sebelius v. Hobby Lobby Stores

    The Religious Freedom Restoration Act of 1993 (RFRA) 42 U.S.C. 2000bb et seq., provides that the government “shall not substantially burden a person’s exercise of religion” unless that burden is the least restrictive means to further a compelling governmental interest. 42 U.S.C. 2000bb-1(a) and (b). The question presented is whether RFRA allows a for-profit corporation to deny its employees the health coverage of contraceptives to which the employees are otherwise entitled by federal law, based on the religious objections of the corporation's owners.

     

    Conestoga Wood Specialties Corp. v. Sebelius

    Whether the religious owners of a family business, or their closely-held business corporation, have free exercise rights that are violated by the application of the contraceptive-coverage Mandate of the Patient Protection and Affordable Care Act of 2010 (“ACA”).

    Under the Patient Protection and Affordable Care Act (“ACA”), employment-based health care plans covered by the Employee Retirement Income Security Act (“ERISA”) are required to provide coverage for certain preventative health services. SeeHobby

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