Biosimilar dispute headed to the Supreme Court

Biosimilar manufacturers will soon have a definitive answer on the timing of giving notice of commercial marketing, thanks to the Supreme Court. On January 13, 2017, the Court granted and consolidated Sandoz, Inc.’s petition for writ of certiorari and Amgen, Inc.’s conditional cross-petition for writ of certiorari. The dispute appeals the Federal Circuit’s July 21, 2015 decision holding that Amgen was entitled to an additional 180-day marketing exclusivity period because of Sandoz’s late notification of its intention to market a biologic product that is biosimilar to Amgen’s Neupogen® (see Court interprets biosimilar ‘enigma’ in favor of abbreviated biologic license applicant, Health Law Daily, July 22, 2015).

The Court also granted Apotex, Inc.’s motion for leave to file a brief as amici curiae; Apotex was involved in a similar dispute with Amgen (see Biosimilar applicant must give 180-day post-licensure notice to reference sponsor, Health Law Daily, July 6, 2016), though the Court denied Apotex’s petition for writ of certiorari earlier this term (see SCOTUS denies cert in biosimilar licensing dispute, Health Law Daily, December 12, 2016).

The Biologics Price Competition and Innovation Act (BPCIA), which was passed in 2010 as sections 7001-7003 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), created an abbreviated pathway for FDA approval of a “biosimilar” biologic product. Amgen originally brought suit against Sandoz in federal court asserting various violations of Amgen’s approved license for its cancer-fighting biologic Neupogen (filgrastim) and infringement of Amgen’s patent for a particular method of using filgrastim. The Court will be hearing arguments relating to Sandoz’s question regarding the 180-day notice of commercial marketing and Amgen’s cross-petition on the optionality of a process to settle patent disputes known as the “patent dance” (see Shall we dance? Biosimilars step toward new legal and regulatory future, Health Law Daily, March 31, 2016).

Makeup of the Court

Since the February 13, 2016, death of Justice Antonin Scalia, there have been eight Justices sitting on the Court. President Barack Obama’s nominee to replace Scalia, D.C. Court of Appeals Chief Judge Merrick Garland, was not considered by the Senate; President-elect Donald Trump plans to nominate a successor early into his term. In order to receive a vote in cases pending before the Court, a Justice must be seated on both the day of the oral argument and the day the written decision is released. Trump’s nominee will only be part of the decision if he or she is confirmed and duly sworn in before the oral arguments, which are not yet scheduled.

How will access to contraception coverage fare in light of the ACA repeal?

With the uncertainty about continued contraception coverage, a number of states have either enacted or introduced legislation to ensure that individuals continue to have access to contraception coverage and the number of women inquiring about birth control has increased. Since the November election and, in the wake of the imminent repeal of Obamacare, requests for intrauterine devices (IUDs) have been increasing significantly. Cecile Richards, President of Planned Parenthood, told CNN on January 9, 2017, that the demand for IUDs, a form of long-term birth control, has shot up 900 percent at Planned Parenthood branches because women “are desperately concerned that they will lose their access to health care,” SFGate news reported.

A December 7, 2016, Kaiser Family Foundation report that addressed private insurance coverage of contraception stated that many states have mandated minimum benefits for decades, including contraceptive coverage. Moreover, since the passage of the Affordable Care Act (ACA) (P.L. 111-148), states have strengthened and expanded the federal contraceptive coverage requirement. Among those states that have recently adopted contraceptive laws expanding ACA mandates for contraceptive coverage are New York, California, Oregon, Illinois, and Vermont.

New York

On January 11, 2017,  New York Attorney General Eric T. Schneiderman introduced “The Comprehensive Contraception Coverage Act of 2017” (CCCA), legislation that would provide access to cost-free contraception for women and expand coverage to men to ensure the continuation of contraception coverage under state law in light of Republicans’ goal of repealing the ACA.  The CCCA would (1) statutorily require state-governed health insurance policies to provide cost-free coverage for all FDA-approved methods of birth control, including emergency contraception, (2) prohibit insurance companies from “medical management” review restrictions that can limit or delay contraceptive coverage; (3) cover men’s contraceptive methods and bring their insurance coverage in line with the benefits enjoyed by women; and (4) allow for the provision of a year’s worth of a contraceptive at a time.

Crain’s New York Business addressed a number of items that are at stake in terms of women’s access to health care in New York under Donald Trump’s presidency. Although New York’s contraception legislation “has taken on new urgency for advocates since Trump’s victory,” the bill faces opposition from insurers because the provisions go beyond the ACA mandates, Crain’s predicted. In addition, Crain’s pointed out that Republicans in Congress will renew their efforts to defund Planned Parenthood, noting that access to services such as breast exams, Pap tests, STD screenings and family planning are most likely at risk of elimination for female Medicaid enrollees. Finally, abortion rights in New York might be curtailed if President-elect Trump’s Supreme Court judge appointee provides the Court with a majority of votes to overturn Roe v. Wade, the case that affirmed a woman’s constitutional right to an abortion under the 14th amendment. New York state law allows an abortion after 24 weeks only if it’s a matter of life and death for the woman, while constitutional law allows a woman to get a late-stage abortion if an anomaly poses a serious risk to her health or makes the fetus unviable, Crain’s explained.

Other States

In 2014, California passed the Contraceptive Coverage Equity Act of 2014 that requires plans to cover prescribed FDA-approved contraceptives for women without cost-sharing. In April of 2016, under the law, girls and women are able to drop by their neighborhood pharmacy and pick up birth control such as pills, patches, and injections without a doctor’s prescription but must speak with a pharmacist and fill out a questionnaire. Starting in January 2016, health plans were required to provide access to the full range of contraceptive methods approved by the FDA, including a variety of IUDs, for all insured individuals without cost-sharing, delays, or denial of coverage.

In 2015, Oregon passed two laws in 2015  expanding women’s access to birth control that became effective January 1, 2015.  HR2879 permits pharmacists to prescribe hormonal contraceptive patches and self-administered oral hormonal contraceptives, while HR3343 requires insurers to pay for a three-month supply of contraceptives when first prescribed, followed by a 12 month supply of contraceptives regardless of whether the woman was insured by the same plan at the time of the first dispensing. This law applies to oral contraceptive pills, the patch, and the vaginal ring.

The State Journal Register reported that Illinois adopted House Bill 5576, which will take effect January 1, 2017. Under the law, all ACA options must be covered without co-payments or deductibles, at least for women covered through health plans regulated by the state and plans that cover state employees, retirees, and their dependents. In addition, insurance companies must allow women to get a 12 month supply all at once.

The Burlington Free Press reported that Vermont legislation includes mandates from the ACA in the state law, but also expands upon the mandates to include additional birth-control methods, such as vasectomies. The bill specifies the 12 contraceptive products and services that must be included in health insurance plans as well as restrictions on cost-sharing for contraceptive services. It directs the Department of Vermont Health Access to establish 15 value-based payments for the insertion and removal of long-acting reversible contraceptives comparable to those for oral contraceptives.

Conclusion

Whether Congress repeals the ACA mandates requiring health insurance plans to provide contraceptive coverage and defunds Planned Parenthood is not certain. As of this writing, Congress has already taken initial steps to repeal the law. It remains to be seen if the actions the states have taken to ensure that both men and women have access to contraception under state law will hold up, and whether states that have introduced bills to ensure coverage will progress to enactment in the face of strong opposition.

 

High Court won’t hear case alleging discriminatory Medicare claims denial scheme

The U.S. Supreme Court declined to hear a case alleging that HHS participated in a racially discriminatory scheme of Medicare claims denials. The Fifth Circuit dismissed Edwards v. Burwell for lack of subject matter jurisdiction and failure to state a claim due to untimely filing, failure to specify improperly denied claims, and sovereign immunity. The High Court denied certiorari without comment.

A Texas physician was subject to a Medicare review process between 1997 and 2001 that resulted in denial of most of his claims. Most of those denials were successfully overturned on appeal, but the physician claimed that he was forced to close his practice in 2001 as a result of the initial denials. He filed a lawsuit against HHS, the HHS Secretary, and other unknown agents in 2014, alleging that his claims were initially denied as a result of racial profiling.

In affirming the district court’s dismissal of the doctor’s claims, the Fifth Circuit stated that the claims were filed outside of the 60-day window for judicial review required by 42 U.S.C. § 405(g) and were barred under § 405(h), which holds that a suit against the government or its officers or employees cannot be brought for Medicare actions. Furthermore, the physician failed to specify those claims that were not reversed on appeal (see No jurisdiction for discrimination suit based on reversed claim denials, Health Law Daily, August 3, 2016). He then filed his ultimately-denied petition for certiorari.

SCOTUS denies cert in biosimilar licensing dispute

The Federal Circuit’s decision finding it mandatory that a biosimilar-product applicant give a post-licensure notice to the manufacturer of the original FDA-approved biologic (the reference product sponsor) 180 days prior to beginning commercial marketing will remain law, because the Supreme Court denied a petition for writ of certiorari in Apotex Inc. v. Amgen Inc. A preliminary injunction granted by a district court will remain in effect, despite the biosimilar applicant giving notice to the reference product sponsor of its filing of an application to market the biosimilar (see Biosimilar applicant must give 180-day post-licensure notice to reference sponsor, Health Law Daily, July 6, 2016).

Background

In 2002, Amgen Inc. received a biologics license from the FDA for Neulasta® (pegfilgrastim), a human-engineered protein for patients undergoing chemotherapy. In 2014, Apotex Inc. filed an application for an FDA license to market a biosimilar version of Neulasta, invoking the abbreviated pathway for regulatory approval of follow-on biological products that are highly similar to a previously approved reference product. The abbreviated biosimilar pathway was allowed by the Biologics Price Competition and Innovation Act of 2009 (Biologics Act), which was created by sections 7001-7003 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148).

Under the Biologics Act, a biosimilar-product application may not be submitted until four years after the reference product was first licensed by the FDA and a biosimilar-product license may not be made effective until 12 years after the reference product was first licensed. The Biologics Act also contains detailed requirements that are focused on ways to avoid or streamline potential patent litigation by requiring the exchange of patent information between the biosimilar-product applicant and the reference product sponsor after the FDA accepts the biosimilar-product application for review. Finally, the Biologics Act requires the biosimilar-product applicant to give notice to the reference product sponsor 180-days before commercial marketing of its FDA-licensed product.

After the FDA accepted Apotex’s application for review, Apotex and Amgen engaged in the exchange of patent information as required by the Biologics Act. After negotiations, the parties agreed to an action for infringement of two patents, but after one of the patents expired, Amgen’s patent infringement action against Apotex was only based on the one remaining disputed patent. This appeal, however, did not involve the infringement action but rather Amgen’s motion for a preliminary injunction to require Apotex to provide Amgen notice if and when it receives a license from the FDA and to delay any commercial marketing for 180 days from that notice. The Federal Circuit upheld the injunction and found that giving post-licensure notice to the manufacturer was mandatory.

Supreme Court

In September 2016, Apotex filed a petition for writ of certiorari with the Supreme Court. It requested review of two issues: (1) whether the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the Biologics Price Competition and Innovation Act for the resolution of patent disputes must also provide the reference product sponsor with a notice of commercial marketing; and (2) whether the Federal Circuit improperly extended the statutory 12-year exclusivity period to 12 1/2 years by holding that a biosimilar applicant cannot give effective notice of commercial marketing for its biosimilar product until it receives a FDA license and therefore may not commercially market its biosimilar product for 180 days after receiving its license. On December 12, 2016, the Court denied Apotex’s petition.