On October 14, 2016, Mylan Pharmaceuticals and the Biosimilars Council, a subsidiary of the Generic Pharmaceuticals Association (GPhA), filed amicus briefs in support of granting review in Apotex v. Amgen, No. 16-332.  As previously reported, Apotex petitioned the U.S. Supreme Court in September for certiorari to clarify provisions of the 2009 Biologics Price Competition and Innovation Act (the “BPCIA”).  Apotex asked the High Court to reverse the Federal Circuit’s July 2016 ruling in Amgen v. Apotex, where it held that the 180-day commercial marketing notice provision is mandatory even when the parties engaged in the patent dance.

Both the Council and Mylan side with Apotex, arguing that biosimilar applicants who have already engaged in the patent dance with a reference product sponsor should not need to provide further notice of commercial marketing under section 42 U.S.C. § 262(l)(8)(A).  Mylan stressed that only the High Court can correct the Federal Circuit’s interpretation of the BPCIA, which binds subsequent Federal Circuit panels and district courts nationwide.

The case centers on biosimilars of Amgen’s Neupogen^® and Neulasta^® products.  In 1991, Amgen received FDA approval for filgrastim, which it markets under the brand name Neupogen^®.  Amgen received FDA approval in 2002 for a PEGylated version of filgrastim, which it markets under the brand name Neulasta^®.  Filgrastim is a recombinant form of human granulocyte colony-stimulating factor that stimulates white blood cells.  For patients receiving chemotherapy, stimulation of white blood cells aids in the fight against infection.  The PEGylated version of filgrastim exists longer in circulation than filgrastim.

Amgen owns U.S. Patent Nos. 8,952,138 (the “’138 Patent”) and U.S. Patent No. 6,162,427 (the “’427 Patent”) both of which allegedly cover Neupogen^® and Neulasta^®.  The ‘138 patent is directed to improved methods for refolding the proteins made in bacterial cells, allowing for industrial scale protein production, and the ‘427 patent is directed to an improved means of enhancing the mobilization of hematopoietic stem cells in patients undergoing stem cell transplants.

Apotex seeks to market a biosimilar to Neulasta^® and has an abbreviated biologic license application (“aBLA”) pending before the FDA.  Apotex and Amgen took several steps in the BPCIA patent dance before Amgen asserted that Apotex’s proposed marketing would constitute patent infringement if and when the FDA licenses Apotex’s proposed biosimilar.  The district court preliminarily enjoined Apotex from entering the market until it gives Amgen notice of its FDA licensure and waits 180 days.  The Federal Circuit affirmed, citing its holding in Amgen v. Sandoz, where it theorized that “[r]equiring that a product be licensed before notice of commercial marketing ensures the existence of a fully crystallized controversy regarding the need for injunctive relief.  It provides a defined statutory window during which the court and the parties can fairly assess the parties’ rights prior to the launch of the biosimilar product.”  Through this reasoning, Apotex expanded the reach of Sandoz to parties who had already engaged in the patent dance.  Amgen’s infringement allegations were subsequently resolved at the district court level in Apotex’s favor.  Amgen’s infringement allegations related to the ‘427 patent were dismissed by stipulation and the district court found that Apotex’s biosimilar does not infringe the ‘138 Patent, a ruling that Amgen is appealing.

In its petition for review, Apotex asks the Supreme Court to resolve (1) whether the Federal Circuit erred in holding that biosimilar applicants who make all disclosures necessary under the BPCIA 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 12½ years by holding that a biosimilar applicant cannot give effective notice of commercial marketing for its biosimilar product until it receives FDA approval.

Both Mylan and the Biosimilars Council urge the High Court to hold that effective notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A) can occur prior to a biosimilar receiving FDA approval.  The Council argues that if Congress intended for patent litigation to occur only after there was a “fully crystalized controversy” post-licensure, it would not have permitted infringement suits to be filed shortly after an applicant submits an aBLA.  Similarly, Mylan argues that Congress structured the BPCIA to allow both parties to begin litigation pre-licensure, thereby resolving all patent disputes between the earliest possible aBLA filing date and the earliest possible aBLA product licensure.

Further in this vein, the Council emphasized that Congress crafted “an artificial ‘act of infringement’” permitting infringement suits based on biosimilar applications prior to FDA approval to channel litigation to the period before FDA approval.  This, according to the Council, removes the threat of damages.  Both amici assert that the BPCIA was intended to encourage applicants to resolve patent issues before a product launch can result in millions of dollars’ worth of damages, which would position litigation after an aBLA is filed but before FDA approval.

The Biosimilars Council also maintains that the Court should hold that “biosimilar applicants are never required to wait until license approval to provide a notice of commercial marketing” because in some cases, by the time an aBLA is filed or FDA approval is granted, there may not be any unexpired patents to litigate.  In other instances, it is possible that by the time the FDA grants approval of a biosimilar, all unexpired patents will already be the subject of litigation or resolved through litigation.  The Council stressed that in cases such as these, the additional 6 months would serve no useful purpose and could lead to “absurd results.”

Mylan takes the argument further, arguing that the Federal Circuit’s interpretation overreaches by creating a private right of action to enforce § 262(l)(8)(A), by allowing a reference product sponsor to compel notice, something only Congress can authorize.

As the GPhA lobbies for generic drug companies, its Biosimilars Council stresses that pharmaceutical companies developing biosimilars need certainty regarding what the BPCIA requires and what rules govern their efforts to develop and market safe, effective and low-priced biologic therapies.  The Council emphasized in its brief that the cost to produce a biosimilar is significantly greater than that required to produce a small molecule generic drug; the first costing between $100-200 million and taking 8-10 years, and the second costing between $1-5 million and taking 3-5 years.  While a 180-day delay may not appear substantial at a glance, it amounts to significant lost dollars that need to be recouped to incentivize the successful development of safe, effective biosimilars, says the Council.  Both amici point to issues concerning competition and health care policy, including the need to increase patient access to more affordable biosimilar medicines.

The Council also compares the BPCIA to the Hatch-Waxman Act, stating that it is similarly based on the premise that litigation occurs while the FDA is considering whether to approve a generic drug.  Based on this, the Council’s brief claims there that is no reason to believe suits concerning products that never obtain FDA approval would waste judicial resources any more than do suits concerning yet-to-be-approved small molecule generics.

The Biosimilars Council filed an amicus brief supporting Sandoz’s petition in Sandoz v. Amgen, No. 15-1039 as well.  In its brief filed on October 14, 2016, the Council encouraged the High Court to grant review in the Sandoz and Apotex cases together on appeal because each presents a different factual scenario under which the notice issue arises.

In June of 2016, the Supreme Court sought advice from the U.S. Solicitor General concerning the Sandoz certiorari petition, hinting that the Supreme Court is seriously considering the BPCIA questions pending before it.  There has been no brief filed by the Solicitor General at this time.

We will continue to monitor this litigation and provide updates.