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Finding against the Federal Circuit once again on a patent case, the Supreme Court issued a unanimous decision in Sandoz v. Amgen relating to the interpretation of the Biologics Price Competition...
United StatesFood, Drugs, Healthcare, Life Sciences
Finding against the Federal Circuit once again on a patent case,
the Supreme Court issued a unanimous decision in Sandoz v. Amgen relating to the interpretation of the
Biologics Price Competition and Innovation Act of 2009
("BPCIA") in its first decision on the Act. The Supreme
Court's decision firmly establishes the availability of a third
biosimilar "dance," at least as far as Federal law is
concerned.
The BPCIA provides the mechanism by which companies can bring to
market "biosimilar" compounds, i.e., products that can
compete with biological drugs much the same way as generic drugs
compete with traditional "brand" pharmaceutical products.
On appeal, the Supreme Court considered two issues. First, the
biosimilar applicant, Sandoz, challenged the Federal Circuit's
interpretation of the BPCIA as requiring an applicant to wait until
after the FDA approved its biosimilar application before providing
the requisite 180-day notice of commercial marketing to the brand
company. This meant that a biosimilar applicant had to wait an
additional 180 days after its application was granted before it
could launch a competing product. The FDA cannot approve
("license") a biosimilar product until twelve years after
the biologic was first approved by the agency. Thus, the Federal
Circuit's decision effectively provided the brand manufacturer
with 12½ years rather than 12 years of market
exclusivity.
The Supreme Court reversed the Federal Circuit and explicitly
determined that applicants can provide notice before or after FDA
approval. According to the Supreme Court, the pertinent statutory
language in the BPCIA has two separate requirements: (1) that the
biosimilar application is "licensed" before it is
marketed; and (2) that the biosimilar applicant gives notice 180
days before marketing occurs. The Federal Circuit thus erred in
requiring licensure before notice could be given.
The second issue tackled by the Supreme Court relates to the
"patent dance" provisions of the BPCIA. The "patent
dance" is a statutory scheme through which the biosimilar
applicant and the brand manufacturer exchange information and legal
theories until deciding upon which patents to litigate first.
Sandoz refused to provide the biosimilar application and
manufacturing information contemplated in the dance, leading Amgen
to seek an injunction under federal and state law to compel
participation. The district court and Federal Circuit determined
that an injunction was not available.
On cross-appeal, the Supreme Court agreed with the Federal
Circuit that injunctions under federal law are not permitted, but
remanded the case to review state law remedies. According to the
Court, the BPCIA allows the brand company immediately to bring a
declaratory judgment action against the biosimilar applicant if
they do not provide their application and manufacturing
information. This remedy deprives the applicant of the ability to
control the scope of the litigation (i.e., which patents to
litigate) and the timing of the suit. The Supreme Court determined
that the remedy of immediate suit was the only federal remedy
contemplated for an applicant's failure to dance. The Supreme
Court remanded the case to address whether non-compliance with the
BPCIA can be considered a violation of California law entitling
Amgen to an injunction and/or whether the BPCIA's remedy
pre-empts any state law remedies.
Seyfarth will be closely monitoring the remand of
Sandoz in the coming months.
The SANDOZ Dance
Step 1: Skip
42 U.S.C. § 262(l)(2)(A)
Applicant refuses to provide aBLA and information describing
manufacturing
Step 2: File Suit
42 U.S.C. § 262(l)(9)(C)
Reference sponsor chooses what patents to sue upon and when to
bring suit against Applicant
The FAST BPCIA Dance
Step 1: Disclose
42 U.S.C. § 262(l)(2)(A) – 20 days
Applicant provides a copy of aBLA and information describing
manufacturing
Step 2: Disclose
42 U.S.C. § 262(l)(3)(A) – 60 days
Reference sponsor provides list of assertable patents and
identifies any patents it is willing to license
Step 3: Disclose
42 U.S.C. § 262(l)(3)(B) – 60 days
Applicant provides its own list of assertable patents, responds
to licensing offer, and gives "detailed statements" why
all listed patents are invalid, unenforceable, or will not be
infringed
Step 4: Disclose
42 U.S.C. § 262(l)(3)(C) – 60 days
Reference sponsor gives "detailed statements" why the
claims of all listed patents are infringed and responds to
Applicant's detailed statements
Step 5: Negotiate
42 U.S.C. § 262(l)(4)(A)
Applicant and Reference sponsor negotiate to develop a final
and complete list of patents for the initial patent infringement
lawsuit and agree
Step 6: File Suit42
U.S.C. § 262(l)(6)(A) – 30 days
Reference sponsor files suit on agreed-upon patents
The SLOW BPCIA Dance
Step 1: Disclose
42 U.S.C. § 262(l)(2)(A) – 20 days
Applicant provides a copy of aBLA and information describing
manufacturing
Step 2: Disclose
42 U.S.C. § 262(l)(3)(A) – 60 days
Reference sponsor provides list of assertable patents and
identifies any patents it is willing to license
Step 3: Disclose
42 U.S.C. § 262(l)(3)(B) – 60 days
Applicant provides its own list of assertable patents, responds
to licensing offer, and gives "detailed statements" why
all listed patents are invalid, unenforceable, or will not be
infringed
Step 4: Disclose
42 U.S.C. § 262(l)(3)(C) – 60 days
Reference sponsor gives "detailed statements" why the
claims of all listed patents are infringed and responds to
Applicant's detailed statements
Step 5: Negotiate
42 U.S.C. § 262(l)(4)(B) – 15 days
Applicant and Reference sponsor negotiate to develop a final
and complete list of patents for the initial patent infringement
lawsuit but FAIL TO agree
Step 6: Choose
42 U.S.C. § 262(l)(5)(A)
Applicant gives reference sponsor the number of patents it
proposes to litigate
Step 7: Exchange
42 U.S.C. § 262(l)(5)(B) – 5 days
Applicant and Reference sponsor simultaneously exchange list of
patents that should be part of infringement action; Reference
sponsor's list limited to same number given by Applicant
Reference sponsor files suit on all patents on lists.
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