Celltrion, Inc. (“Celltrion”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on August 15, 2016 for inter partes review (“IPR”) of U.S. Patent No. 7,820,161 (“the ’161 patent”) related to Genentech’s Rituxan® (rituximab).  On February 24, 2017, the PTAB issued a decision instituting review of claims 1–3, 5–7, and 9–11 of the ’161 patent.  The challenged claims of the ’161 patent are directed to a method for treating rheumatoid arthritis by administering more than one intravenous dose of a therapeutically effective amount of rituximab and administering methotrexate.

Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma, chronic lyphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis, and microscopic polyangitis.

The proceeding is IPR2016-01614. The real party-in-interest identified for Petitioner is Celltrion, Inc.  The real parties-in-interest identified for Patent Owner are Genentech, Inc. and Biogen, Inc.  The PTAB previously instituted an IPR for certain claims of the ’161 patent (claims 1, 2, 5, 6, 9, and 10) on a petition filed by Boehringer Ingelheim. That proceeding (IPR2015-00415) was terminated on October 1, 2015, following a Request for Adverse Judgment by Petitioner. Celltrion also previously filed a petition challenging certain claims of the ’161 patent, IPR2015-01744, on August 17, 2015.  Celltrion filed a motion seeking to join that proceeding with IPR2015-0415, but when IPR2015-00415 was terminated by Boehringer Ingelheim (before an institution decision on Celltrion’s petition), Celltrion moved to dismiss the petition in IPR2015-01744 without prejudice.  Celltrion currently has a separate petition for IPR pending for U.S. Patent No. 7,967,838.  A decision on institution in that proceeding is expected shortly.

A complete list of IPRs related to rituximab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.

Celltrion’s Truxima (CT-P10, rituximab), a biosimilar to Rituxan® received approval from the European Commission on February 22, 2017.  Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma, chronic lyphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis, and microscopic polyangitis.   The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Truximab for approval on December 15, 2016.  Truxima is the first biosimilar product for the treatment of cancer that has been approved in Europe.  Truxima was approved in South Korea in November 2016 and it has been reported that Celltrion plans to submit an application for rituximab to the FDA in early 2017.

Celltrion, Inc. (“Celltrion”) filed a new petition with the Patent Trial and Appeal Board (“PTAB”) on February 21, 2017 for inter partes review (“IPR”) of U.S. Patent No. 8,591,897 (“the ’897 patent”) related to Genentech’s Herceptin® (trastuzumab).  The challenged claims of the ’897 patent are directed to methods for treating patients with nonmetastatic HER2-positive breast cancer by administering anthracycline/cyclophos-phamide (AC) based chemotherapy, followed by sequential administration of a taxoid and trastuzumab.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor (HER2)/neu. Herceptin® is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

The proceeding is IPR2017-00959. The real parties-in-interest identified for Petitioner are Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH.

In addition to the four petitions filed by Celltrion for the ’897 patent, several other petitions for IPRs on other patents related to Herceptin® have been filed with the PTAB by Hospira (discussed here and here) and Mylan.  A complete list of IPRs can be found in RFEM’s IPR Dashboard.

We will continue to provide updates as these cases progress.

On February 15, 2017, Genentech filed litigation accusing Amgen of violating the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262.  A dispute arose between the parties during the first step of the “patent dance” for Amgen’s bevacizumab product (ABP 215), a proposed biosimilar to Genentech’s Avastin®.

Amgen announced in November 2016, that it submitted a biologics license application to FDA for bevacizumab, an anti-vascular endothelial growth factor (Anti-VEGF) specific monoclonal antibody that inhibits formation of new blood vessels  and is used to slow the growth of tumors related to several types of cancers.  Avastin® is indicated for treatment of conditions related to metastatic colon cancer, lung cancer, glioblastoma, ovarian cancer and cervical cancer.

The litigation concerns the scope of the information, if any, in addition to a copy of the 351(k) application, that an applicant must provide to the reference product sponsor at the beginning of the “patent dance” pursuant to section 262(l)(2)(A) of the BPCIA.  The parties also disagree as to whether Genentech should be permitted to share Amgen’s confidential information with its outside scientific experts at this stage of the proceeding, subject to a confidentiality agreement.

According to the Complaint, Amgen notified Genentech on January 4, 2017 that its abbreviated application for a bevacizumab biosimilar had been accepted for review by FDA.  For those applicants who decide to avail themselves of the benefit of the patent dance, section (l)(2) of the BPCIA provides that “no later than 20 days after the FDA notifies the applicant that the application has been accepted for review,” the section (k) applicant:

(A) shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application; and

(B) may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.

See 42 U.S.C. § 262(l)(2) (emphasis added).  The statue further requires that no later than 60 days “after the receipt of the application and information under paragraph (2),” (cited above), the reference product sponsor shall provide to the subsection (k) applicant, a list of patents for which it believes a claim of patent infringement could reasonably be asserted (“the 3A list”) and identify the patents from the 3A list that the reference product sponsor would be willing to license to the applicant.  Id. at § 262(l)(3)(A).  The exchange of information, including detailed statements on each party’s claims and defenses of patent infringement/non-infringement and validity/invalidity continues thereafter, but it is the exchange of information for the first two steps (under sections (l)(2)(A) and (l)(3)(A)) that gave rise to the Complaint.

The Federal Circuit has held that an applicant using the 351(k) pathway may “opt-out” of the patent dance entirely, in which case it is not required to provide early access to its application prior to the filing of a lawsuit.  See Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347, 1356–57 (Fed. Cir. 2015).  As discussed in this post, the Supreme Court recently granted certiorari and will consider the appeal of that decision later this term.  The Amgen v. Sandoz, decision, however, does not address the specific issue presented here – namely, what is required to satisfy the disclosure requirement of 262(l)(2)(A).

Genentech alleges in the Complaint that “Amgen has refused to provide Genentech with anything except its aBLA” and that Amgen has “[taken] the position that producing the aBLA alone was sufficient under the statute.”  More specifically, Amgen asserts that “Amgen has purported to opt into the BPCIA’s information exchange procedures, and consequently, it should have given Genentech access to certain specific categories of Amgen manufacturing information” that Genentech says are “highly relevant for Genentech (and its outside expert consultants) to review in order to determine whether the manufacture and/or sale of Amgen’s product would infringe Genentech’s patents.” Genentech characterizes the consequences of not receiving the requested information as “potentially disastrous,” because if Genentech fails to list a patent, it could be barred permanently from asserting that patent against Amgen’s biosimilar Avastin®.”

The Complaint includes a separate count accusing Amgen of violating 42 U.S.C. § 262(l)(1)(C) by “unreasonably withholding consent” for Genentech to share Amgen’s information with Genentech outside scientific experts (subject to confidentiality requirements).   Although Genentech interprets section (l)(1)(c) as imposing an affirmative obligation to “reasonably” allow access by experts, subsection (l)(1)(c) is actually written as a limitation that prohibits the disclosure of confidential information to any person, including the reference product sponsor’s outside scientific consultants,  without the applicant’s written consent.  The full text of that subsection provides that:

No person that receives confidential information pursuant to subparagraph (B) shall disclose any confidential information to any other person or entity, including the reference product sponsor employees, outside scientific consultants, or other outside counsel retained by the reference product sponsor, without the prior written consent of the subsection (k) applicant, which shall not be unreasonably withheld.

Genentech also criticizes Amgen in the Complaint for allegedly taking a position on the scope of the required disclosures here that is contrary to the position Amgen has taken when it has been on the other side of patent dance negotiations (as the reference product sponsor) for other products.  For example, Genentech cites to specific statements Amgen made in prior litigation with Hospira (involving Epogen®) and with Sandoz (involving Neupogen®) and characterizes Amgen’s position here as “an about face” on the scope of the required disclosures.

It is interesting to note, however, that Amgen’s position here in the bevacizumab patent dance appears to be consistent with the positions that it took in the patent dance with AbbVie regarding adalimumab (Amjevita® and Humira®), where Amgen (as an applicant for a proposed biosimilar) only provided access to its BLA and did not provide any other manufacturing information.  See AbbVie v. Amgen, Civ. No. 16-cv-00666, (D. Del.), Doc. No. 1 (Complaint) and Doc. No. 13 (Answer).  During the patent dance for adalimumab, Amgen also declined Abbie’s request to expand the scope of confidential access to include outside experts at this stage of the proceeding.  Id.

Finally, the Complaint seeks declaratory relief that because of Amgen’s failure to provide the information required by section (l)(2)(A), Genentech should not be required to provide its 3A list of patents until after Amgen has satisfied its obligations discussed above.

The issues presented in the Complaint are new issues of statutory interpretation that have not yet been addressed by the Courts.  The plain language of the statue says that the biosimilar applicant “shall provide . . . a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” The use of the conjunctive term “and” as well as the specific reference to other manufacturing information seems to indicate that, at least in some instances, manufacturing information outside of the application must be provided when an applicant elects to participate in the patent dance. However, the statue does not identify what specific manufacturing information is required to satisfy the requirement for “such other information that describes the process or processes used to manufacture the biological product that is the subject of such application” in the second prong of clause (l)(2)(A).

Elsewhere in the BPCIA, section (l)(1)(B) separately states that:

When a subsection (k) applicant submits an application under subsection (k), such applicant shall provide . . . confidential access to the information required to be produced pursuant to paragraph (2) and any other information that the subsection (k) applicant determines, in its sole discretion, to be appropriate (referred to in this subsection as the ‘‘confidential information’’).

See 42 U.S.C. § 262 (l)(1)(B) (emphasis added).  Thus, section (l)(1)(B) makes it clear that the decision to provide any additional information requested by the reference product sponsor pursuant to section (l)(2)(B) is within the sole discretion of the applicant.  Once again, however, section (l)(1)(B) does not identify or further clarify what information other than the application, if any, must be provided by the applicant to satisfy the second part of clause (l)(2)(A) by an applicant who is participating in the patent dance.

Another threshold question that will have to be addressed by the Court is whether the Complaint contains a claim for which relief can be granted.  The BPCIA expressly provides in section (l)(9)(C) that if an applicant “fails to provide the application and information required under paragraph (2)(A),” then the reference product sponsor (but not the applicant) may bring a declaratory judgment action for infringement, validity, or enforceability of “any patent that claims the biological product or a use of the biological product.”  See 42 U.S.C. § 262(l)(9)(C).  Subsection (l)(9)(b) further provides that the reference products sponsor may file a declaratory judgment action for infringement, validity or enforceability of any patent on the reference product sponsor’s 3A list if the applicant fails to cooperate in subsequent steps of the patent dance (for example, by not providing a 3B detailed statement, failing to identify the number of patents to be listed in accordance with paragraph 5, and the failure to provide  notice of commercial marketing, among others). See 42 U.S.C. § 262 (l)(9)(B).

On the other hand, section (l)(9)(A), expressly provides that if the applicant “provides the application and information required under paragraph (2)(A),” neither the reference product sponsor nor the subsection (k) applicant may bring a declaratory judgement for infringement, validity, or enforceability of any patent that is described in clauses (8)(b)(i) and (ii) prior to the date notice of commercial marketing is received.

Here, the parties disagree whether Amgen has provided “the information required under paragraph (2)(A).” If Amgen has not provided sufficient information to satisfy the disclosure requirement of section (l)(2)(A), then Genentech is permitted to bring a claim for patent infringement, validity or enforceability pursuant to section (l)(9)(C).  If Amgen has satisfied the disclosure requirements of section (l)(2)(A), then Genentech is prohibited from bringing a declaratory judgment claim for patent infringement, validity or enforceability until after the notice of commercial marketing is received.

The Complaint filed by Genentech, however, does not assert a claim for patent infringement or any claim regarding the validity or enforceability of any patent. Rather, the Complaint asserts claims discussed above, and Genentech’s Complaint seeks the following relief:

  1. an order directing Amgen to comply with its obligations under 42 U.S.C. § 262(l)(2)(A) by providing manufacturing information;
  2.  an order directing Amgen to comply with its obligation under and § 262(l)(1)(C)  by not withholding consent for Genentech to share the information with experts;
  3. a resetting of the BPCIA deadlines for resolving patent disputes; and
  4. an order prohibiting Amgen from selling its proposed biosimilar to Avastin®, until the statutory process is completed.

 This raises the threshold question of whether Genentech has the right to bring claims for violation of the BPCIA based on an alleged “failure to provide the application and information required under paragraph (2)(A),” other than a declaratory judgment claim for patent infringement, validity or enforceability as permitted by (l)(9)(C) – particularly in view of the Federal Circuit’s statement in Amgen v. Sandoz that section (l)(9)(C) and 35 U.S.C. § 271(e) provided the only remedies available to Amgen and that “the BPCIA has no other provision that grants a procedural right to compel compliance with the disclosure requirement of paragraph (l)(2)(A).”   See Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347, 1365 (Fed. Cir. 2015), cert. granted, 85 U.S.L.W. 3343 (Jan. 13, 2017) (Nos. 15-1039 and 15-1195).

Amgen has not yet filed an Answer to the Complaint.  Absent entry of an expedited case schedule, Amgen’s answer to the complaint is due on March 8, 2017, and Genentech has identified the 60-day deadline for its 3A list as March 24, 2017.  If this matter is not resolved quickly, it seems unlikely that Genentech would let that date pass without providing at least a partial (if not complete) patent list to Amgen.

The FDA has accepted for review an application submitted by Mylan N.V. (“Mylan”) and Biocon Ltd. (“Biocon”) under the 351(k) pathway for MYL-1401K, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim).  According to the announcement, the BSUFA date (FDA’s target goal) for a decision on the application is October 9, 2017.

The FDA has not yet approved a pegfilgrastim biosimilar but there are several applications under review, including applications from at least Apotex (accepted by FDA in December 2014), Sandoz (accepted by FDA in November 2015) and Coherus (accepted by FDA in October 2016).

Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team at CDER, recently participated in a podcast on biosimilars.  During the discussion, she provided a “snapshot” of the biosimilar landscape at FDA.

According to Dr. Christl, as of February 1, 2017, there are 64 programs enrolled in the biosimilar development program, and CDER has received meeting requests for 23 different reference products.  Pending applications are confidential.  However, since program inception through February 1st of this year, nine different companies have publicly announced the submission of 13 BLAs using the 351(k) pathway.

Dr. Cristl also discusses communicating with TBBS, summarizes FDA’s policy on Advisory Committee meetings for biosimilars, and looks ahead at interchangeability and BsUFA II. The podcast is available here from Pharma Intelligence.

Coherus Biosciences, Inc. (“Coherus”) has filed four petitions with the Patent Trial and Appeal Board (“PTAB”) for inter partes review (“IPR”) of U.S. Patent No. 9,085,619 (“the ’619 patent”) related to AbbVie’s Humira® (adalimumab).  The challenged claims of the ’619 patent are directed to formulations of adalimumab and closely-related antibodies.  Adalimumab is a TNF (tumor necrosis factor) inhibitor that binds to TNF-alpha (TNF-α) preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Humira® is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The proceedings are IPR2017-00822; IPR2017-00823; IPR 2017-00826; and IPR2017-00827. The only real party-in-interest identified for Petitioner is Coherus BioSciences Inc.  The real parties-in-interest identified for the Patent Owner are AbbVie Biotechnology Ltd. and AbbVie Inc.

In addition to the four petitions filed by Coherus for the ’619 patent, several other IPRs have been instituted by the PTAB on other patents related to Humira®.  A complete list of IPRs can be found in RFEM’s IPR Dashboard.

We will continue to provide updates as these cases progress.

Hospira, Inc. (“Hospira”) filed two additional new petitions with the Patent Trial and Appeal Board (“PTAB”) on January 30, 2017 for inter partes review (“IPR”) of U.S. Patent Nos. 6,627,196 (“the ’196 patent”) and 7,371,379 (“the ’379 patent”) related to Genentech’s Herceptin® (trastuzumab).  These filings come on the heels of three petitions Hospira filed earlier in January 2017 as discussed here. The challenged claims of the ’196 and ’379 patents are generally directed to methods of treating cancers characterized by the overexpression of ErbB2 by administering an effective amount of an anti-ErbB2 antibody using a dosage regimen that provides a large initial dose, followed by the subsequent administration of additional dosages in amounts that are the same as or less than the initial dosage spaced two to three weeks apart (referred to in the specification as “front loading”).

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor (HER2)/neu. Herceptin® is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

The proceedings are IPR2017-00804 (involving the ’196 patent) and IPR2017-00805 (involving the ’379 patent). As in the earlier filed petitions, the real party-in-interest identified for Petitioner is Hospira, Inc. Petitioner also identified Pfizer, Inc. as a real party-in-interest who, going forward, may have control or an interest in the outcome of the proceeding. Here again, the only real party-in-interest identified by the Patent Owner is Genentech, Inc.

With the filing of these most recent petitions, Hospira has filed a total of six IPR petitions related to Herceptin® (trastuzumab).  Mylan has also filed a petition regarding Herceptin® (trastuzumab).  The PTAB has not yet issues a decision on institution in any of the proceedings.  A complete list of IPRs can be found in RFEM’s IPR Dashboard.

We will continue to provide updates as these cases progress.

The Supreme Court has agreed to hear its first biosimilar case interpreting two provisions of the Biologics Price Competition and Innovation Act (“BPCIA”).  On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari in Sandoz, Inc. v. Amgen, Inc., et al. No. Case No. 2015-1039 and on Amgen’s conditional cross-petition for certiorari in Amgen Inc., et al. v. Sandoz, Inc., Case No. 2015-1195.  The consolidated cases raise two critical issues related to the patent dispute resolution provisions of BPCIA. This is the first time the Supreme Court has accepted an opportunity to consider and interpret the BPCIA statutory scheme. The issues before the Supreme Court are central to the applicability of the statute and arose between Amgen and Sandoz in conjunction with Sandoz’s filing of an abbreviated biologics license application for filgrastim (a proposed biosimilar to Amgen’s Neupogen®) and pegfilgrastim (a proposed biosimilar to Amgen’s Neulasta®).

Issues to Be Decided

The issues the Supreme Court will decide in the appeal of Amgen v. Sandoz are: (1) whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the applicant “shall provide;” and (2) whether, where an applicant fails to provide that required information, the sponsor’s sole recourse is to commence a declaratory judgment under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii).

The issues that the Supreme Court will decide in the appeal of Sandoz v. Amgen are: (1)  whether notice of commercial marketing given before Food and Drug Administration approval can be effective; and (2) whether, in any event, it is improper to treat Section 262(l)(8)(A) – the Biologics Price Competition and Innovation Act of 2009’s “Notice of commercial marketing” provision which states that a biosimilar applicant shall provide notice to the incumbent seller of the biological product “not later than 180 days before the date of the first commercial marketing of the biological product licensed under” an abbreviated pathway for biosimilars – as a stand-alone requirement and as creating an injunctive remedy that delays all biosimilars by 180 days after approval.

Factual Background

The BPCIA established an abbreviated approval pathway allowing applicants seeking approval of biologics to rely on certain clinical data contained in an earlier application submitted by the reference product sponsor if they can demonstrate that product is “biosimilar” to the previously approved reference product. The BPCIA amended the Patent Act to create an artificial “act of infringement” based on the filing of a biosimilar application.  See 35 U.S.C. § 271(e)(2)(C), (e)(4), (e)(6). The BPCIA further provides a series of steps for the exchange of patent information and the potential for early resolution of patent infringement claims related to the product that is the subject of the application. See 42 U.S.C. 262(l).  This process is commonly referred to as the “patent dance.”

Pertinent to the issues presented here, section § 262(l)(2)(A) of the BPCIA states that, upon FDA acceptance of an application for review, the applicant “shall provide” the reference sponsor with a copy of its application and other information describing the manufacturing processes for the biosimilar product.  See 42 U.S.C. § 262(l)(2)(A).  Separately, the BPCIA provides that, under § 262(l)(8)(A), an applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”

Amgen markets filgrastim under the brand name Neupogen®. In May 2014, Sandoz submitted an abbreviated biologics license application seeking FDA approval of its proposed biosimilar filgrastim product. In July 2014, Sandoz informed Amgen of its filing and of its intent to launch the product immediately once it received FDA approval. Subsequently, upon FDA’s acceptance of its application, Sandoz informed Amgen that it had decided not to disclose a copy of its application or manufacturing information to Amgen and advised Amgen that it was entitled to sue Sandoz under § 262(l)(9)(C) for declaratory judgment of patent infringement, validity, and enforceability. Paragraph 9(C) provides that if an applicant does not provide the application and information as required under (2)(A), “the reference product sponsor, but not the subsection (k) applicant may bring an action under section 2201 of title 28, United States Code, for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.”

The FDA approved Sandoz’s product in March 2015 and Sandoz again gave Amgen notice of its intent to commercially market its product. Amgen subsequently filed suit alleging that Sandoz violated the BPCIA by failing to provide Amgen with a copy of its application and by giving ineffective notice of commercial marketing. Ruling on the parties’ cross-motions for judgment on the pleadings, the district court concluded that the plain language and statutory scheme of the BPCIA render Sandoz’s decision not to disclose its application permissible and that such a decision does not provide the reference sponsor a basis for injunctive relief. The district court further concluded that an applicant may give 180-day notice of commercial marketing to a sponsor prior to obtaining FDA approval.

The Federal Circuit Decision

On appeal, the Federal Circuit concluded that the while the language “shall provide” in section (l)(2)(A) would appear to create a mandatory requirement that an applicant disclose its application and manufacturing information to the reference sponsor when read in isolation, the provision cannot be read in isolation. The Court recognized that other portions of the BPCIA explicitly contemplate that an applicant may fail to disclose the required information by the statutory deadline and specifically provide the consequence of such a failure is the exposure to an infringement action under 42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. § 271(e)(2)(C)(ii). The Court further concluded that (l)(9)(C) and § 271(e) provide the only remedies available to a reference product sponsor under the circumstances because “the BPCIA has no other provision that grants a procedural right to compel compliance with the disclosure requirement of paragraph (l)(2)(A).” Thus, according to the Federal Circuit, by taking actions specifically addressed by the BPCIA, Sandoz did not violate the statute.   The effect of this decision is that a section (k) applicant may “opt out” of the disclosure requirements of the patent dance.

The Federal Circuit, however, agreed with Amgen that notice of commercial marketing is only effective for a “licensed” product, meaning that the notice must be provided after the product is approved (licensed) by the FDA.  The Court reasoned that providing notice only after approval of a license allows the reference sponsor to definitively determine the patents involved and the scope of injunctive relief to seek. The Court ultimately held that Sandoz’s initial notice was ineffective, but that its notice subsequent to its approval was effective. The Court further concluded that notice of commercial marketing is an independent mandatory requirement that is not excused if the applicant chooses not to disclose its application and participate in the patent dance.

The Supreme Court’s decision to hear the cases was surprising to some because the Court previously denied the petition for certiorari in Apotex v. Amgen, another case involving the notice of commercial marketing requirement.  After Amgen v. Sandoz had been decided, the Federal Circuit issued another decision, a year later, reiterating the principles of its earlier decision – namely that the notice of commercial marketing required by 42 U.S.C. § 262(l)(8)(A) must occur post-licensure. The issue in Apotex v. Amgen was whether the commercial notice requirement of section (8)(A) was also necessary post-licensure if the applicant had elected to provide access to its application pursuant to section (2)(A) of the BPCIA rather than “opting out” of the patent dance.

Unlike Sandoz, Apotex had elected to participate in the patent dance and provided Amgen with a copy of its application and information regarding its manufacturing process for its biosimilar product within 20 days of the FDA’s acceptance of its application pursuant to section (l)(2)(A) of the BPCIA.  During the exchange of information, Apotex sent a letter to Amgen providing notice of its future intent to commercially market its product, prior to receiving approval from FDA for its product. Following the required negotiations, the parties agreed to an infringement action on two patents and Amgen subsequently filed suit on August 6, 2015. In October 2015, Amgen filed a motion for a preliminary injunction requesting the district court require Apotex to provide the notice of commercial marketing pursuant to section (8)(A) once receiving a license (i.e. upon product approval), and confirming that commercial marketing would not begin until 180 days following that notice. The district court granted the motion and Apotex appealed.

The Federal Circuit affirmed the district court’s ruling, stating that the fact that “Apotex gave (2)(A) notice provides only a factual distinction, not a legally material distinction, between its situation and that of Sandoz in Amgen v. Sandoz.” The Court concluded that the (8)(A) post-licensure notice requirement is mandatory and enforceable by an injunction regardless of whether disclosure under (2)(A) has been provided. The Court also rejected Apotex’s contention that § 262(l)(9)(B) makes a declaratory-judgment suit the exclusive remedy for violation of the commercial notice requirement of section (8)(A). Amgen filed a petition for writ of certiorari but the Supreme Court denied the petition in that case.

On January 25, 2017, the Supreme Court issued a briefing schedule.  According to the schedule, Sandoz’s opening brief in 15-0139 is due February 10, 2017, Amgen’s consolidated opening brief in 15-1195 and response in 15-039 is due on March 10, 2017, Sandoz’s consolidated reply in 15-0139 and response in 15-1195 is due March 31, 2017, and Amgen’s reply in 15-1195 is due on April 14, 2017.  Amici briefs in support of Sandoz or in support of neither party are due February 17, 2017.  Amici briefs in support of Amgen are due March 17, 2017.

Hospira, Inc. (“Hospira”) filed three petitions with the Patent Trial and Appeal Board (“PTAB”) on January 20, 2017 for inter partes review (“IPR”) of U.S. Patent Nos. 7,846,441 (“the ’441 patent”) and 7,892,549 (“the ’549 patent”) related to Genentech’s Herceptin® (trastuzumab).  The challenged claims of the ’441 patent are directed to a method of treating cancers linked to the overexpression of the human ErbB2 protein by administering an anti-ErbB2 antibody that binds to epitope 4D5 and a taxoid chemotherapeutic agent in the absence of an anthracycline derivative.  The challenged claims of the ’549 patent are directed to a method of treating cancers characterized by the overexpression of ErbB2 by administering a combination of an anti-ErbB2 antibody, a taxoid chemotherapeutic agent, and another therapeutic agent which may be another antibody, a growth inhibitory agent, or a cytokine.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor (HER2)/neu. Herceptin® is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

The proceedings are IPR2017-00731 (involving the ’441 patent), IPR2017-00737 (involving the ’549 patent) and IRP2017-00739 (also involving the ’549 patent). The real party-in-interest identified for Petitioner is Hospira, Inc. Petitioner also identified Pfizer, Inc. as a real party-in-interest who, going forward, may have control or an interest in the outcome of the proceeding. The only real party-in-interest identified by the Patent Owner is Genentech, Inc.

This is not the first petition for IPR filed by Hospira regarding trastuzumab.  In September 2016, Hospira filed a petition for IPR on U.S. Patent No. 7,807,799.  Mylan has also filed a petition regarding Herceptin® (trastuzumab).  The PTAB has not yet issued a decision on institution in any of these proceedings.  A complete list of IPRs can be found in RFEM’s IPR Dashboard.

We will continue to provide updates as these cases progress.