Samsung Bioepsis UK Limited (“Samsung”), Biogen Idec Limited (“Biogen”), and Fujifilm Kyowa Kirin Biologic Company Limited (“Fujifilm Biologics”) have prevailed against two of AbbVie’s patents for Humira® in the UK.

On March 3, 2017, Justice Henry Carr of the UK High Court of Justice issued a decision declaring that administration of 40mg of adalimumab once every two weeks by subcutaneous injection for the treatment of rheumatoid arthritis was obvious as of June 8, 2001 (the priority date awarded by the Court to European Patent No. 1406656) and that administration of 40mg of adalimumab subcutaneously every other week for the treatment of psoriasis and psoriatic arthritis was obvious and/or anticipated as of July 18, 2003 (the priority date of the European Patent No. 1944322).

The opinion notes that “Humira is the highest selling prescription drug in the world by global sales, achieving net sales in 2014 in excess of US$ 12.5 billion.”  The case was originally filed in March 2016.  During the course of the litigation, AbbVie revoked (abandoned) the ’656 and ’322 patents in Europe.  AbbVie also de-designated a third patent in the UK that was going to be added to the litigation, European Patent No. 2940044.  AbbVie offered to sign an undertaking in which it agreed, inter alia, “not to obtain patent protection in the UK that would be infringed by certain dosage regimens.”  AbbVie asserted that in view of its agreed undertakings, declaratory judgment from the Court “would serve no useful purpose.”

The Court disagreed with AbbVie, however, characterizing the language of the proposed undertakings as “complicated and very long,” and specifically pointing out that “they do not refer to anticipation or obviousness, and they do not acknowledge that the Claimants’ products were anticipated or obvious at the priority date(s).”  The Court further reasoned that “threats of worldwide litigation” by AbbVie’s CEO, Mr. Richard Gonzalez, “are intended to have, and are likely to have had, a chilling effect on competition from biosimilars, including on third-party suppliers.”  The Court accepted Claimant’s allegations that such threats were “likely to impede the Claimants’ ability to market successfully their products in the United Kingdom.”  Therefore, the Court found that under the circumstances, the grant of declaration from the Court “would serve a useful purpose.”

Justice Carr’s opinion included additional, “[s]pecial reasons for or against the grant of the declarations,” where the Court stated that:

[O]n the most unusual facts of this case, there are special reasons which support the grant of the declarations. These include AbbVie’s conduct of threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny); the amount of money at stake for the Claimants in terms of investment in clinical trials and potential damages if they launch at risk; and the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world.

The Court provided its conclusions at the end a 99-page opinion in which it separately addressed the facts and evidence in support of the request for declaratory relief, the priority dates, and the merits of the technical case.

The UK Court’s ruling does not have any direct legal effect in the United States.  However, there is litigation pending before Judge Robinson in the United States District Court of Delaware involving ten of AbbVie’s patents and Amgen’s proposed biosimilar adalimumab product.  See AbbVie v. Amgen, Civ. No. 1:16-cv-666, (D. Del.)(SLR).  Several patents related to Humira® are currently being challenged in post-grant proceedings before the PTAB.  A summary of IPR proceedings on patents related to Humira® can be found in the RFEM Biologics IPR Dashboard.

 

On March 2, 2017, the PTAB issued a decision denying Celltrion, Inc.’s (“Celltrion”) request for inter partes review (“IPR”) of claims 1-14 of U.S. Patent No. 7,976,838 related to Genentech’s Rituxan® (rituximab).  This denial comes less than a week after the PTAB instituted IPR of U.S. Patent No.     7,820,161, related to the same product, in response to a separate petition filed by Celltrion as discussed in this post.  

The challenged claims of the ’838 patent are generally directed to methods of treating rheumatoid arthritis in a patient who experiences an inadequate response to a TNFα-inhibitor by administering an anti-CD20 antibody, such as rituxan, intravenously at certain dosages.  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 Board denied institution in proceeding IPR2016-01667 filed on August 25, 2016. The real parties-in-interest identified for Petitioner are Celltrion, Celltrion Healthcare Co. Ltd. (“CTHC”), and Teva Pharmaceuticals International GmbH (“Teva”).  The only real party-in-interest identified for Patent Owner is Genentech, Inc.  The PTAB previously instituted an IPR for certain claims of the ’838 patent on a petition filed by Boehringer Ingelheim. That proceeding (IPR2015-00417) 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 ’838 patent, IPR2015-01733, on August 14, 2015.  Celltrion filed a motion seeking to join that proceeding with IPR2015-0417, but when IPR2015-00417 was terminated by Boehringer Ingelheim (before an institution decision on Celltrion’s petition), Celltrion moved to dismiss the petition in IPR2015-01733 without prejudice.

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

Genentech’s lawsuit against Amgen has come to a quick (although perhaps temporary) end, with the Court dismissing Genentech’s complaint without prejudice on March 1, 2017 for lack of subject matter jurisdiction in light of Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015).  As discussed in our earlier post (which raised the question of whether Genentech had stated a claim on which relief could be granted), the Complaint for Declaratory Judgment filed by Genentech on February 15, 2017, alleged that Amgen failed to comply with the disclosure requirements of section (l)(2)(A) of the Biologics Price Competition and Innovation Act (“BPCIA”) in the “patent dance” involving Amgen’s bevacizumab product, a proposed biosimilar to Genentech’s Avastin®.

The whirlwind began on February 22, 2017—a week after the complaint was filed—with Genentech requesting a “speedy hearing” pursuant to Federal Rule of Civil Procedure 57.  Genentech sought a quick resolution because Genentech itself alleges that it faces a statutory deadline of March 24, 2017 to provide Amgen with its patent list under section (l)(3)(A) of the BPCIA.  Judge Sleet scheduled a teleconference with the parties on the morning of February 24, 2017 and then held follow-up teleconferences later that same day.  The Court ordered the parties to submit 3-page letter briefs on February 27 and 28, 2017, respectively, and scheduled a hearing for March 1, 2017.

Amgen argued that although it disagreed with the Federal Circuit’s interpretation of 42 U.S.C. § 262(l)(2)(A) in Amgen v. Sandoz, the Federal Circuit’s decision in that case mandated that the only course of action provided by the BPCIA for non-compliance with the disclosure requirements of section (l)(2)(A) is a declaratory judgment action for patent infringement, and therefore the relief sought by Genentech’s declaratory judgment complaint was procedurally improper.

Genentech countered that “the Federal Circuit did not (and did not purport to) foreclose declaratory judgment actions to determine whether an applicant complied with its statutory obligations” in Amgen v. Sandoz and that “it is only after [the] dispute regarding Amgen’s compliance is resolved that Sandoz’s guidance on remedies even becomes relevant.” Genentech argued that Amgen was simply seeking to defer resolution and force Genentech’s hand into a potential procedural default because if Genentech files a declaratory judgment action for infringement, Amgen will then move to dismiss that action under § 262(l)(9)(A).

Section (l)(9)(C) of the BPCIA provides 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 of “any patent that claims the biological product or a use of the biological product.”  See 42 U.S.C. § 262(l)(9)(C).   On the other hand, section (l)(9)(A) of the BPCIA expressly states that if the applicant “provides the application and information required under paragraph (2)(A),” the reference product sponsor may not bring a declaratory judgement for infringement of any patent that is described in clauses (8)(b)(i) and (ii), prior to the date notice of commercial marketing is received.  Therefore, as explained in our earlier post, 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).  But, 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 until after the notice of commercial marketing is received.

For now, Judge Sleet has agreed with Amgen and dismissed the suit in light of the existing Federal Circuit precedent (which is currently on appeal to the Supreme Court as discussed here).  However, the order of dismissal expressly provides that the Complaint is being dismissed without prejudice, with leave to amend within forty-five days. While this case is dismissed for the moment, the dispute is surely not at an end.

This decision leaves for another day the answer to the question of what information, if any, in addition to the application, an applicant must provide to the reference product sponsor to satisfy the second clause of section (l)(2)(A).  Stay tuned.

Inter partes review (“IPR”) is one of several post-grant procedures created by the Leahy Smith America Invents Act (“AIA”).  An IPR provides a mechanism for challenging the patentability of one or more claims of an issued patent through an administrative “trial” conducted by three Administrative Patent Judges from the United States Patent and Trademark Office’s Patent Trial and Appeal Board (“PTAB” or “Board”).  An IPR is available for any patent regardless of the issue date, but for patents examined under the AIA (those filed on or after March 16, 2013), an IPR petition may not be filed until nine months after the patent issues.  Additionally, if a petition for a post-grant review (“PGR”) has been instituted for the patent, the PGR must be concluded before an IPR petition can be filed.

IPRs were intended to provide a faster, more efficient, and less expensive means for challenging patents compared to traditional litigation.  The potential benefits of IPR over federal court litigation include:  a lower burden of proof, the absence of a presumption of validity, and a broader standard for claim construction.  An IPR may also be available earlier than litigation on biosimilar products (because it is not necessary to wait until a BLA has been filed and accepted for review by FDA before filing an IPR petition), and an IPR may provide faster resolution than litigation because of the short statutory deadlines imposed on the proceeding.

On the other hand, the grounds that can be asserted in an IPR are limited to challenges under 35 U.S.C. §§ 102 and 103 (anticipation and obviousness) based on patents and printed publications.  Another difference is that although discovery is permitted in an IPR, the scope of discovery is much narrower than in district court litigation.  Also, the direct testimony of expert witnesses is submitted in form of written declarations and cross-examination of experts is conducted by deposition.  Therefore, the only live testimony presented to the Board is generally attorney argument at the oral hearing, which is often limited to an hour or less per side (rather than the multi-day or multi-week trials held by district courts).  One should also be aware of the potential for estoppel under 35 U.S.C. § 315(e), as discussed in a post on RFEM’s PTAB website here.  Finally, each individual petition for IPR may only address one patent, so challenges to more than one patent require multiple IPR petitions.  Thus, IPRs may be a particularly useful alternative for biosimilar product manufacturers and developers to challenge individual patents or a small set of key patents outside of BPCIA litigation.

The preliminary portion of an IPR proceeding begins with the filing of a petition by a third party.  The patent owner has three months to file a preliminary response, and the PTAB will make a determination on whether to “institute” review within six months of the filing date of the petition.  The Board will institute an IPR if the petitioner has demonstrated “a reasonable likelihood that it will prevail with respect to at least one of the challenged claims.”  If the IPR is instituted, the “trial” portion of the proceeding will begin, and the Board will issue a final written decision within one year of the institution decision.  The one year statutory deadline may be extended by up to six months for good cause shown.

Petitions for IPR have been filed on many patents related to proposed biosimilar products.  A complete summary of IPR proceedings for patents related to proposed biosimilar products is provided in RFEM’s Biosimilars IPR Dashboard.

RFEM has an extensive PTAB practice.  For more information about our practice and other useful information about recent decisions from the PTAB, visit our PTAB site at www.ptablaw.com.

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.