• European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of adalimumab biosimilar
  • U.S. Food & Drug Administration approves second adalimumab biosimilar

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.  Global sales for the top nine branded biologic drugs were estimated to total $63 billion in 2016[1].  Competition in the heavily regulated marketplace for these blockbuster therapeutics is expected to substantially impact the pharmaceutical industry and national health systems.  To date, the U.S. has considerably lagged behind Europe’s expansion of biosimilar drug options.  The RAND Corporation estimates that biosimilar products can save the U.S. health system approximately $44 billion over the next decade.

Since 2005, the biosimilar regulatory framework in Europe has been implemented through the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).  The CHMP provides initial assessments for marketing authorization of new medicines that are ultimately approved centrally by the EMA.  Since Sandoz’s somatotropin biosimilar Omnitrope® was first authorized on April 12, 2006, an additional 34 out of 40 applications have been approved in Europe.  Three of the authorizations have been withdrawn post-approval by the marketing authorization holders (Table 1).

The U.S. did not implement a regulatory framework for biosimilar evaluation until after enactment of the Biologics Price Competition and Innovation (BPCI) Act of 2009.  Given that the first U.S. biosimilar drug was approved almost a decade after the first in Europe, the number of authorized biosimilar drugs in Europe far exceeds the number of biosimilars approved in the United States.  Sandoz’s filgrastim biosimilar Zarxio® received the first U.S. approval in 2015, whereas nine filgrastim biosimilars have been approved in Europe dating back to multiple authorizations in 2008.  Zarxio® (in the U.S.) and Zarzio® (in Europe) are biosimilar to the reference product Neupogen marketed by Amgen and originally licensed in 1991.   Subsequent to Zarxio’s approval, only five other biosimilar drugs have gained U.S. approval to date (Table 2).  As illustrated in the following graph, the EU’s significant head start led to the existent imbalance in the number of biosimilar drugs available in the respective markets.

Currently, thirteen biosimilar applications are under review by the EMA for marketing authorization (Table 3).  As an increasing number of U.S. patents expire on blockbuster biologic drugs, the number of abbreviated biologics license applications are also increasing.  Biosimilars for at least nine different original biologics are currently navigating the FDA’s biosimilar pathway or are in late stage development (Table 4).

On August 29, 2017, Boehringer Ingelheim announced (here) that the FDA approved its CyltezoTM biosimilar to AbbVie’s Humira®.  Boehringer Ingelheim indicated that its adalimumab biosimilar is a pre-filled syringe for the treatment of multiple chronic inflammatory diseases.  The CyltezoTM approval marks the second adalimumab biosimilar to clear the FDA’s regulatory review following Amgen’s Amjevita® approved in September 2016, although no adalimumab biosimilars are commercially available yet in the United States.

Despite the recent FDA approval of CyltezoTM, the European market extended its large lead in biosimilar drug approvals during the summer of 2017.  Given biosimilar applicant experience in navigating the EMA process and the EMA’s high authorization rate, the FDA will need to continue to provide useful guidance and streamline the approval process in order to reduce the imbalance.

Table 1. European Medicines Agency List of Approved Biosimilar Drugs (updated September 6, 2017).

Table 2. U.S. Food and Drug Administration List of Approved Biosimilar Drugs (CDER list of licensed biologics updated on September 1, 2017).

Table 3. European Medicines Agency List of Biosimilars Under Evaluation for Marketing Approval (Source: EMA list of applications for new human medicines updated on September 5, 2017).


Table 4. Biologics with recent or nearing primary patent expiry in the U.S. that have biosimilars in the regulatory pipeline.

***

[1] Mullard, Asher. “Bracing for the biosimilar wave.” Nature Reviews Drug Discovery 16.3 (2017): 152-154.

 

 

 

Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue.  Abbvie’s Humira® (adalimumab) rocketed to the best-selling drug in the world with sales generating over $16 billion USD in 2016. The top biologic drugs are all driving revenues well beyond the $1 billion sales revenue demarcation that traditionally defines a blockbuster drug.  The staggering revenue generated by the latest generation of drugs has launched major efforts by companies over the last 10 years to quickly develop biosimilar versions of these drugs to carve out their own market share.

Recent market analysis indicates that there could be a tidal shift in the biologic drug market in the years to come. Evaluate Pharma’s 2017 World Preview reports that the entry of biosimilars into the global markets is expected to erode the total sales of biologic drugs by as much as 54% through 2022.  According to the report, biologic sales may stand to lose up to $194 billion USD as patents on the top biologic drugs set to expire.  In particular, patents covering infliximab, bevacizumab, trastuzumab, and rituximab will be expiring in the next couple of years.  The table below lists the top grossing biologic drugs in 2016 compared to the projected sales in 2022.  Despite the market changes, biologics are expected to contribute 52% of the top 100 product sales by 2022.

Netscribes – a global marketing intelligence and content management firm – recently released its own analysis of the world-wide biosimilar market.  Netscribes reports the biosimilar global market value is expected to reach $36 billion USD by the year 2022.

The biggest impact on global biologic sales will likely come from the European block.  Europe has already vastly outpaced the rest of the world in biosimilar approvals.  In fact, the EU has given marketing authorization to 28 biosimilar drugs, compared to a mere five biosimilar drugs receiving approval in the U.S.  Given the substantial lead in the biosimilar field, Europe stands to dominate the global biosimilar landscape for years to come.

The European Commission recently released a report analyzing data from the year 2016 over six established therapy areas with biosimilar competition, including epoietin, G-CSF, hGH, anti-TNF, fertility/gonadotropin drugs, and recombinant human insulins.  The report provided several interesting details into the effects from biosimilar market entry.

  • Biosimilar entry consistently reduced drug pricing over the whole product class, not just for the challenged reference product
  • The first biosimilar entering the market grabs the largest market share
  • The correlation between biosimilar market share and market price reduction is weak
  • Biosimilar entry significantly increased product consumption
  • Lowering the price of certain biologics (anti-TNF and hGH) reduced market penetration of the biosimilar competitor

The analysis by the European Commission provides a useful glimpse into the changes that are soon expected to take shape more broadly across the globe.  Biosimilars will significantly impact the sales revenue across many therapeutic areas, even if the initial market penetration is weak.  However, the overall impact on the major pharmaceutical companies manufacturing the originator products is less clear as the report indicates certain variables could potentially mitigate lost revenue.  In particular, price reduction of the originator product appears to slow market penetration of the biosimilar.  In addition, entry of the biosimilar appears to increase product consumption overall.

Biosimilar drugs will undoubtedly reshape the global pharmaceutical market as they grab market share in the years to come.  The speed with which this happens will depend on how the biosimilar manufacturers choose to use their capital to position themselves in the global market.  Given the enormous revenue generated by biologic drugs, even shaving a few years off market exclusivity by attacking pharmaceutical patents could render a major win for the generic company, particularly as the report from the European Commission shows that early entry into the market has major advantages.

Recently, AbbVie, Inc. and AbbVie Biotechnology, LTD (collectively “AbbVie” or “Plaintiffs”) filed a Complaint in the United States District Court for the District of Delaware against Boehringer Ingelheim International GMBH, Boehringer Ingelheim Pharmaceuticals, Inc., and Boehringer Ingelheim Fremont, Inc. (collectively “Boehringer Ingelheim” or “Defendant”) related to Boehringer Ingelheim’s adalimumab product, a proposed biosimilar to AbbVie’s Humira®.  The Complaint, filed on August 2, 2017, alleges that Boehringer Ingelheim’s filing of a biologics license application (“BLA”) for adalimumab under the abbreviated section (k) pathway of the BPCIA constitutes an artificial action of statutory patent infringement pursuant to 35 U.S.C. §271(e)(2)(C).

Boehringer Ingelheim announced in January of this year that the FDA had accepted for review its abbreviated biologics license application for BI 695501, a proposed adalimumab biosimilar.  The FDA’s BSUFA date (target goal) for Boehringer’s adalimumab application is estimated to be in September 2017.  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.

AbbVie alleges in the Complaint that “Boehringer seeks to copy AbbVie’s work and ignore AbbVie’s patents.” According to the Complaint, AbbVie has identified 74 patents related to Humira, which “AbbVie has identified as infringed” by Defendants.  However, the current complaint asserts infringement of only eight patents, including: U.S. Patent No. 8,926,975; U.S. Patent No. 9,018,361; U.S. Patent No. 9,090,867; U.S. Patent No. 9,096,666; U.S. Patent No. 9,255,143; U.S. Patent No. 9,266,949; U.S. Patent No. 9,272,041; and U.S. Patent No. 9,546,212.

According to AbbVie, after the parties exchanged patent lists in accordance with the BPCIA’s patent dance, “Boehringer selected the number of patents … each side could litigate in this first wave.” See Complaint.  Boehringer selected five patents per side, and “the eight patents-in-suit constitute the compilation of the two lists” after accounting for the fact that two patents appeared on both side’s subsequent list.  Id.  AbbVie further notes that it “will have the opportunity to assert the remainder of the patents” later in the case “if and when Boehringer provides its 180-day Notice of Commercial Marketing, and as circumstances otherwise warrant.”  Id.

The new Boehringer Ingelheim litigation is Civ. No. 17-cv-00165, and the case has not yet been assigned to a specific judge.  According to the court’s docket system, Defendants currently have until August 23, 2017, to file an Answer or otherwise respond to the Complaint.

This is not the only litigation involving adalimumab.  AbbVie previously filed an infringement suit against Amgen in Delaware related to its proposed biosimilar adalimumab therapeutic.  Other manufacturers have also filed IPRs on patents related to Humira® (adalimumab), as reported here and here.

Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab), to the Food and Drug Administration (“FDA”).  According to the press release, Amgen and Allegan have “formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines.”

Celltrion and Teva also announced last week that the FDA has accepted their BLA for CT-P6, a proposed trastuzumab biosimilar, for review.  According to the announcement, the companies expect regulatory action on the CT-P6 application during the first half of 2018.

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.

Several other companies, including at least Pfizer (Hospira), Mylan, and Biocon are also developing biosimilars of trastuzumab, as discussed in this prior post.  A complete list of IPRs related to trastuzumab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.

Sandoz, Inc. (“Sandoz”) entered into the battlefield over patents related to AbbVie’s Humira® (adalimumab).  On July 20, 2017, Sandoz filed petitions with the Patent Trial and Appeal Board (“PTAB”) for inter partes review (“IPR”) of two patents assigned to AbbVie, U.S. Patent No. 8,802,100 (“the ’100 patent”) entitled “Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders,” and U.S. Patent No. 9,512,216 (“the ’216 patent”) entitled “Use of  TNF- α Inhibitor.”

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 IPR2017-01823 (involving the ‘100 patent) and IPR2017-01824 (involving the ’216 patent). The only real party-in-interest identified for Petitioner is Sandoz.

Several other companies including Coherus, Boehringer Ingelheim, and Amgen have previously filed IPR petitions 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.

On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis® (infliximab-abda) in the United States.  According to Merck’s press release, Renflexis® “will be introduced in the U.S. [at] . . . a 35 percent discount to the current list price” of the reference product.  Renflexis® is the second FDA-approved commercially available biosimilar to Jansen’s Remicade® (infliximab) available in the United States.  As we previously reported, the FDA approved Reflexis® in April of this year, and Janssen filed patent litigation (arising to the BPCIA) against Samsung in New Jersey in May 2017 based on the filing of the BLA.

The first FDA-approved infliximab biosimilar, Sandoz’s Zarxio®, was launched in September 2015.  Litigation related Sandoz’s infliximab is also currently pending in New Jersey, as discussed in RFEM’s Litigation Spotlight series here and here.

The approval dates and launch status of all FDA-approved biosimilars in the United States are shown in the table above.  Two additional biosimilars, Amgen and Allergan’s bevacizumab and Mylan and Biocon’s trastuzumab, have been recommended for approval by the FDA’s Advisory Committee but have not yet been formally approved and licensed.

The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by the House last month, as reported here. The President immediately signed it into law.

As we previously reported, the Biosimilar User Fee Act “BsUFA II” portion of the FDA Reauthorization Act of 2017 creates important changes for biosimilar applicants, including new user fees and application timelines.  In particular, the bill would increase user fees from $508 million to $1.3 billion in 2018 and extend the application review timeline by two months, while empowering the FDA to collect $9 billion in user fees between 2018 and 2022. More complete details on the changes to the legislative authority can be found in our previous post here.

Since our prior article on the litigation between Amgen and Hospira over Hospira’s proposed biosimilar to Amgen’s Epogen®, there have been several developments, including those that occurred after the Supreme Court’s recent Amgen v. Sandoz decision.

The last major development we previously discussed was a motion for a preliminary injunction filed by Amgen seeking “to enjoin [Hospira] from launching a biosimilar version of Amgen’s EPOGEN® (epoetin alfa) product until Hospira has complied with the [notice of commercial marketing] requirement of 42 U.S.C. § 262(l)(8)(A).” Since then, the brief supporting the motion, which was initially sealed, was filed in redacted form on June 5, 2017.

In its original supporting brief, Amgen relied heavily on the Federal Circuit’s earlier holding in Amgen v. Sandoz to support its position that the notice of commercial marketing was required to be given after FDA approval. Amgen also cited to this holding in support of its arguments with respect to Hospira’s alleged failure to disclose manufacturing information. While compelling such disclosure was not a direct point of this motion (as this exact point is currently pending before the Federal Circuit in an interlocutory review), Amgen used this alleged failure of disclosure as a factor in support of the preliminary injunction, citing to a Federal Circuit statement that a party in Amgen’s position can “access the required [manufacturing] information through discovery” in a patent-infringement action.

Then, on June 12, 2017, the Supreme Court issued its decision reversing the portion of the Federal Circuit’s Amgen v. Sandoz decision regarding notice of commercial marketing on which Amgen had relied. Specifically, the Supreme Court held that the notice of commercial marketing may be provided before a biosimilar applicant obtains a license (e.g. FDA approval).

The Supreme Court also emphasized that federal law does not provide the right to an injunction to force compliance with the disclosure requirements of section (l)(2)(A) of the BPCIA.  However, the Court left open the issue of whether state laws may provide an alternative avenue for injunctive relief, as discussed in this article.

On June 12, 2017, the parties in the Epogen® litigation stipulated to an extension of time regarding the motion for a preliminary injunction to allow the parties to consider and address the impact of the Supreme Court decision. A week later on June 19, 2017, Amgen moved to file an amended brief in view of the decision, and following grant of the motion, a sealed amended brief was filed on June 20, 2017. Hospira’s sealed opposition brief was filed June 26, 2017.

Amgen’s amended brief (as seen in its redacted form filed on June 29, 2017) seems to focus on the argument that notice of commercial marketing is mandatory and that Hospira’s notice is ineffective. While much of the rationale as to why the notice was allegedly ineffective is currently redacted, the argument appears to be based on an assertion that because Hospira had received a complete response letter from the FDA requiring resubmission of its application, any notice provided prior to such resubmission was no longer effective.   Amgen’s position on the discovery of manufacturing information remained largely the same as in its original brief.

Hospira’s amended opposition brief (as seen in its redacted form filed on July 6, 2017) noted that there is no requirement for additional notice following receipt of and response to a complete response letter.  Hospira characterized Amgen’s argument as “a repackaged version of its argument in Sandoz, which was explicitly rejected by the Supreme Court” and argued that “Amgen now links its argument to the submission of additional data and information to the FDA, rather than the date of FDA approval.” Hospira did not address Amgen’s points regarding disclosure of manufacturing information and the pending interlocutory review.

The district court held oral argument on several motions, including the motion for preliminary injunction, on June 28, 2017.  Amgen requested and received an extended deadline to submit a reply in response to Hospira’s amended opposition brief.  Then, on July 12, 2017, Amgen filed a notice of withdrawal of its preliminary injunction motion.  Not only has there been a change in the law, as discussed above, but the pertinent facts have also changed since the filing of the motion seeking a preliminary injunction. When At the time the motion initially filed, the FDA’s Oncologic Drugs Advisory Committee had recommended approval of Hospira’s Epogen® biosimilar. Amgen cited this recommendation in support of its claim of imminent harm absent an injunction. However, as we previously discussed in this post, Pfizer/Hospira announced in late June that its pending application had received another complete response letter, thus delaying any approval. Such delay would make it more difficult to establish imminent irreparable harm for purposes of a preliminary injunction, and this may have also impacted Amgen’s decision.

Unfortunately, for those looking to the limited number of biosimilar litigations for guidance, this case has presented additional questions but has not yet provided an answer to the question of what exactly is required to provide sufficient notice of commercial marketing.  Perhaps the pending appeal will provide further answers regarding the disclosure of manufacturing information.

On July 20, 2017, the parties filed a joint stipulation regarding the case schedule.  The pretrial order is currently due on August 31, 2017, and a five day jury trial remains scheduled to begin on September 18, 2017.

Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection LusdunaTM NexvueTM,  a follow-on biologic to Sanofi’s Lantus®.  Because Merck’s application for insulin glargine was filed using the abbreviated 505(b)(2) regulatory pathway provided by the Hatch-Waxman Amendments (not a section (k) application under the BPCIA), the product is properly characterized as a follow-on biologic, not a biosimilar.

Insulin glargine is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.  According to Merck, LusdunaTM NexvueTM  is being developed with funding from Samsung Bioepis.

Sanofi and Merck are currently involved in patent litigation related to this application. Sanofi filed a suit against Merck in the United States District Court for the District of Delaware in September 2016.  See Sanofi v. Merck, Civ. No. (D.Del.).  As a result of the litigation, final approval of Merck’s application is subject to the automatic 30-month stay of approval provided by Hatch-Waxman.  This is not the first follow-on biologic for insulin glargine. In December 2015, the FDA granted final approval to Basaglar®, Eli Lilly’s follow-on insulin glargine product.

Several other companies are reportedly developing insulin glargine products.  In June of this year, Mylan filed IPR petitions on two of Sanofi’s patents related to insulin glargine, as reflected in RFEM’s IPR Dashboard.

As we previously reported here, earlier this year the Supreme Court agreed to hear its first case arising under the Biosimilars Price Competition and Innovation Act (“BPCIA”) in the cases of Sandoz v. Amgen and Amgen v. Sandoz.  Our earlier post provides the factual background on this case, which involves Sandoz’s application to market Zarxio®, a biosimilar to Amgen’s Neupogen® (filgrastim) product.

This case is very important in determining how two key provisions of the BPCIA will be interpreted: (1) Can a biosimilar applicant provide an effective 180-day notice of commercial marketing prior to FDA approval (licensure); and (2) Is an injunction available to require a biosimilar applicant to provide the reference product sponsor with a copy of its biologics license application and its manufacturing information (i.e., to take the first step of the “patent dance”)?

Briefing was completed on April 14, 2017, as discussed in this prior article, and we also provided a summary of oral argument in this article.

The Court issued its unanimous decision on June 12, 2017.  Sandoz Inc. v. Amgen, Inc., 137 S. Ct. 1664 (2017).  The Court provided clear guidance that biosmilar applicants may provide 180-day notice of commercial marketing prior to the FDA’s approval of the application.  This holding means that an applicant that provides early notice of its intent to commercially market a biosimilar product may be able to launch that product immediately upon receiving FDA approval (provided no injunction has been entered pending resolution of patent disputes).

The Court left some open questions, however, regarding whether the biosimilar applicant can unilaterally “opt out” of the BPCIA’s patent dance.  The Court held that Federal law does not provide for an injunction requiring a biosimilar applicant to start the patent dance by providing its application and manufacturing information to the reference product’s sponsor under 42 U.S.C. § 262(l)(2)(A).  The Court left open the possibility, however, that state law (e.g., California’s unfair competition statute) may provide a remedy for the biosimilar applicant’s failure to provide its application to the reference product’s sponsor.

1.Notice of Commercial Marketing Can Be Provided Before the FDA Approves the Application

The BPCIA requires that a biosimilar 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).”  42 U.S.C. § 262(l)(8)(A).  The Federal Circuit had interpreted this provision as requiring 180-day notice to be provided following the FDA’s approval of the application, reasoning that phrase “the biological product licensed under subsection (k)”refers only to a product that has already received a license.  Amgen, Inc. v. Sandoz Inc., 794 F.3d 1347, 1357 (Fed. Cir. 2015), rev’d and remanded by Sandoz, 137 S. Ct. 1664.

The Supreme Court disagreed.  The Court held that “[t]he statute’s use of the word ‘licensed’ merely reflects the fact that, on the ‘date of the first commercial marketing,’ the product must be ‘licensed.’”  Slip Op. at 16.  The Court therefore held that “the applicant may provide notice either before or after receiving FDA approval.”  Id.

The Court dismissed both sides’ policy arguments, stating that “[t]he plausibility of the contentions on both sides illustrates why such disputes are appropriately addressed to Congress, not the courts.”  Id. at 18.  Interestingly, Justice Breyer’s short concurrence suggests that the FDA could later issue a rulemaking that departs from the Court’s interpretation of the BPCIA in the Sandoz case.  Justice Breyer states his view that “Congress implicitly delegated to the [FDA] authority to interpret [the statutory terms at issue].”  Therefore, Justice Breyer reasons that if, “after greater experience administering this statute,” the FDA “determines that a different interpretation would better serve the statute’s objectives, it may well have the authority to depart from, or modify, today’s interpretation.”

2.Federal Law Does Not Provide for an Injunction Requiring the Biosimilar Applicant to Provide its Application and Marketing Information (to begin the “Patent Dance”), But the Court Left Open the Question of Whether State Law May Provide Such a Remedy

A. The Patent Dance

The Sandoz v. Amgen decision also addresses whether a biosimilar applicant can “opt out” of the patent dance, as Sandoz elected to do in this case.  The patent dance involves a series of steps for the exchange of information between the biosimilar applicant and the sponsor of the reference product that is designed to narrow the issues for patent litigation.  As the Supreme Court explains, “[i]f the parties comply with each step outlined in the BPCIA, they will have the opportunity to litigate the relevant patents before the biosimilar is marketed.”  Sandoz, 137 S. Ct. 1664, Slip Op. at 7.

The steps of the patent dance, set forth in 42 U.S.C. §262(l), are summarized in the chart below.

Note that if the parties take the full time allotted for each step, 250 days will have passed from the FDA’s acceptance of the application until the litigation is filed.  A biosimilar applicant that anticipates receiving FDA approval relatively soon may seek to avoid this lengthy process, despite the various advantages of participating in the patent dance.  The question before the Supreme Court in this case was whether the reference product sponsor can obtain an injunction forcing the biosimilar applicant to provide the information required by § 262(l)(2)(A).

B. No Federal Injunction to Require Participation in the Dance

Although § 262(l)(2)(A) states that the biosimilar applicant “shall provide” the reference product sponsor with a copy of its application and manufacturing information to begin the patent dance, § 262(l)(9) expressly contemplates a situation in which the biosimilar applicant fails to provide its application and manufacturing information.  In that case, the sponsor of the reference product (but not the biosimilar applicant) may immediately bring an action “for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.”  42 U.S.C. § 262(l)(9)(C).

The Supreme Court held that “[t]he remedy provided by §262(l)(9)(C) excludes all other federal remedies, including injunctive relief.”  Sandoz, Slip Op. at 12.  The Court found the BPCIA’s “carefully crafted and detailed enforcement scheme” evidences that Congress did not intend to authorize other remedies.  Id.

The Federal Circuit had reached the same conclusion that no injunctive relief was available, but under somewhat different reasoning.  The Federal Circuit relied on both 42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. § 271(e), finding those statutes “expressly provide the only remedies for a violation of § 262(l)(2)(A).”  Amgen, 794 F.3d at 1357.  In reaching its conclusion, “the Federal Circuit relied primarily on § 271(e)(4), which states that it provides ‘the only remedies which may be granted by a court for an act of [artificial] infringement.’”  Sandoz, 137 S. Ct. 1664, Slip Op. at 11.

The Supreme Court explained that “[f]ailing to disclose the application and manufacturing information under §262(l)(2)(A)” does not itself constitute an artificial act of infringement under § 271(e)(2)(C)(ii).  Id.  Rather, it is the act of filing the application that constitutes an artificial act of infringement.   The Court explained that 35 U.S.C. 271(e)(2)(C)(ii) “facilitates [the § 262(l)((9)(C) declaratory judgment] action by making it an artificial act of infringement, with respect to any patent that could have been included on the §262(l)(3) lists, to submit a biosimilar application.”  Id. at 7, 11.

Accordingly, § 271(e)(4) does not provide the remedy for failure to disclose an application and manufacturing information under 42 U.S.C. § 262(l)(2)(A).  This is a potentially important distinction because of Amgen’s unfair competition claims under California state law.

C. State Law Claims Remanded

California’s unfair competition law prohibits “any unlawful … business act or practice.”  A practice is considered “unlawful” if it violates a rule in some other state or federal statute.  However, California’s unfair competition law does not provide a remedy when the underlying statute specifies an “expressly … exclusive” remedy.  The Federal Circuit thus rejected Amgen’s state law claims because § 271(e)(4) expressly states that it provides the exclusive remedy for artificial acts of infringement.  See Sandoz, Slip. Op. at 13-14.

The Supreme Court rejected the Federal Circuit’s reasoning, holding “[b]ecause §271(e)(4) provides remedies only for artificial infringement, it provides no remedy at all, much less an ‘expressly … exclusive’ one, for Sandoz’s failure to comply with §262(l)(2)(A).”  Id. at 14.

The Court also declined to rule on the Federal Circuit’s alternative basis for its holding: that Sandoz’s choice not to provide information under 42 U.S.C. § 262(l)(2)(A) was not “unlawful,” because it is a course expressly contemplated by the BPCIA.  The Court held that the issue of whether Sandoz’s conduct is “unlawful” is a state law question, and Federal Circuit had erred by trying to answer it solely by looking to the BPCIA.  Id. at 15.

The Court remanded to the Federal Circuit to determine “whether California law would treat noncompliance with § 262(l)(2)(A) as ‘unlawful,’” and, if so, whether Federal law nonetheless preempts the state law claims.  Id.  Alternatively, the Court noted that the Federal Circuit could first address the pre-emption issue by assuming that a remedy under state law exists.  Id.  The latter course might provide the Federal Circuit with the opportunity to clarify that there are no state law remedies available to require biosimilar applicants to participate in the patent dance—rather than limiting the holding to California law issues.  However, the Federal Circuit noted that “Sandoz did not argue preemption as a defense to Amgen’s state law claims,” so this case may not be the appropriate vehicle for the Federal Circuit to reach a broad preemption holding.

Sandoz has now asked the Federal Circuit to remand the state law claims to district court, rather than determining these questions in the first instance.  Appeal No. 2015-1499, ECF #174 (filed June 29, 2017).  The Federal Circuit has not yet issued an order determining how the remand will be handled.

We will continue to keep you apprised of further developments.