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The Ripple Effect of the Federal Circuit’s Decision in Amgen v. Apotex on Biosimilar Litigation

IRENA ROYZMAN
August 30, 2016

In July, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed, Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009 (BPCIA). The Federal Circuit affirmed the district court’s preliminary injunction barring Apotex from selling its proposed biosimilar until 180 days after post-licensure notice of first commercial marketing. The Federal Circuit held that 180 days’ notice was mandatory regardless of whether the biosimilar maker provided its regulatory application to the innovator as prescribed at the outset of the BPCIA procedures or not. The decision has impacted other district court litigation, including the Janssen v. Celltrion/Hospira and Amgen v. Hospira cases, since the biosimilar makers in those cases also argued that they did not need to provide 180 days’ notice of commercial marketing after being licensed by FDA.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, PATENT LITIGATION

Judge Dismisses Amgen’s BPCIA Declaratory Judgment Action Against Sandoz

NATHAN MONROE-YAVNEH
July 28, 2016

Judge Chesler of the U.S. District Court for the District of New Jersey has dismissed one of Amgen’s pending lawsuits against Sandoz under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (“BPCIA”).

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Federal Circuit’s Application of Mayo Revives Biotech Patent

In Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., the Federal Circuit reversed a ruling of patent invalidity under Section 101, reviving a biotech patent to a method of preserving hepatocytes, liver cells, for medical use. The Federal Circuit reversed the district court at both steps of the Supreme Court’s framework for patent eligibility set out in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012). In the wake of the Supreme Court’s recent denial of certiorari in Sequenom Inc., v. Ariosa Inc., where Sequenom sought guidance on the proper application of the Mayo two-step test, the Federal Circuit’s decision provides important guidance for how to determine patent eligibility for biotech inventions that build on natural discoveries. It also may help stem what many, including several Federal Circuit judges, have described as a crisis in medical innovation due to how courts and the Patent Office have applied Mayo.

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Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling

Amgen and Hospira have fired off a dueling letters to the court in their litigation over Amgen's Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA), contains a private right of action. The letters come in the wake of the Federal Circuit’s Amgen v. Apotex decision, which held that the BPCIA’s 180-day notice of commercial marketing provision is mandatory and enforceable by an injunction.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, PATENT LITIGATION

Federal Circuit Decides Amgen v. Apotex, Holds that 180-Day Notice of Commercial Marketing is Always Mandatory in Biosimilar Litigation

Today, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed. Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009 (BPCIA). The Federal Circuit affirmed the district court’s preliminary injunction barring Apotex from selling its proposed biosimilar on the U.S. market during the 180-day post-approval notice of commercial marketing period. Writing for a unanimous panel that also included Judges Wallach and Bryson, Judge Taranto held that “the commercial marketing provision is mandatory and enforceable by injunction even for an applicant in Apotex’s position.”

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Amgen v. Sandoz Biosimilar Litigation Update: Sandoz Follows the Patent Dance With Neulasta

SHENG T. LI | ARON FISCHER
June 29, 2016

Prominent among the first generation of U.S. biosimilar litigations under the Biologics Price Competition and Innovation Act (“BPCIA”) are the disputes between Amgen and Sandoz concerning Amgen’s related cancer drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim).

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Supreme Court Denies Sequenom’s Cert Petition, Leaving the Federal Circuit’s Interpretation of the Mayo/Alice Patent Eligibility Framework Intact For Now

MICHAEL FRESCO | IRENA ROYZMAN
June 27, 2016

The Supreme Court today denied Sequenom Inc.’s petition for writ of certiorari, in which Sequenom asked the Court to review a decision of the Federal Circuit invalidating its patent on a breakthrough prenatal diagnostic procedure. In denying the petition, the Court has declined to revisit the patent eligibility framework it set out in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012) and reaffirmed in Alice Corp. Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014).

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Apotex Drops Sham Litigation Counterclaims in Neupogen and Neulasta Biosimilar Litigation


June 23, 2016

In a consolidated litigation in the Southern District of Florida involving Apotex’s proposed biosimilars of Amgen’s Neupogen, an anti-infection drug for cancer patients, and of Amgen’s Neulasta, a long-acting version of Neupogen, Apotex participated in the pre-suit information exchanges of the BPCIA, agreed with Amgen as to what patents should be asserted in the BPCIA’s immediate litigation phase but then counterclaimed that Amgen engaged in sham litigation by bringing suit on one of the agreed patents. With trial to begin in July, Apotex recently stipulated to dismissal of its sham litigation counterclaims, leaving for another case the question of whether a biosimilar maker can both agree as to which patents to litigate in the immediate litigation phase and sustain a claim of sham litigation against the innovator for asserting agreed patents.

READ MORE BIOSIMILARS, BPCIA, PATENT LITIGATION

Full Federal Circuit Denies En Banc Review of Jurisdictional Decision with Important Implications for BPCIA Litigation

On June 20, 2016, the full Federal Circuit declined to rehear Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016) en banc. Acorda affirmed two District of Delaware decisions finding specific jurisdiction over Mylan Pharms., an out-of-state ANDA filer, based on its plans to sell its proposed generic drugs in Delaware. After the Supreme Court’s decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014), Mylan has argued that it could only be sued in its home state of West Virginia in ANDA cases since future sales of its proposed generic drugs could not confer specific jurisdiction in Delaware. The Federal Circuit disagreed. Under Acorda, plaintiffs in ANDA cases as well as in cases brought under the Biologics Price Competition and Innovation Act (BPCIA) can bring suit in their forum of choice based on future sales of proposed generic or biosimilar products so long as considerations of fairness, such as efficiency or undue burden, do not render jurisdiction in the forum unreasonable.

READ MORE BPCIA, PATENT LITIGATION

Supreme Court Affirms Cuozzo – Leaving in Place BRI and Judicial Review Limitation for IPR Proceedings

JASON VITULLO | IRENA ROYZMAN
June 21, 2016

In Cuozzo Speed Technologies, LLC v. Lee, No. 15-446, the Supreme Court affirmed the Federal Circuit’s holdings that an alleged defect in the PTO’s institution of an inter partes review (IPR) was not subject to judicial review even on appeal of a final decision, and that the PTO can apply the “broadest reasonable interpretation” claim construction standard in IPR proceedings. Over 30 amicus briefs were filed in this case, with pharma/biotech innovators urging the Court to reverse the Federal Circuit.

READ MORE PATENT LITIGATION, PTO TRIAL PROCEEDINGS

Amgen Appeals Ruling on Requirement to Produce Manufacturing Information for a Biosimilar Product under Amgen v. Sandoz

Amgen has appealed a partial denial of its motion to compel in Amgen v. Hospira, which sought discovery of the formulation for the cell culture media that Hospira uses to manufacture its proposed biosimilar of Amgen’s Epogen. Judge Andrews of the District of Delaware granted Amgen’s motion to the extent it sought information relevant to infringement of an asserted patent, but did not agree with Amgen’s broader argument that disclosure of manufacturing information was required under the Federal Circuit’s decision in Amgen v. Sandoz, which held that an innovator company can commence suit when a biosimilar maker fails to provide required information under the statutory process set forth in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and “access the required information through discovery.” Amgen’s discovery dispute with Hospira represents an important lesson in the aftermath of Amgen v. Sandoz. Innovator companies that assert only a subset of their manufacturing patents, as Amgen did, may only be able to obtain discovery relevant to those patents. As a result, innovator companies may choose to assert all of their manufacturing patents in order to obtain manufacturing information that biosimilar makers fail to provide under the BPCIA.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, PATENT LITIGATION

Supreme Court Asks Solicitor General to Weigh In on Amgen v. Sandoz

Today, the Supreme Court deferred a decision on certiorari in Amgen v. Sandoz, inviting the Solicitor General to file a brief expressing the views of the United States. Sandoz petitioned for review of one aspect of the Federal Circuit’s 2015 decision, that court’s first and so far only interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and Amgen filed a conditional cross-petition asking for review of another aspect of the decision if Sandoz’s petition were granted. The Supreme Court’s order asks the Solicitor General to comment on both petitions.

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Update on Naming Biosimilars

JACOB F. SIEGEL | ARON FISCHER
June 13, 2016

Last year, FDA published a draft guidance recommending that the nonproprietary names of biologics, including biosimilars, should consist of “core names” along with unique suffixes that are “devoid of meaning.” In a recent notice in the Federal Register, FDA stated that it will allow biologics sponsors to submit ten suggested suffixes for their products under FDA’s proposed naming scheme. This new recommendation represents a change from last year’s guidance, which invited sponsors to submit three suggested suffixes.

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Ariosa Files Opposition to Sequenom’s Cert Petition


May 31, 2016

Ariosa Diagnostics, Inc., Natera, Inc., and DNA Diagnostics Center, Inc. have filed briefs in opposition to Sequenom’s petition for writ of certiorari to the Supreme Court for review of the Federal Circuit’s decision holding Sequenom’s fetal DNA diagnostic patent ineligible under Section 101 and the test set out in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012).

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Patient and Provider Groups Urge FDA to Institute Meaningful and Memorable Names for Biosimilars

A 70-group coalition of healthcare stakeholders urged the FDA to incorporate meaningful and therefore memorable suffixes into its distinguishable naming system for biological medicines to provide strong patient protections and provider confidence. The coalition emphasized that “meaningful suffixes are easier for patients, providers and pharmacists to both recognize and remember, thus facilitating accurate association between adverse effects and specific products.” The coalition explained that meaningful suffixes based on the name of the manufacturer, such as the “sndz” suffix used for the first approved biosimilar, Sandoz’s Zarxio (filgrastim-sndz), instead of the random suffixes proposed in FDA’s most recent draft guidance and used for the first time in FDA’s recent approval of a second biosimilar, Celltrion and Pfizer’s Inflectra (infliximab-dyyb), would promote manufacturer accountability. Notably, FDA used a random suffix for the nonproprietary name of Inflectra despite widespread criticism by innovators and biosimilar makers alike of FDA’s naming approach.

READ MORE BIOSIMILARS, FDA, NAMING

A Breakthrough Technology is Caught in an Epic Patent Battle

In the last couple of years, a new gene editing technique called CRISPR has taken biology by storm. Scientists worldwide are using CRISPR to turn off, turn on and alter genes in living cells. CRISPR is so precise that it is expected to turn into a promising therapy for correcting genes in people, thereby curing devastating illnesses. Gene editing startups have burst onto the scene and industry has jumped in to develop this technology for therapeutic use. But CRISPR is now embroiled in a massive patent fight between the research institutions that lay claim to the technology. In January, the Patent Trial and Appeal Board (PTAB) declared an interference, an arcane and largely obsolete proceeding, to decide who was first to invent CRISPR gene editing in eukaryotic cells (using Cas9, a CRISPR associated protein), and thus who may be able to profit from its far-reaching applications.

READ MORE BIOTECHNOLOGY, PATENT LITIGATION

Biotech Industry Supports Cert in Sequenom to Avert “Crisis of Patent Law and Medical Innovation”

MICHAEL FRESCO
April 27, 2016

The biotechnology and life sciences industry has voiced strong support for Sequenom’s recent request that the Supreme Court review the Federal Circuit’s decision holding that Sequenom’s patent on prenatal diagnosis using fetal DNA was invalid under 35 U.S.C. § 101 for claiming ineligible natural phenomena. Twenty-two amici have filed briefs in support of Sequenom’s petition, representing a diverse contingent of stakeholders: biotech and life science companies, innovators in other technological fields, academics, international and domestic professional organizations, and IP licensors. Many elaborate on the arguments raised by Sequenom in its petition, including the potential for a Mayo-induced “crisis of patent law and medical innovation.”

READ MORE BIOTECHNOLOGY, PATENT LITIGATION

FDA Announces Approval of Second U.S. Biosimilar


April 7, 2016

On April 5, the FDA announced the approval of Inflectra, Celltrion and Pfizer’s biosimilar of Johnson & Johnson’s Remicade (infliximab). Inflectra is now the second biosimilar approved for sale in the United States, after Sandoz’s Zarxio. Inflectra’s label and naming reflect the latest FDA guidance.

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Update on Enbrel Biosimilar and Related US Litigation

MICHAEL FRESCO | IRENA ROYZMAN
April 5, 2016

Amgen’s Enbrel (etanercept), a blockbuster biologic treatment for a number of autoimmune diseases, including rheumatoid arthritis and psoriasis, has been an attractive target for biosimilar makers. Sandoz, the maker of Zarxio (filgrastim-sndz), the only biosimilar launched in the US to date, is also first in line with an Enbrel biosimilar in the US. Last October, Sandoz announced that FDA accepted its regulatory application for a proposed Enbrel biosimilar for review. Sandoz is seeking marketing approval for all of Enbrel’s medical indications. But Sandoz’s proposed Enbrel biosimilar brought litigation under the US biosimilars statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

READ MORE BIOSIMILARS, BPCIA, FDA, PATENT LITIGATION, PTO TRIAL PROCEEDINGS

FDA Guidance for Biosimilar Labeling Largely Stays with Generic Model

JACOB F. SIEGEL | IRENA ROYZMAN
April 1, 2016

On Thursday, FDA released draft guidance clarifying its position on labeling biosimilar products. While the guidance addresses some of the concerns raised by physicians and innovator companies, FDA’s guidance largely continues to treat biosimilars like generics for purposes of labeling.

READ MORE BIOSIMILARS, BPCIA, FDA, LABELING

Amgen Opposes Sandoz’s BPCIA Cert Petition and Files Conditional Cross-Petition on Patent Dance

Amgen has fired back in response to Sandoz’s cert petition in Amgen v. Sandoz, arguing that the Supreme Court should not hear the case—but that if it does, it should also review the Federal Circuit’s holding on the Biologics Price Competition and Innovation Act’s (BPCIA’s) “patent dance.” Though Amgen declined to seek cert on the patent dance issue, which it lost at the Federal Circuit, it has now filed a conditional cross-petition on that issue along with its opposition to Sandoz’s petition for review of the Federal Circuit’s holding on the BPCIA’s notice of commercial marketing.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, PATENT LITIGATION

Sequenom Seeks Supreme Court Review of Non-invasive Prenatal Diagnosis Patent

MICHAEL FRESCO | ARON FISCHER
March 25, 2016

On March 21, 2015, Sequenom filed a petition for writ of certiorari to the Supreme Court in Sequenom, Inc. v. Ariosa Diagnostics, et al. (No. 15-1182). Sequenom seeks Supreme Court review of a Federal Circuit decision holding Sequenom’s patent on a breakthrough non-invasive fetal DNA diagnostic method invalid as directed at patent-ineligible natural phenomena. In its petition, Sequenom calls its case the “ideal vehicle” for the Supreme Court to address mounting concern – acknowledged by the Federal Circuit below – that Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012), has been interpreted too broadly, rendering otherwise meritorious inventions patent ineligible. Sequenom argues that the Federal Circuit’s interpretation of Mayo is incorrect and would have sweeping and devastating effects on innovation in biotechnology.

READ MORE BIOTECHNOLOGY, PATENT LITIGATION

Federal Circuit’s Jurisdictional Decision for ANDA Cases Has Important Implications for BPCIA Litigation

The Federal Circuit affirmed two decisions by the District of Delaware to assert personal jurisdiction in ANDA cases over West Virginia-based manufacturer Mylan. Mylan had argued that it could only be sued in West Virginia in ANDA cases post the Supreme Court's decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014) because such cases are litigated before actual sales of its generic drug product are made in Delaware (and elsewhere). The Federal Circuit grounded its rejection of Mylan's approach on Mylan's filing of its ANDAs with the clear intent to market its proposed generic drugs in Delaware upon FDA approval, as well as the injury Mylan would cause in Delaware through such sales. Under the Federal Circuit's decision, plaintiffs in ANDA and BPCIA cases can obtain jurisdiction over defendants in their forum of choice based on defendants' regulatory filings with the intent to market their proposed products so long as consideration of fairness, such as undue burden on defendants, do not render jurisdiction in the chosen forum unreasonable.

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Biosimilar Makers Turn To IPRs Despite Mixed Results

ZHIQIANG LIU | IRENA ROYZMAN
March 16, 2016

Despite mixed results, biosimilar makers continue to turn to inter partes review (IPR) proceedings in order to challenge innovator patents protecting some of the most important biologics.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, FDA, PATENT LITIGATION, PTO TRIAL PROCEEDINGS

Sandoz Sued for Cutting Short BPCIA “Patent Dance” for Neulasta Biosimilar

In the latest skirmish between Amgen and Sandoz under the U.S. biosimilars statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA), Amgen has filed a new declaratory judgment claim alleging violations of the BPCIA. As described in Amgen’s March 4 complaint, after filing an application for a biosimilar version of Amgen’s cancer drug Neulasta, Sandoz cut short the BPCIA patent dance and demanded that Amgen file an immediate patent infringement suit, claiming that Amgen would otherwise lose its rights to seek lost profits and injunctive relief. Amgen responded with a suit for a declaration that it had no obligation to go forward with the immediate litigation phase of the BPCIA after Sandoz cut off the pre-suit procedures.

READ MORE BIOSIMILARS, BPCIA, FDA, PATENT LITIGATION

Sandoz Seeks Cert on 180-Day Issue in Amgen v. Sandoz

ARON FISCHER | NATHAN MONROE-YAVNEH
February 18, 2016

Sandoz has filed a petition for a writ of certiorari in Amgen v. Sandoz, the first and, to date, only Federal Circuit decision interpreting the Biologics Price Competition and Innovation Act (BPCIA). Sandoz is challenging the Federal Circuit's ruling that biosimilar applicants must observe a 180-day notice period after their products are approved by the FDA.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, PATENT LITIGATION

AbbVie Submits Citizen Petition on Interchangeable Biosimilars

AbbVie, Inc., a biopharmaceutical company, has submitted a citizen petition to the FDA regarding determinations of interchangeability under the BPCIA. An interchangeable biological product is biosimilar to a reference product and meets additional, heightened standards for interchangeability. While biosimilars are required to be highly similar to an FDA-approved reference product, an interchangeable biological product is expected to produce the same clinical result as the reference product in any given patient. A determination of interchangeability is significant because an interchangeable biological product may be substituted for a reference product by a pharmacist without requiring permission from the physician who prescribed the reference product. While the FDA approved the first biosimilar biological product in early 2015, it has yet to issue a decision that one biological product is “interchangeable” with another.

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The US Biosimilars Pathway: Key Questions

JACOB F. SIEGEL | IRENA ROYZMAN
February 9, 2016

In 2015, FDA issued a number of final guidance documents for biosimilars but many fundamental questions remain unsettled, including the requirements for labeling of biosimilars, interchangeability, and naming. There is much ahead for the US biosimilars pathway in 2016.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, FDA

The US Biosimilar Pathway: What’s Ahead

JACOB F. SIEGEL | IRENA ROYZMAN
February 8, 2016

2015 was a landmark year for biosimilars. It began with the approval of the first US biosimilar, Sandoz’s Zarxio, in March 2015 under the biosimilars pathway. Zarxio entered the US market in September. Many expected the floodgates to open after Zarxio’s approval but Zarxio remains the only approved US biosimilar to this day, although that is expected to change this year. Seven other biosimilar applications were filed in 2014/2015 and are either being reviewed by FDA or have to be refiled. Most of these applications are to complex biologics. 2016 should provide significant insights into how FDA determines biosimilarity and extrapolation for these complex products.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, FDA

Final WHO Biosimilar Naming Proposal Resembles FDA Approach

SHENG T. LI | IRENA ROYZMAN
February 3, 2016

On January 26, 2016, the World Health Organization (WHO) unveiled the final version of its proposal for a worldwide biosimilar naming convention. The WHO proposes to add a “biologic qualifier” (BQ), which consists of four random consonants and an optional two-digit checksum, as an identifier that follows the nonproprietary name of each biologic and biosimilar product. This proposal resembles FDA’s biosimilar naming proposal, which adds four random consonants as a suffix to nonproprietary names. Industry and healthcare stakeholders have criticized FDA’s proposal to use random suffixes, instead of meaningful—and therefore memorable—ones, due to a greater likelihood of reporting and prescription errors with meaningless names. The WHO proposal, which uses a randomly generated separate identifier, is likely to draw similar criticism.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, FDA, NAMING

U.S. Biosimilar Litigation So Far

ARON FISCHER
February 1, 2016

Nearly six years after the U.S. biosimilar statute was passed, the number of reported decisions addressing the statute can still be counted on the fingers of two hands, but this has been enough for some clear patterns to emerge. Again and again, biosimilar applicants and innovators have taken consistent, but diametrically opposed, positions on fundamental issues concerning the operation of the statute. As the courts have resolved these disputes, the basic framework for biosimilar patent litigation has taken shape – at least until the next generation of biosimilar applications raises new issues.

READ MORE BIOSIMILARS, BPCIA, PATENT LITIGATION

Amgen Declines to Seek Cert in Amgen v. Sandoz

ARON FISCHER | NATHAN MONROE-YAVNEH
January 19, 2016

Amgen has decided not to seek Supreme Court review of the Federal Circuit’s Amgen v. Sandoz decision, as the January 14, 2016 deadline to file has now passed without Amgen petitioning for certiorari. In Amgen, the Federal Circuit held that the BPCIA’s “patent dance” patent dispute resolution procedures are essentially optional. With the Federal Circuit having already denied en banc review, Amgen’s decision not to seek cert appears to mean that the patent dance is now optional as a matter of settled law. There is, however, one caveat: if Sandoz seeks cert and the Court accepts, Amgen could file a cross-motion on the patent dance issue.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, PATENT LITIGATION

PTAB Declares Interference for Groundbreaking Gene-Editing Technology

BENJAMIN H. WEISSMAN | IRENA ROYZMAN
January 15, 2016

Earlier this week, the Patent Trial and Appeal Board (PTAB) set the stage for what is expected to be an epic battle over who owns the intellectual property rights to “the biggest biotech discovery of the century.” On January 11, 2016, the PTAB declared an interference to decide who was first to invent the use of the groundbreaking gene-editing technique known as CRISPR in eukaryotic cells. The CRISPR proceeding may be one of the last great biotech interferences. The claims at issue are viewed by many as the “holy grail” for correcting and curing human genetic diseases and interferences will ultimately become obsolete under the America Invents Act.

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The Federal Circuit Will Hear Apotex’s Appeal from a Preliminary Injunction Under the BPCIA in Early 2016

ANDREW D. COHEN | IRENA ROYZMAN
January 4, 2016

In early 2016, the Federal Circuit will hear Apotex’s appeal from a preliminary injunction barring Apotex from selling its proposed Neulasta biosimilar for 180 days after FDA approval. Briefing will be complete on February 12, 2016, and the Federal Circuit agreed to place the case on the oral argument calendar soon thereafter. Apotex had asked for a more expedited schedule but was not able to provide any specific evidence of when its proposed biosimilar product will be approved.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, FDA, PATENT LITIGATION

Florida Federal Court Enjoins Apotex from Selling Neulasta Biosimilar for 180 Days After Approval

ARON FISCHER
December 11, 2015

On December 9, a federal district court in Florida issued a preliminary injunction prohibiting Apotex from selling a proposed biosimilar version of Amgen’s cancer drug Neulasta for 180 days after the biosimilar is approved. In the decision, the district court resolved in Amgen’s favor a dispute over the meaning of the Federal Circuit’s recent decision in Amgen v. Sandoz, the first and to date the only appellate decision addressing the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

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Ten Years of Biosimilars in Europe

JACOB F. SIEGEL | ARON FISCHER
December 8, 2015

This fall marks the tenth anniversary of the effective date of the European Medicines Agency's Guideline on Similar Biological Medicinal Products. Over the past ten years, the EMA has approved 19 biosimilars corresponding to 6 different reference drugs, under the Guideline, and a biosimilar of a seventh is nearing final approval. Since the EU system served as the model, in many respects, for the biosimilar approval process in the U.S. and other developed countries, the European experience sheds light on what we can expect in the development and commercializations of biosimilars in the U.S. in the next several years.

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Enbrel Biosimilar in Europe and US

MICHAEL FRESCO | IRENA ROYZMAN
December 1, 2015

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Samsung Bioepis’s Benepali, the first biosimilar of Enbrel (etanercept), in Europe. Enbrel is a blockbuster treatment for rheumatoid arthritis and a number of other autoimmune conditions associated with elevated levels of tumor necrosis factor alpha (TNF-alpha), a protein that plays an important role in promoting inflammation. The CHMP recommended approval of Benepali for these conditions. In the US, FDA recently accepted Sandoz’s regulatory application for its proposed biosimilar of Enbrel for review. Sandoz is seeking approval for all of Enbrel’s indications. FDA’s review of Sandoz’s proposed biosimilar will provide important information on the requirements for biosimilarity and extrapolation for complex biologic products.

READ MORE BIOSIMILARS, BPCIA, EMA, FDA

Stakeholders Say Biosimilars Names Should Be Meaningful and Memorable

JACOB F. SIEGEL | IRENA ROYZMAN
November 30, 2015

FDA has received comments from more than 170 groups on its proposal for naming biosimilars. Biosimilar makers, insurers and pharmacies largely oppose distinct nonproprietary names (also known as proper names) for biosimilars. By contrast, innovators (including those that develop biosimilars), healthcare providers and patient advocacy groups view them as critical to ensuring patient safety. However, most stakeholders in both camps urged FDA to use meaningful suffixes to distinguish biosimilars from originator products rather than suffixes “devoid of meaning.” FDA proposed to add meaningless suffixes to the nonproprietary names of originator products to address concerns of biosimilar makers that distinct names would discourage adoption of biosimilar products. But biosimilar makers expressed concern that such meaningless suffixes will lead to a variety of errors and ultimately endanger public safety. FDA may now revisit its proposal given the largely uniform preference of innovators and biosimilar makers alike for meaningful and memorable nonproprietary names, such as those that identify the manufacturer of the biologic.

READ MORE BIOSIMILARS, BPCIA, FDA, NAMING

Naming of Interchangeable and Biosimilar Biological Products Likely to Be Same

JACOB F. SIEGEL | IRENA ROYZMAN
November 23, 2015

In its draft guidance, FDA proposed distinguishable nonproprietary names for biosimilars to promote the safety of patients receiving biologic medicines and minimize inadvertent substitution of biologics that have not been determined to be interchangeable. FDA did not make a proposal for naming interchangeable biological products. Instead, FDA requested comments on how to name such products in addition to seeking comments on its approach to naming biosimilars. Stakeholders’ comments are now in. Innovator companies (including those that also develop biosimilars), healthcare providers and patient advocacy groups favor distinguishable nonproprietary names for biosimilars. Biosimilar makers, insurers, pharmacies, and the FTC, by contrast, largely fall into a different camp; they argue that distinct names are unnecessary for monitoring biosimilars and will likely bias providers against prescribing them. Notably, the two camps came together on the naming of interchangeable products. Since interchangeable products will likely first be approved as biosimilars, both camps advocated keeping the initial biosimilar name rather than changing it after approval as an interchangeable product. As a result of this unified view, FDA is likely to expand the naming approach it ultimately adopts for biosimilars to interchangeable products.

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Amgen Uses Agreement to Litigate Patents Under the BPCIA to Rebuff Sham Litigation Claims


November 17, 2015

Last month, in a case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) involving Apotex’s proposed biosimilar of Amgen’s Neulasta (pegfilgrastim), Apotex accused Amgen of sham litigation for bringing a patent infringement claim on a that the parties agreed to litigate during the immediate litigation phase of the BPCIA. In its Answer to Apotex’s Counterclaims, Amgen pointed out that Apotex had agreed to include the patent in the BPCIA infringement action, despite having a statutory option to disagree.

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Impact of Nautilus on Biotech and Pharmaceutical Patents

EUGENE M. GELERNTER | ZHIQIANG LIU
November 13, 2015

In Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014), the Supreme Court rejected the Federal Circuit’s “insolubly ambiguous” standard for determining whether a patent claim meets the definiteness requirement under 35 U.S.C. §112, ¶ 2, and that “a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” In the ensuing one and a half years, the Federal Circuit and several trial courts have applied the Nautilus standard in the biotechnology and pharmaceutical contexts. We discuss three notable decisions.

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FDA Rejects Hospira’s EPO Biosimilar Application

ANDREW D. COHEN | IRENA ROYZMAN
November 5, 2015

After the FDA approved the first U.S. biosimilar, Sandoz’s Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products. That has not been the case. No other U.S. biosimilar product has been approved. And, as FDA’s recent rejection of Hospira’s EPO biosimilar application suggests, Zarxio’s approval may ultimately provide little guidance for more complex products.

READ MORE BIOSIMILARS, BPCIA, FDA, PATENT LITIGATION

Final Text of Trans-Pacific Partnership Released

NATHAN MONROE-YAVNEH | IRENA ROYZMAN
November 5, 2015

At long last, the final text of the Trans-Pacific Partnership, a free trade agreement among a dozen Pacific Rim nations, has now been made available to the public. The chapter on intellectual property, however, does not appear to have any material changes relating to exclusivity for new biologics from the leaked draft released by WikiLeaks last month. Just as the provisions in the leaked draft did, Articles 18.50 and 18.52 give countries a choice between, on the one hand, at least eight years of exclusivity or, on the other hand, at least five years of exclusivity plus unspecified “other measures” and protection through “market circumstances.” Additionally, the agreement seems to provide for only market exclusivity, not data exclusivity. The TPP bars biosimilar applicants from entering the market during the exclusivity period, but does not appear to prevent them from accessing innovators’ regulatory data.

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Apotex Follows the BPCIA “Patent Dance” Again

SHENG T. LI | IRENA ROYZMAN
November 4, 2015

The first biosimilar makers to file regulatory applications with FDA attempted to bypass all or a subset of the patent litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Apotex, the third biosimilar maker to file an application for approval of a biosimilar product with FDA, chose a different course. Apotex participated in and completed the BPCIA’s pre-suit information exchanges (also known as the “patent dance”) for its proposed biosimilar of Amgen’s Neulasta (pegfilgrastim). As Amgen’s recent lawsuit shows, Apotex followed the patent dance again for its proposed biosimilar of Amgen’s Neupogen (filgrastim).

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TPP Biologics Exclusivity Period Maintains The Status Quo

NATHAN MONROE-YAVNEH | IRENA ROYZMAN
October 28, 2015

After half a decade of negotiations, the Trans-Pacific Partnership seems to do little more than maintain the status quo for biologics. A leaked draft of the agreement appears to require member states to provide between five and eight years of exclusivity for new biologics. But almost all TPP signatories provide that duration under current law, and some governments have already said that the pact will not require them to change their laws. The United States will be able to maintain its current twelve years of protection. Additionally, the agreement appears to provide only market exclusivity, which prevents biosimilars from being sold, and not data exclusivity, which prevents biosimilar makers from using innovators’ regulatory data. Because the TPP largely reflects existing exclusivity periods for biologics, many view it as a missed opportunity for incentivizing global investment in new biologics.

READ MORE BIOSIMILARS, BPCIA, LEGISLATION, NON-PATENT EXCLUSIVITY

Federal Circuit Declines to Rehear Amgen v. Sandoz En Banc


October 16, 2015

This morning, the full Federal Circuit declined to rehear en banc Amgen v. Sandoz, the first appellate decision interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The decision to deny en banc review comes as something of a surprise, as the panel decision was fractured, and neither party disputed that it raised important issues of first impression. Indeed, both parties sought en banc review, albeit on different issues. In a per curiam order issued this morning, the court denied both petitions. Unless the Supreme Court (or a later en banc court) intervenes, the panel’s decision will stand as the Federal Circuit’s authoritative statement on the issues presented.

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Hospira Moves to Dismiss Amgen’s BPCIA Claims in Epogen Biosimilars Suit


October 14, 2015

Last month, Amgen sued Hospira in Delaware under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) over Hospira’s proposed biosimilar version of Amgen’s Epogen (epoetin alfa). Amgen brought, among others, two BPCIA-specific claims under 42 U.S.C. § 262(l)(2)(A) (relating to Hospira’s alleged failure to provide the required manufacturing information) and 42 U.S.C. § 262(l)(8)(A) (relating to Hospira’s allegedly ineffective 180-day notice of commercial marketing). On October 13, Hospira moved to dismiss these claims, arguing that Congress did not create a private right of action to enforce the BPCIA. The issues raised in Hospira’s motion to dismiss are currently before the Federal Circuit in Amgen’s and Sandoz’s petitions for rehearing en banc.

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Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

NATHAN MONROE-YAVNEH | IRENA ROYZMAN
October 14, 2015

A final agreement has been reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. The final text of the agreement is not yet officially available and its exact contours are unclear, but reports indicate that it includes a complicated compromise providing for between five and eight years of exclusivity. This represents a setback for the United States, which sought twelve years of exclusivity throughout the negotiations. Industry groups have also expressed disappointment.

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Apotex Accuses Amgen of Sham BPCIA Litigation


October 8, 2015

Amgen recently sued Apotex under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) over Apotex’s proposed biosimilar of Amgen’s Neulasta (pegfilgrastim), a long-lasting version of Neupogen. This is the first BPCIA suit to reach the courts after completion of the BPCIA’s pre-suit information exchange, the so-called patent dance. On October 5, 2015, Apotex filed its Answer with Counterclaims. Despite agreeing on which patents should be the subject of immediate patent infringement litigation under the BPCIA, Apotex now alleges that Amgen’s suit on one of those patents is sham litigation in violation of the Sherman Act.

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FDA Accepts for Review Sandoz’s Application for a Biosimilar of Amgen’s Enbrel


October 5, 2015

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to bypass the litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). It remains to be seen whether Sandoz now will follow the BPCIA and provide its regulatory application and other manufacturing information to Amgen since the Federal Circuit has recently held that doing so is optional in Amgen v. Sandoz, another case involving the same parties and the Federal Circuit’s first decision to interpret the BPCIA. Amgen is currently seeking en banc review of this ruling.

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Update on FDA’s Approach to Labeling Biosimilars Like Generics

The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns. Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s Neupogen and that it has not been determined to be interchangeable to Neupogen. Instead, Zarxio’s label is nearly identical to that of Amgen’s Neupogen and does not identify the information provided by Sandoz to FDA to obtain Zarxio’s approval, including information on immunogenicity specific to Zarxio. AbbVie has supplemented its citizen petition urging FDA not to allow biosimilars to be labeled like generic drugs since biosimilars, unlike generic drugs, are not identical to the originator product and requesting distinct labeling for biosimilars. In briefing U.S. senators on September 17, FDA promised to issue guidance on labeling of biosimilars.

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Update on Personal Jurisdiction for BPCIA Litigants after the Supreme Court’s decision in Daimler

Defendants in Hatch-Waxman cases continue to contest personal jurisdiction outside of their "home" state, in reliance on the Supreme Court's decision in Daimler AG v. Bauman. Most district courts have rejected such arguments, and found that jurisdiction is proper in the patent owner's preferred forum based on consent-by-registration jurisdiction or specific jurisdiction. Both theories of personal jurisdiction are on appeal before the Federal Circuit, and oral argument is likely to occur early in 2016. The lessons learned in the Hatch-Waxman context will provide guidance for litigation under the BPCIA.

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Amgen Sues Hospira in Fourth Lawsuit Under the BPCIA


September 24, 2015

On September 18, 2015, Amgen sued Hospira in a fourth lawsuit under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The lawsuit concerns Hospira’s proposed biosimilar of Amgen’s Epogen (epoetin alfa). Amgen filed the case in Delaware and it has been assigned to Judge Andrews. In addition to its claims for patent infringement, Amgen sued Hospira for failing to comply with the patent litigation provisions of the BPCIA. Hospira’s proposed biosimilar has not been licensed by FDA. FDA also has not announced plans for an advisory committee meeting for Hospira’s product.

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FDA’s Proposal for Naming Biosimilars Pleases Some, Disappoints Others

ELIZABETH L. CALLAHAN | IRENA ROYZMAN
September 15, 2015

The FDA has issued a long-awaited draft guidance document and proposed rule on the nonproprietary names for biosimilar medicines. FDA proposes to give biosimilars a “core name” shared with all related biological products and a four-letter suffix, unique to each product. The four-letter suffix, unlike the placeholder name for the first US biosimilar, Sandoz’s Zarxio (filgrastim-sndz), does not identify the product’s manufacturer. Instead, it is a random collection of four letters, “devoid of meaning.” Patient groups and physicians have applauded FDA’s use of unique suffixes to differentiate biological products but innovator companies prefer meaningful suffixes, such as the one for Zarxio, and biosimilar manufacturers argue for no distinguishing names at all.

READ MORE BIOSIMILARS, BPCIA, FDA, NAMING

Strong Support for Sequenom’s Petition for Rehearing En Banc

ANDREW D. COHEN | IRENA ROYZMAN
September 9, 2015

In Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.’s noninvasive prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012). Sequenom petitioned the court for rehearing en banc, arguing that the panel failed to consider the claimed method as a whole and that its analysis was therefore contrary to Supreme Court precedent. Sequenom’s petition received strong support from amici from numerous organizations, companies and academic groups. There were 12 amicus briefs in total, raising a variety of additional arguments in support of en banc review. On September 3, 2015, the court invited appellees to file a response to the petition for rehearing en banc.

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Apotex Follows the Pre-Suit Information Exchange Provisions of the BPCIA

IRENA ROYZMAN
September 8, 2015

In the first skirmishes between biosimilar makers and innovator companies, biosimilar makers attempted to bypass the litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) through the filing of declaratory judgment actions, or by not participating in all or a subset of the BPCIA’s pre-suit information exchanges (also known as the “patent dance”). Apotex, the third biosimilar maker to file an application for approval of a biosimilar product with FDA, chose a different path. As Amgen’s recent lawsuit against Apotex reveals, Apotex is the first biosimilar applicant to participate in and complete the carefully orchestrated pre-suit information exchanges of the BPCIA.

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The United States’ First-Ever Biosimilar Reaches the Market


September 3, 2015

Today, Sandoz (a Novartis subsidiary) launched the first biosimilar approved under the BPCIA: the cancer drug Zarxio (filgrastim-sndz), which is a biosimilar version of Amgen’s Neupogen. The launch follows the Federal Circuit’s decision enjoining Sandoz from launching Zarxio for 180 days and the court’s recent denial of Amgen’s emergency motion to extend the injunction pending Amgen’s and Sandoz’s cross-petitions for rehearing en banc.

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Amgen Panel Denies Emergency Motion for Injunction Pending En Banc Consideration


September 2, 2015

Today the Federal Circuit panel that decided Amgen v. Sandoz denied Amgen’s emergency motion for an injunction pending consideration of its petition for en banc review. The panel (Judges Lourie, Newman, and Chen) denied the motion without opinion, but did note that Judge Newman would have granted the motion.

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Biosimilar Makers’ IPR Strategy Yields Mixed Results

ZHIQIANG LIU | IRENA ROYZMAN
August 31, 2015

A number of biosimilar makers have turned to inter partes review (IPR) proceedings to challenge innovator patents prior to submitting their biosimilar applications to FDA. IPRs have been attractive to biosimilar makers because in addition to offering procedural and substantive advantages for challenging patents they do not require the filing of a biosimilar application. As a result, they make it possible for biosimilar makers to obtain patent certainty at a time when litigation under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is premature and, depending on the results of the IPRs, may be avoided entirely. The first such IPRs, however, are yielding mixed results, leaving potential patent disputes for later BPCIA litigation.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, FDA, PATENT LITIGATION, PTO TRIAL PROCEEDINGS

Both Parties Seek En Banc Intervention in Amgen v. Sandoz

ARON FISCHER
August 28, 2015

Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz. Amgen is the court’s first decision interpreting the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). But if the parties have their way, the panel decision will not be the Federal Circuit’s last word on the issues in dispute – and the court’s next intervention may come sooner rather than later. Last week, both parties petitioned for en banc rehearing of the panel’s decision. And on Wednesday, Amgen filed an emergency motion for an injunction pending en banc consideration and review, asking the full court to make a preliminary assessment of the issues before September 2, when the injunction issued by the original panel expires.

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Exclusivity Period of Biologics Remains a Hurdle in Trans-Pacific Partnership Talks


August 26, 2015

The latest round of talks over the Trans-Pacific Partnership (TPP), a proposed Pacific Rim free-trade agreement, has ended with disagreement on a number of key issues, including the non-patent exclusivity period for biologic medications.

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First Federal Register Notice of BPCIA Suit


August 24, 2015

Today, FDA published notice of Janssen’s lawsuit against Celltrion and Hospira on March 6, 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in the Federal Register. Although Janssen’s lawsuit is not the first action under the BPCIA, today marks the first time the FDA published notice of any BPCIA lawsuit.

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Expansion of Direct Infringement in Federal Circuit’s Akamai Decision a Big Win for Patent Holders

In a victory for holders of method patents, the Federal Circuit issued an en banc decision yesterday expanding the scope of direct infringement when multiple parties perform different steps of an invention. In its unanimous Akamai Techs. v. Limelight Networks decision, the appeals court provided a fact-based test for determining when “all method steps can be attributed to a single entity” such that direct infringement can be found under 35 U.S.C. § 271(a). Unlike the earlier panel decision that was overturned, the en banc court held that infringement can, in some circumstances, be attributed to a single entity even when there is an arms-length business relationship between that entity and the other parties that perform steps of the patented method.

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Federal Circuit Issues Its First Decision Interpreting BPCIA

ANDREW D. COHEN | IRENA ROYZMAN
July 21, 2015

Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23, 2015), an historic case of first impression, a divided panel of the Federal Circuit interpreted the BPCIA. The court (per Judges Lourie and Chen) held that a biosimilar applicant can opt out of the BPCIA’s patent dance provisions by withholding its aBLA and manufacturing information, and that the only consequence of doing so is being subject to a patent infringement action on any patent that could have been listed during the patent dance. The court (per Judges Lourie and Newman) also held that a biosimilar applicant is required to provide a notice of commercial marketing under the BPCIA, and that such a notice can only be provided after the FDA has approved the biosimilar product. In short, both reference product sponsors and biosimilar manufacturers will find good and bad news in today’s decision.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, FDA, PATENT LITIGATION

Debate Over the Exclusivity Period for Biologics in the Trans-Pacific Partnership

Debate continues over the exclusivity period for biologics in the Trans-Pacific Partnership. Lawmakers from both sides of the aisle have weighed in on the inclusion of a 12-year exclusivity period in the free-trade agreement.

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Disclosure Requirements Under the BPCIA

The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.” In determining the standard and appropriate level of detail required by the disclosures pursuant to the patent dance, looking to analogous disclosure requirements in the Hatch-Waxman context provides helpful guidance. Gleaning from the Hatch-Waxman context, “detailed statement” disclosures under the BPCIA should have a reasonable basis and establish a prima facie case of invalidity or non-infringement. Moreover, as in the Hatch-Waxman context, filing “baseless” non-infringement or invalidity positions may risk sanctions as an “exceptional case” that may warrant attorney fees under 35 U.S.C. § 285.

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First Round of Post-Teva Claim Construction Decisions: Business as Usual?

In Teva v. Sandoz, the Supreme Court held that findings of fact subsidiary to a claim construction decision are entitled to deference on appeal. Teva has the potential to transform claim construction proceedings, but the extent of the impact will depend on how it is applied by the Federal Circuit. Three recent Federal Circuit decisions give mixed signals about its post-Teva approach to appellate review.

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Biobetters: The Advantages and Challenges of Being Better

ANDREW D. COHEN | IRENA ROYZMAN
June 26, 2015

The BPCIA created an abbreviated pathway for FDA approval of biological medicinal products that are “biosimilar” to an already FDA-approved product. The FDA recently approved the first U.S. biosimilar – Sandoz’s biosimilar of Amgen’s Neupogen – and is currently reviewing at least four other proposed biosimilars. Many innovators and biosimilars manufacturers are responding to the changing landscape for biologics by developing “biobetters”: new and improved versions of biologic medicinal products. While biobetters require discovery and an original Biologics License Application (BLA) with a full complement of pre-clinical and clinical data for marketing approval, they also offer many advantages. By offering superior and longer-acting medicine, biobetters provide a competitive advantage over biosimilar products. In addition, unlike biosimilars, they generally would be entitled to patent protection and 12 years of non-patent exclusivity under the BPCIA.

READ MORE BIOBETTERS, BIOSIMILARS, BIOTECHNOLOGY, BPCIA, FDA, NON-PATENT EXCLUSIVITY, PATENT LITIGATION

Mayo Test Dooms Breakthrough Biotech Invention

ANDREW D. COHEN | IRENA ROYZMAN
June 18, 2015

The Federal Circuit recently handed down a long-awaited Section 101 decision, one with potentially far-reaching consequences for biotech diagnostic patents. In Ariosa Diagnostics Inc. v. Sequenom Inc., No. 14-1139 (Fed. Cir. June 12, 2015), the Federal Circuit, applying the U.S. Supreme Court’s test for patent eligibility set out in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012), invalidated Sequenom’s breakthrough patent on noninvasive prenatal diagnosis through the amplification and detection of paternally inherited cell-free fetal DNA (“cffDNA”) in the blood of pregnant women. According to the court, “even such valuable contributions can fall short of statutory subject matter” under the test set out in Mayo. In addition to its implications for other biotech patents and investment in diagnostics, the Federal Circuit’s decision illustrates the potentially unintended consequences of Mayo and the need for a legislative solution so that breakthrough manmade inventions remain patent-eligible.

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FDA Approach to Labeling Treats Biosimilars Like Generics

A recent FDA guidance document eliminated biosimilar labeling information that FDA previously viewed as “necessary” for physicians to make prescribing decisions, including whether the biologic is biosimilar to or interchangeable with the reference product. The FDA also approved a label for the first approved US biosimilar that omits this information. The FDA’s actions have drawn criticism from associations of physicians who routinely prescribe biologic medicines and the innovator companies that develop them.

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Federal Circuit Oral Arguments in Amgen v. Sandoz

On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). While both sides received heavy questioning, several commentators have suggested that the panel’s comments favored Amgen, which previously obtained an injunction pending appeal. There is no timetable for a decision but the appeal is expedited.

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Supreme Court’s Decision in Commil v. Cisco: Big Win for Pharmaceutical Industry

CHARLENE CHOI | IRENA ROYZMAN
May 27, 2015

On May 26, 2015, the Supreme Court reversed the Federal Circuit’s decision in Commil USA, LLC v Cisco Systems, Inc. and held that a defendant’s belief regarding patent validity is not a defense to an induced infringement claim. The Supreme Court’s Decision is a big win for the pharmaceutical industry, where method of treatment patents provide important protection for innovative medical therapies. The Federal Circuit’s good-faith belief in invalidity defense gutted liability for inducing infringement of such patents. The Supreme Court’s reversal allows these valuable patents to be enforced against the companies that induce infringement. It also deters “at risk” launches prior to a district court decision on the validity of the patents.

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FDA Issues Biosimilars Q&A Guidance Document

On May 13, the FDA released additional draft question-and-answer guidance on the implementation of the BPCIA. The draft document resurrects a number of the questions from FDA’s original 2012 draft guidance that were omitted from last month’s final version of the 2012 document. As a result, FDA’s final answers to important questions from three years ago may not be forthcoming for some time.

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Biosimilar Makers Turn to IPRs before Litigation under the BPCIA

ZHIQIANG LIU | IRENA ROYZMAN
May 15, 2015

A number of biosimilar makers have turned to inter partes review (IPR) proceedings in order to litigate the validity of patents that cover their proposed products in advance of submitting their regulatory applications to FDA. Since IPRs, unlike district court proceedings, do not require a case or controversy, they allow biosimilar applicants to resolve potential patent disputes long prior to being able to litigate these disputes in district court and to potentially avoid the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA) of 2009 entirely.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, FDA, PATENT LITIGATION, PTO TRIAL PROCEEDINGS

Lessons in Personal Jurisdiction for BPCIA Litigants after the Supreme Court’s decision in Daimler

In the wake of the Supreme Court’s decision in Daimler AG v. Bauman, some defendants in Hatch-Waxman litigation have contested personal jurisdiction anywhere outside their “home” state. District courts have universally rejected such arguments, finding personal jurisdiction in the patent owner’s chosen forum on the basis of consent or specific jurisdiction. The Federal Circuit will consider two of these cases this summer. The lessons learned will be equally applicable to litigation under the BPCIA.

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Amgen v. Sandoz: Federal Circuit Grants Injunction Pending Appeal

ARON FISCHER
May 6, 2015

Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation Act (BPCIA). While this is an interim decision without a substantive opinion, it indicates that the court is taking Amgen’s arguments seriously.

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The Soon-to-Be Reality of Medicare Part B Reimbursements for Biosimilars

Medicare Part B covers drugs prescribed and administered in an outpatient setting (e.g., a doctor’s office or outpatient clinic), including many biologic drugs (given that they are often injectable drugs that must be administered by a health practitioner). In the wake of the recent approval of Sandoz’s Zarxio (filgrastim-sndz), the first FDA-approved biosimilar, the practical impact of Medicare Part B’s reimbursement policy will soon be tested in the marketplace.

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Amgen v. Sandoz BPCIA Dispute Heads to the Federal Circuit

Amgen v. Sandoz, the first full-fledged dispute under the Biologics Price Reduction and Innovation Act, is headed to the Federal Circuit on an expedited briefing schedule, with oral argument to be held on June 3. The Federal Circuit’s decision is likely to answer basic questions about how the statute operates.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, PATENT LITIGATION

The Value of Being Highly Similar: First U.S. Biosimilar


April 21, 2015

On March 6, the Food and Drug Administration (FDA) approved the first biosimilar in U.S. history—Sandoz’s biosimilar of Amgen’s blockbuster drug used to prevent infections in cancer patients, Neupogen. Sandoz, a Novartis company, reaped tremendous savings in cost and time by taking advantage of the new biosimilar pathway rather than submitting a full biologics license application (BLA) to the FDA and undertaking all the studies that Amgen had to perform to obtain approval for Neupogen. The extent to which these savings will be passed on to the U.S. health care system as envisioned by the Obama administration, however, is less clear.

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Navigating Protective Order and Prosecution Bar Issues in BPCIA Litigation

Protective orders preventing litigation counsel from participating in the prosecution of litigation-related patents are commonplace. These restrictions, however, could prejudice brand companies in light of the increasing trend among generic and biosimilar applicants to file IPR proceedings on the same patents that are at issue in litigation. In such cases where “the PTO and district court are just two fronts in the same battle,” courts have been liberal in allowing litigation counsel to participate in IPR proceedings, post-grant proceedings, and reexaminations.

READ MORE BPCIA, PATENT LITIGATION, PTO TRIAL PROCEEDINGS

Impact of Supreme Court’s Commil v. Cisco?

CHARLENE CHOI | IRENA ROYZMAN
April 2, 2015

On March 31, the Supreme Court heard oral argument in Commil USA LLC v. Cisco Systems Inc. The Supreme Court considered the Federal Circuit’s holding that a belief in a patent’s invalidity is a defense to inducing infringement under 35 U.S.C. § 271(b). The Justices posed tough questions to both sides. But the ultimate outcome of this case should not impact litigation under the BPCIA where inducing infringement of method of treatment and manufacturing patents offers important protection to innovators since the validity of such patents is typically determined prior to launch of a biosimilar product.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, PATENT LITIGATION

FDA Denies Amgen’s Citizen’s Petition Awaiting Guidance from the Courts

ANDREW D. COHEN
March 30, 2015

On March 25, 2015, FDA denied Amgen’s Citizen Petition asking the FDA to require biosimilar applicants to certify compliance with the information disclosure provisions of the BPCIA before the FDA formally accepts the biosimilar application for review. FDA did not decide whether the disclosure provisions were mandatory, deferring to ongoing litigation on that issue.

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Biosimilars Await Naming Guidance From FDA

Despite its recent approval of the first biosimilar product, the FDA has yet to release a naming policy for biosimilars. With more biosimilar applications in the pipeline, a number of industry groups are taking opposing positions on the future of biosimilar nomenclature.

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California District Court Denies Amgen’s Motion for a Preliminary Injunction on BPCIA

NATHAN MONROE-YAVNEH
March 20, 2015

On March 19, Judge Seeborg of the Northern District of California denied Amgen’s motion for a preliminary injunction in Amgen v. Sandoz. Sandoz recently won the first-ever FDA approval for a biosimilar for its product Zarxio, which is based on Amgen’s blockbuster Neupogen.

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“Biosimilars” Under the 505(b)(2) Pathway

SCOTT B. HOWARD | RYAN M. MOTT
March 19, 2015

Zarxio is the first biosimilar approved under the 351(k) pathway, but it is not the first “biosimilar” to be approved in the U.S. For a small category of follow-on biologics, there is another pathway for marketing approval -- and it is only available for the next five years.

READ MORE BIOSIMILARS, BIOTECHNOLOGY, BPCIA, FDA, NON-PATENT EXCLUSIVITY

FDA Announces Approval of First Ever U.S. Biosimilar

ANDREW D. COHEN | IRENA ROYZMAN
March 6, 2015

Today the FDA announced approval of the first ever biosimilar in the United States, Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen (filgrastim) product. Although Sandoz has cleared FDA obstacles, when Zarxio reaches the market depends on the outcome of Amgen’s lawsuit under the BPCIA.

READ MORE BIOSIMILARS, BPCIA, FDA, NAMING

The Day the BPCIA Was Struck Down

ANDREW D. COHEN | ARON FISCHER
March 5, 2015

Although the most recent challenge to the Affordable Care Act does not affect the Biologics Price Competition and Innovation Act (BPCIA), it calls to mind the first round of Obamacare litigation, in which the BPCIA, while not directly challenged, briefly became collateral damage.

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Twelve Years, or Fewer? Two Current Debates on the Exclusivity Period for Biologics

NATHAN MONROE-YAVNEH | IRENA ROYZMAN
February 24, 2015

The exclusivity period for biologic drugs has recently become a hot topic in both domestic and foreign policy. At home, the Obama administration’s latest budget proposes reducing the exclusivity period to seven years, down from its current 12. Abroad, the exclusivity period for biologics has developed into a sticking point in negotiations over the Trans-Pacific Partnership.

READ MORE BIOSIMILARS, BPCIA, FDA, LEGISLATION, NON-PATENT EXCLUSIVITY

First Round of BPCIA Litigation: Declaratory Judgment Act Can’t Be Used to Avoid the “Patent Dance”

ARON FISCHER
February 19, 2015

In the first reported cases on the BPCIA patent provisions, biosimilar makers have sought to bring declaratory judgment actions before engaging in the statutory “patent dance.” The courts have unanimously dismissed these actions as non-justiciable.

READ MORE BIOSIMILARS, BPCIA, FDA, PATENT LITIGATION

Welcome to BiologicsBlog.com


February 17, 2015

Welcome to the Biologics Blog, which will track and analyze developments in intellectual property law related to biologic medical products as well as regulatory and legislative changes. Our impetus for starting the blog is the recent onset of regulatory activity and litigation under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which created a new regulatory and legal framework for biosimilar and interchangeable biologic products.

READ MORE BIOBETTERS, BIOSIMILARS, BIOTECHNOLOGY, BPCIA, FDA, LEGISLATION, NON-PATENT EXCLUSIVITY, PATENT LITIGATION, PTO TRIAL PROCEEDINGS

The U.S. Biosimilar Pathway: The First Five Years and What’s Ahead

IRENA ROYZMAN
February 12, 2015

Nearly five years have passed since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law. Although the BPCIA regulatory pathway has been much slower to take shape than its European counterpart, 2015 promises to be a landmark year, with the first biosimilar in U.S. history expected to be approved next month.

READ MORE BIOSIMILARS, BPCIA, FDA

DNA Primers: The Trouble with Being Short

IRENA ROYZMAN
February 10, 2015

In a recent case, the Federal Circuit held that short synthetically created DNAs are not patentable after the Supreme Court’s decision in Association for Molecular Pathology v. Myriad.

READ MORE BIOTECHNOLOGY, PATENT LITIGATION