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Category: Patent Litigation

Strong Support for Sequenom’s Petition for Rehearing En Banc

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

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

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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Biosimilar Makers’ IPR Strategy Yields Mixed Results

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.  

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Both Parties Seek En Banc Intervention in Amgen v. Sandoz

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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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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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

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.  

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Mayo Test Dooms Breakthrough Biotech Invention

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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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

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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Biosimilar Makers Turn to IPRs before Litigation under the BPCIA

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.   

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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

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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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. 

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Impact of Supreme Court’s Commil v. Cisco?

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.

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Gilead’s Cert Petition Denied

In Gilead Sciences v. Natco Pharma, the Federal Circuit held that for post-GATT patents, i.e., patents filed after June 8, 1995 and subject to a 20 year term from the filing of the patent applications under the General Agreement on Tariffs and Trade (GATT),...
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Welcome to BiologicsBlog.com

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.

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