In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation. The Federal Circuit affirmed the jury’s finding that Hospira’s pre-approval manufacture of batches of its biosimilar was an act of infringement of Amgen’s manufacturing patents not protected by the Safe Harbor, even though data from those batches was used to support Hospira’s BLA. The court held that the relevant Safe Harbor inquiry “is not how Hospira used each batch it manufactured, but whether each act of manufacture was for uses reasonably related to submitting information to the FDA.” Hospira has now petitioned for rehearing en banc, arguing that the court’s holding “calls into question the continuing viability of the Safe Harbor, particularly in the context of BPCIA litigation.”
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Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes. Our team includes highly experienced trial attorneys with extensive technical knowledge, many of whom have advanced scientific degrees and industry experience in fields such as molecular biology, biochemistry, chemistry, statistics and nuclear engineering.
On September 23, 2019, the Patent Trial and Appeal Board (“PTAB”) issued a decision dismissing Sigma-Aldrich’s interference petition related to the revolutionary CRISPR-Cas9 biotechnology. The claims at issue in Sigma-Aldrich’s petition were directed to methods of genetically modifying a eukaryotic cell using a CRISPR-Cas9 system. The petition was unusual because it sought an interference although none of Sigma-Aldrich’s claims had yet been allowed. On this basis, PTAB denied the petition as premature (and on other procedural grounds) and dismissed it without prejudice to refiling.
On July 19, 2019, Sigma-Aldrich filed a petition with the Director of the U.S. Patent and Trademark Office (“USPTO”) and the Chief Administrative Patent Judge (“CAPJ”) of the Patent Trial and Appeal Board (“PTAB”) seeking an interference between itself and the Regents of the University of California (“UC”) that would parallel an interference that was recently declared between UC and the Broad Institute (“Broad”). The claims at issue are directed to methods of genetically modifying a eukaryotic cell using a CRISPR-Cas9 system. The petition is unusual because it seeks to provoke an interference although Sigma-Aldrich’s pending claims have not been allowed, contrary to 37 C.F.R. § 41.102 and MPEP § 2303. Sigma-Aldrich argues that the circumstances here are extraordinary and warrant an exception to the rule.
At the end of 2017, inter partes review (IPR) proceedings for biosimilar products were on the rise. 2018 and the first half of 2019, however, have seen a dip in the number of new filings. And looking back at biosimilar IPRs that have been decided, results have been mixed. The Patent Trial and Appeal Board has denied institution in about half (47%) of its institution decisions on petitions challenging biologics-related patents. For those petitions actually reaching a Final Written Decision, the patentability of at least one claim has been upheld in just over half (53%) of the Board’s decisions. Notwithstanding the mixed results for petitioners and the recent dip in new filings discussed here, IPR remains a key battlefield for biologic innovators and biosimilar makers.
The Federal Circuit ruled that Amgen’s state law unfair competition claims, which were premised on Sandoz’s failure to follow the patent dance, are preempted by the BPCIA. The decision largely affirms the status quo, making clear that biosimilar applicants may opt out of the patent dance without incurring any consequences besides those specified in the statute.
On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s Neulasta and Neupogen. Judge James Cohn of the Southern District of Florida ruled in Apotex’s favor in September 2016 after a bench trial. On appeal, the Federal Circuit found sufficient evidence in the record to support the judgment of noninfringement.
Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab). On October 6, in a complaint filed in the Central District of California, Amgen brought an action seeking a declaratory judgment that 27 of Genentech’s patents are not infringed, invalid, and unenforceable. Amgen’s suit appears to be the first post-approval declaratory judgment action brought by a biosimilar applicant under the young U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA). Shortly after Amgen filed its declaratory judgment action, Genentech filed its own suit in the District of Delaware, alleging that Amgen had failed to honor promises made during the pre-suit BPCIA process and infringed Genentech’s patents. Amgen then promptly moved to transfer the Delaware case to California. Genentech then filed another complaint in the District of Delaware, followed by another Amgen motion to transfer.
In July, a split panel of the Federal Circuit upheld the district court’s use of an adverse inference from litigation misconduct to hold a patent unenforceable for inequitable conduct. The Federal Circuit’s decision in the case, Regeneron Pharmaceuticals Inc. v. Merus NV, raises interesting questions about the relationship between attorney misconduct during litigation (which is not supposed to affect the enforceability of a patent) and misconduct during prosecution of the patent (which can). Because the court’s opinion gives no clear answer to these questions, it opens new tactical opportunities for defendants asserting inequitable conduct defenses in patent cases and may incrementally expand the use of a doctrine that the Federal Circuit has famously referred to as a “plague” and repeatedly tried to rein in.
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Supreme Court Decides Amgen v. Sandoz: Patent Dance Cannot Be Enforced by Federal Injunction, Notice of Commercial Marketing Can Be Given at Any Time
On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is available to force biosimilar applicants to participate in the BPCIA’s patent dispute resolution procedures (a/k/a the patent dance); but it remanded to the Federal Circuit to address whether such an injunction is available under state law. Second, the Court held that under the BPCIA, a biosimilar applicant may provide 180-day notice of commercial marketing before the biosimilar product is licensed, meaning that as a practical matter, the 180-day notice period need not affect the timing of the biosimilar product’s launch.
Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that the case is dismissed without prejudice for lack of subject matter jurisdiction in light of Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015).
On Wednesday, February 15, 2017, the Patent Trial and Appeal Board (“PTAB”) ruled in favor of the Broad Institute of MIT and Harvard in a closely watched patent fight with UC Berkeley over the breakthrough CRISPR genome-editing technology. The PTAB concluded that the Broad Institute’s later-filed patents for using CRISPR in eukaryotic cells did not interfere with Berkeley’s earlier-filed patent application that disclosed the use of CRISPR technology in vitro and claimed the use of CRISPR technology in general.
Last week, the Solicitor General submitted its brief in Amgen v. Sandoz, arguing that the Supreme Court should review and decide in Sandoz’s favor both questions presented by the parties’ cross-petitions for certiorari. Two days later, however, the Supreme Court denied cert in Amgen v. Apotex, which raised similar issues.
Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen (filgrastim) and Neulasta (pegfilgrastim). That dispute has resulted in the first final judgment in a BPCIA lawsuit. Earlier this month, Judge James Cohn of the Southern District of Florida ruled after a consolidated bench trial addressing both products that Apotex’s biosimilar applications did not infringe Amgen’s sole remaining patent, U.S. Patent No. 8,952,138 (the ‘138 patent). Meanwhile, Apotex, which remains subject to an injunction prohibiting it from marketing its biosimilar products for 180 days after they are approved, has filed a petition for a writ of certiorari to the United States Supreme Court challenging that injunction.
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.
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.”
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).
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.