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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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