Source: https://www.orangebookblog.com/
Timestamp: 2019-04-22 08:16:32+00:00

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Apparently it is not impossible to change the PTAB's mind. In a rare decision last week, the Board granted Hospira's request for rehearing of its earlier decision denying institution, and instituted review of U.S. Patent No. 7,846,441. Genentech is expected to assert the '441 patent in BPCIA litigation over biosimilar versions of Herceptin (trastuzumab).
The '441 patent, entitled "Treatment with Anti-ErbB2 Antibodies," claims a method of treating a cancer "characterized by overexpression of ErbB2 receptor, comprising administering a combination of an intact antibody which binds to epitope 4D5 within the ErbB2 extracellular domain sequence and a taxoid, in the absence of an antracycline derivative."
studies employed the combination of an anti-ErbB2 antibody "with paclitaxel or anthracycline, not together;" and (3) Baselga ʼ94 shows that the combination with paclitaxel was superior to the combination with doxorubicin, an anthracycline derivative.
Genentech countered that Hospira did not show that an ordinary artisan would have avoided anthracyclines when pursuing the combination therapy of antiErbB2 antibody with a taxoid." The Board agreed, and therefore denied institution.
In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation "in the absence of an anthracycline derivative" as requiring "avoidance" of an anthracycline derivative. According to Petitioner, this term "is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative." After reconsidering the current record, we find Petitioner's argument persuasive. In particular, because Baselga '94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation "in the absence of an anthracycline derivative."
In support of its decision, the Board cited Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) for its conclusion that a claim to a composition that is "essentially free of antioxidants" is anticipated when the prior art teaches "optional inclusion" of antioxidants, "despite no express teaching to exclude the antioxidants."
Although Hospira did not cite the Upsher-Smith case in its Petition (or propose a construction of the disputed claim limitation), it did so in its request for rehearing.
1. Teva's enoxaparin is not "made by" a patented process within the meaning of § 271(g) because the process is used merely "to ensure that the intended product or substance has in fact been made." In other words, the process simply "provides information regarding a substance that has already been made but does not transform it."
2. The safe harbor of § 271(e)(1) does not apply to Amphastar's "routine quality control testing of each batch of generic enoxaparin as part of the post-approval, commercial production process."
Momenta and Sandoz, which were the first to market a generic version of Sanofi's anticoagulant Lovenox (enoxaparin), asserted U.S. Patent No. 7,575,886 against Teva and Amphastar. The '886 patent claims methods for analyzing enoxaparin to determine whether it has the appropriate chemical structure. Momenta alleged that Teva's and Amphastar's enoxaparin manufacturing processes infringe the '886 patent.
The Federal Circuit's decision concerning § 271(g) was a split decision, with Judges Wallach and Moore in the majority and Judge Dyk dissenting. According to the majority opinion, Momenta argued that its patented method "is used [by Teva] to select and separate batches of intermediate drug substance that conform to USP requirements for enoxaparin from batches that do not," and that selected batches are then used to make the finished drug product. The majority concluded, "Although Momenta's arguments are not without merit, it is more consonant with the language of the statute, as well as with this court's precedent, to limit § 271(g) to the actual 'ma[king]' of a product, rather than extend its reach to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made."
Patents on purification methods or the quality control method at issue here, which may be integral to the regulatory or commercial viability of a product, but which do not create or transform a product, combine components, or confer new properties, could be freely infringed simply by outsourcing those processes abroad. Congress could not have intended to create this loophole when it sought to protect process patent owners from foreign competitors using U.S. manufacturing processes abroad.
The Federal Circuit's decision concerning the 271(e)(1) safe harbor is especially interesting because the court previously reached the opposite conclusion during the preliminary injunction phase of the case (Momenta I). There, the court found that Amphastar's testing according to the patented method was protected by the safe harbor because it was "necessary both to the continued approval of the ANDA and to the ability to market the generic drug." The majority in that case distinguished the facts from those in Classen, where the court held that § 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained." In Momenta I, Judge Moore wrote the opinion for the majority, which included Judge Dyk, while Chief Judge Rader vigorously dissented.
This time around, the panel (which again included Judges Dyk and Moore) unanimously held that § 271(e)(1) does not exempt Amphastar's testing. The court states, "With the benefit of additional briefing in the current appeals, which reflects the full district court record developed by all parties after the preliminary injunction phase, we conclude Amphastar's submissions are appropriately characterized as 'routine.'" According to the court, "The conclusion in Momenta I that Amphastar's commercial use of Momenta's patented method falls within the safe harbor of § 271(e)(1) would result in manifest injustice. Amphastar points to no case, until Momenta I, extending immunity under § 271(e)(1) to encompass activities related to ongoing commercial manufacture and sale." Thus, the court vacated the district court's grant of summary judgment to Amphastar and remanded the case.
In a per curium Order today, the Federal Circuit granted Amgen's Emergency Motion for an Injunction Pending Appeal, stalling, at least temporarily, Sandoz's commercial launch of Zarxio, a biosimilar version of Amgen's Neupogen (filgrastim). Zarxio is the first biosimilar product approved by FDA under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). FDA approved Zarxio on March 6, and Sandoz agreed not to commercially launch the product until May 11 or a Federal Circuit ruling in its favor.
The primary issue in the case is whether the pre-litigation information-exchange provisions of the BPCIA are mandatory, as Amgen argues, or optional, as Sandoz contends. The BPCIA states that a biosimilar applicant "shall provide" a copy of its FDA application and manufacturing information to the Reference Product Sponsor (RPS)--here, Amgen. The statute further states that in the event that a biosimilar applicant fails to provide its application and manufacturing information, the RPS may file a declaratory judgment action against the applicant. Sandoz argues that a biosimilar applicant therefore has a choice: either provide a copy of its application and manufacturing information to the RPS and proceed to the subsequent information-exchange provisions of the BPCIA (including the exchange of patent lists, invalidity and non-infringement contentions, etc.), or accept the consequence of a declaratory judgment action filed against it.
Amgen filed suit against Sandoz last October, alleging state-law claims of unfair competition and conversion based on Sandoz's alleged failure to comply with the BPCIA, as well as patent infringement. With Sandoz's biosimilar application proceeding quickly toward FDA approval, Amgen filed a motion for preliminary injunction against Sandoz in February. On March 19, the district court denied Amgen's motion, ruling that the information-exchange provisions of the BPCIA are optional and that Sandoz fully complied with the law.
Amgen immediately appealed to the Federal Circuit, and, two days after the district court denied Amgen's motion for injunction pending appeal, filed the emergency motion that the court granted today. Amgen's appeal attracted the support of three amicus filings, by BIO, AbbVie, and Janssen, while GPhA, Celltrion, and Hospira filed amicus briefs in support of Sandoz.
Amgen and Sandoz requested an expedited appeal schedule, which the Federal Circuit granted. Briefing is complete, and the court scheduled oral argument for June 3rd. The standard for granting a motion for injunction pending appeal is high--"whether the movant has made a strong showing of likelihood of success on the merits." It therefore appears likely that that Federal Circuit will ultimately reverse the district court and rule that the pre-litigation information-exchange provisions of the BPCIA are mandatory.
McAndrews Shareholder Sandra Frantzen will be one of the featured speakers at American Conference Institute's "Summit on U.S. Biosimilars" conference in Munich, Germany, April 20-21. Ms. Frantzen will be speaking on "Incorporating Inter-Partes Review and New USPTO Procedures into Branded and Biosimilar Litigation Strategies."
Other speakers include in-house counsel and executives from AbbVie, Boehringer Ingelheim, IPM Biotech, PAREXEL, Sandoz, and Sanofi, as well as outside counsel from U.S. and European firms.
"Diving into the Science of Biologics and Biosimilars: What Counsel Needs to Know to Formulate a Regulatory and Patent Strategy"
"Understanding the Structure of the USFDA and Its Role in Approving and Regulating Biosimilars"
"Delving into the Mechanics of the USFDA Biosimilars Approval Process and Section 351(k) Applications Under the Pathway"
"Mastering the Essentials of New USPTO Post-Grant Proceedings for Effective Use in the Biosimilars Space"
"Obtaining Adequate Patent Protection in the U.S.: Factoring Key Cases into Your Biosimilars Patent Strategy"
"U.S. Federal Trade Commission and State Law Updates: Understanding the Controversy Surrounding Competition, Substitution, and Naming in the Biosimilars Arena"
"Minimizing the Uncertainty Surrounding the Pathway: Insights Into USFDA's Current Initiatives Regarding the First Wave of Biosimilars Applications"
"Evaluating the Risk and Commercial Opportunity in the Emerging U.S. Biosimilars Landscape"
"Timing is Everything: A Cheat Sheet for Managing the Logistics of the BPCIA Exchange Process"
"Biosimilars Litigation Spotlight: Immediate Action Plans for Innovators and Biosimilars to Prepare for the Battles to Come"
"Incorporating Inter-Partes Review and New USPTO Procedures Into Branded and Biosimilar Litigation Strategies"
"Open Floor Session: Lessons Learned So Far: Comparing and Contrasting the U.S. and E.U. Biosimilars Experience"
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