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District Court Declines to Lift Stay Even After Patent Trial and Appeal Board Issued Written Decision on CBM Petitions

The district court stayed several consolidated cases pending certain proceedings before the Patent Trial and Appeal Board ("PTAB"). In the order granting the stay, the district court stated: "Upon issuance of a final decision...more

Senju Pharm. Co., Ltd. v. Metrics, Inc.

Case Name: Senju Pharm. Co., Ltd. v. Metrics, Inc., Civ. No. 14-3962-JBS/KMW, 2015 U.S. Dist. LEXIS 41504 (D.N.J. Mar. 31, 2015) (Simandle, J.) ....more

Can One Bad Apple Spoil the Bunch?

According to their recent press release, Intrexon Corp (NYSE:XON) recently purchased a Canadian specialty food producer, namely Okanagan Specialty Fruits Inc., the inventor of the “Arctic®” apple. ...more

An In-Depth Look at USPTO Patent Quality Problems

The comment period for the USPTO’s proposed patent quality initiatives is open until May 6, 2015, and the Office of Inspector General for the Commerce Department has given stakeholders plenty to think about in its final...more

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

As discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015...more

Section 337’s Potential for Defending Biologics Market Share Against Biosimilars

Enforcement of biologic patents at the United States International Trade Commission under Section 337 provides certainty and tactical advantages to patent holders that are unavailable in district court under the BPCIA. For...more

Amgen Receives No Help from the FDA -- A Biosimilar Update

Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and...more

Stricter Standing for Inter Partes Review?

Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more

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. The Biologics Price Competition and Innovation Act (“BPCIA”), for example, provides a...more

Exela Pharma Sciences LLC v. Lee (Fed. Cir. 2015)

Late last month, the Federal Circuit handed Exela Pharma Sciences its latest defeat in litigation relating to its ANDA filing on Cadence Pharmaceuticals' injectable acetaminophen-based drug Ofirmev®, in Exela Pharma Sciences...more

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...more

FDA Denies Request to Make “Patent Dance” a Prerequisite for Biosimilar Approval

In a decision released on March 25, 2015, FDA denied a Citizen’s Petition that would have effectively made the information and patent exchange described in § 262 of the Biologics Price Competition and Innovation Act (“BPCIA”)...more

Amgen Inc. v. Sandoz Inc.

On March 19, 2015, the United States District Court for the Northern District of California issued its decision in Amgen Inc. v. Sandoz Inc., construing the patent negotiation provisions of the Biologics Price Competition and...more

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

On the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates...more

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

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,...more

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

As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more

FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements

Late last week, the U.S. Food and Drug Agency (FDA) dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their...more

No Collateral Challenge of Patent Application Revival

In Exela Pharma Sciences, LLC v. Lee, the Federal Circuit held that the USPTO’s decision to revive a patent application “is not subject to third party collateral challenge” under the Administrative Procedures Act (APA). In so...more

Claims Must Be Limited to Financial Activities to Be Covered Business Methods - Salesforce.com, Inc. v. Applications in Internet...

Narrowing the application of covered business method (CBM) patent review, in two recent cases, the Patent Trial and Appeal Board (PTAB or Board) concluded that patents whose claims may apply to industries other than the...more

Dismissal of a Related Suit with Prejudice Can Negate Petitioner’s Grounds for Standing - Global Tel*Link Corp. v. Securus...

Addressing the issue of standing, the Patent Trial and Appeal Board (PTAB or Board) denied institution of a covered business method (CBM) patent review, finding that the petitioner failed to show sufficient proof...more

Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance

As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that...more

IP Newsflash - March 2015 #4

U.S. SUPREME COURT CASES - B&B Hardware, Inc. v. Hargis Industries, Inc., Potential Issue Preclusion on Likelihood of Confusion Rulings - On March 24, 2015, the United States Supreme Court ruled that that a...more

Strike Two – FDA Rejects Amgen’s Certification Petition for Biosimilar Applicants

In parallel with the district court case where Amgen is asserting that Sandoz has not complied with the BPCIA because they have not provided Amgen with a copy of their biosimilar application, in October 2014 Amgen filed a...more

TTAB Decisions May Be Determinative Of Trademark Infringement Litigation

In a well-written opinion, the Supreme Court ruled this week that a final TTAB decision on likelihood of confusion regarding a particular mark can be binding in separate trademark infringement litigation. The Court reversed a...more

The Tyranny of the Judiciary

There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a...more

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