Administrative Agency Intellectual Property

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
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FDA Rejects Otsuka’s Assertions of Orphan Drug Exclusivity for Abilify®, Allowing Generics to Proceed

The FDA last week granted several pharmaceutical companies approval to market generic versions of the bestselling antipsychotic drug Abilify® (aripiprazole), despite the assertions of the drug’s patent-holder, the Japanese...more

SCOTUS Opts Not To Remand Case Raising Preclusion Question Answered in B&B Hardware

On April 27, the Supreme Court surprisingly denied certiorari in Escamilla v. M2 Tech., Inc., U.S., No. 14-1012 rather than remanding the case for further consideration in light of the High Court's recent decision in B&B...more

The High Price of Challenging a Refusal to Register a Trademark in District Court

Applicants who challenge in a federal district court a Trademark Trial and Appeal Board decision that upholds a PTO refusal to register a trademark may be required to reimburse the government for PTO attorney fees, even if...more

Mixology 101: Blending Trade Secret Protections and Fracking Chemical Reporting

Whether you live in the East, the Great Plains, the Southwest, or the Rocky Mountain West, the oil and gas industry’s use of hydraulic fracturing or “fracking” in oil and gas development is something you have likely heard a...more

“Indirect” Common Inventorship Not Sufficient To Support Priority Claim Under 35 U.S.C. §120

The PTAB recently took up the issue of whether, in a family of patents and applications, a later patent in the family is entitled to the benefit of the filing date of an earlier-filed application in the family where the later...more

Trademark Review | April 2015

The Supreme Court Rules TTAB Findings May Have Preclusive Effect in Later Federal Court Proceedings - B&B and Hargis have long contested each other’s rights in the mark "SEALTIGHT" for fasteners. B&B was the first to...more

Federal Circuit Patent Updates - April 2015

Biosig Instruments, Inc. v. Nautilus, Inc. (No. 2012-1289, 4/27/15) (Newman, Schall, Wallach) - April 27, 2015 11:12 AM. Wallach, J. On remand from the Supreme Court, reversing district court summary judgment...more

Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

Amgen v. Sandoz BPCIA Dispute Heads to the Federal Circuit

After a series of preliminary skirmishes, the first full-fledged litigation under the Biologics Price Reduction and Innovation Act is Amgen’s lawsuit against Sandoz concerning Sandoz’s Zarxio, a biosimilar version of Amgen’s...more

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

Benefits of Showing Discovery as “Routine” Instead of “Additional”

The PTAB issued an order granting in part a request for discovery by an IPR petitioner. IPR2014-00727 - C&D Zodiac, Inc. v. B/E Aerospace, Inc. ...more

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

Can You Keep a Secret? The SEC Says to Ask Carefully

Employers have a lot to be worried about. Employees are given access to trade secrets, customer lists, financial accounts, and other highly sensitive, confidential information. Most employers attempt to deter improper use of...more

30 Months of IPR Practice – By the Numbers

UntitledWelcome to Volume 9 of our IPR-PGR Report. After 30 months of IPR practice, some trends are taking shape. Overall, the percentage of petitions put into trial has gradually decreased, down to 76% this quarter, from a...more

Texas eMediaLaw Legislative Update: 2015

It’s Spring in Texas which means one of two things – the bluebonnets are out and in odd years, our legislature is back at work. One makes me grateful to be in Texas and the other only meets every other year. Here are a few...more

Supreme Court Holds that TTAB Decisions May Have Preclusive Effect, Raising Stakes for Trademark Agency Proceedings

On March 24, the US Supreme Court issued a decision that is likely to raise the stakes of proceedings before the Trademark Trial and Appeal Board (TTAB). In B&B Hardware, Inc.v. Hargis Industries, Inc., No. 13-352 (March 24,...more

Analysis: The Supreme Court’s B&B Hardware Decision Could Have a Significant Impact on Trademark Infringement Disputes

On March 24, 2015, the U.S. Supreme Court held that, under certain circumstances, rulings by the U.S. Patent and Trademark Office’s Trademark Trial and Appeal Board (TTAB) on the core issue of “likelihood of confusion” in...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

Live Testimony for Fact Witness Can Be Appropriate at IPR Oral Hearing

With the Patent Office considering changes to inter partes review practice to potentially increase the use of live testimony at oral hearings, it is worth reviewing the first case in which the Board allowed such live...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

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