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Activities For sNDA and Citizen’s Petition Protected by “Safe Harbor” - Classen Immunotherapies, Inc. v. Elan Pharmaceuticals,...

In a case addressing the “safe harbor” provision of 35 U.S.C. § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s ruling that information submitted to the U.S. Food and Drug...more

Preparing For The Obvious At The PTAB

There is little debate that inter partes reviews have proven to be an effective means of challenging the validity of a patent. During the first two-and-a-half years, more than 73 percent of claims originally challenged in IPR...more

Newsflash, Politico: ‘Patent Death Squad’ Alive and Well

Politico, the popular political journalism publication, recently ran the story “Patent Reform Advocates: PTO Process Not Patent ‘Death Squad.’” The story was based on a blog post by patent reform advocate Unified Patents. ...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

USPTO Pilots Expedited Patent Appeal Program But at What Price?

In a June 15, 2015 Federal Register Notice, the USPTO announced the Expedited Patent Appeal Pilot program, which will run until 2,000 ex parte patent appeals are expedited under the program, or until June 20, 2016, whichever...more

New USPTO Expedited Patent Appeal Pilot Program

On June 15, 2015, the United States Patent and Trademark Office (“USPTO”) issued Notice in the Federal Register announcing a new pilot program, the Expedited Patent Appeal Pilot. Under the program an appellant may have an ex...more

Federal Circuit Issues First Reversal & Remand of an Inter Partes Review in Microsoft Corporation v. Proxyconn, Inc. Addressing...

The Federal Circuit issued its first reversal and remand of a final decision in an inter partes review issued by the Patent Trial and Appeal Board (“PTAB”). In Microsoft Corporation v. Proxyconn, Inc., No. 14-1543, a panel...more

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA...more

PTAB Grants Fourth Motion to Amend in an IPR Proceeding

For only the fourth time in its history, the Patent Trial and Appeal Board (“PTAB”) has granted a motion to amend in an inter partes review (“IPR”) proceeding, finding all substitute claims proposed by the patent owner...more

Patent Trial and Appeal Board Grants Rare Motion to Amend Claims in Inter Partes Review

On June 5, 2015, a three-judge panel at the Patent Trial and Appeal Board (“PTAB”), granted a motion to amend in an inter partes review (“IPR”) proceeding, ruling that the patentee Neste Oil Oyj (“Neste”) could amend the...more

IP/Unfair Comp. Case Applies Buckman

The very name “intellectual property law” suggests it’s not for us. There are episodes of The Simpsons that seem too complicated for our pretty little heads. Anything deemed “intellectual” scares us away. We usually race...more

Interim Guidance Status Check

As of Tuesday, June 16th, we have been living with the U.S. Patent and Trademark Office's "2014 Interim Guidance on Patent Subject Matter Eligibility" ("Guidance") for six months. Although the USPTO subsequently issued some...more

BPCIA: A “Choose Your Own Adventure” Statute?

On June 3, 2015, the Federal Circuit heard oral argument on Amgen Inc.’s (“Amgen”) appeal of the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent...more

PTAB to Consider Motion for “Abuse of Process” Sanctions Against Kyle Bass Hedge Fund IPR Petition

In a recent order, the Patent Trial and Appeals Board (PTAB) indicated that it will consider a motion for sanctions based on a claim of “abuse of process” in Inter Partes Review (IPR) proceedings filed by the Coalition for...more

Federal Circuit Oral Arguments in Amgen v. Sandoz

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). The appeal is focused on two questions:...more

Supreme Court Corner: Q2 2015

B&B Hardware, Inc. v. Hargis Industries, Inc. Trademark - Holding: A Trademark Trial and Appeal Board (TTAB) ruling refusing registration on likelihood of confusion grounds can have preclusive effect on a district...more

D.C. Circuit Affirms: FTC Can Change HSR Rules Targeted at Pharmaceutical Patents

In a confluence of IP and antitrust law, a three judge panel for the D.C. Circuit recently affirmed a lower court decision upholding the Federal Trade Commission’s (“FTC”) 2013 modification of regulations under the Hart Scott...more

Are IPRs impacting the pharmaceutical industry?

The use of inter partes review (IPR) to challenge patents has grown significantly since its initiation in September 2012. In the first four months of IPRs, the USPTO received 97 petitions. In the parallel months of 2014, 578...more

A Sea Change for IPRs? Late-Breaking Section 11 Regarding IPRs Part of the PATENT Act Approved by Senate Judiciary Committee

As reported here last week, the Senate Judiciary Committee passed the PATENT Act bill, with a Managers Amendment that includes several IPR-specific provisions. With this Amendment, the PATENT Act now has two major...more

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

Patent Reform Heads to the Senate Floor

Yesterday, the Senate Judiciary Committee voted 16-4 to send an amended version of S. 1137, the Protecting American Talent and Entrepreneurship (PATENT) Act, to the full Senate for debate. The PATENT Act is this year’s...more

Act II: Oral Argument in Amgen v. Sandoz is heard at the Court of Appeals for the Federal Circuit

The Court of Appeals for the Federal Circuit yesterday heard oral arguments on the applicability and interpretation of two key provisions of the Biologics Price Competition and Innovation Act (BPCIA). Briefly, oral argument...more

Otsuka Suit Results in Victory for FDA

According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though...more

Backup Anticipation with Obviousness - Dell Inc. v. Elecs. & Telecomms. Research Inst.

Addressing the issue of estoppel and joinder, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) denied a petitioner’s challenge, finding the petitioner was estopped from requesting the additional...more

Life Sciences Litigation Update - May 2015

Trends in Post-grant Review of Orange Book Patents. The America Invents Act’s post-grant challenges (“AIA proceedings”) continue to grow as an option for companies challenging a patent’s validity. In the first full fiscal...more

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