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Luitpold Pharmaceuticals, Inc. v. Pharmacosmos A/S (Fed. Cir. 2018)

Which parties to an IPR proceeding have standing to either appeal or participate in an appeal from an adverse final written decision by the Board? The Federal Circuit had previously held that a petitioner that did not...more

PTAB Grants Two Motions to Amend in March -- Aberration or Sign of Things to Come?

The U.S. Patent and Trademark Office appears to have taken the position that neither party has the burden of persuasion with regard to Motions to Amend after the Aqua Products v. Matal en banc decision. It was unclear,...more

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 16, Issue 1

Fair Use and Social Media Sites like BuzzFeed - Fair use, an evolving doctrine and a very popular fallback for those on the Internet, has continued to be “the most troublesome in the whole law of copyright.” Its goal has...more

Bosch Automotive Service Solutions, LLC v. Matal -- Follow-up on Who Has Burden After Aqua Products?

We recently noted that the U.S. Patent and Trademark Office appears to have taken the position that neither party has the burden of persuasion with regard to Motions to Amend after the Aqua Products v. Matal decision. ...more

PTAB Releases Orange Book-Listed Patent Study

Pharmaceutical patent owners have been one of the more vocal groups decrying the creation and existence of inter partes reviews and other PTAB post-issuance proceedings. And for good reason. Congress enacted the...more

Motions to Amend at the PTAB after Aqua Products, Inc. v. Matal – What’s a Patent Owner to Do?

In 2011, Congress enacted the America Invents Act and created new mechanisms to challenge issued claims at the Patent Office. The goal was to expeditiously resolve issues of patent validity in response to the public outcry...more

Motions to Amend at the PTAB -- Does Anyone Have the Burden (And Will That Change)?

Last year, the Federal Circuit decided the Aqua Products, Inc. v. Matal case en banc in what could be considered the epitome of a fractured decision. After 148 pages and five separate opinions, the only agreed-to result...more

PTAB Releases Another Update to Its Motions to Amend Study

On January 12, 2018, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board announced that it had updated its Motion to Amend Study to include all AIA trials through the end of Fiscal Year 2017 (which ended on...more

More Aqua Products Fallout -- Taiwan Semiconductor Manufacturing Co. v. Godo Kaisha IP Bridge

In November, Chief Judge David P. Ruschke of the U.S. Patent and Trademark Office's Patent Trial and Appeal Board issued a memorandum entitled "Guidance on Motions to Amend in view of Aqua Products" (see "PTAB Motions to...more

Wi-Fi One, LLC v. Broadcom Corp. (Fed. Cir. 2018) (en banc)

On Monday, January 8, 2018, the en banc Federal Circuit held in Wi-Fi One, LLC v. Broadcom Corp. that PTAB time-bar determinations under 35 U.S.C. § 315(b) are appealable because they do not fall within the scope of the...more

PTAB Motions to Amend Post-Aqua Products -- Chief Judge Ruschke Issues Guidance

On November 21, 2017, PTAB Chief Judge Ruschke issued a memorandum entitled "Guidance on Motions to Amend in view of Aqua Products." As we reported at the time, the Federal Circuit in Aqua Products determined that the PTAB...more

Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2017) -- One Last Dance . . .

Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the...more

More Views on Venue -- Federal Circuit Addresses In re Micron Fallout

Last Spring, the Supreme Court in TC Heartland LLC v. Kraft Foods Group Brands LLC held that the word "resides" in the patent venue statute, 28 U.S.C. § 1400(b), "refers only to the State of incorporation" of the alleged...more

Remands at the PTAB -- Board Issues Standard Operating Procedure 9

Earlier this month, the Patent Trial and Appeal Board released it Standard Operating Procedure 9 entitled "Procedure for Decisions Remanded from the Federal Circuit for Further Proceedings." To date, the Federal Circuit has...more

Oil States Preview Take II -- Just What Did the Supreme Court Hold in McCormick Harveting Machine v. Aultman?

Last week, we provided a preview of the Supreme Court case Oil States Energy Services, LLC. v. Greene's Energy Group, LLC. that will be argued on November 27, 2017. The underlying case has received a lot of attention, so it...more

Supreme Court Preview -- Oil States Energy Services, LLC v. Greene's Energy Group, LLC

On November 27, 2017, the Supreme Court will hear arguments in two cases that were ultimately appealed from IPR Final Written Decisions issued by the PTAB. The first of these, Oil States Energy Services, LLC v. Greene's...more

CAFC Shifts the Burden for IPR Claim Amendments from the Patent Owner to the Petitioner

In Aqua Products Inc. v. Matal, a highly fractured en banc Federal Circuit determined that the PTAB, in ruling whether to allow claim amendments in an IPR proceeding, can no longer place the burden to establish the...more

Aqua Products, Inc. v. Matal (Fed. Cir. 2017)

More Than a Mere Academic Exercise - On October 4, 2017, in Aqua Products, Inc. v. Matal, a highly fractured en banc Federal Circuit determined that the PTAB can no longer place the burden of establishing the patentability...more

HUMIRA® Biosimilar Update -- Settlement in AbbVie v. Amgen Case Announced and AbbVie v. Boehringer Ingelheim Litigation Begins

On September 28, 2017, both parties to the AbbVie v. Amgen litigation announced a settlement that resolves all intellectual property-related litigation over Amgen's FDA-approved adalimumab biosimilar AMGEVITA™/AMJEVITA™. ...more

Views on Venue -- Take Two: Did the District of Delaware Get It Right?

We recently reported that Chief Judge Stark of the District of Delaware interpreted the second prong of the patent venue statute, 28 U.S.C. § 1400(b), in Bristol-Myers Squibb Company v. Mylan because the first prong was no...more

Views on Venue -- District of Delaware Provides Some Guidance on Venue in ANDA Cases Post-TC Heartland

Last Spring, the Supreme Court in TC Heartland LLC v. Kraft Foods Group Brands LLC held that the word "resides" in the patent venue statute, 28 U.S.C. § 1400(b), "refers only to the State of incorporation" of the alleged...more

FDA Approves First Cancer-Treatment Biosimilar -- Amgen's Mvasi

Earlier on September 14, 2017, the U.S. Food and Drug Administration approved Amgen's application to market Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin therapeutic antibody for the treatment of multiple...more

9/15/2017  /  aBLA , Amgen , Biosimilars , FDA , Life Sciences

Amgen Inc. v. Hospira, Inc. (Fed. Cir. 2017)

In the third installment of the "Amgen v." trilogy of BPCIA Federal Circuit cases, the Court in Amgen Inc. v. Hospira, Inc. answered a question that had been lingering since the very first case -- can a reference product...more

FDA Report: Agency Announces Expedited Review of Certain ANDAs

On June 27, 2017, the U.S. Food and Drug Administration issued a press release stating how it would begin implementing its plan to increase competition for prescription drugs. This comes on the heels of FDA Commissioner...more

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