News & Analysis as of

Pharmaceutical Patents

Allergan Sales, LLC v. Sandoz. Inc.

by Robins Kaplan LLP on

Case Name: Allergan Sales, LLC v. Sandoz. Inc., Nos. 2017-1499, 2017-1500, 2017-1558, 2017-1559, 2017 U.S. App. LEXIS 26312 (Fed. Cir. Dec. 22, 2017) (Circuit Judges Moore, Mayer, and Hughes presiding; Opinion by Hughes, J.)...more

CD Cal Stays Dismissal of Amgen DJ Complaint Pending Delaware Decision on Genentech’s Motion to Transfer in MVASI® litigation

by Goodwin on

As we previously reported, on October 6, 2017, Amgen and Genentech filed separate lawsuits regarding Amgen’s bevacizumab biosimilar (MVASI®), with Amgen filing for declaratory judgment in C.D. Cal. of non-infringement,...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In the sole precedential patent case decided this week, Flexuspine v. Globus, the Circuit affirms rulings of the district court relating to verdict forms where the verdict form included a “stop” instruction in the event the...more

Claims Against Sanofi for Improper Orange Book Listings and Sham Litigation Dismissed

On January 10, 2018, in In re Lantus Direct Purchaser Antitrust Litig., the District Court for the District of Massachusetts dismissed the antitrust case against Sanofi-Aventis U.S. LLC (“Sanofi”), the manufacturer of Lantus...more

Prosecution History Informs Claim Meaning Even Without Unmistakable Disclaimer

by Foley & Lardner LLP on

Although non-precedential, the Federal Circuit decision in Aptalis Pharmatech, Inc. v. Apotex Inc. is worth a read to see how the court “tiptoes” the “fine line between reading a claim in light of the specification, and...more

Generic drugs taking hold in the Asian marketplace: STAT News interview

by Hogan Lovells on

Aging populations and rising healthcare costs across Asia — particularly in Japan — have created new market opportunities for generic drug makers operating in the region. For originator drug manufacturers, that means...more

PTAB Life Sciences Report - January 2018

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Micro Labs Ltd. v. Santen Pharmaceutical Co. - PTAB Petition: IPR2017-01434; filed May 12,...more

Top 10 Highlights of Canadian IP Law and Practice in 2017

by Smart & Biggar on

2017 was a year of significant developments to Canadian IP law and practice, with important court decisions and numerous legislative amendments. We have taken the opportunity to review the top 10 highlights from the past...more

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

by Smart & Biggar on

The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Liability for Inducement Where There is Divided Infringement

by Workman Nydegger on

In 2017, the Federal Circuit issued a decision Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 845 F.3d 1357 (Fed. Cir. 2017) that found Teva liable for inducement of method claims in U.S. Patent No. 7,772,209 even though no...more

Amgen Moves to Dismiss Genentech’s Misrepresentation Claim

by Morgan Lewis on

Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act. Shortly after Amgen received US Food and Drug Administration (FDA)...more

Bristol Myers Squibb, Bavarian Nordic, and Enzo Biochem file amicus brief supporting Amgen’s petition for en banc consideration of...

by Goodwin on

As we reported previously, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)...more

Declarations as New Evidence to Overcome § 325(d)

by Jones Day on

We have published other blog postings relating to 35 U.S.C. §325(d), including a blog posting that addresses the PTAB’s October 24, 2017 notice designating three of its decisions as informative (here). Recently, the PTAB...more

Top Stories of 2017: #5 to #9

After reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories. For 2017, we identified nineteen stories that were covered on Patent Docs last year that we believe...more

FDA Announces “New Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices”

by Locke Lord LLP on

The FDA has taken action to accelerate the approval of Abbreviated New Drug Applications (“ANDAs”). With a goal of reducing the number of review cycles needed to reach approval, the FDA will save generic drug companies money...more

Federal Circuit Clarifies the “Reasonable Expectation of Success” Required in Hatch-Waxman Obviousness Challenges

by Dechert LLP on

The U.S. Federal Circuit recently clarified the standard that patent challengers must satisfy when attempting to invalidate patented inventions directed to new uses for known drugs. Although designated as a nonprecedential...more

New Year's Resolutions For The U.S. Patent System

by Foley & Lardner LLP on

It’s that time of year when we make resolutions to improve our health, our relationships, our careers, or other areas of our lives. I’m not starting a new diet today (although if I were, the invention described in this patent...more

Allergan’s Mohawk Gambit May Be Doomed – PTAB Rethinks the Scope of Sovereign Immunity

by Pepper Hamilton LLP on

A few months ago, the Irish drug company Allergan moved to shield its key patents on its dry-eye drug Restasis from challenge at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent Office by assigning these patents to...more

PTAB Life Sciences Report - December 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Visionsense Corp. v. Novadaq Technologies, Inc. PTAB Petition: IPR2017-01426; filed May 11,...more

Federal Circuit Rules BPCIA Preempts State Law

by Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Biosimilars: Strategic Considerations for 2018

by Polsinelli on

2017 was an eventful year for biosimilars in the U.S. As the number of biosimilar filings increased, important legal and regulatory decisions changed the strategic landscape of the biosimilars market for both innovators and...more

Federal Circuit Finds Preemption Of State Law Penalty For Sitting Out Biosimilar Patent Dance

by Foley & Lardner LLP on

The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not...more

Judge Sleet Denies Macleods Defendants’ Motion For Judgment On The Pleadings In ANDA Action

by Fox Rothschild LLP on

By Memorandum Order entered by The Honorable Gregory M. Sleet in Amgen Inc. v. Macleods Pharmaceuticals, Ltd., Civil Action No. 17-817-GMS (D.Del. December 19, 2017) (consolidated), the Court denied the Motion for Judgment on...more

Federal Circuit Issues Mandate in Amgen v. Apotex

by Goodwin on

As we previously reported, last month a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s protein refolding method...more

Genentech Files Complaint Against Sandoz in New Jersey Regarding Rituximab

by Goodwin on

We previously reported that on September 12, 2017, the FDA accepted for review Sandoz’s aBLA for a proposed biosimilar of Rituxan® (rituximab), which is indicated for the treatment of certain blood cancers and immunological...more

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