Patents Pharmaceutical Industry

News & Analysis as of

Intendis GMBH et al. v. Glenmark Pharms. Inc., USA

Case Name: Intendis GMBH et al. v. Glenmark Pharms. Inc., USA, 822 F.3d 1355 (Fed. Cir. May 16, 2016) (Circuit Judges Prost, Moore, and Taranto presiding; Opinion by Moore, J.) (Appeal from D. Del., Robinson, J.) - Drug...more

Spectrum Pharms., Inc. v. Burwell

Case Name: Spectrum Pharms., Inc. v. Burwell, No. 15-5166, 2016 U.S. App. LEXIS 10095 (D.C. Cir. June 3, 2016) (Circuit Judges Griffith, Cavanaugh, and Wilkins presiding; Opinion by Griffith) (Appeal from D.D.C., Lamberth,...more

En Banc CAFC Requires UCC Sale For On Sale Bar

In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more

ANDA Update - Volume 2, Number 2

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

USPTO Releases Memorandum on Subject Matter Eligibility

On May 4th the U.S. Patent and Trademark Office issued its latest Guidance on how Examiners are to apply recent U.S. Supreme Court and Federal Circuit precedent related to subject matter eligibility (see "USPTO Issues Update...more

Court Report - July 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company et al. v. Apotex Inc. et al. 1:16-cv-00475; filed June 22, 2016 in the District Court of...more

En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented...more

Federal Circuit Finds That Use of a Contract Manufacturer Does Not Trigger the On-Sale Bar Provision

The court’s decision provides insight into which activities trigger the on-sale bar provision. On July 11, in The Medicines Co. v. Hospira, Inc., No. 14-1469 (Fed. Cir. July 11, 2016), the U.S. Court of Appeals for the...more

Federal Circuit Limits On-Sale Bar’s Reach

If you were concerned that outsourcing the manufacture of your invention before you filed your patent application triggered a "sale" that could put your patent at risk, you can rest easy. In The Medicines Company v....more

Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling

Amgen and Hospira have fired off dueling letters to the court in their litigation over Amgen’s Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009...more

Federal Circuit Holds Again That BPCIA's 180-day Notice Is Mandatory

On July 5, 2016, the Federal Circuit affirmed a district court's preliminary injunction against proposed biosimilar manufacturer Apotex, holding that Apotex was enjoined from entering the market until Apotex: (1) provides...more

New Guidance on Mandatory Notice in the Biosimilar ‘Patent Dance’

The Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 16-1308, provides new guidance on the timeline of biosimilar approval and the impact to commercial marketing. The ruling weighed in on a key...more

Additional IP Considerations in Light of Brexit

Pharmaceutical and agricultural companies in particular should consider the effect of Brexit on their European patent portfolios. Supplementary Protection Certificates (SPCs) are governed by EU regulations and are thus...more

28 Organizations Seek Clarification from President Obama Regarding Colombian Compulsory License -- U.S. Chamber of Commerce...

On July 5, 2016, we reported on two letters sent by two Senators and fifteen Representatives to Michael Froman, the U.S. Trade Representative ("USTR"), seeking clarification regarding the Administration's position on...more

Recent Court Cases Interpreting “Reverse Payments” Post-Actavis

Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...more

Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term

Ever since the Biologics Price Competition and Innovation Act (BPCIA) was passed along with the rest of the healthcare law commonly called "Obamacare" in 2010, the Obama Administration has included in every budget a proposal...more

PTAB Can Rely Upon Prior Art Not Cited in an IPR Institution Decision to Establish the State of Art

The Federal Circuit affirmed the PTAB’s final determination in Genzyme Therapeutic Products Limited Partnership v. Biomarin Pharmaceutical Inc., Nos. 2015-1720, 2015-1721 (Fed. Cir. June 14, 2016), holding that the PTAB did...more

Court Report - June 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. et al. 1:16-cv-11117; filed June 14, 2016 in the District Court of...more

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

Bloomberg/BNA Releases Report on Biopharma IPRs

As part of a session on the effects of inter partes review on biopharma patents presented today at the 2016 BIO International Convention, Bloomberg/BNA released a report on more than 300 biopharma patents that have been...more

Court Report - June 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Orexo AB et al. v. Actavis Elizabeth LLC et al. 1:16-cv-00397; filed May 27, 2016 in the District Court of Delaware...more

BIO International Convention 2016 Preview

BIO and Biosimilars - The 2016 BIO International Convention begins next week in San Francisco. This convention has become an important destination for all organizations working in the biotechnology space, but the large...more

Court Report - May 2016 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Allergan, Inc. et al. v. Somerset Therapeutics, LLC 1:16-cv-00392; filed May 26, 2016 in the District Court of...more

Post-Grant Review Roils Patent Litigation Waters

The America Invents Act (AIA) has had a profound impact on patent litigation, particularly surrounding inter partes and other post-grant proceedings. Below, Manish K. Mehta, who handles patent litigation across an array of...more

Court Report - May 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of...more

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