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Complimentary CLE Webinar: BPCIA Update: The 180-day Notice of Commercial Marketing in the Courts

April 19th, 2016
in Pharmaceuticals / Biotech / Life Sciences |

Biosimilars Webinar


Complimentary Webinar

Register to the Webinar Now

Subject: BPCIA Update: The 180-day Notice of Commercial Marketing in the Courts
Date/Time: Thursday, April 28
1:00 pm – 2:00 pm EST, 12:00 pm – 1:00 pm CST, 10:00 am – 11:00 am PST

Featured Panelists:

Mark I. Bowditch Mark Bowditch
Vice President, Intellectual Property and Litigation
Coherus BioSciences, Inc.
(Redwood Shores, CA)

Donald R. Ware Bio photo for Donald Ware
Partner and Chair, Intellectual Property Department
Foley Hoag LLP
(Boston, MA)

Last year, in Amgen v. Sandoz, a divided Federal Circuit panel held that a biosimilar applicant who “opted out” of the BPCIA patent dance cannot give the reference product sponsor the required 180-day notice of the applicant’s intent to commence commercial marketing until after the FDA formally approves the biosimilar. The effect of the ruling is to give the reference product sponsor an additional six months of data exclusivity beyond the 12-year period specified in the statute. After the Federal Circuit denied en banc review, Sandoz filed a cert petition in the Supreme Court, which is currently pending. Based on this decision, in litigation against another biosimilar applicant, Apotex, Amgen obtained a preliminary injunction against the commercial launch of Apotex’s biosimilar until 180 days after post- approval notice of commercial marketing is given. Apotex appealed based on the argument that the Sandoz decision does not apply where the applicant complied with the information exchange provisions of the BPCIA. The Federal Circuit heard argument on April 4. (more…)

Cargill, Herbalife, J.M. Smucker, Pepsi, TreeHouse and Unilever gather to benchmark with the FDA, CARU, CFBAI, NAD and many others in Chicago this May at ACI 6th Advance Regulatory and Compliance Summit on Food & Beverage Marketing and Advertising

March 21st, 2016
in Advertising & Marketing, Food and Beverage |



NEW YORK - March 21, 2016 - American Conference Institute (ACI) is pleased to announce that some of the Food and Beverage Industry’s largest companies will be sending their senior legal representatives to ACI’s 6th Advanced Regulatory and Compliance Summit on Food & Beverage Marketing and Advertising conference, which will take place at the Omni Chicago on May 10-12, 2016.  These industry leaders will also be joined by the Food and Drug Administration, the National Advertising Division, the Children’s Food & Beverage Advertising Initiative as well as the Children’s Advertising Review Unit. (more…)

ACI’s FDA Boot Camp, March 9-11, 2016 – Top Reasons to Attend

January 20th, 2016
in Pharmaceuticals / Biotech / Life Sciences |

ACI’s FDA Boot Camp – Top Reasons to Attend 

Breaking News – Pacira First Amendment Case Settles

December 22nd, 2015
in Pharmaceuticals / Biotech / Life Sciences |

Published on Drug and Device Law on December 15, 2015

We learned about it yesterday from a reporter, but were sworn to secrecy until today.  Pacira Pharmaceuticals and the FDA settled their litigation with Pacira getting essentially everything it wanted – what the company calls “favorable resolution.” Pursuant to the settlement agreement, the FDA is formally rescinding its unfortunate warning letter that attempted a retroactive reduction in the scope of the indications of Exparel’s (the drug at issue) approval. [Read More] (more…)

ICMAD Supports The Introduction of The Safe Cosmetics Modernization Act – Nov 19, 2015

November 20th, 2015
in Pharmaceuticals / Biotech / Life Sciences, Press Release |

Press Release Published by ICMAD on November 19, 2015

The Independent Cosmetic Manufacturers and Distributors (ICMAD) association is proud to support legislation introduced today by U.S. Congressman Pete Sessions (R-TX), H.R.4075, The Safe Cosmetics Modernization Act. H.R.4075 modernizes and improves the Food and Drug Administration’s ability to assure the safety of cosmetic products by examining ingredient safety, establishing manufacturing processes and tracking and quickly addressing adverse health impacts from potentially unsafe products and requiring that all manufacturers be registered with the FDA. [Read More] 

Related Event

American Conference Institute’s 3rd Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products

ACI is pleased to partner with ICMAD (Independent Cosmetic Manufacturers and Distributors) on the Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products, taking place on March 7-9, 2016 at The Carlton Hotel in New York City. Click here to learn more about the event, which will provide you with the critical information you need to:

  • Review the provisions of the Personal Care Products Safety Act and The Safe Cosmetics Modernization Act
  • Analyze when a cosmetic product must also meet the FDA requirements for OTC drugs
  • Understand when you may need FDA approval for a beauty device
  • Explore legal and regulatory enforcement activity at the state level
  • Demystify retailer requirements for cosmetic and personal care products
  • Design strategies for trade dress protection for packaging
  • Examine Prop 65 reform in California
  • Improve claim substantiation efforts by monitoring enforcement activity at the federal and state level as well as litigation from private parties
  • Comprehend FDA’s jurisdiction over social media marketing tactics for cosmetic products

Register before January 15, 2016 for Advance Pricing by visiting or calling 888-224-2480.

Current Good Manufacturing Practices: Drug and Biologics

November 20th, 2014
in Legal Conferences, Pharmaceuticals / Biotech / Life Sciences |

Complimentary presentation from ACI’s 23rd FDA Boot camp.

Highlights from this presentation:

- FDA’s GMP  philosophy

- Substantive drug areas

- Sources of GMPs

- FDA Inspection triggers

- Typical investigation activities and much more…




ACI’s 5th Annual conference on Biosimilars

May 15th, 2014
in Pharmaceuticals / Biotech / Life Sciences |



When: Wednesday, June 04 to Friday, June 06, 2014

Where:  InterContinental New York Barclay, New York, NY

To learn more, visit: 



Are Sugary Drink Warnings Coming to California?

April 21st, 2014
in Food and Beverage, Legal Conferences, Litigation |

by Jordan Grotzinger, Originally Published on 

California isn’t exactly known as a business-friendly state.  In some ways, the governor has tried to change that.  He’ll have an interesting choice to make if a recently-passed senate bill reaches his desk.


Weekly Industry News – Pharma & Healthcare

March 17th, 2014
in Healthcare, Legal Conferences, Pharmaceuticals / Biotech / Life Sciences |

Pharma & Healthcare – the latest on FDA’s proposed generic drug labeling rule, FDA bans imports from India’s Sun Pharma and more.


Weekly Industry News: Pharma & Healthcare

February 10th, 2014
in Healthcare, Legal Conferences, Litigation, Pharmaceuticals / Biotech / Life Sciences |

Pharma & Healthcare – the latest on Pfizer Inc v. Teva Pharmaceuticals, the USFDA imposes penalties on Indian pharma cos’ and more.


FDA panel could give Bayer painkiller an edge over rivals from Pfizer, J&J by Tracy Staton Published on

What if every drug in a class posed a risk to the heart–all except one? That’s the question we could soon be asking about nonsteroidal anti-inflammatories, or NSAIDs, among the most commonly used drugs in the world… [ Read More ]

‘USFDA has imposed disproportionate penalties on Indian pharma cos’ by Amiti Sen Published on The Hindu Business Line

Reacting strongly to the recent string of actions against Indian pharmaceutical companies by the US Food & Drug Administration (FDA), India has said that in some cases the authority has imposed disproportionately strong penalties…[ Read More ]

Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2014) by Andrew Williams Published on

The standard of review at the Federal Circuit is important.  Even though it often appears like cases are re-litigated at the Appeals Court, it is actually very difficult (or at least should be) to overturn a lower court’s factual determinations…[ Read More

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