Biotechnology Pharmaceutical Industry

News & Analysis as of

Cipla to Open Biotech Facility in South Africa

Cipla has announced that it is investing 1.3 billion South African Rand (approximately 91 million USD) to open a biotech plant in South Africa. According to Cipla’s press release, this will be South Africa’s first...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

Full Federal Circuit Curbs On Sale Bar's Threat to Patents

Biotech and pharmaceutical companies received critical guidance from the Federal Circuit yesterday, when the en banc court exempted a broad category of common manufacturing and supply arrangements from the reach of the patent...more

New Patent Office Initiative Provides a Boost to Cancer Immunotherapy Patent Applications

On June 29, 2016, the United States Patent and Trademark Office (USPTO) announced that it is implementing a pilot program to more quickly review patent applications related to treating cancer using immunotherapy. This...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

New Stats From The AAA

The American Arbitration Association (AAA) has not released statistics for years (other than to the CFPB). But recently, arbitration geeks got a summer solstice gift of (limited) new information. The piece is only three...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

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

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

Q1 2016 IPO Market Review

The first quarter of 2016 produced a meager eight IPOs with gross proceeds of $667 million. Only once over the prior 12 years has the first quarter produced a lower tally—there were only two new offerings in the glum...more

Court Report - May 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Hetero USA, Inc. et al. 3:16-cv-02356; filed April 26, 2016 in the...more

Biocon Announces Insulin Glargine Biosimilar Has Met Key Phase III Milestones, Is On Track for US and EU Regulatory Filings

Biocon recently announced that its global phase III clinical development program for biosimilar insulin glargine “has crossed key interim milestones,” putting Biocon “on track for regulatory filings in US and EU in FY...more

To be prepared is half the victory

In the second in our series of alerts relating to drug pricing, we identify several considerations and potential actions that a pharmaceutical or biotechnology company can take to address the current headwinds impacting...more

AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Legislative Developments in Post-Grant Proceedings

Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

PTAB Statistics From Spring BIO IPCC Meeting

At the end of March, the Intellectual Property Counsels' Committee (IPCC) of the Biotechnology Innovation Organization (BIO) held its Spring meeting, convening in-house counsel and outside counsel involved in patenting the...more

[Webinar] Avoiding Drug Substance Patents and Exclusivities: Prodrugs, Deuterated Drugs, and 505(b)(2) - April 14th, 9:00am...

Join Kurt Karst (Hyman, Phelps & McNamara, P.C.) (coauthor, "The FDA Blog") and Jeffrey Hovden (Robins Kaplan LLP) (coauthor, Generically Speaking) for a collaborative webinar. For generic drug companies, the biggest and...more

[Webinar] Recent Legal & Economic Developments That Affect Your Biotech Business - March 29th, 2:00pm EST

The greatest asset of a young biotech company is its intellectual property. Strategic decisions made during the initial organization and early growth of your company have a lasting impact on its success. In this webinar, we...more

Court Report - March 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Vanda Pharmaceuticals Inc. v. Roxane Laboratories Inc. 1:15-cv-00919; filed October 13, 2015 in the District Court of...more

Outlook for Patent Reform in 2016

With the final session of the 114th Congress under way, the likelihood of Congress taking up and passing comprehensive patent litigation reform legislation becomes more and more remote. From a timing standpoint alone, the...more

Court Report - February 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Actavis Laboratories UT, Inc. v. Par Pharmaceutical, Inc. 1:15-cv-00886; filed October 2, 2015 in the District Court of...more

Record breaker: US M&A in 2015

As the dust settles from the explosion of US M&A activity in 2015, it is fitting to reflect on the forces that fueled the boom and consider what last year’s trends may tell us about the year ahead. The record year...more

[Event] Do Not Enter: Privacy & Security for Life Sciences Companies - Regulatory Roundtable Immersion Series - Session #7 - Jan....

Cooley's Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant...more

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