News & Analysis as of

Biopharmaceutical

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

by Hogan Lovells on

Right-to-try laws and the future of access to investigational treatments - The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more

JPM Conference Takeaways: Biotech and Biopharma Set for Growth in 2018

Coming off a year that saw a record number of new drug approvals, significant scientific breakthroughs and a year-end tax reform package that both significantly lowers corporate taxes and provides the long-awaited tax...more

Worldwide Divisional Strategy Considerations

Dividing a single patent application into multiple patents is often essential for deriving maximum economic benefit from the disclosed inventions. When an applicant wants to protect multiple inventions disclosed in a single...more

Obviousness-Type Double Patenting Dangers in the U.S.

The Federal Circuit’s decision in Gilead Sciences, Inc. v. Natco Pharma Ltd. introduced even more confusion in an already confusing area of the law – namely obviousness-type double patenting. Obviousness-type double patenting...more

Worldwide Bolar-type Provisions*

Please see full chart for Bolar Excemption rules in foreign countries regarding Clinical Trials, New Drugs, Biosimilars and Foreign Jurisdiction issues. ...more

Bolar Exemption in Europe and Asia

Bolar exemption in Europe - The Bolar exemption is governed by European Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Article 10(6) excludes from infringement of patent rights or...more

Bolar Exemptions in North America

Bolar Exemptions in the U.S. Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use exemption with respect to regulated...more

Global Patent Prosecution Newsletter - December 2017

Worldwide Bolar Exemptions - Many countries have exemptions for patent infringement for a product and/or process that is not being used for direct commercialization and profit. For biopharmaceuticals, this exemption,...more

Blog: Biotech Files Rulemaking Petition For Pilot Program Mandating Public Disclosure Of Short-Sale Positions

by Cooley LLP on

A rulemaking petition has been submitted to the SEC by a biopharmaceutical company that is “developing and marketing regenerative and therapeutic biologics.” The petition requests that the SEC promulgate rules to establish a...more

BioPharma Patents Quick Tips & News – November 2017

Diagnostic Method Claims in the U.S. I. Let’s recap the last five years! Mayo (2012) = Supreme Court prohibits patents for diagnostic methods without “significantly more” (essentially, you must not only discover a...more

AGG Food and Drug Newsletter - October 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's 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 Washington, DC...more

Compulsory Licensing of Biopharmaceutical Inventions

Very few topics in international intellectual property have been as controversial as compulsory licenses. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for...more

Conditional Optimism or Securities Fraud? Appellate Court Affirms Dismissal of Class Action against Biopharmaceutical Company;...

by Arnall Golden Gregory LLP on

On August 22, 2017, the United States Court of Appeals for the First Circuit (the “Court”) affirmed the dismissal of a securities fraud class action against Sarepta Therapeutics, Inc. (the “Company”), a biopharmaceutical...more

Global Patent Prosecution Newsletter - October 2017

March-in Rights and Compulsory Licensing of Biopharmaceutical Inventions - Very few topics in international intellectual property have been as controversial as compulsory licensing. In the US, consumer groups have...more

Recent Trends on the U.S. Doctrine of Equivalents

U.S. courts have long recognized that a product or process which does not literally infringe a patent can nevertheless infringe under the "doctrine of equivalents" if it is equivalent to the claimed invention. The percentage...more

FDA re-approves Mylotarg® antibody-drug conjugate seven years after it had been withdrawn from the market

by Knobbe Martens on

Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more

Considerations for Developing a Global Patent Term Extension Strategy

Many jurisdictions provide for the extension of the term of the patents that cover a regulated product. Patent term extension (PTE) is particularly important in the bio/pharma industry given that development of an innovative...more

Patent Term Extension Considerations for BioPharma Patents

Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the term of patent protection during which an innovator can recover its...more

Global Patent Prosecution Newsletter - August 2017

Worldwide Patent Term Extension Provisions - Mechanisms to recover patent term lost during regulatory approval are available in many countries throughout the world. The August 2017 issue of Sterne Kessler’s Global Patent...more

Scientific progress enables EMA to improve guidance on medicinal products containing genetically modified cells

by Hogan Lovells on

The European Medicines Agency (EMA) has released a concept paper concerning a proposed revision of the current guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified...more

How Life Sciences and Pharmaceutical Companies Can Harness Opportunity in Their Supply Chains

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells counsel Penny Powell talks about disruptive technologies, the increasing trend towards collaboration and joint venture agreements, the opportunities and regulatory burdens...more

INC Research Merges with inVentiv Health Creating a $7.4B Combined Entity

by Knobbe Martens on

According to press releases, INC Research Holdings, Inc. has agreed to merge with inVentiv Health, creating a combined company having an enterprise value of approximately $7.4 billion. The press release further notes that the...more

First Circuit Holds that Scienter Requires Knowledge That Non-Disclosure Risked Misleading Investors, Not Just Knowledge of...

In Brennan v. Zafgen, Inc., — F.3d –, 2017 WL 1291194 (1st Cir., April 7, 2017), the First Circuit affirmed a District of Massachusetts decision dismissing claims against Zafgen, Inc., a biopharmaceutical developer, and its...more

EMA on optimising the development of advanced therapies

by Hogan Lovells on

On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory conference concerning the optimisation of the development of...more

Aralez’s YOSPRALA wins FDA approval

by Knobbe Martens on

On September 15, 2016, the U.S. Food and Drug Administration approved once-daily YOSPRALA™, a tablet that combines the anti-platelet agent, aspirin, with the anti-acid drug, omeprazole for decreasing the risk of...more

48 Results
|
View per page
Page: of 2
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.