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Biotechnology Considerations for the Unitary Patent System in Light of Brexit and Other Current Developments

Written by Daniel A. Kamkar and Eric Furman, Ph.D. After the United Kingdom voted to leave the European Union, dubbed “Brexit” by the press, many have called into question whether the UK would ratify the Unitary Patent...more

Potential Intellectual Property Issues on the Table in the 115th Congress

Over the past decade, intellectual property issues have often taken center stage in Congress. The America Invents Act, passed in 2011, changed patent landscape in many ways, most notably by changing the U.S. patent system...more

Advertising Law - January 2017 #2

SPECIAL FOCUS: Ohlhausen Named Acting Chair of FTC - On January 24, 2017, President Donald Trump designated Maureen Ohlhausen as acting chairwoman of the Federal Trade Commission. Ohlhausen, a Republican, has been...more

Health Law Insights: January Newsletter

ALERT: Health Reform Outlook for 2017: A Year of Major Uncertainty - Fulfilling their promises, Congressional Republicans moved to repeal the Affordable Care Act (ACA) on the first day of the new Congress when Senate...more

Obama Administration Antitrust Enforcers Take Last-Minute IP Licensing Actions

As the Obama Administration drew to a close, its antitrust enforcers took two actions of note for those involved in intellectual property (IP) licensing. The first, the joint release by the U.S. Department of Justice (DOJ)...more

2017: Predictions From Socially Aware’s Editors and Contributors

The beginning of a new year is a time for resolutions and predictions. We won’t bother Socially Aware readers with our resolutions for 2017, but we thought that we would share some predictions for the new year from our...more

Unitary Patent Inches Closer to Adoption with UK’s Ratification Announcement

The Intellectual Property Office of the United Kingdom (UK)—together with the Minister of State for Energy and Intellectual Property and Prime Minister May—issued a press release on Nov. 28 confirming that the country will...more

UK announces intention to ratify the Unified Patent Court Agreement

The UK Government yesterday announced that its plans to ratify the Unified Patent Court Agreement (“UPCA”) will not be derailed by Brexit. The UK Minister of State for Intellectual Property, Baroness Neville Rolfe, made the...more

Brexit and Supplemental Protection Certificates: Hope for the Best but Plan for the Worst

On June 23, 2016, the United Kingdom voted through a national referendum to exit the European Union after more than 40 years of membership. One of the key arguments in favor of the so-called “Brexit” was to return full...more

U.S. Biosimilars Pathway Under Trump

This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception. Two of Trump’s stated policies...more

CETA Implementation in Canada - Implications of Bill C-30 on the Pharmaceutical Industry

Bill C-30 presents significant changes to Canada’s pharmaceutical landscape by introducing supplementary protection for pharmaceutical products and proposing substantial modifications to the Patented Medicines (Notice of...more

Hillary Believes in the Patent System

Hillary Clinton has released a position paper: “Initiative on Technology and Innovation” which contains two paragraphs on actions she would promote to reduce litigation by trolls and strengthen the USPTO. She notes that...more

Clinton vs. Trump: How the U.S. Presidential Election Could Impact IP Law

A great deal has been made of the distinct policy differences between Democratic Presidential Nominee Hillary Clinton and Republican Nominee Donald Trump in such areas as immigration, national defense, crime and taxation. But...more

Letter to Colombian President Encourages Grant of Compulsory License for Imatinib

Last month, we reported on letters sent by two Senators and fifteen Representatives to the U.S. Trade Representative, seeking clarification regarding the Administration's position on compulsory licenses. The letters were...more

Rising Tide of State-Enacted Patent Reform

It started with Vermont in 2013. Since then, over half the states have enacted legislation aimed at curbing patent infringement suits from non-practicing entities. Now, the band may add another member: Massachusetts....more

The PRICED Act Would Expedite Biosimilar Market Entry

Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...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

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...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

Senators Introduce the CREATES Act

In furtherance of the government’s efforts to bring down healthcare costs, Senators Patrick Leahy (D-VT.), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) have introduced the Creating and Restoring Equal...more

Legislation Tracker: PRICED Act Proposes to Shorten Biologic Exclusivity Period from 12 to 7 Years

A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.” Titled the “Price...more

Seeking Shelter From the Patent Eligibility Storm: Does the DTSA Provide Sanctuary?

For many charged with the development of intellectual property portfolios in the life sciences and software industries, navigating the stormy waters of patent eligibility has recently proven difficult. U.S. Supreme Court and...more

In re: TC Heartland LLC: Status Quo for Venue Selection in Patent Suits (For Now)

The Federal Circuit, in In re: TC Heartland LLC (No. 2016-105), recently issued an opinion denying TC Heartland’s petition for a writ of mandamus to direct the U.S. District Court for the District of Delaware to either...more

DOJ Files IPR Petitions Against Discovery Patents

The U.S. Department of Justice (DOJ) filed six petitions for inter partes review (IPR) of three patents assigned to Discovery Patents, LLC. The patents cover security alarm systems and methods for providing secure real-time...more

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