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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

Cuba: A Playing Field for Trademark Pirates

Now that President Obama has lifted trade restrictions, American businesses are considering whether to expand their operations to Cuba. For some corporations, it makes immediate sense. For others, it may not. But regardless...more

Medical Device Manufacturer’s Association Comments on Senate Hearing

The Senate Committee on Small Business and Entrepreneurship held a meeting titled “An Examination of Changes to the U.S. Patent System and Impacts on America’s Small Businesses” on February 25, 2016. ...more

Patent Venue Legislation Could Have A Dramatic Impact on Popular Patent Venues

This March, three United States Senators introduced the “Venue Equity and Non-Uniformity Elimination Act of 2016.” The bill would dramatically narrow the venue statute that applies to patent cases and, it appears, prevent...more

Federal Circuit Finds Personal Jurisdiction Based On Plans To Market ANDA Product

In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the...more

Forum Shopping in Patent Litigation

This month, both the Federal Circuit and the Senate Judiciary Committee took up the issue of “forum shopping” in patent infringement suits. Right now, a patent plaintiff can essentially file suit in the district court of its...more

A Closer Look at Cybersecurity Legislation and Regulations in the US and Abroad - United States

Legal Framework - Summarise the main statutes and regulations that promote cybersecurity. Does your jurisdiction have dedicated cybersecurity laws? The United States generally addresses cybersecurity...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

IP & Technology Newsletter: Winter 2016

In today’s business world, protecting trade secrets is of vital importance. A trade secret is anything which gives a company a competitive advantage and is kept confidential, including a design, formula, manufacturing...more

Representatives Send Letter to HHS and NIH Seeking Response to Pharmaceutical Costs

In a letter sent earlier this month to Secretary Sylvia Mathews Burwell of the U.S. Department of Health & Human Services and Director Francis S. Collins of the National Institutes of Health, fifty members of the U.S. House...more

Senate Committee Considers Legislation To Address Theft Of Trade Secrets

On December 2, 2015, the Senate Judiciary Committee held a hearing entitled “Protecting Trade Secrets: the Impact of Trade Secret Theft on American Competitiveness and Potential Solutions to Remedy This Harm.” The hearing...more

With Trans-Pacific Partnership Negotiations Concluded, Administration Turns to Clearing Domestic Hurdles

The working text (all 5,500+ pages) of the 12-country Trans-Pacific Partnership Agreement (TPP) was released to the public on November 5. This text is still undergoing an intense legal scrub and must be translated into its...more

Final Text of Trans-Pacific Partnership Released

At long last, the final text of the Trans-Pacific Partnership, a free trade agreement among a dozen Pacific Rim nations, has now been made available to the public. The chapter on intellectual property, however, does not...more

What May Be the IP Provisions of the Trans Pacific Partnership Agreement

The diplomats negotiating the Trans Pacific Partnership (TPP) agreement have done the seemingly impossible: they have kept the details of the draft agreement secret from the press and interested parties in the United States,...more

Amendments in Kazakhstan’s medicinal products registration system: new hope for rights holders

In January and June 2015 Kazakhstan’s legislation was amended in order to protect the interests of developers of new pharmaceuticals and apparatus used in healthcare....more

101 Patient Organizations Ask Congress to Curb IPR Abuse

Last month, in a letter to the Senate and House Committees on the Judiciary, 101 patient organizations expressed "concern[] that, as currently written, H.R. 9 [the Innovation Act] falls short of preserving important patent...more

Pacific Rim Countries Reach Historic Agreement on the Trans-Pacific Partnership, But Will Congress Approve It?

Trade ministers from 12 Pacific Rim countries announced, on October 5, 2015, that they had reached an agreement in principle on the Trans-Pacific Partnership (TPP). The TPP would arguably be the largest free trade agreement...more

New IP Legislation Under Consideration Regarding Tax Relief for Income Generated From IP Assets

McGraw Hill Financial, Oracle and Facebook, announced they are forming a group called “American Innovation Matters” (AIM) to lobby Congress to revise the U.S. international tax code rules in an effort to encourage innovation...more

U.S., China Announce Cybersecurity Agreement During Xi Jiping’s Visit

Chinese President Xi Jinping made his first state visit to the United States last week, and his itinerary included meetings with U.S. technology company leaders as well as President Barack Obama. Not surprisingly, his hosts...more

Intellectual Property Newsletter - September/October 2015

PTAB Update on Inter Partes Review - On August 19, 2015, the Director of the USPTO released a blog post reporting on the state of post-grant review proceedings created by the Leahy-Smith America Invents Act of 2011 and...more

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