Briefs

FDA Warns of Counterfeit Version of Avastin Cancer Treatment
FDA Warns of Counterfeit Version of Avastin Cancer Treatment

February 14, 2012

The U.S. Food and Drug Administration issued a safety alert on Feb. 14 to warn the public about the dangers posed by a counterfeit version of the Avastin® cancer treatment being distributed in the United States.

Bevacizumab is a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor. The drug is used approved for the treatment of colon cancer and is covered in a patent 6,054,297 owned by Genentech Inc.

The FDA here is warning healthcare professionals and patients about a counterfeit version of the injectable Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin and purports to be manufactured by Roche, but does not contain the medicine's active ingredient, bevacizumab. Roche only manufactures Avastin approved for marketing outside of the United States; the only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). According to the FDA, 19 practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.

Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:
- are labeled with Roche as the manufacturer
- display batch numbers that start with B6010, B6011 or B86017
The FDA-approved version does not include the Roche logo on the packaging or vials. To report suspected counterfeit products, please:
- Call FDA's Office of Criminal Investigations (OCI) at 800-551-3989,
- Visit OCI's website, or
- Email
Read the Genentech press release on this safety alert.
The International Intellectual Property Alliance Makes “Special 301” Review Recommendations to the U.S. Trade Representative

The International Intellectual Property Alliance Makes “Special 301” Review Recommendations to the U.S. Trade Representative

February 10, 2012

The International Intellectual Property Alliance (IIPA) on Feb. 10 submitted recommendations in a letter to the Office of the United States Trade Representative (USTR) in its annual “Special 301” review of global copyright piracy issues that affect U.S. jobs, markets, and economic growth.

The “Special 301” Report is an annual review of the global state of intellectual property rights (IPR) protection and enforcement, which the USTR conducts pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994). This report examines intellectual property concerns that the USTR identifies in countries and territories around the world. As noted in an earlier Intellirights story, the USTR released its 2011 Special 301 Report on May 2, 2011. In formulating this annual report, the USTR invites the public to submit written comments on intellectual property issues.

With the release of the USTR’s 2012 Special 301 Report coming in a few months, the IIPA submitted recommendations for consideration. Among them, the IIPA has called for the following 10 countries to be placed on the Priority Watch List of countries and territories that represent heightened IPR concerns for the United States:

• Argentina
• Canada
• Chile
• China
• Costa Rica
• India
• Indonesia
• Russia
• Thailand
• Ukraine

The IIPA’s recommendation letter also discusses in detail the following list of “cross-cutting initiatives or challenges” relevant to reducing piracy, opening markets to legitimate U.S. copyright business, and ensuring that adequate legal structures are in place to lower piracy levels in the future:

1) The Need for Deterrent Enforcement Responses to Copyright Piracy;
2) Internet Piracy;
3) Enterprise (including Government) End-User Piracy of Software and Other Copyright Materials;
4) Unauthorized Loading Onto PCs (Hard-Disk Loading) and Mobile Devices (Mobile Device Piracy);
5) Circumvention of Technological Protection Measures (TPMs);
6) Illegal Camcording of Theatrical Motion Pictures;
7) Piracy of Books and Journals;
8) Optical Disc and Game Cartridge Piracy;
9) Pay TV Piracy and Signal Theft;
10) Using bilateral or regional free trade agreements (FTAs) to Improve Global Standards of Copyright Protection and Enforcement;
11) Implementation of the WIPO Copyright Treaty (WCT) and WIPO Performances and Phonograms Treaty (WPPT); and
12) Market Access Barriers

Undergirding the IIPA’s recommendation letter is the recent research study it funded entitled Copyright Industries in the U.S. Economy: The 2011 Report. This report, prepared by Stephen Siwek of Economists Inc., shows that U.S. core copyright industries − business software, entertainment software, motion picture, television and home video entertainment, music, and book and journal publishing – are key drivers of the U.S. economy, contributing heavily to domestic growth and employment, including roughly 6.4% to the U.S. economy, nearly 5.1 million workers or 5% of all U.S. private sector jobs, and $134 billion annually in revenue from foreign sales and exports.

In the Feb. 10 press release announcing the recommendations to the USTR, IIPA Counsel Steven J. Metalitz stated:

We thank the U.S. Government, the many senior officials at USTR, Commerce, State, USPTO, the Copyright Office, the Office of the IP Enforcement Coordinator and Members of Congress, along with their staffs, who have worked steadfastly over the years to ensure that our trading partners respect U.S. intellectual property and open their markets to our products and services. We also applaud the Administration and Congress for ratification and implementation of Free Trade Agreements (FTAs) with Korea, Colombia, and Panama, and express our hopes for a robust Trans-Pacific Partnership FTA. These initiatives with strong IP chapters are critical vehicles to open foreign markets, encourage free and fair trade for America’s most productive companies, and boost U.S. jobs and exports.
Usher and Alicia Keys Successfully Defend Copyright Infringement Suit

Usher and Alicia Keys Successfully Defend Copyright Infringement Suit

February 9, 2012

Grammy Award winners Usher and Alicia Keys on Feb. 9 succeeded in having the dismissal of a copyright suit against them affirmed by a federal appeals court (Pyatt v. Raymond, 2d Cir., No. 11-2507-cv, 2/9/12).

In this case, Wadena Pyatt sued Usher Raymond IV, a/k/a Usher, and Alicia Keys, a/k/a Alicia Augello Cook, along with Sony BMG Management, EMI Music Publishing Inc., and others for copyright infringement over the song “Caught Up.” The song that appears on Usher’s Confessions album was written and produced by Jason Boyd, Ryan Toby, and other musical collaborators, and was released in the United States in 2004.

In a nonprecedential ruling, the U.S. Court of Appeals for the Second Circuit said that Pyatt’s originally registered copyrighted works and Usher’s “Caught Up” have “little in common beyond the title and the phrase ‘Caught Up’.” “The songs are lyrically and musically distinct and the district court correctly concluded that the claim failed the ordinary observer test,” it wrote, citing Yurman Design Inc. v. PAJ Inc., 262 F.3d 101, 111 fn. 3 (2d Cir. 2001).

Continuing, the appellate court also agreed with the district court’s decision to analyze Pyatt’s infringement claims based only on the originally copyrighted works—not on those works registered after the filing of the complaint and the defendants’ motions to dismiss. In noting that these post-complaint works could not be brought within the scope of Pyatt’s complaint, the appellate court quoted Supreme Court authority stating that the "Copyright Act . . . requires copyright holders to register their works before suing for copyright infringement." Reed Elsevier Inc. v. Muchnick, 130 S.Ct. 1237 (2010).

The district court’s dismissal in favor of the defendants was affirmed.

Pyatt was represented by Robert Pritchard of Gallo & Associates, Plainview, N.Y.

Usher and Sony BMG were represented by Jonathan D. Davis of Jonathan D. Davis P.C., New York.

Alicia Keys was represented by John J. Rosenberg of Rosenberg & Giger, New York.

Jason Boyd was represented by Christine Lepera of Mitchell Silberberg & Knupp, New York.

Ryan Toby was represented by Dorothy M. Weber of Shukat Arrow Hafer Weber & Herbsman, New York.

Read the Pyatt v. Raymond ruling.
Newt Gingrich Is Sued for Infringing “Eye of the Tiger” Copyrights

Newt Gingrich Is Sued for Infringing “Eye of the Tiger” Copyrights

January 30, 2012

2012 Republican presidential candidate Newt Gingrich was on Jan. 30 named as a defendant in a suit charging that he infringed the copyrights in the song “Eye of the Tiger,” the principal theme song for the 1982 Rocky III movie (Rude Music Inc. v. Newt 2012 Inc., N.D. Ill., No. 1:12-cv-00640, filed 1/30/12).

The suit was filed by plaintiff Rude Music Inc., co-owner of the copyright in the Grammy-winning hit song performed by the group Survivor. In its complaint, Rude Music asserts that Gingrich, Newt 2012 Inc., and the American Conservative Union, violated the Copyright Act by using the song in campaign events and materials without permission.

Among other things, the suit charges that:

•The American Conservative Union has posted on the internet video recordings of at least the 2010 and 2011 conferences, featuring Mr. Gingrich and “Eye of the Tiger.” The reproduction and distribution of these recorded performances of the copyrighted composition is unlicensed and unauthorized.
•As his campaign for the Republican presidential nomination has ramped up, Mr. Gingrich and Newt 2012, Inc. have caused a recording of “Eye of the Tiger” to be publicly performed at numerous campaign appearances by Mr. Gingrich. For example, in Doylestown, Pennsylvania, Mr. Gingrich entered the packed Moose Lodge for a speech as the song “pulsed,” according to the Newt 2012, Inc. website. More recently, during the campaign’s pre-caucus swing through Iowa, the copyrighted song played as Mr. Gingrich made his entrance and exit at an event in Des Moines; heralded his arrival at an event in Burlington, Iowa; and blared as his campaign bus rolled into an excavation business in Walford, Iowa. Newt 2012, Inc.’s and Mr. Gingrich’s use of the copyrighted work is unlicensed and unauthorized.
•Newt 2012’s and Mr. Gingrich’s unauthorized public performance, or inducement of or contribution to the public performance, of the copyrighted work infringes Rude Music’s copyright. Similarly, the American Conservative Union’s reproduction and distribution of the video recordings, featuring Mr. Gingrich and “Eye of the Tiger” is unlicensed and unauthorized, and also infringes Rude Music’s copyright in the composition.

The complaint continues by noting that the infringement in this case is willful, and that enhanced damages are therefore warranted under the Copyright Act.
Rude Music is represented by Marianne C. Holzhall and Annette Michele McGarry of McGarry & McGarry, Chicago.
President Obama Exhorts Protection of U.S. Products in State of the Union Address

President Obama Exhorts Protection of U.S. Products in State of the Union Address

January 24, 2012

President Barack Obama in his Jan. 24 State of the Union address called for greater protection of U.S. products to expand U.S. business markets and announced the creation of “a Trade Enforcement Unit that will be charged with investigating unfair trading practices in countries like China.”

The president recognized the achievement of the recently passed U.S.-Panama, U.S-Colombia, and U.S.-South Korea trade agreements and said that more work lies ahead to ensure fairer treatment for U.S. products and businesses in other foreign markets. He also offered a stern warning for countries that allow piracy, counterfeiting, and other types of unlawful trade practices.

Obama stated:

"We’re also making it easier for American businesses to sell products all over the world. Two years ago, I set a goal of doubling U.S. exports over five years. With the bipartisan trade agreements we signed into law, we’re on track to meet that goal ahead of schedule. (Applause.) And soon, there will be millions of new customers for American goods in Panama, Colombia, and South Korea. Soon, there will be new cars on the streets of Seoul imported from Detroit, and Toledo, and Chicago. (Applause.)

"I will go anywhere in the world to open new markets for American products. And I will not stand by when our competitors don’t play by the rules. We’ve brought trade cases against China at nearly twice the rate as the last administration –- and it’s made a difference. (Applause.) Over a thousand Americans are working today because we stopped a surge in Chinese tires. But we need to do more. It’s not right when another country lets our movies, music, and software be pirated. It’s not fair when foreign manufacturers have a leg up on ours only because they’re heavily subsidized.

"Tonight, I’m announcing the creation of a Trade Enforcement Unit that will be charged with investigating unfair trading practices in countries like China. (Applause.) There will be more inspections to prevent counterfeit or unsafe goods from crossing our borders. And this Congress should make sure that no foreign company has an advantage over American manufacturing when it comes to accessing financing or new markets like Russia. Our workers are the most productive on Earth, and if the playing field is level, I promise you -– America will always win."

Click here to see the video of President Obama’s comments.
Kodak, Leading Innovator of Camera Technology, Files for Chapter 11 Bankruptcy
Kodak, Leading Innovator of Camera Technology, Files for Chapter 11 Bankruptcy

January 19, 2012

Eastman Kodak Co., the company that George Eastman founded and led to innovations in photography and imaging, issued a statement Jan. 19 announcing that it is seeking Chapter 11 bankruptcy protection.

As noted in an earlier story, Kodak had stated in November that it expected proceeds from the future sale of digital imaging patents to “materially increase” its cash balance. “The business reorganization is intended to bolster liquidity in the U.S. and abroad, monetize non-strategic intellectual property, fairly resolve legacy liabilities, and enable the Company to focus on its most valuable business lines. The Company has made pioneering investments in digital and materials deposition technologies in recent years, generating approximately 75% of its revenue from digital businesses in 2011,” the company said in the Jan. 19 announcement.

“Kodak is taking a significant step toward enabling our enterprise to complete its transformation,” said Antonio M. Perez, Kodak chairman and CEO. “At the same time as we have created our digital business, we have also already effectively exited certain traditional operations, closing 13 manufacturing plants and 130 processing labs, and reducing our workforce by 47,000 since 2003. Now we must complete the transformation by further addressing our cost structure and effectively monetizing non-core IP assets. We look forward to working with our stakeholders to emerge a lean, world-class, digital imaging and materials science company.”

“Chapter 11 gives us the best opportunities to maximize the value in two critical parts of our technology portfolio: our digital capture patents, which are essential for a wide range of mobile and other consumer electronic devices that capture digital images and have generated over $3 billion of licensing revenues since 2003; and our breakthrough printing and deposition technologies, which give Kodak a competitive advantage in our growing digital businesses,” Perez added.

Just yesterday, Kodak issued a statement announcing its filing of a patent infringement suit against Samsung over the following digital imaging patents:
- • U.S. Patent No. 6,292,218 – “Electronic Camera For Initiating Capture of Still Images While Previewing Motion Images”
- • U.S. Patent No. 7,210,161 – “Automatically Transmitting Images from an Electronic Camera to a Service Provider Using a Network Configuration File”
- • U.S. Patent No. 7,742,084 – “Network Configuration File for Automatically Transmitting Images from an Electronic Still Camera”
- • U.S. Patent No. 7,453,605 – “Capturing Digital Images to be Transferred to an E-Mail Address”
• U.S. Patent No. 7,936,391 – “Digital Camera with Communications Interface for Selectively Transmitting Images over a Cellular Phone Network and a Wireless LAN Network to a Destination”
In the Wake of Blackout Protests, FBI Shuts Down Megaupload for Massive Online Copyright Infringement
In the Wake of Blackout Protests, FBI Shuts Down Megaupload for Massive Online Copyright Infringement

January 19, 2012

One day after Internet websites like Wikipedia and Google protested the SOPA and PIPA anti-piracy bills with a “Blackout Day,” the Federal Bureau of Investigation Jan. 19 shut down Megaupload.com and related sites based on a Jan. 5 federal grand jury indictment in one of “the largest criminal copyright cases ever brought by the United States,” the U.S. Department of Justice announced.

Seven individuals and two companies— Megaupload Limited and Vestor Limited—were targeted in an indictment that brings charges for engaging in a racketeering conspiracy, conspiracy to commit copyright infringement, conspiracy to commit money laundering, and two substantive counts of criminal copyright infringement. According to the DOJ press release, the individuals each face a maximum penalty of 20 years in prison on the charge of conspiracy to commit racketeering, five years in prison on the charge of conspiracy to commit copyright infringement, 20 years in prison on the charge of conspiracy to commit money laundering, and five years in prison on each of the substantive charges of criminal copyright infringement.

The individuals charged in the indictment are:
- Kim Dotcom, aka Kim Schmitz, who is founder of Megaupload Limited, the director and sole shareholder of Vestor Limited, and a citizen of both Hong Kong and New Zealand
- Finn Batato, 38, a citizen and resident of Germany;
- Julius Bencko, 35, a citizen and resident of Slovakia;
- Sven Echternach, 39, a citizen and resident of Germany;
- Mathias Ortmann, 40, a citizen of Germany and resident of both Germany and Hong Kong;
- Andrus Nomm, 32, a citizen of Estonia and resident of both Turkey and Estonia; and
- Bram van der Kolk, aka Bramos, 29, a Dutch citizen and resident of both the Netherlands and New Zealand.
“This action is among the largest criminal copyright cases ever brought by the United States and directly targets the misuse of a public content storage and distribution site to commit and facilitate intellectual property crime,” the DOJ press released stated, noting that the alleged scheme has generated more than $175 million in criminal proceeds and caused more than half a billion dollars in harm to copyright owners. It noted that more than 20 search warrants have been executed in the United States and eight other countries, and that more than $50 million in assets have been seized, along with 18 domain names associated with the alleged conspiracy.

This case is being prosecuted in the U.S. District Court for the Eastern District of Virginia and investigated by the FBI at the National Intellectual Property Rights Coordination Center, with assistance from U.S. Immigration and Customs Enforcement’s Homeland Security Investigations and authorities in the United Kingdom, Canada, Germany, Hong Kong, Australia, New Zealand, and the Philippines.

The press release continues as follows:

According to the indictment, for more than five years the conspiracy has operated websites that unlawfully reproduce and distribute infringing copies of copyrighted works, including movies – often before their theatrical release – music, television programs, electronic books, and business and entertainment software on a massive scale. The conspirators’ content hosting site, Megaupload.com, is advertised as having more than one billion visits to the site, more than 150 million registered users, 50 million daily visitors and accounting for four percent of the total traffic on the Internet. The estimated harm caused by the conspiracy’s criminal conduct to copyright holders is well in excess of $500 million. The conspirators allegedly earned more than $175 million in illegal profits through advertising revenue and selling premium memberships.

The indictment states that the conspirators conducted their illegal operation using a business model expressly designed to promote uploading of the most popular copyrighted works for many millions of users to download. The indictment alleges that the site was structured to discourage the vast majority of its users from using Megaupload for long-term or personal storage by automatically deleting content that was not regularly downloaded. The conspirators further allegedly offered a rewards program that would provide users with financial incentives to upload popular content and drive web traffic to the site, often through user-generated websites known as linking sites. The conspirators allegedly paid users whom they specifically knew uploaded infringing content and publicized their links to users throughout the world.

In addition, by actively supporting the use of third-party linking sites to publicize infringing content, the conspirators did not need to publicize such content on the Megaupload site. Instead, the indictment alleges that the conspirators manipulated the perception of content available on their servers by not providing a public search function on the Megaupload site and by not including popular infringing content on the publicly available lists of top content downloaded by its users.

As alleged in the indictment, the conspirators failed to terminate accounts of users with known copyright infringement, selectively complied with their obligations to remove copyrighted materials from their servers and deliberately misrepresented to copyright holders that they had removed infringing content. For example, when notified by a rights holder that a file contained infringing content, the indictment alleges that the conspirators would disable only a single link to the file, deliberately and deceptively leaving the infringing content in place to make it seamlessly available to millions of users to access through any one of the many duplicate links available for that file.

The indictment charges the defendants with conspiring to launder money by paying users through the sites’ uploader reward program and paying companies to host the infringing content.