Briefs

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.

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

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 complaint continues by noting that the infringement in this case is willful, and that enhanced damages are therefore warranted under the Copyright Act.

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:

Click here to see the video of President Obama’s comments.

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”

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:

Wikipedia, Google, Wired and Others Protest Anti-Piracy Measures With Site Blackouts

January 18, 2012

While Internet sites such as Wikipedia, Google, and Wired on Jan. 18 protested recent congressional anti-piracy legislation by joining in a “Blackout Day” against measures they denounce as censorship, former U.S. Senator Christopher Dodd, now chairman and CEO of the Motion Picture Association of America (MPAA), rejected the blackout as a mere publicity stunt that draws public attention away from the real issue—combating Internet piracy.

Google’s blacked-out site urges visitors to “Tell Congress: Please don’t censor the web!”

However, in sponsoring H.R. 3261, the "Stop Online Piracy Act" (SOPA), Congressman Lamar Smith (R-Tex.) said in a press release that this legislation targets “a vast virtual market online run by criminals who steal products and profits that rightly belong to American innovators. These foreign rogue websites not only steal movies and music, they offer counterfeit medicine, automobile parts and even baby food, which harm American industries and put American lives at risk.”

Similar legislation in the Senate, S.968, entitled the Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act, or PROTECT IP Act (PIPA), was introduced by Senators Patrick Leahy (D-Vt.), Orrin Hatch (R-Utah), and Chuck Grassley (R-Iowa). In May, this bill was unanimously approved by the Senate Judiciary Committee on a voice vote.

“Copyright infringement and the sale of counterfeit goods can cost American businesses billions of dollars, and result in hundreds of thousands of lost jobs,” said Leahy in a press release. “Protecting intellectual property is not uniquely a Democratic or Republican priority – it is a bipartisan priority.” U.S. Chamber of Commerce president and CEO Thomas J. Donohue issued a press release applauding the senators for their work and stressed that sites “dedicated to trafficking in counterfeit products and digital theft dupe consumers, steal our jobs, and threaten the vibrant Internet marketplace.” According to the U.S. Chamber of Commerce statistics, America’s IP industries account for more than $7.7 trillion of the U.S. GDP, drive 60% of U.S. exports, and employ more than 19 million Americans. “The Constitution protects both property and speech, both online and off,” said Hatch, insisting that the Internet “is not a lawless free-for-all where anything goes.”

But the constitutional arguments raised by certain Web entities claim that these bills go too far in shutting down sites simply because they may contain some infringing content. In an interview with Intellirights, Consumer Electronics Association president and CEO Gary Shapiro shared these concerns, saying that PIPA could be used by the government as a “club” to shutdown websites and chill free speech. However, First Amendment expert Floyd Abrams, in a November letter to Congressmen Smith and John Conyers (D-MI), rejected the notion that the SOPA bill was any threat to freedom of expression on the Internet.

Abrams wrote:

A firestorm over SOPA and PIPA in recent weeks spurred White House officials to issue a statement saying that, “[w]hile we believe that online piracy by foreign websites is a serious problem that requires a serious legislative response, we will not support legislation that reduces freedom of expression, increases cybersecurity risk, or undermines the dynamic, innovative global Internet.” The White House statement was authored by Victoria Espinel, Intellectual Property Enforcement Coordinator at Office of Management and Budget, Aneesh Chopra, the U.S. Chief Technology Officer and Assistant to the President and Associate Director for Technology at the Office of Science and Technology Policy, and Howard Schmidt, Special Assistant to the President and Cybersecurity Coordinator for National Security Staff.

Still, some feel that this organized blackout was a mere publicity stunt by Web companies like Google and Wikipedia. Speaking on behalf of the motion picture industry, MPAA’s Dodd issued a statement calling the blackout a “gimmick, albeit a dangerous one, designed to punish elected and administration officials who are working diligently to protect American jobs from foreign criminals.”

Dodd argued:

The blackout ends Jan. 18, but the debate in this battle over Internet power and influence will no doubt rage onward.