Stent Wars: Cordis Corp v. Boston Scientific Corp., Fed. Cir. (2011)

The Stent Wars

The Court of Appeals for the Federal Circuit (“CAFC”) decision in Cordis Corp v. Boston Scientific Corp., 2011 (“Cordis”), is the latest episode in the ongoing Stent Wars, and provides an example of CAFC review of JMOL verdicts and review of the intent prong of inequitable conduct under the new standard in Therasense.

The Stent Wars involve four major players: Abbott Labs, Boston Scientific, Medtronic, and Johnson & Johnson.  These manufacturers have been engaged in bitter patent lawsuits against each other since the mid 1990s. A stent is a small tubular expanding scaffold that is inserted into a blocked artery during balloon angioplasty surgery.  The stent expands with the balloon and then prevents the artery from collapsing after the surgery is complete. However, many question the medical efficacy of stents in relation to their high cost.  The most recent development in the Stent Wars is that J&J’s stent-manufacturing subsidiary, Cordis, announced it will exit the stent market by the end of this year.

Cordis is the latest ruling in a 14 year lawsuit of Cordis Corp. (“Cordis”) against Boston Scientific Corp and Boston Scientific Scimed, Inc (“BSC”).  In Cordis, the CAFC held that, first, the BSC NIR stent did not literally infringe claim 25 of the Cordis ‘370 patent, and, second, that the Cordis U.S. Patent No. 5,879,370 (‘370) was not unenforceable due to inequitable conduct.

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Patent Trolls Under the Patent Reform Act

On September 16th, 2011, President Obama signed the (Leahy-Smith) America Invents Act.  The official White House Press Release and countless blogs describe the Act as “the most significant reform of the Patent Act since 1952.”  One of the stated objectives of the Act is to let American companies and inventors focus on innovation and job creation rather than costly, and sometimes unnecessary, litigation.  The Act attempts to achieve this goal through several changes to the patent system, most notably including a transition from a first-to-invent to a first-to-file patent regime.

There is much debate as to whether the various components of the Act will accomplish this goal.  One way to approach this question is by examining the impact it will have on patent troll behavior.  Some conceive of patent trolling as a “tax on innovation” through the brandishing of invalid patents.  A Boston University study claims patent trolls “have cost innovators $500 billion in lost wealth from 1990 through 2010.”  Many assert that the new Act does nothing to hinder patent troll litigation; however, that remains unclear.  A deeper analysis of this question will also elucidate some of the salient features of the Act.

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In re Google Inc. Street View Electronic Communications Litigation: Radio Communications and Privacy by Convention

N.D. Cal.’s Chief Judge Ware has permitted the Wiretap Act claims against Google to go ahead in the consolidated litigation over the collection of Wi-Fi data by Google’s Street View vehicles. Google attempted to argue that it could not be held liable under the Wiretap Act because the collected data was “readily accessible to the general public.” Judge Ware disagreed in a holding that could have implications for how courts understand privacy and security.

Background

Google maintains a fleet of Street View vehicles used primarily to take photographs of public roads. Google also used these vehicles to collect Wi-Fi data, most likely to map out the locations of Wi-Fi networks for use in triangulating the location of mobile devices. Google claimed it was interested only in the public SSIDs (names) of the Wi-Fi networks, but that in collecting this data, it inadvertently captured sensitive private information such as e-mails and passwords.

Several Wi-Fi network owners subsequently brought suit for violations of the Wiretap Act, as amended by the Electronic Communications Privacy Act (ECPA), and related state law claims. Google moved to dismiss on the ground that ECPA did not protect communications on a Wi-Fi network configured such that communications were “readily accessible to the general public.”

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Therasense, Inc. v. Becton, Dickinson and Co.: A Radical Change in the Legal Standard of Inequitable Conduct

Overview

On May 25, 2011, the Federal Circuit issued its en banc opinion in Therasense, Inc. v. Becton, Dickinson and Co., radically changing the legal landscape of the inequitable conduct doctrine.  In creating these new standards, the Therasense majority aimed to balance the competing goals of encouraging honesty of applicants before the United States Patent & Trademark Office (“PTO”) and setting a logistically appropriate standard for determining whether inequitable conduct occurred. The majority stressed that the “low standards for intent and materiality” set in its previous opinions coupled with the harsh consequences of inequitable conduct have resulted in “unintended consequences.” Specifically, under the old standards, “allegations of inequitable conduct are routinely brought on the slenderest grounds” and “patent prosecutors regularly bury PTO examiners with a deluge of prior art references, most of which have marginal value.” To address these concerns, the majority tightened the requirements for findings of both materiality and intent to deceive.

Changes in Legal Standard

Under the old standard, in order to invalidate a patent, the party alleging inequitable conduct had to show “clear and convincing evidence that the applicant (1) made an affirmative misrepresentation of material fact, failed to disclose material information, or submitted false material information [to the PTO], and (2) intended to deceive the [PTO].” Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359, 1363-64 (Fed. Cir. 2007).

The Therasense majority first tightened the intent requirement by reaffirming previous cases stressing the need for clear and convincing evidence of specific intent to deceive. Thus, proof of negligence and gross negligence is not sufficient, and in cases of nondisclosure, the evidence must show that the “applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it.”  As before, deceptive intent may inferred from indirect and circumstantial evidence. However, the specific intent to deceive must be “the single most reasonable inference able to be drawn from the evidence.” Furthermore, the patentee need not offer a good faith explanation unless the accused infringer first proves a threshold level of intent to deceive by clear and convincing evidence. Continue reading

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Lewton v. Divingnzzo: Hidden Audio Recorder in Teddy Bear Violates Federal Privacy Law

Overview of Lewton

Parents who are concerned about their child’s well being might use hidden electronic monitoring devices such as hidden audio recording devices and nanny cams.  Unfortunately, parents who use these devices may unwittingly violate federal and state law.  In Lewton v. Divingnzzo (PDF), a mother was convicted of violating the Wiretap Act of The Electronic Communications Privacy Act (ECPA) 18 U.S.C. §§ 2510-2522 after she concealed an audio recording device in her daughter’s teddy bear (“Little Bear”) for the purpose of gathering evidence to sabotage the child custody rights of her ex-husband.  Over five months she downloaded the recorded conversations from the audio recording device to her computer, burned CDs of the conversations, and ultimately had transcripts made of the conversations.

Application of the Wiretap Act in Lewton

The Lewton Court held that the mother violated the Wiretap Act of ECPA, §§ 2511(1)(a) and (b) by “intercepting the oral communications of all plaintiffs using the device planted in Little Bear”; and §§ 2511(c) and (d) by “intentionally using and disclosing the plaintiffs’ oral communications in conjunction with the state court Custody Case.”  An “oral communication” under the Wiretap Act is “any oral communication uttered by a person exhibiting an expectation that such communication is not subject to interception under circumstances justifying such expectations…” § 2510(2).  The Court found that the Plaintiffs had a justified expectation that their conversations were not being intercepted.

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Centocor v. Abbott Labs: Enforcing the Written Description Requirement in the Unpredictable Arts

In the recent Centocor Ortho Biotech, Inc. v. Abbott Laboratories (PDF), the Federal Circuit found that Defendant Abbott was not liable for patent infringement, on the basis of written description insufficiency. The Federal Circuit emphasized the patent statute’s requirement that an application must contain not only claims that define the invention, but also a written description that sufficiently discloses and conveys “possession” of the claimed invention.

About Centocor v. Abbott

The patent at issue concerns a human antibody that binds to the protein tumor necrosis factor-alpha (TNF-alpha). Overproduction of TNF-alpha has been implicated in a number of auto-immune diseases, including Alzheimer’s Disease and arthritis. The antibody, which both Centocor and Abbott claim, binds to TNF-alpha in order to regulate overproduction and reduce incidence of such auto-immune diseases. Although Centocor and Abbott have patents that claim a form of the TNF-alpha antibody, the two parties took different approaches and this resulted in antibodies with a similar “constant” region, but different “variable” regions. Centocor started by identifying a mouse form of the antibody and then modified it to create a “chimeric” protein (contains a human constant region and a mouse variable region). In contrast, Abbott pursued a fully human form, containing both a human constant region and a human variable region, from the beginning of its research.

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Sony v. Hotz: Controversies Regarding DMCA, Jurisdiction, Search Warrant and Subpoenas

Factual Background

When Sony released its PlayStation 3 (“PS3″) video game console, it included a feature that allowed customers to install a version of the Linux operating system so that the machine could be used as a general purpose computer.  In April 2010, Sony released a system firmware update that removed the “OtherOS” functionality.  In late 2010, a group of hackers known as fail0verflow, allegedly working to restore the OtherOS feature, succeeded in circumventing critical technical protection measures (“TPMs”) within the console, allowing users with upgraded PS3s to use the OtherOS feature once again.  George Hotz, a rather notorious New Jersey hacker, built on fail0verflow’s work to successfully circumvent the TPMs protecting the PS3′s Master Key, and he posted explanations of his work on Twitter and YouTube in early January 2011.  The Master Key grants access to the PS3′s core functionality, so third parties who obtain it may write firmware and application software that appears to the console to be legitimate. Essentially, the release of the key has compromised the system. Though Sony has made efforts to upgrade with security patches, hackers quickly unpacked the updated firmware and began efforts to crack it completely.

Responding to the jailbreak, Sony has sued Hotz and others involved in the decryption of the keys, alleging violations of the Digital Millennium Copyright Act (“DMCA”) and the Computer Fraud and Abuse Act, contributory copyright infringement under 17 U.S.C. § 501, and various California state common law and contract claims.  Sony requested damages and a preliminary injunction against distribution of the software.  Additionally, Sony sent a DMCA takedown notice to a site hosting source code to tools based on Hotz’s research that could be used to crack the PS3 firmware. There does not appear to be any way for Sony to effectively correct the problem. As Ben Kuchera at Ars Technica explained, “Sony speaks of ‘closing the door,’ but the simple fact is that there is no door to close. The code sought to be restrained will always be a Google search away.” In a demonstration of how easily the key could be spread, a company representative recently posted it to Twitter by mistake.  To reduce user demand for unauthorized firmware, Sony is threatening to ban any users found using “unauthorized or pirated software” from its PlayStation Network online service.

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People v. Xinos: A Privacy Right in Vehicle Data

A California Privacy Right in Vehicle Data

In People v. Xinos, 192 Cal. App. 4th 637 (2011) (PDF), the California Sixth District Court of Appeal ruled on a person’s privacy right in his vehicle’s sensing and diagnostic module (SDM) data. This issue is a matter of first impression in California.  An SDM stores vehicle data such as engine speed, vehicle speed, throttle percentage, braking, vehicle deceleration, airbag deployment, and the status of restraint systems.  These devices are also termed event data recorders (EDRs).  George Xinos hit and killed a pedestrian with his SUV while he was intoxicated and driving at 60 miles per hour.  His SDM module recorded 5 seconds of data preceding his change in speed upon striking the pedestrian.  He was convicted of vehicular manslaughter based in part on his excessive speed, which was determined from an analysis of his vehicle’s SDM data.

The Court of Appeal in Xinos held that the defendant had a reasonable expectation of privacy under the Fourth Amendment in the digital data stored on the SDM in his vehicle.  The Court held that the SDM data was protected by the Fourth Amendment because “a motorist’s subjective and reasonable expectation of privacy with regard to her or his own vehicle encompasses the digital data held in the vehicle’s SDM.”  Furthermore, the Court held that the SDM data from Xinos’s vehicle was not admissible because the police did not have probable cause when they downloaded the SDM data.  Probable cause exists where “the facts and circumstances within [an officer’s] knowledge and of which [he] had reasonably trustworthy information [are] sufficient in themselves to warrant a man of reasonable caution in the belief that an offense has been or is being committed, and that evidence bearing on the offense will be found in the place to be searched.”  Brinegar v. U.S., 338 U.S. 160 (1949).

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Internet “Kill Switch” Legislation: Can Obama Turn Off the Internet?

During the recent revolution in Egypt, the government disabled Internet access throughout the country with the flip of a switch. Could the same thing happen in America? Practically, because the structure of the Internet in the United States is more complex and decentralized than in Egypt, it cannot be shut down as easily. However, several bills have been proposed that could give the government broad power to take over the Internet communications of any public or private entity it deems necessary.

The first bill introducing the concept of Presidential Internet “kill switch” power was S. 773, the Cybersecurity Act of 2009 (later the Cybersecurity Act of 2010). The original version of the bill gave the President the power to “declare a cybersecurity emergency and order the limitation or shutdown of Internet traffic to and from any compromised Federal government or United States critical infrastructure information system or network.” The bill provides examples of “critical infrastructures,” such as private and public entities in the energy, information, telecommunications, emergency services, agriculture, food, water, public health, government, transportation, defense, banking, finance, chemicals and hazardous materials, postal, and shipping sectors. Due to the unpopularity of the kill switch provision, the bill was amended (PDF) to remove the kill switch power and require the President to work with government and private industry to define “cybersecurity emergency” and develop “detailed response and restoration plans.”  The amended bill also stated that it “does not authorize, and shall not be construed to authorize, an expansion of existing Presidential authorities.”

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The Bolt: Now on Facebook and Twitter!

We here at the Bolt appreciate all of our readers who have found us through Google, incoming links, blog directories, and so on.  We’ve always offered an RSS feed so that you can follow our posts with greater convenience, but today we’re announcing two new options for keeping Bolt updates visible in your social news feeds.  We’ve set up accounts on Facebook and Twitter, where we’ll keep you updated about new posts and any other news relevant to this site or the Berkeley Technology Law Journal generally.  Add us, and pass these links along to your friends as well!

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