A student-run resource for reliable reports on the latest law and technology news
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On August 14, 2014, the U.S. Food and Drug Administration (FDA) issued Draft Guidelines on the direct de novo classification process, a means of accelerating the approval of new types of medical devices posing only low to moderate health risks.[1]  The FDA created de novo classification in 1997, but after the process failed to achieve its purpose of expediting approval, the FDA introduced an alternative de novo process called “direct” de novo.

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Insuring Patents

By Yaping Zhang – Edited by Jennifer Chung and Ariel Simms

Despite its increasing availability, patent insurance—providing defensive protection against claims of patent infringement and funding offensive actions against patent infringers—continues to be uncommon. This Note aims to provide an overview of the patent insurance landscape.

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Defend Trade Secrets Act of 2016 Seeks to Establish Federal Cause of Action for Trade Secrets Misappropriation

By Suyoung Jang – Edited by Mila Owen

Following the Senate Judiciary Committee’s approval in January of the Defend Trade Secrets Act of 2016, the Committee has released Senate Report 114-220 supporting the bill. The bill seeks to protect trade secret owners by creating a federal cause of action for trade secret misappropriation.

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Federal Circuit Flash Digest

By Evan Tallmadge – Edited by Olga Slobodyanyuk

The Linked Inheritability Between Two Regions of DNA is an Unpatentable Law of Nature

HP Setback in Challenging the Validity of MPHJ’s Distributed Virtual Copying Patent

CardPool Fails to Escape an Invalidity Judgment But Can Still Pursue Amended Claims

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Amicus Brief by EFF and ACLU Urging Illinois State Sex Offender Laws Declared Unconstitutional under First Amendment

By Yaping Zhang – Edited by Mila Owen

With the Illinois Supreme Court gearing up to determine the constitutionality of the state’s sex offender registration statute, two advocacy non-profits have filed amicus briefs in support of striking the law down.

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3293465641_b6c5081e87_qBy Danielle Kehl – Edited by Olga Slobodyanyuk

Maximillian Schrems v. Data Protection Commissioner, C‐362/14
(Court of Justice of the European Union Oct. 2015)

In what some are calling a victory against NSA surveillance, the Court of Justice of the European Union (“CJEU”) invalidated a key part of the current transatlantic “Safe Harbor” agreement between the United States and the European Union earlier this month. The case began in 2013 when privacy activist Maximillian Schrems filed a complaint against Facebook with the Irish Data Protection Commissioner, alleging based on evidence disclosed by then-NSA contractor Edward Snowden that American companies were not adequately protecting Europeans’ data from government snooping. Although Schrems’ complaint was initially rejected by the Irish data authority, the High Court of Ireland eventually referred the case to the top court in the European Union, which handed down the unexpected decision on October 6, 2015.

The CJEU held in Schrems v. Data Protection Commissioner that the privacy principles adopted under U.S.-E.U. Safe Harbor agreement violate the 1995 European Data Protection Directive, which provides a level of baseline protections to safeguard the privacy of all European citizens’ data. Since 2000, the Safe Harbor arrangement has allowed American companies to process the personal data of European citizens by self-certifying to the U.S. Department of Commerce that they adhered to certain guidelines and principles, including notice, choice, access, security, data integrity, and enforcement. Over 4,000 American technology companies rely on the Safe Harbor framework to operate in Europe without violating the continent’s privacy laws. Without it, those companies may not be able to send data from their European users back to the United States, a prohibition that could be incredibly costly.

Privacy advocates like the Electronic Frontier Foundation and New America’s Open Technology Institute have characterized the decision as a clear signal that further reform of the National Security Agency’s surveillance programs is needed. NSA whisteblower Edward Snowden even told Schrems he had “changed the world for the better” via Twitter. But many have also expressed concern about the economic ramifications that American technology companies will experience unless and until the United States successfully negotiates a new Safe Harbor agreement with the E.U. As U.S. Secretary of Commerce Penny Pritzker noted in a press release following the ruling, the decision “creates significant uncertainty for both U.S. and E.U. companies and consumers, and puts at risk the thriving transatlantic digital economy.” Just Security provides a nuanced overview of the ruling and its implications.

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Fed. Cir. Flash Digest

By Mila Owen – Edited by Olga Slobodyanyuk

Senate CISA Debates End

The Senate voted Thursday to end debate on a package of amendments to the Cybersecurity Information Sharing Act (CISA). CISA allows businesses to share private consumer data with the federal government in exchange for information on security vulnerabilities and immunity from associated lawsuits. Because CISA covers all consumer data shared with U.S. companies regardless of origin, CISA would allow foreigners to be prosecuted and jailed for crimes outside of the United States. The bill is due to come up for vote the week of 10/26. The bill faces broad opposition from the technology industry and privacy advocates.

The FDA CDRH released its Regulatory Science Priorities for 2016

The FDA Center for Devices and Radiological Health (CDRH) has released its Regulatory Science Priorities for 2016, aimed at improving safety and effectiveness of medical devices. Priorities include harnessing big data for scientific advancement, improving device cyber security and performance. CDRH aims to inform strategic funding for regulators and external stakeholders.

Germany requires all Internet companies to make metadata available to its law enforcement agencies

The German parliament has passed a controversial law requiring telecoms and Internet companies to share metadata with law enforcement agencies, allowing agencies to access data without a warrant for citizens who are suspects of “severe crimes”. This bill revises a 2010 attempt to introduce such measures in Germany. It contains a short data retention period, a localization requirement, and strict security protections for the metadata German law enforcement would obtain. Once the bill is signed by President Gauk, it may still face opposition from the Court of Justice of the European Union (CJEU), where it must meet the requirement of limitation to what is “strictly necessary” laid down as a standard last year in the CJEU invalidation of the EU data retention directive last year.

Posted On Nov - 4 - 2015 Comments Off READ FULL POST

Supreme CourtBy Adi Kamdar – Edited by Travis West

The Supreme Court announced it would take up two parallel patent cases this term: Stryker Corp. v. Zimmer, Inc. and Halo Electronics, Inc. v. Pulse Electronics, Inc. The Court will consider the Federal Circuit’s strict standard for awarding enhanced damages for willful patent infringement — a standard that does not comport with recent high court rulings. This discrepancy has most commentators predicting the Supreme Court will overrule the Federal Circuit, continuing a clear trend that materialized through the Court’s last few terms.

Overruling the Federal Circuit, the appeals court that hears all patent issues, in this consolidated case would be a win for plaintiffs — a marked difference from prior Supreme Court rulings, which have tended to favor defendants. Loosening the Federal Circuit’s standard for willful patent infringement will make it easier for patent owners to secure treble damages, making infringement much more expensive.

And higher damages is exactly what the plaintiffs in these cases want, as Ars Technica reports. Halo Electronics, a small transformer manufacturer, took on the much-larger Pulse Electronics for infringing a patent on a particular component — an “electronic surface-mount package.” Halo won and was awarded $1.5 million, but both the trial court and Federal Circuit threw out its willful infringement claim. Stryker has a very similar case against Zimmer regarding patents covering a medical lavage device used for cleaning wounds and bones. While the plaintiff was awarded $210 million dollars, the Federal Circuit reversed the lower court’s finding of willfulness and lowered the award to $70 million.

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hammerBy Feiran (Felicia) Chen – Edited by Yiran Zhang

Equals Three, LLC. v. Jukin Media, Inc., Case No. 2: 14-cv-09041-SVW-MAN, United States District Court Central District of California, October 13 2015

The rest of the content will be available by clicking this link.

The United States District Court Central District of California granted in part Jukin’s motion for summary judgment to the extent that Jukin asserts Sheep to Balls is not a fair use of Jukin’s videos, and denies Jukin’s motion regarding fair use in all other episodes.

Though at a summary judgment stage, the court almost resolved fair use claims in favor of Equals Three. The court found almost all of Equals Three’s episodes highly transformative as “the jokes, narration, graphics, editing, and other elements that Equals Three adds to Jukin’s videos add something new to Jukin’s videos with a different purpose or character”. The only exception lies when the Sheep to Balls video was used as “news footage without adding transformative to what made the footage valuable”. The court also found speculative employees’ testimony insufficient evidence for market harm despite possibility of substitution. Based on a weighing of the four factors, the court held that the factors weighed in favor of Equals Three’s use within all its videos except the episode titled Sheep to Balls. The court, by ruling this way, noted that commenting on viral videos constituted transformative works, which usually further copyright’s goal to promote the arts and sciences..

Todd Spangler provides an overview of the case. Venkat Balasubramani features a thorough analysis of the decision, especially regarding potential implications this case might have.

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Fed. Cir. Flash DigestBy Colette Ghazarian – Edited by Olga Slobodyanyuk

USPTO Patent Trial and Appeal Board Under No Obligation to Review Evidence Not Originally Presented

The Federal Circuit, in In Re: Thomas Steed, 2014-1458 (Fed. Cir. Oct. 1, 2015), made clear that the United States Patent and Trademark Office’s Patent Trial and Appeal Board “cannot be faulted for not reviewing evidence that was not presented to it or to the [patent] Examiner.” This holding was made in the context of an appeal by Thomas Steed of the rejection of his patent application on the ground of obviousness. During the application process, the patent examiner had rejected Steed’s claims based on a pre-grant publication that anticipated Steed’s invention. Steed appealed to the Board, attempting to “swear back” his invention, whereby Steed would establish that he was in possession of the idea or product before the effective date of the Evans publication. Steed submitted a series of new evidence and documents to the Board on appeal and at the Board hearing. The Board held that the new evidence brought at the hearing should have been presented at the outset of the application process, and therefore should not be considered, and, to the extent any new evidence could be considered by the Board, that information was unintelligible and not self-explanatory. The Court agreed with the Board and held that any proof a patent applicant has of an earlier conception date, should have been presented to the patent examiner in the first instance through a continuation application, and the Board is under no obligation to consider new evidence that was not presented in that manner.

“Substantially Pure” Compound Held Obvious When 50/50 Mixture and Pure Compound Prior Art Exists

In Spectrum Pharmaceuticals, Inc. v. Sandoz, Inc., 2015-1407 (Fed. Cir. Oct. 2, 2015), the Federal Circuit tackled the unusual issue of patent validity, where the patent involves a substantially pure compound, but a 50% mixture and pure compound are both known in the art. Spectrum had developed and patented a pharmaceutical composition of substantially pure levoleucovorin, a compound used to ameliorate the toxic effects of chemotherapy, containing 92% of the active isomer (mixed with another isomer as a carrier). In 2011, Sandoz submitted an Abbreviated New Drug Application (ANDA) for a similar pharmaceutical levoleucovorin product, claiming that it did not infringe on five of Spectrum’s patent claims, and, though stipulating to infringement of two others, argued that Spectrum’s patent was invalid as to those claims. The prior art showed that both a 50/50 mixture of the two isomers and a pure compound were already known. The Court held that, given these existing compounds, Spectrum’s claim that its 92% pure compound was nonobvious, fails. The Court concluded that the available prior art could have enabled one of skill in the art to make and use the substantially pure levoleucovorin compound. The Court of Appeals also affirmed the District Court’s ruling that Sandoz’ product did not infringe on the remaining claims of Spectrum’s patent because the product did not contain enough of the levoleucovorin compound to constitute infringement.

Federal Circuit Expands Patent Enablement Analysis

In In Re: Steve Morsa, 2015-1107 (Fed. Cir. Oct. 19, 2015), the Federal Circuit addressed for the second time the anticipation of claimed inventions by Steve Morsa in a publication entitled Peter Martin Associates Press Release (PMA). The appeal was brought after a finding by the United States Patent and Trademark Office’s Patent Trial and Appeal Board that the anticipating reference (PMA) was enabled. The Board relied on Morsa’s own specification that the system described in his patent “can be implemented by any programmer of ordinary skill” and found that the PMA disclosure combined with what an average-skilled computer programmer would know rendered the reference enabling. The Court, in a 2-1 decision, held that the Board’s enablement analysis was proper. The Court held that the Board did not err in including the patent application specification itself in conducting its enablement analysis. Taking into account the specification, the Court agreed with the Board that it showed an ordinary programmer could implement the invention. This finding, combined with the PMA disclosure would allow an average computer programmer to make the claimed patent herself. Therefore, the Court determined that Morsa’s patents were anticipated. Morsa’s also argued that the Board utilized novel grounds of rejection of his patents, by considering various facts not typically used in enablement analysis. The majority disagreed, contending that the Board’s statements were merely descriptive and not necessary to the Board’s conclusions. Therefore, they were not part of the Board’s enablement analysis.

Posted On Nov - 4 - 2015 Comments Off READ FULL POST
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