Your friends at the National Law Review wish their readers a happy, safe, and healthy 2016!
- Jennifer, Lane, Nicole, Eilene, Colleen and Marlene
Top Patent Law Stories In 2015
There was a lot of IP action in 2015 – much involving the Fed. Cir. and Supreme Court’s resolution of cases in progress in 2014. In no particular order, I pick:
1. Ariosa v Sequenom. This Fed. Cir. decision that a method for isolating “cffDNA” from maternal blood is no more than a natural phenomenon was a big step backwards for the development of patent law in the area of “precision medicine” and clouds the future patent-eligibility of both natural products and methods of diagnosis and treatment. It is a pick to click with the Supreme Court. (There was also a PTO “July 2015 Update” of the December 2014 s. 101 Guidelines that really did not clarify anything.)
2. Biosimilars Hit the Shelves. In April, the FDA finalized its biosimilars guidance and Sandoz soon launched the first biosimilar, a generic version of Neuprogen.
3. Nautilus v Biosig. The Supreme Court redefined the “indefiniteness standard” of s. 112(2) so that a claim term must be reasonably certain to the POSA, not simply amenable to construction. In Dow v. Nova, this new standard compelled invalidation of the claims-in-suit.
4. The Rise of the PTAB. While it seems clear that the Fed. Cir. does not want to review every decision made by the PTAB in IPR, it released important decisions relating to its authority. In re Cuozzo, the court preserved the application of the PTO’s broadest reasonable claim construction rule in IPRs. In Merck v. Gnossis, the court affirmed that it would review PTAB decisions under the deferential “substantial evidence” standard, and not review PTAB decisions for proper application of the preponderance of the evidence standard.
5. Obviousness Post-KSR. With the Supreme Court’s rejection of the teaching-suggestion-motivation by the art requirement, the Fed. Cir. has been developing the legal standards around obviousness questions derived from decisions that the Supreme Court left intact. These include a greater reliance on evaluating whether or not the art “teaches away” from the claimed invention, and evidence tending to show that hindsight was employed by the lower court or the Board. Closer evaluations of secondary considerations such as commercial success, failure of others, long-felt need, etc. are appearing in recent decisions. For example, see Judge Newman’s dissent in Merck v. Gnossis, Appeal no. 2014-1779 (Fed. Cir. 2015); see also Shire v. Anneal.
6. Teva v. Sandoz Reverses Cybor. Fed. Cir. can still review questions of law de novo, but must give deference to the lower court’s findings of fact.
7. Kimbel v. Marvel. In this “Spiderman” decision, the S. Ct. upheld the viability of Brulotte v. Thys: “No royalties for you” patentee/licensee, after the patents have expired. Impact: not huge, since patentees have been designing work-arounds for years.
8. The Gradual but Steady Demise of Invalidations Based on Inequitable Conduct. Even though the decisions on appeals post-Therasense affirmed findings of IC about half the time, there were no important decisions involving IC in 2015. Either it is being pled less or being dismissed earlier in the proceedings. The Fed. Cir. earlier had upheld the invalidation of an Apotex patent, and Apotex has petitioned for cert., calling the Therasense decision just one more rigid Fed. Cir. rule, but I don’t think the Supreme Court will bite.
9. The Gaggle of Decisions on Divided Infringement. This includes Akami v. Limelight (direct infringement can involve multiple actors if one “mastermind” controls their actions), Commil v. Cisco (belief in invalidity does not negate intent to induce infringement), Life Techs. Corp. v. Promega (self-active inducement under 271(f)(1)) and others that never quite captured my interest.
10. The Trans-Pacific Partnership. According to Republicans, one more thing that President Obama got wrong.
So Happy New Year to All! 2016 Promises to be equally interesting – as in the old Chinese curse – “May You Live in Interesting Times.”
© 2015 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.
Year End 2015 Update – gTLD Sunrise Periods Now Open
New generic top-level domains (gTLDs, the group of letters after the “dot” in a domain name) have launched their “Sunrise” registration periods. As of the date of this newsletter, Sunrise periods are open for the following new gTLDs:
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.OFFICE |
.feedback |
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.family |
.auto |
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.cars |
.car |
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.lasalle |
.cloud |
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.wine |
.vin |
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.theatre |
.SECURITY |
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.PROTECTION |
.xn--tckwe (.コム – Japanese for “com”) |
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.YACHTS |
.BOATS |
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.HOTELES |
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ICANN maintains an up-to-date list of all open Sunrise periods here. This list also provides the closing date of the Sunrise period. We will endeavor to provide information regarding new gTLD launches via this monthly newsletter, but please refer to the list on ICANN’s website for the most up-to-date information, as the list of approved/launched domains can change daily.
Because new gTLD options will be coming on the market over the next year, brand owners should review the list of new gTLDs to identify those that are of interest.
© 2015 Sterne Kessler
Extension of 2015 Affordable Care Act Reporting Deadlines
On December 28, 2015, the Internal Revenue Service issued Notice 2016-4 extending the deadline for information reporting requirements under the Patient Protection and Affordable Care Act (the “ACA”). The reporting requirements are intended to assist the IRS in application of ACA penalties and were two-fold: an initial disclosure to the employee and a final report to the IRS. These requirements were to be satisfied by the filing of Form 1095 (with different filings under Form 1095-B or 1095-C dependent on the type of insurance arrangement sponsored by the employer). The deadline for furnishing the form to the employee had been set for February 1, 2016. The deadline for filing Form 1095 with the IRS was to be February 29 for non-electronic filers and March 31 for all employers who are “electronic filers” (filing greater than 250 single 1095 forms).
Notice 2016-4 has now extended those deadlines as follows:
New deadline for furnishing Form 1095 to employees: March 31, 2016.
New deadline for filing Form 1095 with the Service:
Non-electronic filers: May 31, 2016.
Electronic filers: June 30, 2016.
© 2015 Dinsmore & Shohl LLP. All rights reserved.
Center for Devices and Radiological Health (CDRH) Schedules January 2016 Cybersecurity Workshop
Center for Devices and Radiological Health, CDRH has scheduled a cybersecurity workshop entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” on January 20-21, 2016 (see here for the Federal Register announcement).
Background and Workshop Context
As we discussed in a previous post, cybersecurity vulnerability is an increasing concern as medical devices are becoming more connected to the Internet, hospital networks, and other medical devices. Cybersecurity vulnerabilities may result in device malfunction, interruption of healthcare services including treatment interventions, inappropriate access to patient information, and breached electronic health record data integrity.
In the Federal Register announcement for the workshop, FDA states protecting the Healthcare and Public Health (HPH) critical infrastructure from attack by strengthening cybersecurity is a “high priority” of the Federal Government. For example, two recent Executive Orders (here and here) address enhancing cybersecurity infrastructure and increasing cybersecurity information sharing. Additionally, Presidential Policy Directive 21 states that the Federal Government shall work with the private sector to manage risk and strengthen the security and resilience of critical infrastructure against cyber threats.
Given this context, FDA, other governmental agencies, and public/private partnerships have sought to address cybersecurity vulnerability in recent years. For example, last year, CDRH finalized its guidance for industry entitled, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Also in 2014, the National Institute of Standards and Technology (NIST) published a voluntary, risk-based framework focusing on enhanced cybersecurity. According to FDA, the HPH sector has utilized the framework to help manage and limit cybersecurity risks.
Workshop Objectives
At the public workshop, CDRH hopes to address vulnerability management throughout the medical device total product lifecycle. According to the Federal Register announcement, vulnerability management includes: analyzing how a vulnerability may affect device functionality, evaluating the vulnerability effect across product types, and selecting temporary solutions that may be employed until a permanent fix can be implemented. Vulnerabilities can be identified by the device manufacturer or external entities, including healthcare facilities, researchers, and other sectors of critical infrastructure.
The Agency believes an important component of vulnerability management is coordinated vulnerability disclosure (also known as responsible disclosure). Under coordinated vulnerability disclosure, all stakeholders agree to delay publicizing vulnerability details for a certain period of time, while the affected manufacturer works to rectify the vulnerability.
Further, CDRH states that one of the tools medical device manufacturers or healthcare facilities may use to evaluate and manage vulnerability is the Common Vulnerability Scoring System (CVSS). CVSS is a risk assessment tool that “provides an open and standardized method for rating information technology vulnerabilities.” CDRH notes, however, that CVSS does not directly incorporate patient risk and public health impact factors.
Workshop Themes
CDRH states that it hopes to address the following general themes during the workshop:
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Envisioning a roadmap for coordinated vulnerability disclosure and vulnerability management as part of the broader effect to create a trusted environment for information sharing.
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Sharing FDA’s current thinking on the implementation of the NIST framework in the medical device total product lifecycle.
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Adapting cybersecurity and/or risk assessment tools such as CVSS for the medical device operational environment.
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Adapting and/or implementing existing cybersecurity standards for medical devices.
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Understanding the challenges that manufacturers face as they increase collaboration with external third parties (cybersecurity researchers, Information Sharing and Analysis Organizations (ISAOs), and end users), to resolve cybersecurity vulnerabilities that impact their devices.
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Gaining situational awareness of the current activities of the HPH sector to enhance medical device cybersecurity.
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Identifying cybersecurity gaps and challenges that persist in the medical device ecosystem and begin crafting action plans to address them.
Persons interested in attending the workshop must register online by January 13, 2016. Public comments concerning the workshop’s objectives or general themes can be submitted online or by mail.
© 2015 Covington & Burling LLP
FAA and OSHA Enter into Agreement to Strengthen Enforcement of AIR21 Whistleblower Protection Law
Four New Year’s Resolutions to Avoid the Damaging Loss of Trade Secrets
On December 21, 2015, an Illinois jury awarded Miller UK Ltd. $73.6 million against Caterpillar Inc. Miller supplied couplers for Caterpillar’s equipment, and the jury concluded that Caterpillar used its leverage as Miller’s largest customer to demand access to information that Caterpillar then used to manufacturer its own version of the coupler. As a result of the alleged theft, Miller claimed it had to terminate roughly seventy-five percent of its workforce, close an office, and scale back a new business venture. This lawsuit was not between an employer and an employee, but it holds important lessons for employers that operate in industries and environments with valuable trade secrets.
1. Audit Non-Disclosure Agreements
Trade secrets laws across the country provide a layer of protection for misappropriated trade secrets. Non-disclosure and confidentiality agreements can often provide additional protection, by catching disclosures that would not be covered by trade secrets laws.
In the New Year, audit company records to confirm that any company or person who has access to the company’s trade secrets and proprietary information has signed a non-disclosure or confidentiality agreement. If any of these parties did not sign an agreement during the contracting process, get an agreement in place immediately.
2. Review Materials
In the New Year, review the company’s handbooks, policies, offer letters, and employment agreements to ensure that they prohibit theft and misappropriation of trade secrets and proprietary information from third parties (and not just the company).
Not only will this hopefully prevent employees from engaging in misconduct for which the company could be held liable (i.e. engaging in misappropriation), it could help the company avoid being held liable for any misconduct that does occur.
3. Audit Restrictive Covenants
To the extent that your company has trade secrets and proprietary information that can be protected through restrictive covenants under applicable law, in the New Year, audit the company’s agreements with employees to ensure that all employees who have access to that information have signed the required restrictive covenants. If an employee has not signed an agreement, identify what legal consideration will be required to obtain enforceable restrictive covenants. For those employees who have signed restrictive covenants, confirm that the company has signed (if required) and that the company records consist of both the employee’s signature and the body of the agreement that the employee signed. Finally, review the company’s form restrictive covenants to ensure that they have kept up with the growth and development of the company (i.e. that they protect all of the company’s trade secrets and proprietary information) and with the latest developments in the law.
4. Resolve
In the New Year, resolve to follow the three steps above at least once per year. As the verdict demonstrates, an ounce of prevention is worth a pound of cure. Following a regular maintenance schedule is the best way for a company to minimize the risks associated with trade secrets and proprietary information.
Hillshire Brands Company Pays $4 Million to Settle Race Discrimination Suit
African American Bakery Workers Subjected to Racist Comments and Graffiti in the Worksite, Federal Agency Charged
DALLAS – Hillshire Brands Company (formerly known as the Sara Lee Corporation) will pay $4 million to a group of 74 African-American former employees and provide other significant relief to settle a lawsuit where they were subjected to a racially hostile work environment at a former Sara Lee facility in Paris, Texas, the agency announced today.
EEOC claimed African-American employees were subjected to racist graffiti on the walls of the bathrooms and locker room. The former bakery employees also alleged that during work hours, they were berated with racial slurs by supervisors and other white co-workers, and complaints by the plant workers went unaddressed by management.
Race discrimination in the workplace, including race harassment, violates Title VII of the Civil Rights Act of 1964. The EEOC filed suit (Case No. 2:15-cv-1347) in U.S. District Court for the Eastern District of Texas, Marshall Division, after first attempting to reach a pre-litigation settlement through its conciliation process.
“The Commission completed an extensive investigation at the Sara Lee plant, which included conducting interviews with the former bakery workers,” said Meaghan L. Shepard, trial attorney for the Dallas District of EEOC. “EEOC determined racial slurs and graffiti continued at the facility in Paris for years, until the doors finally closed in November 2011.”
“EEOC strongly believes it is critically important for companies to set policies and provide effective avenues for complaints to address racial harassment in the workplace,” said EEOC Supervisory Trial Attorney Suzanne Anderson. “African-American workers on the Sara Lee bakery production lines in Paris felt embarrassed and intimidated by the graffiti in the bathroom and the racial slurs on the production floor. Strong corporate policies and quick remedial action protects against this type of workplace discrimination.”
The two-year consent decree settling the case provides for an injunction where Hillshire Brands will implement various preventative approaches regarding discrimination or harassment against any employee on the basis of race and will periodically report incidents or investigations to EEOC. Hillshire Brands also agreed to engage in remedial measures such as anti-discrimination training and implementation of procedures to prevent and promptly address graffiti issues.
Belinda McCallister, acting director of EEOC’s Dallas District Office, said, “We are pleased with the approach taken by the employer to acknowledge the hostile environment that once existed and for taking positive steps toward ensuring a healthy workplace in the future.”
EEOC enforces federal laws prohibiting employment discrimination. Further information about EEOC is available on its web site at www.eeoc.gov.
See original news release here: http://www1.eeoc.gov/eeoc/newsroom/release/12-22-15.cfm
© Copyright U.S. Equal Employment Opportunity Commission
Happy Holidays from the National Law Review
This holiday season, we at the National Law Review find ourselves grateful to our clients, publishers, and readers. Thanks for reading and we hope you have a happy holiday season!
- Jennifer, Lane, Nicole, Eilene, Karolina, Colleen & Marlene
