Author: National Law Forum

A group of in-house attorneys developed the National Law Review on-line edition to create an easy to use resource to capture legal trends and news as they first start to emerge. We were looking for a better way to organize, vet and easily retrieve all the updates that were being sent to us on a daily basis.In the process, we’ve become one of the highest volume business law websites in the U.S. Today, the National Law Review’s seasoned editors screen and classify breaking news and analysis authored by recognized legal professionals and our own journalists. There is no log in to access the database and new articles are added hourly. The National Law Review revolutionized legal publication in 1888 and this cutting-edge tradition continues today.

“Imitation Two-Year Provisional” Option Extended Through 2012

The National Law Reviewrecently published an article by Jeffrey S. Whittle, Ryan B. McBeth, James E. Bradley, and Michael R. Samardzija, Ph.D. of Bracewell & Giuliani LLP regarding Provisional Patents:

As technology developers make New Year’s resolutions regarding patent filings for 2012, the “Imitation Two-Year Provisional Patent Application” may be a tool worthy of consideration. The U.S. Patent Office (“Patent Office”) has extended, until the end of 2012, what it calls the “Extended Missing Parts Pilot Program.”¹ In essence, this program attempts to imitate what a true two-year provisional application would provide, but it sidesteps international priority risks and patent term issues and necessitates a few extra steps to achieve the “imitation.” Another caveat is that applicants must still file a non-provisional patent application and must still file internationally, if that protection is so desired, both within 12 months of filing a provisional application. The good news under this program, and what makes the program worthy of consideration, is that applicants now have an additional 12 months after filing the non-provisional from which to file any “missing parts,” including perhaps the most beneficial portion of the program—postponement of payment of search, examination, and any excess claims fees. For many entities, the postponement of these fees could be significant.

Traditional Provisional and Missing Parts Practice

Under traditional practice, the filing of a provisional patent application serves as a priority date place holder for an invention while inventors and practitioners have an opportunity to work out finer details of language for the claims. Important to this end is that in order to assert benefits to the priority filing date, a provisional application does not require a single claim, an oath or declaration, formally compliant drawings, or search and examination fees. As such it is also not subject to examination. After filing a provisional application, the more formal non-provisional patent application must be filed within 12 months to take advantage of the provisional application’s earlier priority date.

When filing a non-provisional application under traditional practice, if either a proper oath/declaration by an inventor, sufficient government filing fees, or compliant formal drawings are missing from the application, the Patent Office issues a Notice to File Missing Parts. An Applicant then has to respond to the Notice to File Missing Parts which, in effect, allows an update to a filed non-provisional application to append the “missing parts” not originally included. The Applicant has two months to respond and the option to respond later by paying time increasing, one-month extension fees for up to five months after the initial two month period.² The accumulation of progressively more expensive extension fees limits the use of traditional missing parts practice.

Achieving the “Imitation Two-Year Provisional”

Under the “Extended Missing Parts Pilot Program,” the traditional fee extendable two months turns into a non-extendable 12 months with a requirement to pay a rather minimal surcharge for the late submission of fees.³ Other requirements to file a non-provisional under the “Extended Missing Parts Pilot Program” include: (i) Applicant must submit a formal request⁴ with its non-provisional application to participate in the pilot program; (ii) the application must be an original non-provisional filed before December 31, 2012; (iii) the application must directly claim the benefit of the prior provisional application;⁵ and (iv) Applicant must not have filed a non-publication request. The non-provisional application must also contain at least one claim, at least one drawing, and be ready for publication. By allowing an Applicant to submit a non-provisional application in this manner, while still preserving the beneficial priority filing date of the provisional application, the “Extended Missing Parts Pilot Program” is effectively extending the useful life of a provisional patent application to two years from the filing date, thereby achieving the Patent Office desire of an “Imitation Two-Year Provisional Application.”

The time extension and fee deferral aspects of this program can be utilized from a business standpoint to postpone strategic decisions regarding the further pursuit of an application. For example, an entity may file a number of provisional patent applications in a specific technology space and later change strategic direction or select only one of the areas within the specific technology space to pursue. Under this program an Applicant may defer the search and examination fees, which total almost $900 and are typically due upon filing a non-provisional.⁶ This translates to a deferral of almost 70% of the fees for up to an additional 12 months. For large entities with large patent portfolios, these savings could be quite significant.

Risks and Limitations Associated with Using the “Imitation Two-Year Provisional”

Patent developers should be aware that entities utilizing the “Imitation Two-Year Provisional” may suffer diminishing patent term adjustments. Under this program, when the non-provisional application is filed, the Patent Office will still send a “Missing Parts Notice” to the Applicant. After three months of no response, any additional time taken by the Applicant may be subtracted from any patent term adjustment the Applicant may be eligible for at the end of the application process. Applicants should also keep in mind that the 18-month publication period will still be in effect from the earliest date to which priority benefit is sought,⁷ and this new program does nothing to defer international filing costs or requirements. For a filing outside the U.S. that claims priority to a U.S. provisional application, the Applicant has only 12 months from which to file a foreign or PCT application.⁸ For these reasons, patent developers interested in foreign filings should be aware of these risks and limitations of the “Imitation Two-Year Provisional Program.”

Summary

By providing more time for technology developing entities to make strategic decisions on which patent applications to pursue, and by keeping money in the entities pockets all the while, the “Imitation Two-Year Provisional Application” should provide reason to celebrate for many patent applicants as the New Year begins. Pending further evaluation by the Patent Office this temporary program may see permanent adoption. Should it be made permanent, the “Imitation Two-Year Provisional Application” also strategically could be significant as the Patent Office moves to a modified first-to-file system on March 16, 2013, shortly after this extended option period expires.⁹ For now though, this tool is available for use at least until the end of 2012.

_________________

¹ Extension of the Extended Missing Parts Pilot Program, 76 Fed. Reg. 78,246 (Dec. 16, 2011), available here.
² 37 CFR § 1.136.
³ 37 CFR § 1.16(f).
⁴ See PTO/SB/421, available here.
⁵ See, e.g., 35 U.S.C. § 119(e); 37 CFR § 1.78.
⁶ See USPTO Fee Schedule, available here. (Search and examination fees are deferrable under this program. Minimum fees due at filing: filing $380, search $620, examination $250. Note that small entities pay one-half this amount.)
⁷ 35 U.S.C. § 122(b)(1)(A).
⁸ See, e.g., Paris Convention for the Protection of Industrial Property art. 4, as last revised at the Stockholm Revision Conference, July 14, 1967, 21 U.S.T. 1583, 828 U.N.T.S. 303 (under the Paris Convention, adopted by 174 countries worldwide, a twelve-month priority period is mandated); Patent Cooperation Treaty art. 8, 28 UST 7645; TIAS 8733 (under the PCT the same period is mandated as that provided by the Paris Convention).
⁹ Leahy Smith America Invents Act, Public Law 112-29, Sec. 3, 125 Stat. 284 (2011).

7th Drug & Medical Device Litigation Forum, 7-8 Mar 2012, Philadelphia

The National Law Review is pleased to inform you of the 7th Drug & Medical Device Litigation Forum: Implementing Appropriate Litigation Readiness and Costs Management Policies That Ensure An Effective Defense at Trial

Event Date: 7-8 Mar 2012

Location: Philadelphia, PA, United States

Key conference topics

Mitigate and maintain costs associated with litigation

Gain judical insight on drug and medical litigation and its recent developments

Build better relationships with outside counsel in order to reduce the miscommunciation factor

Understand the limitations of marketing and advertising as it relates to emerging social media issues

Learn the latest on medical device product liability

Conference focus

Pharmaceutical and medical device manufacturers have faced a growing array of legal challenges this year. With the increase of mass tort litigation, as it relates to product liability, pharmaceutical and medical device manufacturers must be prepared to defend the increasingly sophisticated, well-funded and multi-jurisdictional product liability campaigns against their companies.

The 7^th Drug and Medical Device Litigation Conference will be a two-day, industry focused event specific to those within Drug & Medical Device Litigation, Product Liability and Regulatory Affairs in the Medical Device, Biotech and Pharmaceutical industries.

By attending this event, industry leaders will share best practices, strategies and tools on incorporating litigation readiness, utilizing cost efficient litigation strategies and accurately managing policies to ensure an effective defense at trial.

Attending This Event Will Enable You to:
1. Review the current landscape of drug and medical device litigation
2. Learn strategies in settlements and mass tort issues
3. Manage litigation expenses in order to effectively manage costs
4. Review recent case rulings, including the Mensing and Levine cases
5. Take a view from the bench: explore drug and medical device litigation
from a judicial point of view
6. Tackle product liability issues and challenges
7. Uncover the risks for drug and medical device companies when leveraging social media for marketing and advertising campaigns

With a one-track focus, the 7^th Drug and Medical Device Litigation Conference is a highly intensive, content-driven event that includes case studies, presentations and panel discussions over two full days.

This is not a trade show; our Drug and Medical Device Litigation conference series is targeted at a focused group of senior level leaders to maintain an intimate atmosphere for the delegates and speakers. Since we are not a vendor driven conference, the higher level focus allows delegates to network with their industry peers.

Testimonials:

“Great selection & breadth of speakers. Uniformly high quality of presentations. Intimate nature of meeting provided excellent opportunities for networking” – Abbott

“Great venue to learn and exchange best practices. More importantly how to leverage lesions learned from others.” – Baxter

“One of the best meetings I’ve attended. Excellent organization, topics and speakers. Overall extremely well done.” – Sanofi Aventis

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Final health IT innovators win funding for cancer treatment apps

Recently posted in the National Law R eview an article by U.S. Department of Health & Human Services regarding Cancer Treatment Apps Funding for Health IT Innovators:

Innovative winners of an HHS public data and cancer challenge have created health IT applications that use public data

Ask Dory! – submitted by Chintan Patel, Ph.D.; Sharib Khan, M.D., M.A., M.P.H.; and Aamir Hussain of Applied Informatics LLC – helps patients find information about clinical trials for cancer and other diseases, integrating data from www.ClinicalTrials.gov and making use of an entropy-based, decision-tree algorithm. A functional demonstration of the application is available at http://Dory.trialx.com .and existing technology to help patients and health care professionals prevent, detect, diagnose and treat cancer. The two winners presented their submissions during a special symposium today at the Hawaii International Conference on Systems Sciences and were each awarded $20,000 by the Office for the National Coordinator for Health Information Technology (ONC). The two winning applications include:

My Cancer Genome – submitted by Mia Levy, Ph.D., M.D., of the Vanderbilt University Medical Center – provides therapeutic options based on the individual patient’s tumor gene mutations, making use of the NCI’s physician data query clinical trial registry data set and information on genes being evaluated in therapeutic clinical trials. The app is in operation at www.MyCancerGenome.org .

Information on the four semifinalist teams can be found at http://go.USA.gov/5DA.

With the support of the National Cancer Institute, part of the National Institutes of Health, ONC launched the “Using Public Data for Cancer Prevention and Control: From Innovation to Impact” challenge this summer in support of ONC’s Investing in Innovation (i2) program. The i2 program utilizes prizes and challenges to facilitate innovation and obtain solutions to intractable health IT problems. Aligned with the Obama administration’s innovation agenda, i2 is the first federal program to operate under the authority of the America COMPETES Reauthorization Act.

“What makes these health IT challenges so powerful is their ability to catalyze the expertise and creativity of innovators both in and out of health care,” said Wil Yu, ONC’s special assistant for innovations. “We seek breakthrough solutions to nuanced issues; some are ready for the marketplace and some are prototypes, but all will have a great potential to benefit Americans. Ask Dory and My Cancer Genome are examples of results that innovation challenges can incentivize and deliver – we’re really excited to see their impact.”

For additional details on the “Using Public Data for Cancer Prevention and Control” challenge, visitwww.Health2Challenge.org/using-public-data-for-cancer-prevention-and-control-from-innovation-to-impact-2 .

For additional information about ONC or on the Investing in Innovation (i2) program, visit http://HealthIT.gov.

The 15th Annual ABA National Institute on the Gaming Law Minefield Feb 24-25 LasVegas

The 2011 Gaming Law Minefield program is specifically designed to provide in-depth coverage and discussion of the cutting-edge legal, regulatory, and ethical issues confronting both commercial and Native American gaming. Attorneys, compliance officers, Native American leaders, regulators, and legislators will all provide invaluable insights into current trends, opportunities and obstacles in the gaming industry. The program’s subject matter includes new gaming technology, increased IRS CTR and SAR compliance audit activity, Internet gaming, Native American gaming, breaking hot topics in the gaming industry, latest developments in dealing with problem gamblers, and a two-hour CLE-certified ethics program.

The Gaming Law Minefield program constitutes one of the most comprehensive, state-of-the-law gaming programs available. Program attendees have consistently rated the program as a valuable educational experience that provides participants with the opportunity to meet and talk with a wide variety of gaming law experts and leading state and Native American regulators.

Early Bird Registration ends January 24th. For More Information: Click Here:

Four Commonly Asked Questions About Patient Medical Information: VIDEO

Published in the National Law Review recently an article by Kimberly Leonard of the Center for Public Integrity regarding the 4 Most Commonly Asked Questions About Patient Medical Information:

The Center for Public integrity interviewed Harley Geiger, policy counsel for the Center for Democracy & Technology (CDT), about why patients should request a copy of their health records from their doctor.

The questions are based off a guide CDT issued on its website. It discusses the rights patients have to their health information and how they can correct errors that might appear in their record. It also details how they can protect their medical information.

Court of Appeal Reminds Litigants That Settling With Named Plaintiff Does Not Necessarily End Putative Class Action

An article recently published in the National Law Review by Neil A.F. Popović and Lai L. Yip of Sheppard Mullin Richter & Hampton LLP regarding Putative Damages and Class-Action Lawsuits:

If a defendant in a putative class action settles with the class representative prior to class certification, does the defendant nonetheless have to respond to pre-settlement discovery requests to identify absent class members? According to the California Court of Appeal in Pirjada v. Superior Court, 2011 WL 6144930, Case No. B234813 (Cal. App. Dec. 12, 2011), the answer is no, although the appellate court left open the possibility that the trial court could require some form of notice to protect the interests of absent class members.

Plaintiff Seeks Discovery Identifying Putative Class Members

Putative class representative Obaidul Pirjada (“Pirjada”) brought a purported class action on behalf of all security guards who had been employed in California by defendant Pacific National Security, Inc. (“Pacific National”) during the preceding four years, alleging violations of the California Labor Code and the California Business and Professions Code. Pirjada propounded discovery requesting, among other things, the names and addresses of all putative class members. Pacific National did not object or respond to the discovery requests.

Plaintiff, Without Counsel Involvement, Settles Directly With Defendant

Without the involvement of his attorneys, Pirjada settled directly with Pacific National after negotiating with its CEO. Then, by letter to his counsel, Pirjada requested that his claims be dismissed with prejudice, and enclosed the settlement agreement along with payment for legal services.

Plaintiff’s Counsel Files Motion for Order Providing Notice to Putative Class Members; Defendant Files Motion to Dismiss

Instead of dismissing the lawsuit, however, Pirjada’s counsel filed a motion seeking to provide notice to absent members of the proposed class that substitution of a suitable class representative was necessary. Pacific National filed a motion to dismiss based on the parties’ settlement, which Pirjada joined.

Superior Court Denies Both Motions

The superior court denied Pacific National’s motion to dismiss, noting that a plaintiff’s individual settlement does not vitiate plaintiff’s or his counsel’s fiduciary obligations to the putative class members. The court granted sixty days leave to amend to add a new plaintiff as class representative. The court denied counsel’s motion for notice, finding it unnecessary because unlike in CashCall, Inc. v. Superior Court, 159 Cal. App. 4th 273 (2008), and Best Buy Stores, L.P. v. Superior Court, 137 Cal. App. 4th 772 (2006), members of the putative class of security guards know whether they were injured and thus can determine without notice whether to assert claims against Pacific National. The court specifically noted, however, that regardless of notice, plaintiff’s counsel was authorized to communicate with potential class members.

Plaintiff’s Counsel Moves to Compel Discovery to Identify New Class Representative, Which Superior Court Denies

Plaintiff’s counsel then moved to compel responses to the previously propounded requests for information identifying putative class members, arguing that Pacific National had waived its objections by failing to respond; that Pirjada could not provide contact information for other putative class members because he worked at only one Pacific National location and was the only guard assigned there; and that Pirjada contacted counsel only after his employment at Pacific National had ended. The superior court denied the motion to compel, stating that Pirjada had settled his claims and that his discovery requests were therefore moot. The court reiterated, however, that counsel were free to communicate with class members, even if it they were not entitled to discovery.

Court of Appeal Denies Petition, Deciding Superior Court Did Not Abuse Discretion

Plaintiff’s counsel filed a petition for writ of mandate challenging the superior court’s denial of the motion to compel, as well as the denial of the motion to provide notice.

The Court of Appeal concluded that the superior court acted within its broad discretion in denying the motion to compel, and choosing instead to protect absent class members by allowing counsel leave to amend the complaint after using informal means to identify potential replacement class representatives.

With respect to notice, the Court stated:

[P]recertification discovery may be allowed in appropriate circumstances to identify a substitute class representative in place of one who is not able to serve in that capacity, as well as to assist the lead plaintiff in learning the names of other individuals who might assist in prosecuting the action. But the obligation to notify absent class members before dismissing the case rests with the superior court, not the lead plaintiff or class counsel. The nature and extent of that notice must be decided by the court itself.

Pirjada, 2011 WL 6144930. at *14. The Court noted that under California Rule of Court 3.770, no notice to absent class members is required at all “if the court finds that the dismissal will not prejudice them.” Id. Moreover, because the superior court issued an order to show cause regarding dismissal, counsel will have the opportunity at that hearing to demonstrate that some form of notice is required to avoid prejudice to absent class members.

Lessons for Class Action Defendants

The somewhat unique circumstances in Pirjada highlight the importance of making sure to tie up procedural loose ends, such as outstanding discovery, when a defendant settles with the named plaintiff(s) prior to class certification. More broadly, the case serves as a reminder that named plaintiffs and their counsel have an ongoing fiduciary duty to potential class members, and courts must take reasonable steps to protect those interests, including through potential discovery and notice procedures.

Under Parris v. Superior Court, 109 Cal. App. 4th 285 (2003), and its progeny, “‘trial courts must apply a balancing test and weigh the actual or potential abuse of the class action procedure against the potential benefits that might be gained'” by allowing precertification discovery to identify a substitute class representative.Pirjada, 2011 WL 6144930, at *5 (quoting Starbucks Corp. v. Superior Court, 194 Cal. App. 4th 820, 825 (2011)). Addressing that standard remains a key consideration for defendants who seek to avoid ongoing class action litigation when they settle with a named plaintiff.

Inside Counsel presents the 12th Annual Super Conference in Chicago

National Law Review is pleased to bring you information about the upcoming 12th Annual Super Conference sponsored by Inside Counsel .

Reasons why you should Attend This Year’s Event:

Meet with Decision Makers: You’ll meet face-to-face with senior-level in-house counsel
Networking Opportunities: SuperConference offers several networking opportunities, including a cocktail reception, refreshment breaks, and a networking lunch.
Gain Industry Knowledge: You will hear the latest issues facing the industry today with your complimentary full-conference passes.

Who Should Attend – General Counsel and Other Senior Legal Executives from Top Companies Attend SuperConference:

Chief Legal Officers
General Counsel
Corporate Counsel
Associate General Counsel
CEOs
Senior Counsel
Corporate Compliance Officers

The 12th Annual IC SuperConference will be held at the NEW Radisson Blu Chicago.
Radisson Blu Aqua Hotel

221 N. Columbus Drive

Chicago, IL 60601

Recent NLRB Memo Identifies “Hot Topic” Cases for 2012

Recently an article appeared in the National Law Review by Peter T. Tschanz of Barnes & Thornburg LLP regarding Hot Topic cases:

The NLRB recently circulated a memorandum asking all Regional Directors, Officers-in-Charge and Residential Officers to begin tracking what the Agency has defined as “Hot Topic” Cases. The categories include:

– Cessation of Dues Check-Off;

– Information Requests for Financial Records;

– Post Arbitration Deferral;

– Social Media; and

– Use of Employer e-Mail.

The memorandum provides insight into the types of issues likely to grab the NLRB’s attention in 2012. The memorandum can be accessed here.

Author: National Law Forum