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EU Pharma Regulatory Law

April 24th, 2012
in Intellectual Property, Legal, Legal Conferences, Legal Conferences, Litigation |

2012 is set to be a critical year for EU pharma regulation with the implementation of the pharmacovigilance rules, proposals to amend the data protection and clinical trials directives and the new falsified medicinal products directive.

In addition, the Mediator case triggered an overhaul of regulation governing the healthcare sector in France and a drive towards increased transparency and the impact of this case is likely to be felt across the EU.

Questions are being raised about anti-corruption efforts and where we are a year on from the introduction of the UK Bribery Act.

There are a number of competition law developments, there are concerns regarding off-label promotion and a number of legal problems are arising as a result of pharma companies developing their social media presence.

The budgetary pressures across Europe and the Eurocrisis are having a critical impact on health authorities across Europe and the scope of SPCs has been clarified.

Don’t miss this outstanding opportunity to learn from and network with those at the forefront of pharma regulatory law in the EU Market. Confirm your participation today and be rewarded with a significant discount.

Hi-Tech Patent Litigation & IP Strategies

March 22nd, 2012
in Intellectual Property, Legal, Legal Conferences, Legal Conferences, Litigation, Telecoms & Technology |

With significant case law developments, numerous infringement actions and injunctive relief being sought across Europe and beyond, Hi-tech patent law continues to evolve rapidly.

Given the highly competitive and lucrative nature of the industry, coupled with an increasing need to get products to market, it is more important than ever that in-house counsel and patent attorneys stay abreast of recent court decisions and how they impact IP strategy on a global level.

In addition to current litigation tactics, hi-tech manufacturers, distributors, networks, software and hardware developers need to ensure they are implementing the most competitive licensing strategies to protect and defend their patent portfolios and maximise revenues when entering or consolidating their place in the market.

The 2012 Hi-Tech Patent Litigation and IP Strategies forum will focus on the latest case law developments on hi-tech patents across Europe and beyond and offer real-time initiatives on how to use these decisions in the licensing strategies you employ.

You will walk away with fresh insights, tactics and tools to strategise your IP licensing and keep up with the latest case-law and its implications on your patent strategy in this highly competitively market including:

  • UK, Dutch, German and French Counsel on developing a cross-border enforcement strategy
  • KPN, Qualcomm, RIM and Industry analysts Wiseharbor on the opportunities and pitfalls of FRAND licensing
  • Ericsson on protecting your patent portfolio from the threat of NPEs
  • Nokia on using litigation as a catalyst to conduct effective cross-licensing negotiations
  • The inventor of the “Italian Torpedo” procedure on successfully navigating patent thickets
  • The European Commission on the practical implementation of a single EU patent
  • WIPO on proven ADR techniques that work
  • Qualcomm on complying with competition law when drafting licensing agreements

For more information, check the link below:

http://www.c5-online.com/files/pdf/marketing/678L12-LON-E.pdf

 

China IP Counsel Forum

January 18th, 2012
in Intellectual Property |

Do Not Miss What has Become the Premier IP Conference in China. No other IP Conference Will Provide as Much Strategic Insights 

Back by popular demand, and with a completely updated 2012 agenda and speaker faculty, ACI’s 3rd Advanced China IP Counsel Forum will once again provide you with a practical analysis of notable China IP law developments and best practices for IP protection and enforcement in China. Here are the new features for the 2012 Forum:

Upgraded Networking and Q&A Discussion

This one of a kind forum has been increasingly attracting the participation of senior IP attorneys from China, Europe and the USA. Chief IP counsel, Head of China IP, Head of R&D in China gathered at this forum every year to discuss emerging IP challenges and latest solutions for multinational companies.

New this year! The exclusive panel on “Meeting of the China IP Minds” will feature senior members of China IP bar. You will have the chance to learn directly from the industry on China’s IP landscape, opportunities and challenges.

More panel discussion and open Q&A sessions are featured in this year’s program. Come prepared with your questions and get the best solution for your company by discussing with real China IP experts.

A Completely Updated Agenda Based on Research with In-House Counsel in China: New Topics for This Year

-    Patent litigation strategies from both plaintiff and defendant perspectives
-    Understanding new Beijing High People’s Court’s Patent Infringement Establishment’s impact on your litigation strategy
-    Obtaining R&D related tax incentives in high and new technology enterprises status, advanced technology service enterprises status and China’s new five-year plan
-    IP Ownership in Government Funding Research Projects
-    Preventing trade secret theft and gathering evidence for maximum claims
-    Successfully convincing Chinese police department to initiative anti-counterfeiting raids
-    Compliance and royalties issues when conducting IP licensing deals in China

ARE PATENT LITIGATION ALERT: FEDERAL CIRCUIT FINDS ANOTHER COMPUTER IMPLEMENTED METHOD TO BE PATENT-ELIGIBLE UNDER SECTION 101

December 19th, 2011
in Expert Guest Blog Entries, Expert Guest Blogs, Intellectual Property, Legal, Litigation, Telecoms & Technology |

Expert Article by Charles R. Macedo and David P. Goldberg

On September 15, 2011, the U.S. Court of Appeals for the Federal Circuit issued another decision on patent eligibility under 35 U.S.C. § 101 in Ultramercial, LLC v. Hulu, LLC, No. 2010-1544, 2011 U.S. App. LEXIS 19048 (Fed. Cir. Sept. 15, 2011).  This decision, authored by Chief Judge Rader, shows the Federal Circuit’s commitment to continue to clarify that in order for claims to be patent-eligible under Section 101, they need only pass through a “coarse eligibility filter.”

The claims at issue in Ultramercial concerned a method for monetizing and distributing copyrighted material over the Internet.  The district court found that the claims at issue were invalid because they did not claim patent-eligible subject matter.  See Ultramercial, LLC v. Hulu, LLC, No. CV-09-06918, 2010 U.S. Dist. LEXIS 93453, at *1 (C.D. Cal. Aug. 13, 2010).  Despite references in the claim to the “internet,” the district court found that the claims were not tied to a “machine” and did not “transform” an article to a different state or thing.   Rather, the district court found that the claims at issue were directed to the “abstract” idea “that one can use advertisement as an exchange or currency.”  Id. at *17.

On appeal, applying the “coarse” filter test set forth in Research Corp. Techs. Inc. v. Microsoft, 627 F.3d 859, 869 (Fed. Cir. 2010), the Federal Circuit reversed the district court finding, and concluded that the claims at issue were patent-eligible subject matter.

Relying upon the Supreme Court’s admonitions in Bilski v. Kappos, 130 S. Ct. 3218, 3227-28 (2010), Ultramercial rejected efforts to limit the Section 101 analysis to the “machine-or-transformation test”:

While machine-or-transformation logic served well as a tool to evaluate the subject matter of Industrial Age processes, that test has far less application to the inventions of the Information Age.  See [Bilski, 130 S. Ct.] at 3227–28 (“[I]n deciding whether previously unforeseen inventions qualify as patentable ‘processes,’ it may not make sense to require courts to confine themselves to asking the questions posed by the machine-or-transformation test. Section 101′s terms suggest that new technologies may call for new inquiries.”).  Technology without anchors in physical structures and mechanical steps simply defy easy classification under the machine-or-transformation categories.  As the Supreme Court suggests, mechanically applying that physical test “risk[s] obscuring the larger object of securing patents for valuable inventions without transgressing the public domain.”  Id. at 3228.

Ultramercial, 2011 U.S. App. LEXIS 19048, at *9-10.

In determining whether the claimed invention, a method for monetizing and distributing copyrighted material over the Internet, was directed to abstract ideas under Section 101, the Court reemphasized that (a) inventions with specific applications or improvements to technologies in the marketplace and (b) inventions that disclose practical applications of ideas are likely to be patentable.  In so doing, Ultramercial reiterated the “manifestly abstract” test set forth inResearch Corp. Technologies:

In sum, § 101 is a “dynamic provision designed to encompass new and unforeseen inventions.”  J.E.M. Ag Supply, Inc. v. Pioneer Hi–Bred Int’l, Inc., 534 U.S. 124, 135, 122 S. Ct. 593, 151 L.Ed.2d 508 (2001).  With this in mind, this court does “not presume to define ‘abstract’ beyond the recognition that this disqualifying characteristic should exhibit itself so manifestly as to override the broad statutory categories of eligible subject matter and the statutory context that directs primary attention on the patentability criteria of the rest of the Patent Act.”  Research Corp. [Techs. v. Microsoft Corp.], 627 F.3d [859,] 868 [(Fed. Cir. 2010)].

Ultramercial, 2011 U.S. App. LEXIS 19048, at *10-11.

Finally, the Federal Circuit distinguished the claims of Ultramercial with its prior precedent inCybersource.  Here, the Court found the claims at hand patent eligible because the claims specified a number of steps “likely to require intricate and complex computer programming” and they necessarily involved interaction with others on “the Internet and [in] a cyber-market environment.”  Ultramercial, 2011 U.S. App. LEXIS 19048, at *14.  Thus, “[u]nlike the claims inCyberSource [Corp. v. Retail Decisions, Inc., No. 2009-1358, 2011 U.S. App. LEXIS 16871 (Fed. Cir. Aug. 16, 2011)], the claims here require, among other things, controlled interaction with a consumer via an Internet website, something far removed from purely mental steps.”  Ultramercial, 2011 U.S. App. LEXIS 19048, at *18.

We will continue to monitor and report on Section 101 cases, and encourage you to review the publications and events page of our firm website (www.arelaw.com) for more information.  Also, please feel free to contact one of our firm’s attorneys to learn more.

Charles R. Macedo

December 19th, 2011
in Expert Guest Blog Entries, Expert Guest Blogs, Intellectual Property, Legal, Litigation |

Biography

Charles R. Macedo advises and litigates in all areas of intellectual property law, including patent, trademark and copyright law, with a special emphasis in complex litigation. He also assists clients in obtaining, maintaining and enforcing patent and trademark portfolios. He has successfully recovered domain names registered to others using clients’ trademarks.

Mr. Macedo is the author of The Corporate Insider’s Guide to U.S. Patent Practice, published by Oxford University Press and is frequently published by the Journal of Intellectual Property Law and Practice, IP Law 360, and other publications. Mr. Macedo has been cited as an authority on intellectual property issues by various news media including the Wall Street Journal, Dow Jones, BNA, Bloomberg, Inside Counsel, Managing Intellectual Property, Technology Transfer Tactics.

Identifying vulnerabilities and considering variations on design concepts, Mr. Macedo can develop patent strategies intended to maximize patent protection and prevent infringement challenges from arising in the future. He has represented clients in intellectual property litigation and other types of matters involving a wide range of subject matter including photomasks, angular rate sensors, methods of taking checks over the telephone, financial service products, internet websites, inventory control systems, cosmetics, nickel metal hydride batteries, wind mills, nuclear waste disposal, green house gasses reclamation, cell phones, fax machines, answering machines, telephone switching equipment, inflatable chairs, money market mutual funds, deposit sweep programs, designer handbags, apparel, cathode ray tube displays, projectors, DRAM, semiconductor chips, to name a few.

In the internet, computer and business related invention arena, even before the State Street case was decided, Mr. Macedo successfully defended the Discover Card division of Morgan, Stanley from charges of patent infringement and obtained a summary judgment of noninfringement. Mr. Macedo also acts as regular intellectual property counsel to Double Rock Corporation and its related entities. Mr. Macedo was principal attorney on amicus submissions in Bilski v. Doll to the U.S. Supreme Court and In re Bilski to the U.S. Court of Appeals to the Federal Circuit. He is frequently consulted on developing effective patent strategies for computer implemented and business related inventions for financial service companies, Software-As-A-Service providers and clients with other internet and computer based inventions.

In the field of trademarks, Mr. Macedo has enforced and defended against trademark assertions involving a wide range of products and services including financial service providers, non-profit organizations, cosmetic companies, luxury retailers of designer handbags, and department store house brands.

He was the sole law clerk to Hon. Daniel M. Friedman of the U.S. Court of Appeals for the Federal Circuit, 1989 – 1990.

He has published papers, and lectures on various topics and has been the recipient of the prestigious AIPLA Robert C. Watson Award.

Mr. Macedo holds bachelors and masters degrees in physics from The Catholic University of America and a law degree from Columbia Law School, both of which he graduated with honors.

Expert Article

 

Contact Charles R. Macedo

Direct: 212 336 8074
Main: 212 336 8000
Fax: 212 336 8001

Email: cmacedo@arelaw.com

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China IP Counsel Forum

November 23rd, 2011
in Intellectual Property |

Do Not Miss What has Become the Premier IP Conference in China. No other IP Conference Will Provide as Much Strategic Insights 

Back by popular demand, and with a completely updated 2012 agenda and speaker faculty, ACI’s 3rd Advanced China IP Counsel Forum will once again provide you with a practical analysis of notable China IP law developments and best practices for IP protection and enforcement in China. Here are the new features for the 2012 Forum:

Upgraded Networking and Q&A Discussion

This one of a kind forum has been increasingly attracting the participation of senior IP attorneys from China, Europe and the USA. Chief IP counsel, Head of China IP, Head of R&D in China gathered at this forum every year to discuss emerging IP challenges and latest solutions for multinational companies.

New this year! The exclusive panel on “Meeting of the China IP Minds” will feature senior members of China IP bar. You will have the chance to learn directly from the industry on China’s IP landscape, opportunities and challenges.

More panel discussion and open Q&A sessions are featured in this year’s program. Come prepared with your questions and get the best solution for your company by discussing with real China IP experts.

A Completely Updated Agenda Based on Research with In-House Counsel in China: New Topics for This Year

-    Patent litigation strategies from both plaintiff and defendant perspectives
-    Understanding new Beijing High People’s Court’s Patent Infringement Establishment’s impact on your litigation strategy
-    Obtaining R&D related tax incentives in high and new technology enterprises status, advanced technology service enterprises status and China’s new five-year plan
-    IP Ownership in Government Funding Research Projects
-    Preventing trade secret theft and gathering evidence for maximum claims
-    Successfully convincing Chinese police department to initiative anti-counterfeiting raids
-    Compliance and royalties issues when conducting IP licensing deals in China

Biotech Patenting

October 8th, 2011
in Intellectual Property |

With the global biotech market expected to reach $275 billion by 2012 and the number of patent applications in Europe hitting record volumes, it is more important than ever that biotech companies stay abreast of key industry developments to strategically file their patent applications. Biotechnology is an ever-expanding, demanding, and lucrative market and it is essential that companies adopt the correct practices and implement the most competitive strategies to protect and optimise the value of their portfolio.

June2011: ACI Blog update

June 17th, 2011
in Advertising & Marketing, Anti-Corruption / FCPA, Employment & Benefits, Expert Guest Blog Entries, Financial Services, Healthcare, Insurance and Reinsurance, Intellectual Property, International Trade & Defense, Legal Conferences, Litigation, Regulatory Compliance and Trade, Surveys and Polls |

[slideshare id=8101315&doc=june2011-13063523326082-phpapp02-110525150028-phpapp02&type=d]

Bratz, Barbies and Birthers – Tales of Caution and Woe

May 2nd, 2011
in Expert Guest Blog Entries, Intellectual Property |

Guest Article by:  Jonathan Dickstein

Now that another jury has recorded its verdict in the epic legal struggle between Mattel and MGA over the alleged theft of trade secrets and copyrights for MGA’s Bratz line of toy dolls, the case seems to have reached its zenith.  With MGA’s stunning victory, its Bratz now appear to be safe and the case appears to be only a half-dozen appeals away from closure. Its legacy, however, may yet linger for a long time to come.

Among the many lessons to be drawn from this case are the limits and pitfalls of employee confidentiality and assignment agreements and the type of information and IP that can and cannot be protected by a company from its competitors.

For companies like Mattel, whose employee leaves the company to work for a competitor, the employee’s confidentiality and assignment invention agreement is an important tool for securing ownership of IP created by such employee before their departure and for preventing such employee from bringing that IP, or disclosing the company’s confidential information, to the competitor.  Often such agreements (if properly drafted) will extend to cover not only IP created by such employee on the job but also any IP that relates to what the employee or company is doing and is created during (or sometimes even for some period after) the period of employment.  Even so, the company must still prove that the IP in question was actually created by the employee at the relevant times and that such IP constitutes protectable IP or information in the first place.

In Mattel’s case, it was ultimately unsuccessful in proving that the Bratz dolls concept and initial drawings were created by the turncoat employee during his employment with Mattel.  The cardinal rule of IP comes to mind – documentation, documentation, documentation.  Wherever possible, a company should have its employees record in some tangible or electronic form what they are working on as contemporaneously as possible.  Furthermore, companies should take the opportunity during reviews and exit interviews to get some sort of brain dump from their employees and record the results.  Such documentation helps establish not only what IP exists but also when it was generated.

The other thing that the Mattels of the world must keep in mind is that there are natural limits to what they can prevent their former employees from doing for competitors.  In the Bratz case, an appeals court found that the general concept of dolls “with an attitude” was, by itself, not a protectable idea.  Mattel could not claim such a concept as its own proprietary IP and therefore could not stop its former employee from using such concept to create the Bratz dolls for MGA.  Companies can legally prevent former employees from using the companies’ confidential information at a competitor (if they can prove it); however, at the same time, companies must be realistic about what their former employees will be doing at their new companies.  Usually, such former employees will perform a similar job and utilize their accumulated store of expertise at their new company.  For even the most conscientious of such employees, it is often difficult if not impossible to distinguish between legitimate skills and experience and illegitimate proprietary information of their former employer.  Courts in California and other jurisdictions are generally protective of employees and their ability to move freely between companies in search of new jobs.  As a result, companies face an uphill battle when seeking to successfully prove a competitor has stolen its proprietary information by hiring a former employee.

From the perspective of companies hiring new employees from a competitor, such as MGA in this case, such companies should always be mindful of the risk of suit from the former employer for misappropriation of trade secrets or infringement of other intellectual property rights.  Such companies should be aware of any pre-existing obligations of their new hires (such as under their former employer’s confidentiality and invention assignment agreements) so they do not conflict with what the employee will be doing for their new companies.  They should confirm that the employee is not longer still working for the prior employer such that the prior employer’s assignment agreement takes precedence over the IP created by the employee for the new employer.  Ideally, the new company will have the employee work on projects that were already in progress at the company, rather than working on new projects that are similar to things such employee worked on at the old company.  In any event, the current outcome of the Bratz case, if it stands up, may provide some comfort to those hiring employees from their competitors.

Next up in the case – Donald Trump has challenged Barbie to produce her birth certificate. . . .

 

Click here to read more articles from Jonathan Dickstein

What’s a Few Trade Secrets Between Collaborators?

April 27th, 2011
in Expert Guest Blog Entries, Intellectual Property, Pharmaceuticals / Biotech / Life Sciences |

Pharmaceutical Agreements

Guest Article by: Jonathan Dickstein

The high profile patent battles periodically flaring up between technology companies are increasingly being overshadowed by the steady rise of trade secret wars, now being waged across a variety of different industries.  The latest chapter in this epic IP struggle has been initiated by Tekmira Pharmaceuticals who filed suit against Alnylam Pharmaceuticals, a leader in RNAi technology, over the alleged misuse of Tekmira’s proprietary Lipid Nano-particle technology used to deliver RNAi therapeutics. Perhaps this should come as no surprise given the increasing need for technology companies to enter into ever more, increasingly complex and intertwined, collaborations and partnerships to get their products successfully developed and commercially launched.  Even the most well-intentioned collaboration partners can face unexpected problems when personnel involved with the collaborative relationship are needed to work on their company’s separate projects or next generation technology in areas related to the collaboration’s subject matter.  Clean rooms and virtual walls designed to prevent allegations of trade secret theft are fine in theory but often difficult to implement or maintain in practice.  Even the most vigilant of companies can find their key employees “tainted” by interactions with the company’s technology partners — and most companies are not that vigilant.

Fortunately, a well-structured and carefully considered collaboration agreement (along with thoughtful negotiations to set the expectations and ground rules between parties) can help mitigate the risks of trade secret misuse claims while still allowing the parties to proceed with vital collaborative work.  All companies in a collaboration have an important interest in protecting their own trade secrets, but doing so without interfering with the important work of the collaboration as well as each company’s independent business efforts outside the collaboration. Finding that balance is not easy but, with patience and attention, the parties can go a long way toward achieving that goal through a carefully negotiated agreement.  In my fifteen-plus years of structuring and negotiating collaboration and joint development agreements, I have seen this issue tackled many times, often successfully.  Although avoiding the issue during negotiations may be tempting, the time and effort is well spent, particularly in light of the increasing trade secret wars.

Tekmira files suit against Alnylam for misuse of trade secrets & confidential information

http://www.pharmabiz.com/NewsDetails.aspx?aid=61967&sid=2

 

Click here to read more articles from Jonathan Dickstein

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