The U.S. Patent Office has learned of a new technological advance called “rss feed” and has instituted the system for the USPTO Systems Status and Availability site a mere 10 years after Netscape started using it.

On the Electronic Business Center, you can check the web page for the latest information on operating status and availability of Online Business Systems.  However, subscribing to the available feeds will be much easier and more immediate.

For Standard Hours of Availability for Online Business Systems, System Descriptions, and Operating Requirements/Compatibilities, see the links here:

Also, don’t forget the Director’s Forum: David Kappos’ Public Blog.  [No word on David Kappos' Secret Blog] The site, ostensibly by Under Secretary of Commerce for Intellectual Property and Director of the USPTO David Kappos, features fairly frequent updates of the goings-on at the Patent Office.  This blog, while it can’t be completely open, is a good way for the public to dialog on patent issues.

In a post on the Supreme Court’s April 2007 decision in KSR v. Teleflex regarding obviousness, Kappos details how the Office’s first step toward addressing the implications of the KSR decision was to publish examination guidelines – available at http://www.uspto.gov/web/offices/com/sol/notices/72fr57526.pdf – for its personnel to follow when determining obviousness. In accordance with the Supreme Court’s instructions regarding flexibility, the guidelines recognized that an examiner’s approach to obviousness had been broadened beyond the strict teaching-suggestion-motivation test. At the same time, they also stressed that in order to arrive at a proper conclusion of obviousness, examiners still needed to couple sound reasoning with particular findings of fact.

Some have suggested that the Office is determining obviousness in a way that stifles innovation by refusing patents for truly inventive subject matter. Practitioners asked the PTO to provide examples of non-obvious claims in view of KSR to serve as a complement to the examples of obvious claims already in the guidelines.  He indicated that now that a body of case law has been decided in light of the KSR decision, they are able to undertake that task.

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GOClogoJenn_200_200The FDA and Xavier University have co-developed the first annual Global Outsourcing Conference to be held June 13-16, 2010.

GOC 2010, which is billed as “being designed collaboratively by FDA, Innovator Companies, and Contract Organizations to address Global Outsourcing challenges that reside on all sides,” focuses on four key discussions:

  • Global Compliance
  • The “Business” of Quality
  • Supply Chain Control
  • Contract Relationships

Few conferences achieve the level of open dialogue and sharing of ideas amongst participants that the Global Outsourcing Conference will master. An engaging conference is more challenging to host, more difficult to facilitate, but the most rewarding for everyone involved. The topics will be controversial, but the atmosphere will be one of collaboration. We will work together – from all sides of the issues.

Through careful planning and masterful facilitation, you will be engaged with colleagues “from the other side” and will enjoy the interactions that lead to relationships lasting the rest of your careers.

Who Should Attend:

The Conference will benefit companies of all sizes and employees at all levels including:

  • Employees at all levels of the organization – the solutions are not exclusive, and neither is this conference
  • Innovator Company representatives
  • Contract Organization representatives
  • Consultants
  • Government Officials
  • Quality Operations
  • Supply Chain
  • Procurement
  • Regulatory Affairs

Note: Continuing Education Units offered for Industry and Government personnel.  Details here for more information.

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Blawg100The ABA Journal has released third annual Blawg 100 – the best legal blogs as selected by the Journal’s editors.  This year’s list includes 40 blawgs that are new to the list.

In general, I’m uncomfortable in trying to put blogs into any kind of subjective ranking since many are narrowly tailored and have different priorities and audiences.  There’s even the question of what is the definition of a blawg, such as, should the The Am Law Daily by American Lawyer reporters be called a  blawg or a commercial news site?

Even then, it’s quite subjective as what category to place a blawg.  In the Journal’s rankings, just 16 blawgs are in the Practice Specific category.    Paul Caron’s TaxProf Blog is under the Legal Theory and not the Practice Specific category [Disclaimer: Paul lives directly across the street from me.]

Intellectual property law is heavily dominated by tech geeks so there are just flat out a lot of great blogs in the practice area (witness Gene Quinn’s earlier rankings).  Among IP listings, Dennis Crouch at Patently-O and Gene Quinn at IP Watchdog were recognized in the Practice Specific category.

Again this year, you can go vote for your favorite in each of the 10 categories.  They’ll be counting votes from Dec. 1st through Dec. 31st.

Having a short attention span, my personal favorites change weekly, if not daily, depending on my immediate mood and interests.  Blogs I’m currently following closely include:

Of course, I also follow The Secret Diary of Steve Jobs and PhotoshopDisasters so you may not want to take advice from me.

Anyway, the winners of the Blawg 100 will be announced in the February edition of the Journal.

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Final-I-Am-Biotech-Logo-2-color1Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO) is asking those in the biotech industry to support their work and connect you with others across the industry by joining the IAmBiotech community today.

Every day, the men and women in the biotech industry work to solve our most daunting challenges. From the fight against deadly diseases to feeding a growing world population to stopping global warming, you are there on the front lines.

To support your work and connect you with others across the industry, we launched a new website this past year: IAmBiotech.org.

Join the IAmBiotech community today, and you’ll be entered to win free roundtrip airfare and a complimentary registration to the 2010 BIO International Convention in Chicago.

To sign up and enter to win, visit:
http://IAmBiotech.org/join

As part of the biotech industry, you are at the forefront of the innovation economy.

In order to build a better future through biotechnology, we must come together online and offline to collaborate, network and tell our stories. That’s what IAmBiotech is all about.

By signing up, you’ll gain access to some great features including:

  • Insider insights on the direction of the industry from top CEOs and thought leaders;
  • Networking events in your area and the latest tips on how to make connections both online and offline;
  • News and alerts about the legislation and regulatory issues that could impact your business;
  • Social media resources, including advice on how LinkedIn, Twitter and Facebook can help your bottom line;
  • And opportunities to educate the public about how you’re helping to heal, fuel and feed the world.

Sign up today to be entered to win a free registration to the
2010 BIO International Convention:
http://IAmBiotech.org/join

We’re building this movement to support the critical work you do and to help you share that work with the world.

Please join us.
Jim Greenwood
President and CEO
Biotechnology Industry Organization (BIO)

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India and United States have signed two inter-governmental agreements on Intellectual Property Rights (IPR) to help prevent what they say is the misappropriation of traditional knowledge through mistaken issuance of patents, what some call biopiracy.

tumeric‘Biopiracy’ describes a process in which living resources or traditional knowledge and practices are patented, thus applying intellectual property restrictions to their use. The resources in question are predominantly from developing countries, and are the subject of patent applications by companies in developed countries.

The first agreement is the Traditional Knowledge Digital Library (TKDL) Access Agreement signed between the Council of Scientific & Industrial Research (CSIR) and US Patent and Trademark Office (USPTO).  The agreement will enable the USPTO to search the database of India’s traditional knowledge compiled under TKDL.  CSIR will provide training to the USPTO examiners and staff to help them use TKDL tools for search and examination.

This database will be an important addition to the growing array of search tools on traditional knowledge from around the world that is already available to USPTO examiners.  These tools include dictionaries, formularies, handbooks, and historical or classical works, as well as databases such as the TKDL.  USPTO examiners use these tools to help prevent the patenting, and thereby misappropriation, of existing traditional knowledge.   A listing of some of these publicly available traditional knowledge tools can be found on the USPTO’s Web site.

The new database, developed jointly by India’s Council of Scientific & Industrial Research (CSIR) and the Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy (AYUSH), includes over 200,000 traditional medicine formulations on Ayurveda, Unani and Siddha comprising 30 million pages.  The TKDL contains text-searchable English-language translations of these sources, permitting USPTO examiners to search thousands of years of India’s accumulated traditional knowledge.  The TKDL also contains translations into French, German, Japanese and Spanish, from these sources, originally written in Hindi, Sanskrit, Arabic, Persian and Urdu.

Earlier, when the USPTO granted a patent on the wound-healing properties of turmeric, Indian scientists protested and fought to get the patent revoked. And, as we reported earlier, after patent was awarded to the U.S. Department of Agriculture and the multinational company WR Grace & Co. in 1995 for the fungicidal properties of seeds extracted from the neem tree, native to India, the European Parliament’s Green Party, India’s Research Foundation for Science, Technology and Ecology, and the International Federation of Organic Agriculture Movements fought to have it revoked on the grounds of biopiracy.

The basis of the challenge to the patent was that the fungicide qualities of the neem tree and its use had been known in India for over 2,000 years. The neem derivatives have also been used traditionally to make insect repellents, soaps, cosmetics, tooth cleaners and contraceptives. In 1995, WR Grace patented neem-based bio pesticides, including Neemix, for use on food crops. Neemix suppresses insect feeding behavior and growth in more than 200 species of insects. But the EPO agreed that the process for which the patent had been granted had actually been in use in India for many years.

Another Memorandum of Understanding (MoU) was signed between the office of the Controller General of Patents, Designs and Trade Marks, Department of Industrial Policy and India’s Commerce Ministry.  The MoU between patent offices of the two countries would facilitate comprehensive bilateral cooperation on a range of Intellectual Property Right (IPR) issues focusing on capacity building, human resource development and raising public awareness of the importance of IPR.

See the USPTO Press Release here.

Databases used by USPTO are here.

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The Spanish Central Administrative Court of Appeal has confirmed that the holders of innovator medicaments are not entitled to challenge the marketing approvals of generic medicaments issued by the Spanish Agency of Medicaments and Sanitary Products (AEMPS).

The Central Administrative Court of Appeal upheld the Administrative Court’s decision dismissing that Laboratorios Servier SL lacked legal standing to challenge the marketing approval issued by the AEMPS to Laboratorios Cinfa SA for “diosmine” generic medicaments.

Servier argued that the enactment of the new Law 29/2006 of Guarantees and Rational Use of Medicaments and Sanitary Products meant the consequences of the marketing approval of a generic medicament are especially harmful to the holder of the original medicament, unlike what happened with the prior regulation. Specifically, Servier alleged that said marketing approval was susceptible to activate the reference price system (art. 93) and the so-called prescription of active principle (art. 85).

The mere marketing approval of a generic medicament cannot damage any right or legitimate interest of the holder of the innovator medicament, notwithstanding the civil actions based on intellectual property rights which might be brought, if so, upon the effective commercialization of the generic medicament.

The Court of Appeal concluded that the new Law of 2006 did not involve substantial changes in the system for the marketing approval of generic medicaments, or in its consequences to the holders of innovator medicaments. In this regard, it has considered that with the current regulation there are no substantial differences in the reference price system and/or in the prescription of active principle, thus rejecting the allegations of Servier.

The Court explained that within the marketing approval procedure, the Administration limits itself to analyzing the characteristics of the product in question (i.e. security, toxicity, tolerance, effectiveness, quality, pureness, identification and information) to ensure that the particular medicament examined does not involve any risk to consumer health and that it will not be misleading in the therapeutic effects attributed to it. This analysis is undertaken without considering the circumstances which may bring the owner of the generic medicament to its commercialization and the damages that this could cause to the holder of the original medicament.

This means that the mere marketing approval of a generic medicament cannot affect any right or legitimate interest of the owner of the innovator medicament and the owners of original medicaments will have to go through civil proceedings for the protection of intellectual property rights and/or against unfair competition.

Today’s post is by Guest Barista Eduardo Vila, a lawyer in the Barcelona office of Grau & Angulo.

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WADribbon_downloadOn World AIDS Day, 15 organizations — including the Stop Aids Campaign, Médecins Sans Frontières, Unicef and Christian Aid — are calling on nine drug companies to join a patent pool being put together by Unitaid, which aims to improve access to drugs for HIV/Aids and other diseases in poor countries.

The patent pool would allow cheap copies and combinations of Aids drugs to be made without legal restraint or delays from the manufacturers, whose monopolies are protected for 20 years.  A key issues to be resolved is which countries should benefit from medicines made under license from the pool.  While Unitaid wants all developing countries to be included in the pool, some drug companies want to exclude certain countries from the pool.

Andrew Witty, the chief executive of GlaxoSmithKline, said that they have cut the prices of GSK drugs in poor countries to no more than a quarter of the level in the west and promised to reinvest 20% of profits on those drugs in the developing world. They have also launched their own patent pool, with more than 800 compounds and molecules that might be useful to researchers into neglected diseases.

From The Make It Happen Campaign:

Why we need a patent pool

Competition between different companies is the best way to make drugs more affordable. You can make sure competition happens by using the law to limit or overcome the barriers that stand in the way of generic competition; companies can also help build a new way to create drugs at affordable prices: by participating in the patent pool.

We need HIV drugs that will keep patients alive longer: Newer, better antiretrovirals are already used by patients in the US and Europe, but aren’t available to people in developing countries or are simply too expensive. We need these newer drugs, with fewer side effects, to gradually replace older treatments.  Plus, as everyone on long-term treatment will eventually develop resistance to the drugs they are taking, all patients will at some point need to switch treatments, to newer drugs that continue to fight the HIV virus. By making these drugs more affordable, a patent pool will ensure the delivery of these newer drugs for people in the developing world.

We need three-in-one HIV drugs that are easier to take: Treating HIV is complex and often requires patients to take multiple drug cocktails. But by combining the different drugs into one easy-to-take pill, patients are more likely to stick to their treatment.  At the moment, it’s a struggle for generic producers to develop these much needed fixed-dose combinations, because different companies own the patents of the various drugs. By putting these patents under collective management, a patent pool will make it possible for many more combination therapies to be developed.

We need HIV drugs for children: Two million children are living with HIV but less than 10 per cent of them have access to the medicines they need.  All too often, there are no child formulations for drugs, as drug companies don’t have the incentive to develop them when the overwhelming majority of children in need live in developing countries. By putting HIV drug patents in the pool, we remove one of the barriers blocking the development of  child formulated drugs and drug combinations.

Make It Happen!

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In Canada, linkage regulations similar to the Hatch-Waxman Act in the U.S. ensure that generics manufacturers have to address relevant patents listed on the Patent Register (the analog to the Orange Book) if they want to market their product prior to the expiry of listed patents.   Generics manufacturers can do so either by accepting the terms of the patents, or by filing a Notice of Allegation (NOA) alleging, amongst other things, that they will not infringe the patent or that the patent is invalid.

Three recent decisions litigated in this context contain important notes for pharma companies, biotech companies, generics companies and their patent attorneys and agents.

The Patent Act (post-1996) Imposes a Duty of Candour and Good Faith. In Lundbeck Canada Inc. et al  v. Ratiopharm Inc.,  Lundbeck’s patent was invalidated because the patent agents failed to “fully and fairly describe” the prior art in responding to an obviousness rejection raised by the patent examiner.  This decision may take on a broader impact, particularly if it is interpreted to require Canadian applicants to affirmatively inform examiners of aspects of the prior art that are both favorable and unfavorable.

Formulation Patents Must Claim All Medicinal Ingredients.  In Bayer Inc. v. Canada (Minister of Health) et. al., Bayer’s patent was held to be ineligible for listing on the Patent Register, despite reading on the product.  Where the approved product contains a formulation with more than one medicinal ingredient, only patents that claim formulations containing all of the approved medicinal ingredients may be listed on the Patent Register, regardless of whether the product is covered by the patent claims.

Disclaimers Can Be Validly Filed After Receipt of a NOA.  In sanofi-aventis Canada Inc. v. Hospira Healthcare Corporation, sanofi responded to Hospira’s NOA by filing a disclaimer in respect of a portion of one of sanofi’s listed patents.  Hospira argued that the Court should consider the sanofi patent as it read on the date the NOA was served and not as it read after the disclaimer was filed.  Although the court held (in favor of sanofi) that the patent should be read as of the date of the hearing, it also held that sanofi’s particular disclaimer was invalid because the patentee had not unequivocally testified that the disclaimer was a result of claiming too broadly in the patent as issued. Such an admission was necessary to the validity of the disclaimer.  The court also held that having attempted a disclaimer, sanofi could not subsequently assert against Hospira the portions of the patent it had attempted to disclaim.

Thanks to Kavita Ramamoorthy and the whole Life Sciences team.

Today’s post is reposted from The Cross-Border Biotech Blog by Guest Barista Jeremy Grushcow, a corporate lawyer at the Canadian law firm Ogilvy Renault LLP.

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