At the recent PharmaBiotechIP summit, a speaker discussed a problem that really struck a cord with the audience – that the language used in FDA regulatory filings can have a serious impact on patent applications. In communications with the FDA, the authors of regulatory documents like to use words such as “conventional”. The term “conventional” helps to assure the FDA that there is nothing unusual for them to worry about. I can see how this makes sense. If something is conventional it is not unique and hence in need of additional scrutiny.

Therein lies the problem for the intellectual property side of the house. We want IP to be unique, innovative, and special. In fact, we want it to be so special that it would not have been obvious to other people reasonably well versed in whatever industry or technology that we are dealing with. For FDA approval to go smoothly, you have to declare that the product is, in many ways, like other products. For the patent filing process to go smoothly, you have to show that the product is, in most ways, unlike any other product. If you are a patent examiner trying hard not to award a patent to something obvious, you might think to look at the regulatory filings related to the same drug that a company is trying to patent. If the company expresses the view that it conventional, you can easily read obvious.

This sounds very much like a Publication Clearance problem. Typically, with a Publication Clearance process, a company tries to insure that nothing contained in a technical or scientific publication will jeopardize intellectual property rights. The Regulatory – IP conflict is very much the same. Companies need to insure that what is written in a published document, in this case an FDA filing, does not inhibit the ability to gain patent protection later. A well thought out Publication Clearance system, modified for the particular workflow of regulatory filings, should help to provide this level of oversight. Like all publications, the document has to go out on time but needs to be reviewed to insure that it is correct in many ways.

So, why continue to risk patent approvals because of the wording of an FDA document? An easy solution exists by way of the same process necessary to release other publications.

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It was interesting to see this interview with Harvard Business School professor Josh Lerner on the subject of Monetizing IP. Particularly topical this week was Professor Lerner's answer to this question about patent pools, posed by Sean Silverthorne:

Q: What is happening in the area of patent pools? Are these becoming more popular and, if so, in which industries?

A: In a patent pool, firms blend their patents with those of other firms. These pools allow users to access a number of firms' patents simultaneously, thereby avoiding the "patent thicket." In many cases, the pooling agreements also specify the pricing schedule in the agreement that establishes the pool, assuring that no party attempts to extract very high fees or to increase its fees after users are locked in.

Patent pools date back as far as the 1850s but have proliferated in recent years. Goods covered by patent pools totaled at least $100 billion in the United States in 2000, while multiple standard-setting bodies today cover virtually every high-technology product. Moreover, the scope of these activities is likely to grow in future years. In many industries, leaders have expressed frustration about the proliferation of patent thickets—the large number of overlapping awards—and the ensuing rise of costly and time-consuming litigation. In many cases, technology sharing has been proposed as a remedy.

And the scope of industries considering adopted patent pools has also grown. While the patent pools have been well established in basic manufacturing and electronic industries for decades, they have been seen as a potential solution for increasingly prevalent patent licensing issues elsewhere, such in new biotechnology-related fields. For instance, a great deal of interest has surrounded proposals to use patent pools to address the multiplicity of rights that are slowing research in critical diseases such as AIDS and breast cancer.

Patent pools are only one way in which firms share their technology with each other. The rapid growth of open source software over the course of this decade has been highlighted in numerous press accounts. The multibillion dollar initial public offerings of Red Hat and VA Linux, IBM's embrace of open source and its investment of billions of dollars into these projects, and the recent (though qualified) embrace of Linux by Microsoft, formerly a bitter opponent: all these events have been extensively documented. What is much less well appreciated, however, is that open source is only the tip of the iceberg of the technology sharing that is reshaping high-technology industries. Patent pools, standard-setting organizations, and technology licensing efforts are having a profound effect on how firms seek to exploit new discoveries.

This Q&A is especially topical this week  when, that very same day the interview was published, it was announced that Alcatel-Lucent, Cisco, Clearwire, Intel Corporation, Samsung Electronics and Sprint have formed the Open Patent Alliance (OPA) to advance a competitive and open intellectual property rights model stimulating a larger WiMAX industry that supports innovation through broader choice and lower equipment and service costs for WiMAX technology, devices and applications globally.

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Whenever I travel in Asia outside of Japan, I get asked the same question “What are you doing there?” The question always comes with one of two follow up statements. It's either “They don't really have any intellectual property of their own. They just make things for the real innovative companies.” or “They just steal everyone else's IP as well as each others.”

Both the question and the statements are pretty ugly and, even worse, ignorant. Two myths should immediately be dispelled about what is happening in Asia. First, there is a lot more going on in Asia than manufacturing. Second, they care very much about IP, and not just their own.

Myth 1: Asia only makes things for other people.
Ignoring for the moment that Asia is a big, diverse, place that simply can't be painted with the same brush, there is wholesale change going on in China, Taiwan, Singapore, and India. It is true that these countries have a vast, low cost manufacturing base. It is also true that they do tremendous business in contract manufacturing and low-cost services. However, it is no longer the case that this is all they do. Just look at companies like HTC, whose smart phone may give the Apple iPhone a run for the money. Another example is Lenovo, a major producer of laptops computers. Check out Huawei, a huge telecommunications equipment manufacturer just now making inroads in North America. All of these companies are in the business of creating their own innovative products. That means innovation and intellectual property.

Myth 2: They steal IP! They don't want to protect my IP or even their own.
Piracy happens throughout the world but that doesn't make everyone a thief. For example, The Pirate Bay, a bit torrent aggregator, known for their disdain of US intellectual property laws, are in Sweden. Yet, no one would accuse the Swedes of being IP thieves. In fact, people in Asia have the same issues, worries, and goals for intellectual property as the rest of the world. It's only that the people in China, Taiwan, and India came into the game a bit later. Many of legal protections, available in the US or EU are also available in Asia. Some are even better than what we have in the US. They are also investing in infrastructure for managing IP. Companies in Asia are keenly aware that they can't misappropriate other people's IP and expect other countries to protect theirs. That is no different than it is in the US or EU. So, no. Businesses in Asia are just as worried about IP and are as much spending time and money to protect it as anyone else in the world.

All in all, Asia is an exciting environment full companies that are creating really interesting products. Though nascent, Asia is on the road to becoming a technology powerhouse just like the US and EU.

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Mike Dillon, General Counsel of Sun Microsystems, has written an interesting blog in which he describes a new approach for a major company that files hundreds of patent applications every year. He says:

...at some point, a company needs to ask how many patents it really needs. And, that's exactly what we did about three years ago. Up to that time Sun was filing well over 1,000 patent applications per year. But, in 2005, we made the decision to reduce our patent filings to the point that we had about 700 patents issued last year. And this number may decline in the future. While this is still a sizable number for most companies, it is a significant decline for Sun and occurs during a period in which we have more innovation than at any point in Sun's history.

Why the change? Part of the reason is financial. On average, it costs more than $20,000 to obtain a U.S. patent and this figure grows significantly when you file around the world. Also, this amount does not include annual annuities required to keep a patent in effect. Being selective in what you patent can result in significant savings. However, the bigger reason for the change is that our focus has shifted from quantity to quality. To this end, we have completely re-architected the manner in which we determine the innovations we will patent. As part of this process, inventions are reviewed by a panel of the chief technology officers from across our different lines of businesses with input from distinguished engineers and other experienced innovators. We apply a significant amount of scrutiny to determine whether something is truly innovative before we submit it to the PTO. For us, it doesn't make sense to patent everything. Rather, our focus is on patents that represent significant technological innovation.

Makes a lot of sense. Companies that file applications for several hundred patents every year have to consider carefully which of many thousands of inventions by their employees are worth making a patent application for, and which innovations should be protected with a different strategy. Managing the intellectual property review process, especially in large companies with experienced innovators in many locations around the world, is critically important and sometimes challenging to control.

In many cases, companies rely on ad hoc, human driven processes for safeguarding ideas and making decisions about them. Subsequently, a lot of innovative ideas lie fallow or are lost. Since human processes are error prone, a lot of mistakes get made. This represents a significant risk for companies today. That's why many of our larger clients are employing the newest technologies from IP.com to help them organize their processes for intellectual property review in a secure environment customized for their special needs.

InnovationQ helps protect intellectual property by securing and authenticating it. Powerful tracking and reporting capabilities enable managers to see every event associated with an intellectual property asset, helping to detect synergies in their organization and guard against misuse.

The InnovationQ workflow engine also allows companies to automate intellectual property processes in an easy to use, yet deliberate fashion that helps to ensure error-free compliance.

If your company manages a lot of intellectual property, you might find interesting the white paper "Best Practices for Successful Innovation Management" that is available to download free here from our website. And if you'd like to talk confidentially about your special requirements, by all means give us a call and let's see if we can help you.

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In a blog post titled Chinese Patent System: Problems and Best Practices on the California Biotech Law Blog, Kristie Prinz points to a recent article by Thomas Babel on IP Frontline, Patents in China - Is There Any Real Protection?

With increased pressure from the West and the World Trade Organization, China has instituted a number of reforms to its patent system. Much like the United States Patent and Trademark Office (“PTO”), China has a centralized intellectual property office, known as the State Intellectual Property Office ("SIPO"), which processes patent applications, grants patents, and enforces patents in China. At first blush, the patent system and SIPO seem to be modern and in tune with the concepts and protections found in Western patent systems. Unfortunately, the actual functioning of the patent system in China is far different from its official representation of performance.

The article goes on to make a comparison with the United States patent process. The author concludes, "No protection is foolproof. However, understanding the limitations and risks involved when producing products or components in China can help a company understand the costs of doing business in China and limit its exposure to the loss of patent rights."

IP.com Inc. is providing technologies to companies and organizations to help secure their inventions and innovations in China, where the company's Executive Vice President,  Asia Pacific, Johnson Kong, is now meeting with clients in Hong Kong. Here on our company blog, Johnson will be discussing the special needs of businesses and companies securing innovation in Asia.

Tom Petrocelli, Senior Vice President for Enterprise Software at IP.com Inc., is also travelling on business in Asia. While he writes on this blog about company business, he's also writing a personal blog Tom's Technology Take, where he reports in this weekend from Hsinchu, Taiwan.

Speaking of language translation, we note this recent announcement:

The State Intellectual Property Office of China (SIPO) has launched a free online machine translation service for patent information searchers. The Chinese-to-English translation engine, launched on 25 April 2008, was developed by SIPO and the China Patent Information Center (CPIC). The service supports Chinese patent documents and utility models and allows English language searching for bibliographic data and abstracts of published Chinese patent documents. The machine-translation engine is now open to the public for testing.

In addition, SIPO's Intellectual Property Publishing House (IPPH) has launched an English version of their "China Intellectual Property Net" (CNIPR) website, which includes a new search tool, "C-Pat Search" and offers the possibility for a machine translation.

In the weeks and months ahead, our clients and friends will be able to read more about the business of IP.com Inc. in Asia, and we'll even be blogging in Chinese languages some of our executives are fluent in -- more fluent in Chinese than in blogging, perhaps, so bear with us while we get this blog up to speed for our readers in Asia.

We urge our readers around the world to give generously to the victims of the recent earthquake disaster. Here's an excellent China Earthquake Donation Guide, recommended by our friends at the China Law Blog.

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The authors of  the outstanding "Patent Docs" blog are patent attorneys who hold doctorates in biotech and chemical disciplines, so it's a good place to keep track of all the upcoming continuing education seminars and conferences of interest to patent professionals in those industries.

IP.com Inc. will be represented at two of those upcoming conferences:

May 28-30, 2008 - PharmaBiotech IP Summit (Worldwide Business Research) - Philadelphia, PA

June 17-20, 2008 - BIO International Convention (Biotechnology Industry Organization) - San Diego, CA

In addition to introducing InnovationQ to many prospective clients like these, hopefully, we'll get a chance during these conferences to meet with outstanding bloggers like  the Patent Docs and get together over coffee with the Patent Baristas. If you're going to be attending one of these upcoming conferences and would like to meet up while we're there, contact us and we'll set something up.

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In her Strategic Thinking column on GreenBiz.com, Nancy Edwards Cronin recommends Growing the Eco-Patent Commons to Truly Promote Green Innovation. While lauding the objectives of this green initiative, she suggests that the Eco-Patent Commons itself is in need of some innovation if it truly hopes to accomplish its goal: sharing useful environmental technologies for "the greater good."

The problem is that the project includes only "patents" and not the undisclosed innovations and trade secrets within the intellectual property of companies and independent inventors that have not yet been patented. Many of those inventions might better be published now to promote the progress of science and the useful arts for a sustainable environment and ecology for the future.

To compensate for these drawbacks and make the Eco-Patent Commons as useful and powerful as it can be, the initiative requires expansion to offer truly recent inventions that have not spent years in the patent application process. This involves widening the scope of the initiative to include non-patented inventions that have yet to be marketed and made public.

One way to make these inventions available is through enabled invention disclosures. An enabled invention disclosure (also called “defensive publication” or “technical bulletin”) is a written description of an invention that ideally has the same degree of detail as an issued patent. Therefore a well-written invention disclosure provides sufficient information to the reader to understand and use the invention.

Many companies successfully use enabled invention disclosures as part of their intellectual property (IP) strategies. Companies frequently have inventions that they do not wish to patent because the patent process is so expensive, including invention development costs, legal preparation and patent prosecution fees. However, companies also wish to prevent competitors from patenting those same inventions.

By using enabled invention disclosures to publish the invention, companies accomplish both goals: they save the cost of patenting but they also establish a “prior art bar” to obtaining the patent and make it impossible for competitors to claim it the invention as their own. Several Web site forums exist for publishing inventions, including www.ip.com and www.researchdisclosure.com.

The Eco-Patent Commons should be expanded to include these enabled invention disclosures. Many inventions that companies deem non-strategic for patent application and instead decide to publish may be excellent candidates to be donated to the Eco-Patent Commons. These published inventions would be truly new, fresh and useful -- a good first step to creating the true springboard for green innovation that the Eco-Patent Commons was meant to be.

We couldn't agree more.

As indicated in our original post about the Eco-Patent Commons, IP.com would really like to contribute to this very worthwhile initiative by providing the publishing platform to broaden the scope of the project to include innovations and inventions useful to the environmental movement well beyond those patents that have been contributed by the project's founding companies, some of which are already using the IP.com Prior Art Database. We've got technologies available that could very quickly take this green initiative to a whole new level of global participation.

Let's discuss.

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Today is World Health Day 2008. The World Health Organization has announced that this year's theme is" protecting health from climate change."

World Health Day, on 7 April, marks the founding of the World Health Organization and is an opportunity to draw worldwide attention to a subject of major importance to global health each year. In 2008, World Health Day focuses on the need to protect health from the adverse effects of climate change.

The theme “protecting health from climate change” puts health at the centre of the global dialogue about climate change. WHO selected this theme in recognition that climate change is posing ever growing threats to global public health security.

Through increased collaboration, the global community will be better prepared to cope with climate-related health challenges worldwide. Examples of such collaborative actions are: strengthening surveillance and control of infectious diseases, ensuring safer use of diminishing water supplies, and coordinating health action in emergencies.

Today, on our blog, we'd like to draw attention to a new invention by Dean Kamen that is a very promising innovation to provide safe drinking water in areas of the world that are experiencing drought as a result of climate change.

One person in six lives without regular access to safe drinking water, and more than twice as many lack access to adequate sanitation, according to the United Nations. Water-related diseases kill a child every eight seconds, and are responsible for 80 percent of all easily preventable illnesses and deaths in the developing world. These alarming statistics have not escaped Dean Kamen's attention.

The entrepreneur and quixotic inventor best known for the heavily hyped (and somewhat disappointing) Segway scooter has been working on what he promises will be a revolutionary new water purifier. Dubbed the Slingshot, Kamen's washing machine-sized device produces 10 gallons of clean water an hour on 500 watts of electricity. It uses heat to distill water—boil it, condense it and recycle the energy. The heat that it uses is captured from a new type of generator that, you guessed it, he's also invented. NEWSWEEK's Brian Braiker spoke with Kamen about his mission to bring light and water to the world's poorest.

Click here to read excerpts of the NEWSWEEK interview.

Dean Kamen's water purifier was recognized as a "runner up" among the Coolest Inventions of 2003 selected by Time Magazine. Dean Kamen, founder of DEKA, has registered a number of patents for this invention and others.

If you'd like to see a video of Dean Kamen's Miracle Water Distiller,code-named Slingshot,  check out this video clip from Kamen's appearance on The Colbert Report.

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Lumenis is purportedly Israel's largest medical device company with more than 1,000 employees worldwide. Apparently, some of its former employees are now with another company, Alma Lasers, "in what has become a highly competitive industry and business environment," according to Lumenis CEO Dov Ofer.

In June 2007, Lumenis filed an action against Alma for patent infringement in the US District Court in Chicago, Illinois claiming that Alma infringed seven of Lumenis' patents in the design of the Harmony product. Lumenis initiated the Chicago litigation by filing suit against Alma Lasers on June 28, 2007.

On January 25, 2008, Alma filed counterclaims and, among other things, asked the Court to declare six of the seven Lumenis patents unenforceable due to inequitable conduct in procuring those patents. Alma alleged that, when applying for those six patents, the applicants breached their duty of candor, good faith and honesty to the PTO and engaged in inequitable conduct by making false representations to the PTO and by failing to disclose material prior art to the PTO. Lumenis denied the allegations.

Meanwhile, in December 2007, Alma submitted 22 prior art references to the PTO for consideration with respect to the seven Lumenis patents. Subsequently, the PTO found a "substantial new question of patentability" with respect to each of the seven patents, and commenced reexamination of them. With respect to one of those patents, the PTO, on February 8, 2008, issued an Office Action rejecting 26 claims of the patent as obvious or anticipated by the prior art. On February 21, 2008, the District Court ordered the litigation stayed pending the PTO's reexamination.

In a press release issued on March 26, 2008, Alma seemed pleased to report that: (1) the U.S. Patent and Trademark Office in Alexandria VA ("PTO") has decided to reexamine all seven of Lumenis's patents that are at issue in the litigation, and (2) the Court has stayed the litigation, pending reexamination of the patents.

Also on March 26, 2008, Lumenis issued its own press release announcing that the company had that very day filed a complaint in the Tel Aviv District Court in Israel against Alma Lasers Ltd. and its four founders, Ziv Karni, Yoav Avni, Nadav Bayer, and Ivgeni Kodritzki, all former employees of Lumenis, claiming misappropriation of Lumenis trade secrets and technology and for the use of such technology in Alma's primary Harmony products, which are sold worldwide. Lumenis has requested relief from the court in the form of an injunction against the use of such core technology by Alma in its products and for monetary damages in the amount of 200 million shekels based on the profits earned by Alma and its founders from the utilization of such Lumenis technology. Lumenis will also be filing a similar action against Alma Inc., the US subsidiary and distribution arm of Alma, in the Federal Court in the US.

This new action alleges that Alma went even further than mere patent infringement -- it alleges outright misappropriation of Lumenis technology that was developed by Lumenis over a long period of time and at Lumenis' great expense.

All of the above is reported verbatim from the press releases issued by the companies separately on March 26, 2008, which we've just pieced together to make some sense of the litigation of which both sides appear to be telling their part of the whole story. Anyway, both companies seem to want to get the news out, and we're happy to write about it here.

We're always looking for interesting patent disputes that turn on evidence of prior art and allegations of misappropriation of trade secrets. We'll keep you posted on this one. If either of the parties want to dispute the facts stated in their respective press releases, by all means feel free to have it out in the comments below. We're pleased to provide a forum for discussion of the patents on the merits.

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Over the years I've written dozens of technical articles, blogs, and marketing literature.  Most of what I wrote was reviewed by marketing, engineering, and perhaps sales. My articles have been examined for their ability to carry the corporate message, technical accuracy, and how the pieces positioned products. No one ever brought up the issue of intellectual property. This is not something unique to my experience. Companies worry about the content and form of publications but not the IP that might be revealed in them. When someone does catch some important IP heading out the door it is often by happenstance. It's not so much that companies don't care.

If you bring up the subject of "IP in publications" most companies will sincerely tell you that they are worried about it. Yet despite that, examining publications for IP is not always part of the normal publication review process. On the flip side are the companies that are paranoid about IP in publications. For many, the knee jerk reaction is "publish nothing!" This doesn't work for long since publications are a major part of corporate communications. Are you going to tell scientists that they can't publish a scientific paper? They won't work for you. Just try and shut up an engineer with a good idea for an article. You'll only infuriate him. Marketing has to publish white papers and sales literature so you can't stop them from producing publications. 

The simple solution is a publication clearance process, implemented as a workflow. The process of Publication Clearance pushes the document in front of everyone who should see it including legal counsel, patent counsel, technical and marketing. Publication clearance within InnovationQ also protects the document as intellectual property. It is subjected to the same LegalSafeguarding process as documents in the Trade Secret Management modules. We can even build hooks into docketing or our Trade Secret Management modules to help better identify IP contained in publications before it is too late.

Adopting a publication clearance process is a good first step toward protecting important intellectual property. Having tools to automate this process makes it much easier to live with.

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