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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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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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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It seems like every other day we hear about another company losing important data. Just recently (Thursday, January 17, 2008), Iron Mountain announced that they lost a tape with personal information on over 650,000 people on it. Please don't think I'm picking on Iron Mountain. This type of data loss happen regularly. What we hear about in the news are the situations where financial or private information is lost. What we don't hear about is lost or misplaced intellectual property. Companies keep this quiet since it is an embarrassing internal matter that they don't have to broadcast.

Yet IP data loss happens all the time. Flash drives and flash memory provide high capacity storage at a cheap price. Portable USB hard drives of up to 500GB are now available for very little money. This is big enough to house large corporate databases and as easy to lose as a cell phone. Which brings us to personal digital devices like cell phones and music players. These have substantial amounts of storage which often contain more than just someone's tunes or pictures of their cat.

All of this mobile storage creates an enormous IP problem. Most people don't realize that practically anything can be intellectual property. The end result is that almost everyone is, at some point, walking around with large amounts of intellectual property in an easy-to-lose form. Mobile storage also makes it very easy for folks to go over to the dark side and take intellectual property. It's now all too simple to copy large amounts of information and very hard to track when it happens.

The good news is that the only one who gets hurt if you lose your intellectual property is you (and your shareholders). If someone loses 150,000 Social Security numbers then there are 150,000 people at risk outside your company. The bad news is that you lose big. A simple "flash drive accident" may hand your competitor your most trusted secrets, jeopardizing new products, revenue, and reputation.

As bad as the bad is, it can be mitigated. First, make sure that you have copies of everything that might contain intellectual property in a secure location. This way, if you have to prove prior art, you can do so. If you need to prove that the information was taken(misappropriated), rather than accidentally lost,  you can do that too. Second, continuously monitor the landscape to see if anything is leaking. Many folks only survey the intellectual property space when they are applying for a patent. While there are a dozen reasons to do this, finding where your intellectual property is turning up is one of them. Finally, review important information for intellectual property on a regular basis. Not everything is important but you won't know that until you review it. This way everyone will have a better appreciation of what needs to be locked down and can't ever be copied to mobile storage or devices.

This is where IP.com can help. Our InnovationQ, Prior Art Database, and Patent Search Services can, when taken together, help secure your intellectual property, assist in making decisions about what is or is not IP,  and provide you the business intelligence you need when surveying the IP landscape.

Otherwise you might wake up one day and find your that your IP has sprouted legs and walked off.

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"This is not a tool. This is a toy. THIS is a tool!" - Julia Childs, on rolling pins.

Email has had a major impact on business. It's all but eliminated the need to send letters and memos on paper. The ability to have quick, on-line conversations has made e-mail (and it's kin, instant messaging and texting) the model for modern communications. For teams trying to produce something creative, however, it falls short. The issue with e-mail is that it is totally free form, both in terms of information and user action. With e-mail, you can't produce predictable results. You don't know how the information will be organized or even what information you might get. While the ability to write anything has its strengths, e-mail systems usually need to be coupled with databases and other structured information systems to be useful for managing innovation. The unstructured nature of e-mail also makes tracking difficult. From an IP perspective, this means no inherent way to protect prior art.

The failure of email to support innovative processes and protect IP is part of the reason that IP.com has developed collaboration features in InnovationQ. The Consultation feature available in the InnovationQ workflow engine is a form of structured collaboration. Rather than take interactions offline to e-mail, we have introduced a method of interacting  that mimics the freeform nature of e-mail. At the same time, users can tap into the the structure of a workflow and the structured documents attached to the workflow.

This is only the first step. The next version of InnovationQ will have a new Collaborative Innovation module that provides for group interactions within a structured environment. While maintaining the free flow of ideas, InnovationQ will allow those ideas to be tracked and preserved as IP. Just as important, it will encourage users to drive toward a goal rather than flail about in e-mail.

E-mail is great. Without it, most of us couldn't function. It has its limitations though, especially in the innovation process. We need to recognize these limitations and use tools better suited to our purpose. InnovationQ is about innovation. It's the tool to use when you want to accomplish something creative and protect it at the same time.

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In the wake of all the corporate misdeeds of the early 2000’s, a lot of corporate attention is now focused on data retention policies. New eDiscovery guidelines for Electronically Stored Information (ESI), Sarbanes-Oxley requirements, and HIPPA have companies of all sizes scrambling to put in place rules that govern how long data is kept around.

Data retention policies define how long data must be stored. The philosophy is that data should be deleted in its entirety as soon as it is no longer needed for either a business or regulatory purpose. Let’s be honest, “data retention” really means “data destruction”. The real goal of these policies is to avoid future legal problems by getting rid of data on a schedule . Companies want to do this as soon as they are no longer legally responsible for the data.

Given that data lifecycles vary a lot, most retention policies are based on classes of data. Classes group like types of data together. You can then assign each class its own retention policy. Each policy must account for a number of factors, especially the lifespan of data. One class of data (for example check images) may have a retention policy of years. For another, it might only be weeks. My shopping list has a lifespan of only about two hours.

Intellectual property, as a class, has a very long lifespan. At any point in time, there may be a need to produce prior art. This is true long after a copyright, patent, or trademark is no longer in force. For trade secrets, the lifespan of the data may be the lifespan of the business. A great example of long-lived intellectual property is the formula for Coke. It has been kept a trade secret for over 100 years.

Unfortunately, practically all corporate information can contain important intellectual property. That PowerPoint presentation used for internal sales training might contain your new secret sauce. How about that ancient product design? Absolutely. It’s full of prior art, some of which might still be found in your current products. Even the agenda for last week’s engineering meeting might contain valuable information that, in the future, may help provide the central idea for a new product line. None of this can be thrown away automatically.

This presents an obvious disconnect between many data retention policies and intellectual property needs. To resolve this situation it's important to keep at least one copy of anything that might have intellectual property in it. It is also important to have a process in place to review potential intellectual property.  No matter how you do it, wholesale deletion of data without review will inevitably result in the destruction of valuable intellectual property.

At the end of the day, it’s important to remember that nearly infinite lifespan of intellectual property means nearly infinite retention. Otherwise, you may not be able to back up a claim or  will inadvertently reveal a trade secret.  You might also find yourself without that great idea that has suddenly become really important.

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Integrating with Existing Software Systems

Seldom can a single software system satisfy the needs of an entire business. Integrating best of breed solutions into existing systems is a requirement of any innovation management system. A good innovation management system processes documents in a wide variety of common formats (such as PDF, Word, Excel, and PowerPoint) and accommodates documents or files in any format. Innovation management requires that the system adapt to the environment, not vice versa.

Additionally, an innovation management system should integrate seamlessly with existing infrastructure, such as leading SQL databases (like MySQL, Oracle, or DB2), mail servers (such as Notes, Exchange, or sendmail), and centralized directory management (such as Active Directory or other LDAP system).

Integrated Prior Art Searching

Although thorough prior art searching should be done by search professionals, innovators and managers often require quick access to limited prior art searching. Providing this means providing access to prior art from innovators' desktops, without the need for advanced search skills.

An ideal innovation management system will provide rapid access to both internal and worldwide prior art by using a document as a search query. This would eliminate the need to have any search skills and instantly empower innovators and managers alike to see the technology and IP landscape related to their own innovation.

Integrated Defensive Publishing

The most efficient means of preventing competitors from obtaining patents is defensive publishing. Unlike patents, that require filing in all relevant countries throughout the world, one defensive publication can prevent or defeat patents worldwide. Many of the most innovative companies in the world have integrated defensive publishing capabilities directly into their innovation management systems. This reduces publishing barriers once a decision has been made to place innovation defensively into the public domain.

Since the ideal innovation management system is already capturing innovation records, and making them rapidly available for decision, an integrated defensive publishing capability can be little more than a link.

This is the eighth in a series of articles on this blog about Best Practices For Successful Innovation Management. For more in this series, see:

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To enhance the use of its innovation, a company should not only consider implementing an innovation system, but also implementing certain work procedures and processes that encourage the creation, recognition, and protection of innovation. Sometimes such work processes are enabled or improved by codifying them in a system. Sometimes the system to implement such processes or procedures, along with assisting with compliance, is the innovation management system itself.

Innovation management can embody workflow rules, such as a document approval chain. Many organizations recognize that good practice requires one or more sign-offs before an innovation document may be utilized or released for any purpose. Decisions should be made to patent, publish, release, or hold secret innovation using a well-defined process. An example process might be a review chain where:

1. An engineer submits a document to …
2. A manager, who then may approve or reject it (possibly after seeking third party opinion) for review by …
3. An innovation committee, who then approves or reject it for handling by …
4. The CPC's office, who then approves or rejects it for publication or holding as …
5. A journal article, conference paper, public presentation, patent application, defensive publication, or internal trade secret …

An innovation management system needs to embody the flexibility to express a variety of workflow rules and actions that are appropriate to the procedures, standards, and culture of individual companies. Such workflow rules can incorporate facilities like email notifications of events, automated reminders, process status and aging reports, and rapidly accessible views to encourage use and compliance.

This is the seventh in a series of articles on this blog about Best Practices For Successful Innovation Management. For more in this series, see:

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If an innovation management system captures not only the innovation records but also information about the engineers, automated innovation reports can be generated for executives, managers, and in-house counsel enabling them to sort, slice, and dice information in many different ways. For example, company leaders can drill into all innovation activities of each employee on a daily, weekly, monthly, quarterly, or annual basis. They can quickly analyze document uploads, downloads, previews, searches, etc. With embedded concept clustering tools, leaders can rapidly view activity by product/project to balance resource allocation with business goals.

R&D Executives

One of many challenges facing R&D managers is monitoring the day-to-day innovation activity of their employees. This challenge is exacerbated when their employees are spread out across states or countries. These managers typically do not have the advantage enjoyed by sales managers who can virtually walk in the footsteps of their reps simply by reviewing weekly sales activity reports. At a glance, a sales manager can determine number of calls, sales meetings, contracts sent out, contracts closed, and all the important detail associated with each of those activities. Typically, R&D managers cannot.

With innovation reporting, R&D managers can essentially walk in the footsteps of their employees and have significantly more knowledge about their innovation activities.

Chief Patent Counsel (CPC)

An important function of CPC is to provide guidance to the business units as to patenting and other IP matters. Under ideal conditions, CPC or in-house patent counsel will perform invention “scans.” This typically involves face-to-face meetings with engineers to discuss innovation activity. From these meetings, the CPC can proactively assist the business units in IP decision making. The challenge most CPCs face is that they are so busy responding to the needs of many business leaders or business units, they do not have time to be “proactive” and are often reduced to a more reactive role. It’s all about time, and there is only so much of it each day. A CPC must be highly efficient to get far enough ahead of innovation to add strategic value.

Innovation reports are an outstanding tool for CPCs. With these reports, a CPC can actually conduct invention “scans” from their desk. With a few clicks, they can review the innovation activity of each engineer of interest. They can literally click through from the inventor to actual uploaded invention records or from relevant categories of documents to the necessary inventors. Without leaving their desks, they can glean more information about inventors than they could being face-to-face. Innovation reports can bring CPC closer to the inventors and move them from a reactive/tactical role to a proactive/strategic role.

This is the sixth in a series of articles on this blog about Best Practices For Successful Innovation Management. For more in this series, see:

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Collaboration can be a powerful tool in business or any area of life. A collaborative environment, though, can be difficult to create and maintain. Even in situations where employees are located in the same building, or even on the same floor, collaboration can be stifled by personalities, busy schedules, vacations, and a myriad of other obstacles that come up everyday. When businesses have offices across the US or around the world where colleagues are separated by geography, time zones, and language barriers, a collaborative environment can quickly become a fiction.

In reality, meeting face-to-face or by phone is an inefficient way to collaborate. It is too difficult to connect. An innovation management system should create a collaborative environment in the same way that the Web does … with blogs. Ideally, a good innovation management system should automatically turn innovation records into internal “executive blogs.” It should also allow for concept clustering and user alerts so that relevant ideas can be pushed out to interested colleagues throughout the world. This enables managers to set alerts not only by bibliographic fields such as author and title, but also by concepts. With such capabilities, employees can “collaborate” on their own time. Invention records can be enhanced with comments from employees throughout the company, regardless of where they work or whom they know. Suddenly, many barriers to meaningful communication can be eliminated.

This is the fifth in a series of articles on this blog about Best Practices For Successful Innovation Management. For more in this series, see:

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