Tag Archives: IP

Building a Strong Life Science Company by Avoiding These 5 Common Patent Pitfalls

By:  Peter Kim, Principal – Irvine Pointe Advisory, LLC

King Leonidas

Make sure that your intellectual property is strongly guarded by following these simple steps.

Let’s imagine you came up with a great idea.  You hired a great patent attorney, who interviewed you in detail.  After a few weeks, he emails you the patent application, and asks you to review it before he files it with the U.S. Patent and Trademark Office.  What exactly are you supposed to be checking for when reading a patent?  What is the simplest way to read a patent?  What are the 5 most critical pitfalls in patent drafting?  I’ll give you a hint: most of your time should be spent reviewing the “claims” section.

To infringe a claim or not to infringe a claim:  That IS the question
Why is the claims section important?  A patent claim is a “checklist” for whether someone has copied your invention (i.e. a checklist for infringement).  In a patent lawsuit, the patent claims are what the court and the lawyers will be reviewing, to see who’s right.  Here’s the surprise to most inventors: in order for someone to infringe your patent, they must be copying everything in a patent claim.  “Fairly close copying” doesn’t count.  If someone copies 50% of a patent claim, they are NOT infringing.  If someone copies 75% of a patent claim, they are NOT infringing.  If someone copies 90% of a patent claim, they are NOT infringing.  That’s why it’s so important to get the patent claims right.  The good news is that you can include multiple claims in a single patent.  And someone needs to infringe only one of the claims.

How to review a patent: Tips for the inventor
When I read a patent, I start with the claim section before anything else, because it’s so important.  The claims are the last section of a patent, so start from the back.  I always start with reading the independent claims.  (If an independent claim is not infringed, then it’s impossible that the dependent claim is infringed.  Dependent claims reference a different claim; independent claims do not reference another claim.  Dependent claims can be important if an independent claim is “invalidated” due to prior art.)

Here are the 5 common pitfalls to patent claims:

      1. Claim has multiple ‘actors’
        A claim is like a checklist for infringement.  But the checklist should only be applied to one infringer at a time.  If the claim was a screenplay of a movie, there should only be one “actor” in this movie.  This is important because if the infringement requires multiple entities, each will blame the responsibility on the others.  The law makes it very difficult to sort out these ensemble infringement issues (e.g. contributory infringement or inducement).  This is one of the most common pitfalls in a patent, and also the easiest mistake to correct.  Make sure the claim describes the activity of a single infringer.
      2. Claim is unnecessarily long
        A claim should be as long as it needs to be, and not any longer.  Why?  Because proving infringement requires that everything in the claim has been copied.  A longer-than-necessary claim means that proving infringement is longer and more complicated than it needs to be.  If the claim seems to have many unnecessary details in it, work with the attorney on figuring out if any of the details can be moved to a dependent claim.  Ask whether someone could infringe your patent with a shorter version of the claim, and if that shorter claim still covers your invention.  Make sure the claim is not excessively long.
      3. Claim would be invisible or undetectable in the ‘real-world’
        A claim should describe things that would be visible and detectable in the ‘real-world’ (i.e. can be reverse-engineered from the product or service).  It might take some hard work to detect, but the infringement shouldn’t be invisible.  Examples of invisible features might be software code, or a secret manufacturing process.  If you file a lawsuit for infringement, the court requires solid evidence when you file the lawsuit.  Stated differently, the court will not let you file a lawsuit as a ‘fishing expedition’, in order to guess at infringement.  Make sure the claim describes infringement that can be seen or detected.
      4. Claim uses unusual words that are not well defined somewhere in the patent
        A claim should use simple plain and understandable language, whenever possible.  However, there are some situations when a patent attorney must use an unusual word because it’s being used with a very specific meaning.  If you don’t understand any of the words in a claim, look in the rest of the patent to see if there is an explicit definition or list of examples.  If you explicitly define the words in the patent, the court will give your own definition deference.  But if you don’t define it, the court will decide the meaning during the lawsuit.  Make sure the claim uses understandable and well-defined language.
      5. Claim describes a different idea than what the inventor discussed
        Every invention begins with an important idea.  An inventor should work with a patent attorney to capture that idea in a patent.  And a great patent attorney will provide input on how to focus the idea in the most beneficial way.  But ultimately, the claim should describe the idea that the inventor and attorney have discussed.  If the claim describes something different, there may have been a miscommunication along the way.  Make sure the claim describes the idea that you discussed.

In summary…
One of the most important jobs of an inventor is to read the patent application before it is filed.  These 5 patent pitfalls are very simple to watch for, and don’t require any special legal or technical training.  Spending an hour reading the patent claims will save you countless time and money in the courtroom later on.  And if you make sure these 5 items are covered, most of the hard work of reading a patent has been accomplished.

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Keeping the Patent Wolves at Bay: Three Tips for Protecting the Heart of Your Startup

Grey Wolf

Don’t venture into the ‘wilds’ of commercialization without the protection of rock-solid patent protection. The tips here will insure that the time, effort and cost of doing this will be well worth it.

By:  Andy Golden, Ph.D.

I know several inventors and patent attorneys who have breathed a sigh of relief after realizing that a patent has missed an opportunity to impede their commercialization path.  For example, the patent claims of a prior art patent may contain unnecessary limitations on design or implementation; despite the absence of a preceding prior art landscape.

Although some patents are obtained merely to check a box or promote technology, most are intended to exclude competition from an invention space.  So why spend $10,000 to $100,000 for a patent that does not exclude competition?  Here are three tips for keeping the wolves at bay:

1.  Choose carefully 
Patent attorneys are not commodities so find a good one.  I usually find patent attorneys through the good recommendations of their peers.  Similarly, I have seen several companies benefit from auditing their current patent firm with a second firm.

Select a patent attorney who has the technical background to quickly understand your invention in detail, as well as its role in your business plan.  Understanding the invention is critical for drafting effective claims, enabling the invention and minimizing ‘design-arounds’.  Moreover, time is money and the quicker the patent attorney grasps your invention, the less you spend on patent drafting.

  • Years ago, a research group wanted to patent two inventions earmarked for two academic manuscripts.  The process in the first paper was used in the second to form a material for tissue engineering.  However, the second paper did not require the first, and the first was broader and more valuable than its application in the second.  De-conflating the inventions in the patent application, among other things, wasted many hours and thousands of dollars.  A weak patent application was submitted just before the deadline and then abandoned five years later.

2.  Tear down that wall
Don’t throw the invention over a wall – a good patent requires collaboration with the patent attorney.  Transforming technical details and business objectives into a legal document is an interdisciplinary process.  In particular, the inventor/scientist/engineer must actively participate in identifying novel elements and technical ‘design-arounds’ for protection, so that technically savvy competitors cannot pursue them.  It’s impractical (and costly) to expect the patent lawyer to understand your invention space as well as a specialist who has lived and breathed in the space for years.  A kickoff meeting can be an effective venue for brainstorming potential claims and ‘design-arounds’ with the patent attorney before documentation and billable hours accrue.  Here are a few questions that might lead to anticipation of technical ‘design-arounds’:

  • What are the ways in which you might practice the invention?
  • How might a competitor or potential licensee practice or design around the invention?
  • How might your invention evolve during the R&D process, production scale-up, or post-market surveillance?  In other words, what risks remain and how might they change the course of the product?
  • How might the patent benefit future product lines or adapt to a changing market?
  • What entities are the focus for infringement?  What entities are not the focus (e.g. a medical practitioner or a customer)?

In truth, it is often unlikely that the innovator can anticipate and prevent every creative design-around, but she/he can anticipate much of the low hanging fruit.  The lawyer should capture these technical and legal ‘design-arounds’ in the patent application.

3.  Keep your eyes on the bottleneck
Align your patent application with business objectives.  Focus on identifying the commercially valuable bottlenecks.  These bottlenecks are your invention – not the product that embodies merely an example of the bottlenecks.  Then, instead of describing each component of the product with equal weight and consideration, focus the patent application on protecting the valuable bottlenecks and associated ‘design-around’ risks.  Taking a stab at this in a detailed patent disclosure for the lawyer can improve the final patent application and sometimes reduce the billable hours required for drafting.

  • Theoretical example: An academic group develops a new label-free biosensor for potential use in drug discovery.  The main commercial advantage is that the label-free biosensor is not a destructive test, so, for the first time, the cells can be monitored for days, providing higher quality data.  At the kickoff meeting, the team decides the key bottleneck is long-term monitoring of cells for this particular cell assay.  In contrast, the label-free biosensor is a minor bottleneck; it is treated as one of several possible ways to achieve long-term monitoring, as other companies could conceivably develop labeled tests that are similarly nondestructive.  Although the patent does include claims on the biosensor, it focuses and expands on enablement and valuable embodiments of long-term monitoring, such as previously undetectable cellular events, data analysis, and methods to exclude dedifferentiated cells.

In brief, some people say that a good patent lawyer “gets into the head” of the inventor to extract the invention.  A counterargument is that with good collaboration and alignment of the patent application with business objectives, this may not be necessary.

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Developing Opportunities in the Life Sciences: A Birds-Eye Review

Bald Eagle Soaring

Keeping a Birds-Eye view of the opportunities shaping the life sciences will allow you to develop effective strategies while keeping your head out of the clouds.

By:  Michael Kaiser

A brief preface: although the developing opportunities listed below refer to the life sciences, they can be adapted to the specific needs of other industrial sectors as well.

1. New Frontier: Stem Cells, Bioinformatics, Genomics, and Proteomics

a)  Stem Cells
bBioinformatics
c)  Genomics
d)  Proteomics

(See descriptions of a), b), c) and d) under “General References and Additional Reading”)

The high R&D cost of these “New Frontier” opportunities demands exposure and experience in dealing with academia, scientific personnel and the highest levels of corporate savvy and investment sources; their ultimate value more than merits the effort.

2. Biomaterials
Biomaterials include implant prosthesis, biochips, nanotechnology, fiber optics for minimally invasive implant or corrective surgery and biochemical suturing. They represent a valuable business opportunity for improving human health and a significant contribution in reducing healthcare costs.

3. Intellectual Property
This is a critical solution in protecting nascent opportunities in high-technology sectors. When the topic of intellectual property is discussed, one cannot but bring to mind the title that Kevin Rivette and David Kline came up for their book on the subject: “The Rembrandts in the Attic. Unlocking the Hidden Value of Patents”.

The potential legal implications of violating a patent requires the assistance of expert counsel in areas such as innovation, field of use, royalties, head-of-agreement terms, etc. Although being an expensive process that can negatively impact the financial resources of a biotechnology start-up, legal IP expertise also serves the purpose of prosecuting copy-cats.

4. Competitive Advantage
Competitive advantage: the key challenge and opportunity in commercial transactions and outcomes; its success lies in the axiom “Understand your competition as well, if not better than thyself”.

No company, be that a startup or established corporation, can afford the absence of competitive strategies. Skills in knowledge management and data mining are useful in the planning of corporate strategies in addition to the regular update of marketing e-commerce and social media tools used in the competitive analysis that precedes a successful commercialization. A clear understanding of information transfer technologies, e-commerce and sales and marketing tools is now an essential requirement in competitive analysis.

5. Entrepreneurship and Structure
Ideally, the entrepreneur enjoys and thrives while working in an innovative, fast-paced environment. However, the reality of the economic marketplace suggests that equal attention should be given to the role of ‘intrapreneurs‘, those executives who implement a formal corporate-like structure to reflect the vision of the entrepreneur’s initiative in a manner that conveys a more established and organized company image to investment sources.

6. Globalization
This one is the quintessential opportunity for any business sector and not just for a selected few because it implies an in-depth knowledge and understanding of the socioeconomic and political factors affecting the conduct of business in different regions. Just like we refer to startup companies, we can also refer to growing national economies, e.g., the BRIC countries.

The liberalization of world trade and the integration of regional markets such as the EU, NAFTA and ASEAN dovetail with organizations such as the WTO and GATT. Paradoxically, in the process of lowering trade barriers the pendulum has swung too far and we see an increase in protectionism by both industrial countries and newly industrialized ones. Furthermore, the fact that the Internet became an effective communications facilitator in no way replaces the unique value of face-to-face personal contact in all endeavors of business, sciences and humanities.

7. Mergers and Acquisition; Strategy and Technology Evaluation
The impact of IT has accelerated the process of consolidation and integration in the life sciences, particularly in those cases where a large pharmaceutical concern and a biotechnology company with a valuable technology platform are concerned. Shareholders, institutional investors and venture capital companies have much higher expectations, with a short time horizon, for a return of their investments.

Therefore, the cost of M & A’s requires a thorough analysis of corporate synergies, innovative financial instruments and fundamentals, experienced investment bankers and financial institutions, assessment of net present valuation and internal rate of revenue, evaluation of technology and future corporate strategy, top management succession, and ability to transfer technologies across corporate and international boundaries.

GENERAL REFERENCES AND ADDITIONAL READING (Links)

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