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America Invents Act: part 1

"This is an invited post from patent attorney Vadim Gordin of GordinIP, who is not affiliated with BioBM Consulting. This article is intended to be purely educational and cannot take the place of legal counsel. If you have a patent, trademark, or copyright matter to discuss, the author can be reached via the contact form on his practice website at www.GordinIP.com."

Rules of the Game: What every Engineer, Scientist, and Inventor should know about the Patent Reform Bill

On Friday, September 16th, 2011 President Obama signed into law the America Invents Act (hereafter AIA, full text here: pdf of AIA).

The AIA has had no shortage of both backers and detractors that have each said that it would be either the panacea or poison for American innovation. Regardless of where your own opinion falls as to the AIA, the bill and its changes are now set to become a very real part of the technology development landscape in America.

This article will be published in four weekly installments. In each installment, I will examine how the AIA changes four key areas of the patent process for engineers, scientists, and inventors.

Part 1: Patent Filing Dates and Deadlines
• Part 2: What content needs to be included in a Patent Application, New Mechanisms for Challenging Patents
• Part 3: How products protected by patents should be marked, New mechanisms for Enforcing Patents
• Part 4: Changes to Patent Fees

First To File Explained

This is one of the most talked-about and misunderstood provisions of the new law. In order to understand what it means for inventors and companies, we need to first compare the current US patent system to those in other parts of the world.

Before the AIA, standard advice to American inventors was to keep accurate, signed, and dated records of their innovations before patents were filed. The purpose of these records and notebooks was to establish, as clearly as possible, the dates on which inventions and aspects of inventions were conceived. This was because the patent laws of the United States protected the first person to invent a given technology. Further, because of this focus on inventorship, inventors in the United States were given one year from first sale, public use, or printed disclosure of an invention to file for patent protection.

Other parts of the world, notably Europe and Asia, have strict “First to File” systems whose focus is on the act of submitting a patent application to a given patent office. There, any public use, sale, or pubic disclosure of an invention before its submission as a patent applicaiton prevents anyone, including the inventor, from pursuing patent rights.

With the coming of the AIA, the US has shifted from a First to Invent system to a First Inventor to File system. In broad terms, this means that priority of invention is given to the first inventor to file a patent application. While this sounds similar to the pure “First to File” systems in place in other parts of the world, there are several key differences that American inventors, engineers and scientists should be aware of.

• The AIA maintains the US system’s focus on inventorship. Therefore, in order to receive a patent one must have still have been the actual inventor.
• The AIA shifts the date of priority for US patent rights to the date on which the inventor first filed a Patent Application.
• Under the AIA, American inventors no longer have a one year grace period during which to file a patent application after public use or sale of inventions, bringing US laws largely into line with the rest of the world.
• The AIA creates a one year grace period after publication of the invention by the inventor within which he can file for patent protection.

To illustrate the different patent systems and how they would play out in Europe compared to America before and after the AIA, let’s use a fictional example under the following timetable:

    June: David invents a novel device for time travel.
    July: David publishes an article describing the device in the Annuls of Time Travel.
    August: Another inventor, Rob, working independently from David, also invents a similar device for time travel and immediately files for a patent.
    September: David files for patent protection.


So what would happen under the different systems?

    Pure First to File (Europe, Asia, Canada): Both David and Rob are precluded from getting a patent because David published his article before either filing.
    First to Invent (United States before the AIA): Rob’s patent is barred by David’s invention in June.
    First Inventor to File (United States under the AIA): Rob’s patent is barred by David’s publication in July.


So what has changed about how inventors publish, sell, and patent their innovations?

1. When to File

Even before the AIA, American inventors interested in securing rights in Europe, Asia, and South America had to be weary of publishing or selling their inventions before making filings with a respective patent office. This is double true now that America has aligned itself with the rest of the world by barring applications on inventions that were sold, publicly used, or disclosed before an invention’s filing date.

In order to help alleviate the added cost of these filings, the AIA includes new fee guidelines which will be discussed in the fourth installment of this article.

2. When to Publish

As shown in the example above, an inventor’s own publication of the invention gives him one year within which to file for patent protection. While this may seem like a cheaper, quicker way to prevent others from filing patent applications, several considerable caveats apply:
a. Publishing about a Invention before filing an application bars an inventor from pursuing rights in countries with pure first-to-file systems.
b. Publications prepared by non-attorneys often contain enough information to render an invention obvious and therefor bar patentability without having enough detail to secure patent rights. As before the AIA, your best bet is to have an attorney review a publication before it goes out.
c. If you’ve gone so far as to have you publication checked and edited by an attorney, you should be filing a provisional application as it will not preclude rights in the rest of the world.

3. When to Sell or Publicly Use

In the past, many inventors have delayed the patent process in favor of first generating revenue or buzz around a product. Once the AIA comes into effect in 2013, such actions would preclude patent rights.

Even before the AIA comes into effect however, inventors are cautioned that a delay in submitting a patent application will often result in precluding patent rights in Europe, Asia, and Canada.

4. Lab Notebooks and Invention Records

While many have understood the above changes to mean that the days of lab notebooks and invention disclosures are gone, the answer as to how the AIA will affect innovation record-keeping in America is much more nuanced.

While the AIA has largely obviated the question of “when” an invention was conceived for the purposes of patenting, “who” invented, in what order, and under what circumstances remain important inquiries for the patent system, many universities, tort liability, and regulatory bodies like the FDA. Consequently, inventors are strongly advised to continue, as taught, to maintain accurate records of their labors.

While some of the changes covered in later installments take effect immediately, the AIA sections described in this article will take effect in March of 2013.

Next week: What content needs to be included in a Patent Application, New mechanisms for challenging patent validity.

"About the Author: Vadim Gordin is a patent attorney and technology broker licensed to practice law in the State of New Jersey and before the United States Patent and Trademark Office. He can be reached via the contact form on his practice website at www.GordinIP.com."

Business Plans for Scientists

With online leads, speed is a key factor in conversion.If you have a great biotechnology innovation and you want to start a company to commercialize it, you’re almost certainly going to have to write a business plan. Even if you’re not going to try to obtain investment capital, in which case you would undeniably have to write a business plan, you should still write a business plan to make the case to yourself and anyone else involved in your start-up company that the company is viable and you have an understanding of what you’ll need to do to be successful. Most life scientists, however, have never written a business plan and likely don’t know how to properly compose one. While business plans for established companies or internal use only are not totally uncommon, we will focus on the business plan most relevant to bioscience inventors – an externally-focused business plan for start-up companies.

Every business plan is different, and you shouldn’t feel obliged to stick to any particular format. If you can make a better case for your business by changing the format, then do so. After all, the point of the business plan is to state what your business will be doing and why it will be successful. Making the document look and feel like a standard business plan is secondary. Whatever you do, just make sure you include all the necessary information.

In general, I like my scientific business plans to include the following sections:

  1. Company Overview – The company overview should be a one to three sentence description of your company. This should be very similar to your elevator pitch. It should be to the point, effectively get the readers attention, and explain the company as concisely as possible.
  2. Mission Statement – Your company’s mission statement should effectively state the purpose of the company. Don’t brush this off. Write a mission statement that will be able to guide the strategy and high-level decision making down the road. A mission statement is not a marketing tool, but it should read well.
  3. Management – Introduce your management team. Give some background on them and highlight their strengths as it pertains to the venture and their position within it. A poor management team can easily drive away investors, so be sure that your team looks good both on paper and in person. You should have enough talent on your team to realize your objectives. If there are any key skill gaps that will be addressed through outsourcing, be sure to address those in your operating plan.
  4. Market Analysis – This is where you really start to get into the meat and potatoes of the document, so to speak. The market analysis should give information on competition, market size, trends, challenges and opportunities the market presents, etc. As appropriate, you’ll need to be both descriptive and quantitative, and you will definitely need to back up your numbers. Do your homework, include references as appropriate, and make sure you back up your statements.
  5. Scientific Background – This is where you start talking about your product specifically. Since scientific products are highly technical in nature, you will need to show that your product will work as you claim and also that it will meet the needs of the market that you have just identified. If you can, reference published literature. If you’ve built a working prototype, show some results of testing.
  6. Marketing Plan – How will you market your product? How will you position your product within the marketplace to achieve the projected market share and hit your targets? What marketing channels will you use? You’ve addressed the market in your market analysis, but this is where you address how your company will interact with that market.
  7. Operating Plan – How your new biotech business will operate. You don’t have to go into minutiae, but if there are any important considerations, make sure to include them. Address operational difficulties and areas that would not be considered obvious. Again, if you plan on outsourcing anything be sure to address that here.
  8. Projections – The projections, which can also be referred to as the “financial plan”, etc., is where you will make the case that your venture is worth investing in. Extend your projections out to a relevant but not-too-distant time point. What should that time point be? That will be different for every company and would be based on your projected product development time, how long you project until your product goes to market, and what the life cycle of the product will be, and any other relevant factors. Revenues always involve some guesswork, but make sure that your cost estimates are very close. Also, don’t overestimate your revenues or no one will believe that you’re capable of hitting your targets. It’s better to have a slightly worse financial outlook that’s defensible
  9. Long Term Vision – Are there any important long-term goals or achievements for your life science start-up that would be important to partners or investors? Do you have plans for expansion into new markets to build on successes in your company’s early years? Those are some things to think about when writing a long-term vision.
  10. Disclaimer – Ever read a corporate financial statement where they give a disclaimer about “forward-looking statements”? You need to include something similar to protect yourself from liability. It won’t be a full section, per se, but it should constitute some small print at the end of the body of the document. Basically, your disclaimer should state that projections are subject to risks, not guaranteed, and that you nor your company are liable if they turn out to be incorrect.


Keep in mind this is just how I frame many of the scientific business plans that I write. I don’t even always stick to this format, so you shouldn’t feel obliged to either. This is merely a guideline.

A few other tips… Graphs, charts, and supporting data that is too long to put in the body of the business plan should go into figures and appendices. You’ll probably want a copyright notice in the footer. Don’t forget to include trademark symbols next to any slogans or names that you plan on claiming.

Some may want to include a section about risks and projected difficulties to show that you understand your limitations, are addressing them, and have contingency plans in case any of them become problems. I sit on the fence about this. While I certainly think you need to have thought about these issues in the event that they are asked, I don’t always think that including them in a business plan is a good idea. The business plan is supposed to sell people on the idea of your business, and listing all the drawbacks doesn’t do that. If there are obvious risks or obstacles, however, then you should definitely address them.

At the end of the day, your life science start-up should be able to create a business plan that is every bit as “bulletproof” as your idea. If you’re not a veteran at starting companies then there are likely issues you haven’t thought of. The creation of a business plan is a good way to expose those issues so you can address them before attempting to attract investors or launching your company and having unrecognized issues impact your bottom line. Remember that the business plan should show the value and merits of your idea, your understanding of the marketplace, and your ability to execute and realize commercial value. For maximum effect, don’t hesitate to modify the format and structure of the business plan to the unique needs of your biotech start-up and keep in mind what the purpose is and who your audience will be.

"Writing a business plan can be an intimidating thing for life scientists. If you’re not comfortable writing a business plan, or performing any functions on the road from innovation to successful commercialization, working with an experienced team can be invaluable to the success of your early-phase venture. Feel free to contact BioBM or use the form below if you have any questions that you would like to discuss. Our experience is at your disposal to help ensure your biotechnology start-up is successful."

What Inventors Don’t Think Of

Referral-based marketing works best in environments where there is open and fluid interaction between populations of customers, something that life science research environments lack.Most great life science inventions come straight from the bench. That also means that most great life science inventions come from career scientists, who are most often inexperienced in commercialization. There’s a host of things that you should think about before rushing to commercialize and many scientists turned first-time inventors often neglect one or more such issues. We’ll go over a few commonly skipped considerations so when you have the next great idea, you can properly vet it before you run to your patent attorney.

1) Be sure you own your IP!

There’s a good chance that great idea of yours may not belong to you (at least not totally). If you developed it at work or school, your institution may have a partial or full claim to your IP. Check your employment contract or other signed employment documentation. A similar issue: if you have a great idea that is essentially an improvement of another technology but is based on that other technology (in other words, your invention would require the existing technology in order to operate) you can claim rights to the improvement and file a patent, but will most likely be unable to commercialize it due to needing protected technology in order to do so.

2) Is your idea as good as you think it is?

It’s easy to get really excited about an idea for a new invention, but your emotions have to be tempered with reality and pragmatism. Is your idea really as good as you think it is? Understand the key differentiators of your technology. For example, would it be cheaper, faster, easier to use or would produce better results? What Ask some trusted friends and get some feedback or set up a survey using a free online survey tool (without giving away the idea!) and leverage social networks, forums, colleagues, professional networks, etc. Be sure others think your idea is a good one as well.

3) Is there a market for your invention?

Just because you need something doesn’t mean anyone else does. Would this product be used by a large enough market in order to justify pursuing it? This decision will need to be based primarily on three things: market size, price of the product, and cost to develop it. Ballparking at this stage is perfectly fine, but you want to be reasonably certain that your development costs would be far less than your total potential lifetime sales.

4) What would it cost to make / what would scientists be willing to pay?

This is a frequently overlooked issue early on. While without manufacturing experience or having worked in a manufacturing environment the cost of building a product can be difficult to quantify, you can think in terms of simplicity. Simple things are usually cheaper and easier to make than more complex things. If your invention would be approximately 20% better in a certain performance metric than the next best technology available but would be 100% more complex, think long and hard as to whether researchers would pay about twice as much for that 20% increase in performance.

Another small piece of advice for those innovative minds out there – don’t always think big. Some incredibly profitable yet relatively simple inventions have come in areas that were ignored for decades. Things slip under the radar all the time, and if no one else is thinking about a topic the lack of competition among innovators in that area can make commercialization much easier and improve your likelihood of success.

"Are you a life science inventor and want help or advice regarding commercialization of your invention? BioBM can help you maximize the profits you realize from your idea. Our experience bringing products to market and industry connections can help you validate your idea and bring your product to market faster and more profitably. Contact us to confidentially discuss your idea."

Benchfly: Innovation 3 of 3

The third post in life science innovation in the laboratory has been published on Benchfly. In this final post in the guest blogger series by BioBM Principal Consultant Carlton Hoyt he discusses some considerations regarding intellectual property and options for commercializing and realizing revenues from a life science invention. You can read the post on Benchfly here.

The first post, encouraging and discussing ways for life science inventors to act on their ideas, can also be read on the Benchfly blog. The second post, on ballparking the value or revenue potential of an idea, can also be read on Benchfly.

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Benchfly: Innovation 2 of 3

The second in the BioBM / Benchfly series on laboratory innovation for life scientists has been published on Benchfly. In this post, BioBM Principal Consultant Carlton Hoyt discusses a “back-of-the-envelope” method for life scientists to ballpark how much their ideas or inventions could be worth to them. You can read the post in it’s entirety here.

The first post, encouraging and discussing ways for life science inventors to act on their ideas, can also be read on the Benchfly blog. The final post will be on discussing ways to take your idea from concept to commercialization and will be posted on Benchfly in the coming weeks. We’ll update the news section when it gets released, so feel free to subscribe to our RSS feed if you’d like to stay updated.

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BenchFly: Innovation 1 of 3

BioBM Principal Consultant Carlton Hoyt has been given the honor of writing a three-part series on innovation for life science inventors that is being featured on laboratory technique and advise site BenchFly. The first post focuses on different ways to realize the value of ideas – from small to groundbreaking. Read the post in it’s entirety here.

Subsequent posts will focus on determining if your idea has commercial value (and ball-parking how much) and ways to realize profits from your innovations or inventions. We’ll update the blog as these posts are released, so be sure to subscribe to our blog feed if you would like to stay updated.

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BioBM Launches Inventor Services

BioBM Consulting is pleased to announce the launch of its new “Inventor Services” division, offering commercialization services to life science inventors and others who wish to commercialize intellectual property with a life science research focus. Celebrating the latest in BioBM’s expanding and innovative service offerings, BioBM Principal Consultant Carlton Hoyt gave the following statement:

Statement from Principal Consultant Carlton Hoyt

BioBM recognizes the massive creative capacity of life science researchers and simultaneously realizes that inventors in life science laboratories may lack access to key business and marketing experience necessary for effective and profitable commercialization of such inventions. With BioBM’s unique positioning, we recognize the value we have to offer life science inventors and can help them commercialize novel biotechnology innovations in a variety of ways. We strive to help life science inventors meet their commercial goals while expediting the development and marketing of advancements in life science tools and processes that will forward the sciences and, ultimately, human health. BioBM looks forward to fruitful collaborations with inventors from all areas of the life sciences.


The Inventor Services division of BioBM is already taking inquiries. For more information on how BioBM Consulting works with inventors, click here. For more information on the portfolio of services offered to inventors, click here.