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Design a Patent and Publication Strategy

BioPhotonics
Dec 2017
JOHN MAYNARD, MEDICAL DEVICE & DIAGNOSTICS CONSULTANT

It’s difficult to fund and grow your company without a strategic plan for product development, clinical studies, manufacturing, regulatory filings, marketing and sales. Just as important is a strategy for developing patents and publications. For a commercial company, patents and publications go hand in glove to protect your intellectual property, establish market exclusivity and boost company value, while building awareness and acceptance of your technology and products. Patents and publications also serve as an incentive for company employees because inventorship and authorship are a source of pride and peer recognition inside and outside the company.

From the startup phase to maturity, patents build the value of your biophotonics company. Both the strength of individual patents as well as the number of patents held by your company will factor significantly into the company’s valuation when you are raising capital and establishing strategic partnerships. The more pickets in your patent fence and the more territory you can claim, the more likely that you will have significant competitive advantages when manufacturing and selling your products.

When developing your patent strategy and portfolio, keep the following in mind:

• Identify the countries or regions (e.g., Europe) for patent coverage that represent significant markets for your products, are likely manufacturing sites of potential competitors and have a good track record of upholding intellectual property rights.

• Keep in mind that costs for international patents can add up quickly when you factor in translation, filing, prosecution and maintenance fees. A company with a limited budget should consider international patent filings only if international markets are a key part of its business plan.

• Filing your patent application under the Patent Cooperation Treaty gives you more than a year to decide the countries/regions for which you wish to apply for patent protection.

• A well-written, comprehensive specification with clear figures supports the claims in the application and is the basis for filing patent continuations or continuations in part in the U.S. This can allow you to broaden the extent of your invention with new claims supported by the specification after issuance of the original patent.

• Do your homework on the prior art, including the literature plus published patents and patent applications. Your competitors certainly will do this when trying to invalidate your patent, and you can’t assume the patent examiner will do a thorough job. The good news is once the examiner has considered a piece of prior art when granting your patent claims, it is much harder for that prior art to be used to invalidate the patent claims in later litigation.

Publications are equally important to your business because they raise awareness of your technology, establish scientific and medical credibility, and support due diligence by investors and strategic partners, regulators and health insurers. If you are developing a medical product, publications act as a recruiting tool for key opinion leaders and clinical trial sites. Medical regulatory bodies and health insurers will expect publications on your technology and clinical results to support investigational device exemptions, regulatory filings for marketing clearance/approval, and reimbursement decisions.

Your options include white papers, trade magazine articles, peer-reviewed journal articles or presentations/posters at conferences. For new technologies and approaches, there is considerable temptation to keep things secret for as long as possible to maintain competitive advantage. As you bring your biophotonics products to market, consider when you want to educate the market on how your technology works and how well it works (e.g., clinical trial results). At some point, the value of secrecy reaches diminishing returns.

You need to budget time and resources for your publication strategy. When picking venues, consider your target audience, the publications they are most likely to read and the conferences they are most likely to attend. Be realistic about timelines. White papers placed on your website can be available within minutes, while trade magazines and conferences typically have a three- to six-month lag, and the lag can be greater than six months for many peer-reviewed journals.

Also, it’s important to match the significance and topic of your manuscript to the impact factor and interests of target publications. Submitting pilot clinical study results to the New England Journal of Medicine, for example, is likely to waste both your time and that of the editors. Over time, a well-constructed and executed patent and publication strategy will significantly contribute to the success of your company and its biophotonics products.

It&rsquo;s difficult to fund and grow your company without a strategic plan for product development, clinical studies, manufacturing, regulatory filings, marketing and sales. Just as important is a strategy for developing patents and publications. For a commercial company, patents and publications go hand in glove to protect your intellectual property, establish market exclusivity and boost company value, while building awareness and acceptance of your technology and products. Patents and publications also serve as an incentive for company employees because inventorship and authorship are a source of pride and peer recognition inside and outside the company. <BR><BR>  From the startup phase to maturity, patents build the value of your biophotonics company. Both the strength of individual patents as well as the number of patents held by your company will factor significantly into the company&rsquo;s valuation when you are raising capital and establishing strategic partnerships. The more pickets in your patent fence and the more territory you can claim, the more likely that you will have significant competitive advantages when manufacturing and selling your products. <BR><BR>  When developing your patent strategy and portfolio, keep the following in mind: <BR><BR>  &bull; Identify the countries or regions (e.g., Europe) for patent coverage that represent significant markets for your products, are likely manufacturing sites of potential competitors and have a good track record of upholding intellectual property rights. <BR><BR>  &bull; Keep in mind that costs for international patents can add up quickly when you factor in translation, filing, prosecution and maintenance fees. A company with a limited budget should consider international patent filings only if international markets are a key part of its business plan. <BR><BR>  &bull; Filing your patent application under the Patent Cooperation Treaty gives you more than a year to decide the countries/regions for which you wish to apply for patent protection. <BR><BR>  &bull; A well-written, comprehensive specification with clear figures supports the claims in the application and is the basis for filing patent continuations or continuations in part in the U.S. This can allow you to broaden the extent of your invention with new claims supported by the specification after issuance of the original patent. <BR><BR>  &bull; Do your homework on the prior art, including the literature plus published patents and patent applications. Your competitors certainly will do this when trying to invalidate your patent, and you can&rsquo;t assume the patent examiner will do a thorough job. The good news is once the examiner has considered a piece of prior art when granting your patent claims, it is much harder for that prior art to be used to invalidate the patent claims in later litigation. <BR><BR>  Publications are equally important to your business because they raise awareness of your technology, establish scientific and medical credibility, and support due diligence by investors and strategic partners, regulators and health insurers. If you are developing a medical product, publications act as a recruiting tool for key opinion leaders and clinical trial sites. Medical regulatory bodies and health insurers will expect publications on your technology and clinical results to support investigational device exemptions, regulatory filings for marketing clearance/approval, and reimbursement decisions. <BR><BR>  Your options include white papers, trade magazine articles, peer-reviewed journal articles or presentations/posters at conferences. For new technologies and approaches, there is considerable temptation to keep things secret for as long as possible to maintain competitive advantage. As you bring your biophotonics products to market, consider when you want to educate the market on how your technology works and how well it works (e.g., clinical trial results). At some point, the value of secrecy reaches diminishing returns. <BR><BR>  You need to budget time and resources for your publication strategy. When picking venues, consider your target audience, the publications they are most likely to read and the conferences they are most likely to attend. Be realistic about timelines. White papers placed on your website can be available within minutes, while trade magazines and conferences typically have a three- to six-month lag, and the lag can be greater than six months for many peer-reviewed journals. <BR><BR>  Also, it&rsquo;s important to match the significance and topic of your manuscript to the impact factor and interests of target publications. Submitting pilot clinical study results to the <i>New England Journal of Medicine</i>, for example, is likely to waste both your time and that of the editors. Over time, a well-constructed and executed patent and publication strategy will significantly contribute to the success of your company and its biophotonics products. <BR><BR>  <b>Meet the author</b>  John Maynard is vice president of product management at Avisa Pharma Inc., which is developing a spectroscopy-based breath test for certain virulent types of bacterial pneumonia. In addition, he has an active medical device and diagnostics consulting practice. He was also a co-founder and executive vice president of VeraLight, which commercialized SCOUT DS, a noninvasive diabetes screening device based on skin fluorescence and multivariate spectroscopy; email: maynardjj90@gmail.com.Meet the author

John Maynard is vice president of product management at Avisa Pharma Inc., which is developing a spectroscopy-based breath test for certain virulent types of bacterial pneumonia. In addition, he has an active medical device and diagnostics consulting practice. He was also a co-founder and executive vice president of VeraLight, which commercialized SCOUT DS, a noninvasive diabetes screening device based on skin fluorescence and multivariate spectroscopy; email: maynardjj90@gmail.com.

BiophotonicsBiopinionJohn Maynardpatentspublications

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