Opinion
VIEWPOINT
Eve J. Higginbotham, SM, MD Department of Ophthalmology, Emory University, Atlanta, Georgia, ROI Squared, LLC, Bethesda, Maryland, and currently at Perelman School of Medicine and the Leonard Davis Institute, University of Pennsylvania, Philadelphia. Aparna Upadhyay, BS ROI Squared, LLC, Bethesda, Maryland. Lisa Egbuonu-Davis, MD, MBA, MPH ROI Squared, LLC, Bethesda, Maryland.
Corresponding Author: Eve J. Higginbotham, SM, MD, Perelman School of Medicine and Leonard Davis Institute, University of Pennsylvania, 291 John Morgan Bldg, 3620 Hamilton Walk, Philadelphia, PA 19104 ([email protected] .edu). jamaophthalmology.com
The New Patent Law May Accelerate Innovation in Ophthalmology Ophthalmic practice has changed significantly during the last 30 years. Sparks of innovation and a spirit of creativity have fueled the transformation of our field. When treating patients with glaucoma, for example, current surgical alternatives are far safer than the full-thickness filters of the past. With regard to diagnostics, the optic nerves of patients with glaucoma can be followed up using imaging devices that can detect early changes either in the contour of the disc or in the thickness of the nerve fiber layer. This is a critical advance over the more qualitative approach of comparing disc photographs, especially since skilled ophthalmic photographers are scarce. These are just a few of the changes that have led to better patient outcomes and a more cost-effective delivery of care. Changes in patent law outlined in the Leahy-Smith America Invents Act (AIA)1 may continue to keep the United States at the forefront of translational science. Considering the importance of technology in advancing our discipline, this Viewpoint will explore the essence of the new provisions launched on March 16, 2013, and will consider how they may impact the pace of effectively applying discoveries in the care of patients and our communities. The AIA1 addresses widespread criticisms of the US Patent and Trademark Office (USPTO). Moreover, universities, companies, and the investment community have long voiced frustration with the backlog of nearly 700 000 unexamined applications.2 Business and research communities have also advocated for greater global patent harmonization. As innovators seek to tap into global markets, it is critical that the global patent system provide consistent, cost-effective avenues to obtain reliable patent rights in multiple jurisdictions. Chief among the changes is the First-Inventor-to File provision, which replaces the First-to-Invent patent system in the United States and aligns with international standards. This provision will facilitate the protection of intellectual property internationally compared with the challenge of proving inventor status in the previous nonaligned systems. Consider the following example. Two competing device companies develop similar new methods to reduce intraocular pressure and decide to market publicly. Under the previous rules, the patent would be granted to the company that could prove that it was first to conceive and reduce the invention to practice, by reviewing internal documents, such as laboratory notebooks and engineering documents. Under the AIA, the company that simply files the patent application first will be awarded the patent. Although consistency with other countries is a step forward, inventors must also be cognizant of their responsibility to file a more comprehensive ini-
tial, provisional application. This important first step in the process preserves the 1-year grace period to publish and protects inventors’ intellectual property as they collaborate with others, which is particularly important given the more expanded scope and definition of prior art. Prior art, defined as all information disclosed to the public in any form about an invention, now includes information available globally extending back to the filing date of the patent, rather than just the patent’s publication date.3 Consequently, much more prior art will be available including the types of information. Ensuing patent application claims may be at a greater risk of being limited because of increased volume of allowable prior art now available that an examiner may find or a competitor may submit. Understanding the changes is critical, because failure to conduct a thorough prior art search or to file a timely provisional patent may eliminate inventors’ rights. In the past, inventors could have years to develop data and claims for patent filings. Under the AIA, they must file patent applications quickly or risk losing claim to their inventions. Inventors may now feel the need to be more secretive regarding their innovation efforts to avoid tipping off another party that may then outpace them to a patent. Collaborations with industry partners and between institutions, occurrences that are not unusual in ophthalmology, will now have to be meticulously planned with a detailed communications strategy to mitigate unplanned disclosures. This can be done through dedicated systems that offer secure processes for information exchange, such as an automated submitter communications process, screens, filters, analytics, and other processes to protect both parties without requiring restrictive confidentiality conditions.4 The goal is to establish a balance between an open culture that fosters innovation and the need to monitor the flow of information between collaborators to prevent the disclosure of confidential information. Institutions and inventors must adapt their current intellectual property practices to prepare for these major revisions to protect their rights to a return on innovation. The AIA enables the USPTO to reduce fees by as much as 75%, targeting microentities, a new applicant definition that includes low-income organizations with assigned rights from inventors and institutions of higher education.5 Moreover, the USPTO will now implement a fee-based prioritized examination to support a 1-year accelerated review time. In addition, the USPTO will now retain user fees, enhancing the office’s resources, enabling it to expedite the entire prosecution process and reduce the backlog of applications. The addition of an ombudsman should also reduce the time that the appliJAMA Ophthalmology February 2014 Volume 132, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archopht.jamanetwork.com/ by a University of Arizona Health Sciences Library User on 05/29/2015
137
Opinion Viewpoint
cation may be delayed in the process.1 Ultimately, reduced fees and a shorter process will mitigate the financial burden experienced by patent applicants. The timing of these changes in the AIA comes during a dynamic period when other stages of the development and commercialization process of new inventions are impacted. Consider the recently created National Center for Advancing Translational Sciences supporting Clinical Translational Centers nationally, the Cures Acceleration Network,6 and better collaboration between agencies, particularly between the Food and Drug Administration and the National Institutes of Health. These initiatives may accelerate translational development in ophthalmology and may usher in potentially new streams of funding. Capital is a critical requirement for innovation and is often scarce, particularly during early development stages. Strategic investors not only require solid patent protection but prefer that their investments easily overcome regulatory and reimbursement barriers. Trends, such as interdisciplinary and transdisciplinary research collaborations and
_implementation/20110916-pub-l112-29.pdf. Accessed March 21, 2013.
ARTICLE INFORMATION Published Online: December 5, 2013. doi:10.1001/jamaophthalmol.2013.5645. Conflict of Interest Disclosures: Drs Higginbotham and Egbuonu-Davis and Ms Upadhyay are cofounders and directors of ROI Squared. Additional Contributions: We acknowledge K. Angela MacFarlane, president and CEO of Forsight Labs, and Jeff Grainger for technical review of the manuscript. REFERENCES 1. Leahy-Smith America Invents Act. Public L No. 11-29, 125 Stat 284 (2011). http://www.uspto.gov/aia
138
greater communication between agencies, should advance efforts within ophthalmology to increase the development of new ideas and reduce the time when these new ideas can be applied to the care of our patients. Although the ecosystem of innovation relies on a number of factors working in harmony, the AIA establishes a more even playing field. The potential benefit for accelerating innovation with implementation of the AIA will only occur if organizations take advantage of more timely patent review and international harmonization and carefully manage disclosures, comprehensive initial filings, and prior art searches. Effective allocation of resources, commitment to early filing of comprehensive claims, and education of stakeholders about the more expansive definition of prior art will be key drivers. Those institutions that develop an agile innovation infrastructure will be in a better position to take advantage of the new provisions. We are optimistic that the changes in the patent law and a more robust, national infrastructure that fosters translational research will accelerate innovation in the United States.
2. Director's forum: a blog from USPTO's leadership: first office action backlog dips below 700,000. US Patent and Trademark Office website. http://www.uspto.gov/blog/director/entry/first _office_action_backlog_dips. Published July 12, 2011. Accessed March 21, 2013. 3. Appendix L: patent laws. United States Code Title 35—patents. Updated October 1, 2011. Incorporates the changes made by the Leahy-Smith America Invents Act, Public Law 112-29, 125 Stat. 284 (Sept. 16, 2011). US Patent and Trademark Office website. www.uspto.gov/web/offices/pac /mpep/mpep-9015-appx-l.html#d0e302383. Accessed March 21, 2013.
4. Berry S. First-to-file patent rule threatens Medtech R&D. http://www.mddionline.com/article /first-file-patent-rule-threatens-medtech-rd. Published April 3, 2013. Accessed April 23, 2013. 5. Fees and budgetary issues. US Patent and Trademark Office website. http://www.uspto.gov /aia_implementation/fees.jsp. Accessed March 21, 2013. 6. National Institutes of Health Office of Communications. NIH establishes National Center for Advancing Translational Sciences. http://www .nih.gov/news/health/dec2011 /od-23.htm. Published December 23, 2011. Accessed March 2, 2013.
JAMA Ophthalmology February 2014 Volume 132, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archopht.jamanetwork.com/ by a University of Arizona Health Sciences Library User on 05/29/2015
jamaophthalmology.com
VIEWPOINT
Eve J. Higginbotham, SM, MD Department of Ophthalmology, Emory University, Atlanta, Georgia, ROI Squared, LLC, Bethesda, Maryland, and currently at Perelman School of Medicine and the Leonard Davis Institute, University of Pennsylvania, Philadelphia. Aparna Upadhyay, BS ROI Squared, LLC, Bethesda, Maryland. Lisa Egbuonu-Davis, MD, MBA, MPH ROI Squared, LLC, Bethesda, Maryland.
Corresponding Author: Eve J. Higginbotham, SM, MD, Perelman School of Medicine and Leonard Davis Institute, University of Pennsylvania, 291 John Morgan Bldg, 3620 Hamilton Walk, Philadelphia, PA 19104 ([email protected] .edu). jamaophthalmology.com
The New Patent Law May Accelerate Innovation in Ophthalmology Ophthalmic practice has changed significantly during the last 30 years. Sparks of innovation and a spirit of creativity have fueled the transformation of our field. When treating patients with glaucoma, for example, current surgical alternatives are far safer than the full-thickness filters of the past. With regard to diagnostics, the optic nerves of patients with glaucoma can be followed up using imaging devices that can detect early changes either in the contour of the disc or in the thickness of the nerve fiber layer. This is a critical advance over the more qualitative approach of comparing disc photographs, especially since skilled ophthalmic photographers are scarce. These are just a few of the changes that have led to better patient outcomes and a more cost-effective delivery of care. Changes in patent law outlined in the Leahy-Smith America Invents Act (AIA)1 may continue to keep the United States at the forefront of translational science. Considering the importance of technology in advancing our discipline, this Viewpoint will explore the essence of the new provisions launched on March 16, 2013, and will consider how they may impact the pace of effectively applying discoveries in the care of patients and our communities. The AIA1 addresses widespread criticisms of the US Patent and Trademark Office (USPTO). Moreover, universities, companies, and the investment community have long voiced frustration with the backlog of nearly 700 000 unexamined applications.2 Business and research communities have also advocated for greater global patent harmonization. As innovators seek to tap into global markets, it is critical that the global patent system provide consistent, cost-effective avenues to obtain reliable patent rights in multiple jurisdictions. Chief among the changes is the First-Inventor-to File provision, which replaces the First-to-Invent patent system in the United States and aligns with international standards. This provision will facilitate the protection of intellectual property internationally compared with the challenge of proving inventor status in the previous nonaligned systems. Consider the following example. Two competing device companies develop similar new methods to reduce intraocular pressure and decide to market publicly. Under the previous rules, the patent would be granted to the company that could prove that it was first to conceive and reduce the invention to practice, by reviewing internal documents, such as laboratory notebooks and engineering documents. Under the AIA, the company that simply files the patent application first will be awarded the patent. Although consistency with other countries is a step forward, inventors must also be cognizant of their responsibility to file a more comprehensive ini-
tial, provisional application. This important first step in the process preserves the 1-year grace period to publish and protects inventors’ intellectual property as they collaborate with others, which is particularly important given the more expanded scope and definition of prior art. Prior art, defined as all information disclosed to the public in any form about an invention, now includes information available globally extending back to the filing date of the patent, rather than just the patent’s publication date.3 Consequently, much more prior art will be available including the types of information. Ensuing patent application claims may be at a greater risk of being limited because of increased volume of allowable prior art now available that an examiner may find or a competitor may submit. Understanding the changes is critical, because failure to conduct a thorough prior art search or to file a timely provisional patent may eliminate inventors’ rights. In the past, inventors could have years to develop data and claims for patent filings. Under the AIA, they must file patent applications quickly or risk losing claim to their inventions. Inventors may now feel the need to be more secretive regarding their innovation efforts to avoid tipping off another party that may then outpace them to a patent. Collaborations with industry partners and between institutions, occurrences that are not unusual in ophthalmology, will now have to be meticulously planned with a detailed communications strategy to mitigate unplanned disclosures. This can be done through dedicated systems that offer secure processes for information exchange, such as an automated submitter communications process, screens, filters, analytics, and other processes to protect both parties without requiring restrictive confidentiality conditions.4 The goal is to establish a balance between an open culture that fosters innovation and the need to monitor the flow of information between collaborators to prevent the disclosure of confidential information. Institutions and inventors must adapt their current intellectual property practices to prepare for these major revisions to protect their rights to a return on innovation. The AIA enables the USPTO to reduce fees by as much as 75%, targeting microentities, a new applicant definition that includes low-income organizations with assigned rights from inventors and institutions of higher education.5 Moreover, the USPTO will now implement a fee-based prioritized examination to support a 1-year accelerated review time. In addition, the USPTO will now retain user fees, enhancing the office’s resources, enabling it to expedite the entire prosecution process and reduce the backlog of applications. The addition of an ombudsman should also reduce the time that the appliJAMA Ophthalmology February 2014 Volume 132, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archopht.jamanetwork.com/ by a University of Arizona Health Sciences Library User on 05/29/2015
137
Opinion Viewpoint
cation may be delayed in the process.1 Ultimately, reduced fees and a shorter process will mitigate the financial burden experienced by patent applicants. The timing of these changes in the AIA comes during a dynamic period when other stages of the development and commercialization process of new inventions are impacted. Consider the recently created National Center for Advancing Translational Sciences supporting Clinical Translational Centers nationally, the Cures Acceleration Network,6 and better collaboration between agencies, particularly between the Food and Drug Administration and the National Institutes of Health. These initiatives may accelerate translational development in ophthalmology and may usher in potentially new streams of funding. Capital is a critical requirement for innovation and is often scarce, particularly during early development stages. Strategic investors not only require solid patent protection but prefer that their investments easily overcome regulatory and reimbursement barriers. Trends, such as interdisciplinary and transdisciplinary research collaborations and
_implementation/20110916-pub-l112-29.pdf. Accessed March 21, 2013.
ARTICLE INFORMATION Published Online: December 5, 2013. doi:10.1001/jamaophthalmol.2013.5645. Conflict of Interest Disclosures: Drs Higginbotham and Egbuonu-Davis and Ms Upadhyay are cofounders and directors of ROI Squared. Additional Contributions: We acknowledge K. Angela MacFarlane, president and CEO of Forsight Labs, and Jeff Grainger for technical review of the manuscript. REFERENCES 1. Leahy-Smith America Invents Act. Public L No. 11-29, 125 Stat 284 (2011). http://www.uspto.gov/aia
138
greater communication between agencies, should advance efforts within ophthalmology to increase the development of new ideas and reduce the time when these new ideas can be applied to the care of our patients. Although the ecosystem of innovation relies on a number of factors working in harmony, the AIA establishes a more even playing field. The potential benefit for accelerating innovation with implementation of the AIA will only occur if organizations take advantage of more timely patent review and international harmonization and carefully manage disclosures, comprehensive initial filings, and prior art searches. Effective allocation of resources, commitment to early filing of comprehensive claims, and education of stakeholders about the more expansive definition of prior art will be key drivers. Those institutions that develop an agile innovation infrastructure will be in a better position to take advantage of the new provisions. We are optimistic that the changes in the patent law and a more robust, national infrastructure that fosters translational research will accelerate innovation in the United States.
2. Director's forum: a blog from USPTO's leadership: first office action backlog dips below 700,000. US Patent and Trademark Office website. http://www.uspto.gov/blog/director/entry/first _office_action_backlog_dips. Published July 12, 2011. Accessed March 21, 2013. 3. Appendix L: patent laws. United States Code Title 35—patents. Updated October 1, 2011. Incorporates the changes made by the Leahy-Smith America Invents Act, Public Law 112-29, 125 Stat. 284 (Sept. 16, 2011). US Patent and Trademark Office website. www.uspto.gov/web/offices/pac /mpep/mpep-9015-appx-l.html#d0e302383. Accessed March 21, 2013.
4. Berry S. First-to-file patent rule threatens Medtech R&D. http://www.mddionline.com/article /first-file-patent-rule-threatens-medtech-rd. Published April 3, 2013. Accessed April 23, 2013. 5. Fees and budgetary issues. US Patent and Trademark Office website. http://www.uspto.gov /aia_implementation/fees.jsp. Accessed March 21, 2013. 6. National Institutes of Health Office of Communications. NIH establishes National Center for Advancing Translational Sciences. http://www .nih.gov/news/health/dec2011 /od-23.htm. Published December 23, 2011. Accessed March 2, 2013.
JAMA Ophthalmology February 2014 Volume 132, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archopht.jamanetwork.com/ by a University of Arizona Health Sciences Library User on 05/29/2015
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