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Innovation Patent Law

An Ever-Weakening Patent System is Threatening the Future of American Innovation

dictionary entry for the word "innovate"Over the past ten years, the United States patent system has been transformed by new legislation, regulatory actions, and numerous decisions by the Supreme Court addressing nearly every area of patent doctrine. The many disruptive legal changes have affected infringement remedies, licensing activities, and what types of inventions and discoveries are eligible for patent protection, resulting in a profound sense of uncertainty for most stakeholders. This current state of doubt about the American patent system is pushing investors to look outside of the US for less risky ventures. And because investors are shifting their focus overseas, foreign countries are for the first time poised to bypass the US as the forerunners of innovation.

Last month, the United States Patent & Trademark Office (USPTO), along with the University of Texas Law School and Antonin Scalia Law School, George Mason University, hosted the 12th annual Advanced Patent Law Institute in Alexandria, Virginia. The program featured a distinguished panel of patent experts discussing “current issues around patenting, licensing, enforcing, and monetizing patents in the U.S., and look[ing] at what the UK, EU, and China are experiencing and the impact on U.S. patent practice.” Titled The Current Patent Landscape in the US and Abroad and focusing on the economic factors that spur invention, the consensus was that dramatic changes to the US patent system are driving investment in research and development outside the country and threatening the future of American innovation.

US Patent System No Longer Adequately Incentivizes Investment

Serving as co-moderator with the Hon. Paul R. Michel, Robert Sterne—a leading patent attorney and founding partner of Sterne, Kessler, Goldstein & Fox—kicked off the panel with an overview of a patent system that is falling behind China and the European Union as a driver of innovation. Questioning the Supreme Court’s radical distortion of patent law over the last ten years and the institution of post-grant review, Sterne pointed out that the Patent Trial and Appeals Board (PTAB) has produced over 6,000 proceedings, with patent owner success rates hovering between a meager 30 to 40%. Because of these discouraging numbers, and because injunctive relief has become almost impossible to obtain for patent owners, Sterne warned that critical investment in small and medium-sized companies and universities is rapidly declining.

Judge Michel echoed many of the same sentiments, expressing concern with the “health and vitality and effectiveness of the patent system.” Michel stressed that the principle goal of the patent system is to incentivize investment, but that continued assaults on the system are driving investors to foreign jurisdictions and moving the US in the direction of “off-shore invention.” Citing studies by the Kauffman Foundation and US Census Bureau, Michel explained that most new jobs come from small start-up companies dependent on technology, and that without adequate incentives to invest in these job creators, the patent system and economy are in serious danger.

Expanding on the problem of investment incentivizes, Paul Stone—a partner at venture capital firm 5AM Ventures—discussed his backing over 60 life science startups in the last 15 years, all of which specialized in therapeutics aimed at developing life-saving drugs and drug delivery technologies. Stone offered the following three points to consider regarding the current innovative investment landscape: (1) 60% of the new drugs approved in 2016 came from venture capital-funded small biopharmaceutical companies, not pharma industry giants, (2) of these new approvals, the origin of half the molecules are outside the United States, a much higher percentage than ten years ago, and (3) personalized medicine and the influence of information technology on biotech is leading to smaller market sizes, and a weaker patent system is threatening the ability to realize a return on investments in this area.

Innovation is Moving Overseas

Damon Matteo of Fulcrum Strategy, an IP asset management firm, began his comments with an ominous warning: “Be afraid, be very afraid.” As a practicing IP attorney, Matteo noted that he has seen clients increasingly interested in securing their IP in Europe and China rather than the US, and that China specifically is embracing the software and business method patents that have been abandoned by the US system. Investment has been moving overseas because that’s where patents still have value. Matteo also pointed out that China has been much more favorable to patent owners in IP litigation, as plaintiffs in infringement suits prevail 60% of the time. And injunctive relief—which has become a completely improbable outcome in US litigation—is granted in upwards of 90% of infringement cases in China when there’s been a finding of infringement.

Peter Detkin, founder of the IP development and licensing company Intellectual Ventures, weighed in on some of the “alternative facts” and hysteria that have resulted in the current state of the US patent system. Despite claims over the last 15 years that extortionary demand letters were being sent by the thousands, patent ligation had gotten out of control, and patents were killing investment in R&D and startups, Detkin pointed to multiple analyses by government agencies such as the FTC and the Government Accountability Office that revealed no such exceptional activity. Unfortunately, policymakers took the bait, and entrepreneurs in Silicon Valley have suffered as a result of over-reactive legislative and judicial efforts.

As in-house Chief Intellectual Property Officer of Vivant, a fast-growing home security technology company, Paul Evans provided more insight into how absolutely vital patents are to investments and private equity–backed tech startups, emphasizing how “patents have historically created an important competitive advantage in the marketplace.” Sharing a recent professional anecdote, Evans recounted a conversation with the managing director of a private equity firm with $10 billion in assets in which they discussed the past successful sale of a company based largely on its strong patent portfolio. The two agreed that the transaction would never have happened today due to the immeasurable decline in the value of patents. Evans noted that about 85% of small businesses in the US are now technology based, and that if our patent system can’t protect the inventions they rely on, investments and jobs will be reallocated to jurisdictions that will.

Shifting the discussion to the effect innovation uncertainty is having on universities, patent law and tech transfer expert Chris Gallagher warned that university research funding is at risk, and that the system of grants can no longer be relied upon. Despite a recent case that found the 11th amendment shielded state-chartered schools from IPR exposure, Gallagher encouraged all stakeholders to reach out to Congress to push back on the persistent troll narrative that continues to affect university research.

Efficient Infringement is Devaluing Patents

The panel then moved into a discussion of the increasingly common practice of “efficient infringement,” where companies choose to infringe patents instead of licensing, understanding that the current system has made enforcing patents too expensive and risky. Damon Matteo likened the practice to robbing a bank, getting caught, and as a punishment, only having to return a fraction of the money. Peter Detkin then expanded on the analogy:

It’s a great analogy — the bank robbery — because you not only get to say whether you get caught, but if you get caught, you’ll then be able to argue to the Federal Reserve that the bank really shouldn’t have existed in the first place. Then if that fails, you get to argue to them again that their certificate never should have issued, because it’s a different ground than the first time you argued. Then you could argue that the money was improperly issued to the bank… you have all these administrative ways.

Commenting on efficient infringement, Paul Evans explained that bringing a suit for patent infringement now makes no sense, as the current ecosystem demands high costs to defend patents subject to inter partes review (IPR). According to Evans, the cost of each IPR is between $200,000 and $300,000. IPRs are instituted 70% of the time, and of those cases, 80% of the challenged claims are invalidated. Evans noted that investors are aware of these realities and are hesitant to back certain patent-reliant companies. As a result of the uncertain innovative economy in the US, Peter Detkin noted that patent application filings are down, as well as enforcement actions. Alternatively, countries in Asia and the European Union that have embraced software and biotech patents have seen an increase in filings, enforcement actions, licensing, and investment.

Judge Michel then identified software and health science technology as suffering the most under the current “huge cloud of uncertainty,” and pointed out that China and Europe have broadened patent eligibility in these two tech fields as the US Supreme Court has narrowed it. Michel questioned how anyone could make a eligibility determination given the vague standard set by the Mayo and Alice decisions, and expressed frustration in the Supreme Court’s denial of cert in Sequenom v. Ariosa—a case that would have given the Court an opportunity to correct or at least clarify the Section 101 eligibility analysis. With the Supreme Court unwilling to clean up its mess, Judge Michel expressed support for statutory amendments to 101 recently proposed by the Intellectual Property Owners Association (IPO).

Confidence Must Be Restored in the US Patent System

Wrapping up the panel, Robert Sterne made clear that the patent troll narrative that contributed to so many drastic changes in the US patent system is outdated and no longer relevant. While uncertainty about Section 101 eligibility is ubiquitous, Sterne asserted that “[w]hat is clear is that things are not getting better for innovators in the United States who are relying on the U.S. patent system and who are creating a large bulk of the innovation in our country.” And in addition to losing an edge to foreign jurisdictions in industrial competiveness and job creations, Sterne warned that missing out on innovations in the technology the US employs to protect itself could have dire consequences for national security.

In conclusion, Sterne asked each panelist—as practitioners working in the innovation economy—what they would suggest to bring a sense of confidence back to the bleak patent law landscape. Judge Michel encouraged writing to bring awareness to the situation, including articles, op-eds, and direct letters to members of Congress. Paul Stone urged all stakeholders to focus on quality—specifically on the quality of patents reviewed and the quality of advice given to clients. Damon Matteo suggested adopting a financial mindset that considers the dynamics of returns on investments, which would help stakeholders see patents for the commercial instruments they are and should be. Peter Detkin stressed the importance of relying on hard, verifiable data, not anecdotes and hysteria. Paul Evans discussed the need to create an ecosystem that can be viewed by the investment community with some sense of understanding and confidence. Finally, Chris Gallagher insisted that, no matter the excuses of not having enough time, or not wanting to offend the wrong people, everyone must get involved to insert integrity back into the innovative ecosystem.

The concerns expressed by this panel are being echoed by stakeholders in almost every section of the innovation economy, and without a concerted effort to bring sense and clarity back to the patent system, the US is in danger of losing its competitive and innovative edge.

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Patent Law

CPIP Publishes Prof. John F. Witherspoon’s Tribute to the Late Judge Giles S. Rich

Judge Giles S. RichCPIP has published a tribute to Judge Giles S. Rich by Professor John F. Witherspoon. Prof. Witherspoon is Director Emeritus, Intellectual Property Program, Antonin Scalia Law School. Prof. Witherspoon’s career in government, academia, and private practice spans more than fifty years.

After practicing with a patent law firm in Washington, Prof. Witherspoon was appointed by the President in 1971 to be an Examiner-in-Chief and to serve on the then Board of Appeals in the Patent Office. Prof. Witherspoon returned to private practice in 1978 and continued practicing law until he retired in 2016. In 1992, Prof. Witherspoon was invited to join the adjunct faculty at Antonin Scalia Law School as Distinguished Professor of Intellectual Property Law and to head the School’s intellectual property law program.

Upon graduating from Georgetown Law School, Prof. Witherspoon clerked for the Honorable Giles S. Rich at the U.S. Court of Customs and Patent Appeals (now the U.S. Court of Appeals for the Federal Circuit). This tribute is adapted from Prof. Witherspoon’s remarks delivered at the January 18, 2017, meeting of the Giles Sutherland Rich American Inn of Court. Prof. Witherspoon pays a heart-warming tribute to the late Judge Rich, whom many regard as one of the foremost authorities on U.S. patent law.

To read the tribute, please click here.

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Innovate4Health Innovation

CPIP & ITIF Launch “Innovate4Health” Policy Research Initiative

Innovate4HealthIn celebration of World Intellectual Property Day on April 26, 2017, the Center for the Protection of Intellectual Property (CPIP) today joined with the Information Technology and Innovation Foundation (ITIF) to launch “Innovate4Health,” a joint project to promote the critical role that intellectual property rights play in spurring innovative solutions to pressing global health challenges.

People all over the world live better than ever before thanks to innovation. New medicines prevent or alleviate disease. New devices diagnose problems, repair bodies, and overcome physical challenges. Still other inventions keep vaccines and medicines fresh and effective or ensure their authenticity. New business models help innovation to happen and ensure that it reaches those who need it.

Many of these innovations are secured by intellectual property rights, which support the ability of innovators to invent and bring solutions to market. Property rights, particularly intellectual property rights, foster the freedom of many hands and many minds to work on challenging problems. They put decisions in the hands of those closest to problems — innovators with knowledge of potential solutions and caregivers and consumers who understand their own needs best. They fund individual careers and industries dedicated to fixing health problems, as well as the businesses that get these solutions to individuals.

Our Innovate4Health project is providing case studies that describe how IP-driven innovation is tackling some of the world’s toughest health issues, including:

• A cooler that ensures vaccines are safe in areas without power;
• A portable eye examination kit to move care out of the office and into the field;
Retractable syringes to prevent needlestick injuries;
• A baby warmer that can adapt to volatile electricity conditions;
Point-of-care testing for malaria that anyone can use;
• A smartphone app that instantly checks the authenticity of pharmaceutical drugs; and
• A new anti-inflammatory drug derived from Brazil’s diverse ecology.

Learn more about Innovate4Health here.

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Innovation Pharma

The Drug Innovation Paradox: Matching Incentives to Market Realities

scientist looking through a microscopeThe hardest things are often the most important things. That’s one of the implicit justifications for the intellectual property system. If we want people to do the hard and important work of researching, developing, and commercializing game-changing innovations, then we need to secure the fruits of their labor with property rights.

In her forthcoming paper, The Drug Innovation Paradox,[1] Professor Erika Lietzan of the University of Missouri School of Law gives reason to question whether our IP and regulatory system is properly encouraging pharmaceutical innovators to work on the most important, and hardest, questions.

This paper, produced while Prof. Lietzan was a CPIP Edison Innovation Fellow, considers a paradox. Some of the biggest health challenges, the most important things, are indeed the hardest things. Therapies for diseases such as multiple sclerosis and Alzheimer’s demand research, development, and testing that takes longer. Unfortunately, the longer something takes to develop, the shorter the term of exclusivity under the IP system, and thus the less secure the investment.

The drug innovation paradox is that the hardest and most important cures are often the ones most poorly supported by our IP system.

Combining several different data sources for the first time, Prof. Lietzan presents comprehensive statistical findings that bring the extent of the drug innovation paradox into focus. The implications for innovation policy are profound, especially if we wish to see groundbreaking new therapies that are inherently more difficult to develop.

Incentives are particularly important in the pharmaceutical industry, where the average cost of developing an approved new medicine is over two billion dollars.[2] Drugmakers would hardly invest so much without the promise of exclusivity once the medicine goes to market. However, the period of exclusivity—the incentive—we give to drugmakers depends upon how long it takes them to bring a new medicine to the market. The more time they spend on developing a new medicine, the less reward they receive for their troubles by way of a shorter patent term.

In the United States, it takes 3.5 years on average for a patent to issue, and in many industries, patent owners thus might expect to enjoy around 16.5 years of clear market exclusivity.[3] However, things are very different in the pharmaceutical industry, where the safety and efficacy of a new drug has to be proven before it can be marketed. Years of preclinical testing and clinical trials run down the patent term clock while a drugmaker awaits approval. Congress has instituted measures to restore a portion of the time lost, but the fact remains that longer development programs result in shorter periods of exclusivity.

Pouring over the data going back to 1984, Prof. Lietzan examines the variables that play a role in perpetuating the drug innovation paradox. Critically, she notes that many of the factors that consistently lead to longer development programs—including the drug, disease, and endpoints to be met—are simply beyond a drugmaker’s control. Of course, it is impossible to say for certain what drugs were never invented because the incentives were not there. But the data does give us an accurate sense of how many years spent in development are lost when the patent expires.

For example, Prof. Lietzan breaks down the data with respect to the category of therapy being developed. As the following figure shows, the average length of the clinical testing period for some therapeutic categories ranges from about 3 to 9 years:

Figure 5. Average Clinical Testing Period by Therapeutic Category. Y-axis: therapeutic category (n). X-axis: Length of Clinical Testing Period in Years (0 through 10). Antimigraine agents (6) – 2.99. Ophthalmic (26) – 4.38. Sleep disorder (5) – 4.47. Antibacterials (51) – 4.59. Antivirals (27) – 4.68. Imaging agents (28) – 5.05. Antifungals (14) – 5.13. Genitourinary (12) – 5.29. Dermatological (13) – 5.38. Anesthetics (8) – 5.57. Metabolic bone disease (7) – 5.58. Respiratory/pulmonary (32) – 5.73. Blood glucose regulators (20) – 6.06. Antidementia agents (5) – 6.08. Cardiovascular drugs (65) – 6.12. Hormonal (31) – 6.33. Analgesics & anti-inflammatories (13) – 6.38). Antineoplastics (58) – 6.39. Antiemetics (7) – 6.58. Blood products (17) – 6.70. Gastrointestinal (19) – 6.72. Immunological (10) – 6.77. Antiparkinson’s agents (7) – 7.48. Anticonvulsants (13) – 8.13. Antidepressants (16) – 8.49. Antipsychotics (9) – 8.63. Central nervous system (13) – 9.30.

It is important to note that this lengthy testing period represents only one part of a development program, and the preclinical testing period has to be taken into account as well. Prof. Lietzan estimates that the average preclinical testing period for new drugs is 5.61 years. It is easy to see how the majority of the patent term for drugs that fall into certain therapeutic categories may be gone before the drug even enters the market.

The danger of the drug innovation paradox is that we may be under-incentivizing pharmaceutical research and development for drugs that are inherently more difficult to develop. The next great breakthrough treatment for difficult-to-treat diseases like cancer or multiple sclerosis may never be developed unless the incentives are there to reward drugmakers for taking the risk to develop the treatments in the first place. The data collected by Prof. Lietzan shows us just how time-consuming these endeavors can be, and they suggest that we should break the paradox if we hope to have even greater drug innovation.

CPIP is pleased to once again have Prof. Lietzan as a CPIP Edison Innovation Fellow for 2017 – 2018. We look forward to supporting more of her groundbreaking work on this difficult, but absolutely important, issue.


[1] Erika F. Lietzan, The Drug Innovation Paradox, 83 Mo. L. Rev. ___ (2018), available at https://papers.ssrn.com/abstract_id=2948604.

[2] See Joseph A. DiMasi et al., Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs, 47 J. Health Econ. 20 (2016) (estimating average total pre-approval cost of approved new compound at $2.558 billion in 2013 dollars), available at https://www.ncbi.nlm.nih.gov/pubmed/26928437.

[3] See Mark Schultz & Kevin Madigan, The Long Wait for Innovation: The Global Patent Pendency Problem (Ctr. for the Prot. of Intell. Prop. Oct. 2016), available at http://sls.gmu.edu/cpip/wp-content/uploads/sites/31/2016/10/Schultz-Madigan-The-Long-Wait-for-Innovation-The-Global-Patent-Pendency-Problem.pdf.

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Innovate4Health Innovation

Innovate4Health: Meeting the Needs of Rural Africa with Fyodor’s Point-of-Care Testing for Malaria

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Jaci Arthur

Every year, more than 200 million cases of malaria are reported worldwide. It can often be mistaken for a less serious malady, as symptoms include “fever, chills, and flu-like illness.” If quickly identified, the disease is treatable. Yet more than 655,000 people, mostly children in sub-Saharan Africa, died from malaria in 2016.

Expeditious diagnosis of the disease can result in faster treatment and lower mortality rates. The patented Urine Malaria Test (UMT) developed by Dr. David Sullivan, a Johns Hopkins Bloomberg School of Public Health professor and microbiologist, addresses this global challenge by offering a rapid, accurate, more convenient, and less expensive alternative to traditional laboratory testing. The UMT is also the first point-of-care (POC) test for malaria that does not require the use of trained personnel or a blood sample.

90% of all malaria-related deaths in 2015 occurred on the African continent. Much of this can be attributed to a lack of access to health services and personnel due to poverty, remoteness, and a general lack of healthcare infrastructure. According to a 2011 report, about 31% of Ethiopians live on less than $1.25 a day. Even when health services are free of charge, trips to medical facilities are quite costly for the average, rural African because patients will often have to take an entire day off from work to travel.

In Niger, a patient may have to walk more than four hours to receive medical treatment at an overcrowded, ill-equipped facility. Many people turn to presumptive diagnosis or self-medication at the first sign of a fever, resulting in widespread drug resistance and more expensive treatments. Meanwhile, others gamble on the chance it is simply a virus that will pass, never seeking diagnosis or treatment.

On average, there are 1.15 health workers for every 1,000 people in sub-Saharan Africa, with numbers as low as 0.4 physicians for every 10,000 people in countries like Chad. The few laboratories in rural areas that can identify diseases such as malaria are underfunded, short-staffed, and ill-equipped. Although there are several POC tests for malaria, most of them require trained personnel taking a blood sample. Having a proper diagnosis within twenty-four hours of the onset of symptoms can reduce the mortality rate, but such diagnosis is difficult for most Africans. All these factors lead to a deadly combination, especially for those in rural Africa.

Maryland-based Fyodor Biotechnologies was founded in 2008 by Nigerian biotechnologist Eddy Agbo specifically to address these problems. In 2009, the company was granted an exclusive worldwide license from Johns Hopkins University to research, develop, and commercialize the UMT.

As its name suggests, the UMT tests a patient’s urine, rather than blood, for “novel Plasmodium proteins,” and it provides results in less than twenty-five minutes, thus abating fears, eliminating the need for presumptive diagnosis, and reducing costly, lengthy, and unnecessary trips. Unlike other tests for malaria, the UMT can be taken at home and is as easy to use as an at-home pregnancy test. The UMT is currently priced at about two dollars each; however, Dr. Agbo intends for the price to be reduced once production increases.

Preclinical studies were conducted by researchers at Johns Hopkins University, and the UMT is currently in clinical validation. Fyodor intends to seek concurrent regulatory clearance from both the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) and the US Food and Drug Administration (FDA).

Initial commercialization efforts will be focused in Dr. Agbo’s home country of Nigeria before expanding to other areas significantly affected by malaria. Nigeria accounts “for 25% of all malaria cases in the African region.” Testing is also currently underway at Fyodor Biotechnologies for a “second generation broad-based Urine Malaria Test (UMT-Broad),” which will be useful for detecting other types of infection.

Fyodor Biotechnologies stepped onto the global market specifically to meet the needs of people in malaria endemic regions and reduce the mortality rate associated with this treatable disease. The company relies heavily on its exclusive license to Johns Hopkins University’s patent, as research, development, and production of the UMT are currently its sole function.

Fyodor’s two-dollar, at-home test is the perfect counter to claims that intellectual property rights, specifically patents, result in expensive healthcare and a lack of access to necessary medical services. Intellectual property rights have made quick, efficient, low-cost, and convenient testing for malaria a reality.

The UMT provides an ideal example of how patented innovation can conquer global challenges. It is a reasonable, rapid, efficient, convenient, economical alternative to a system that cannot meet the needs of the rural poor. And it is a reminder that innovation and intellectual property rights can work together for the common good.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Uncategorized

The Lawless Body – “Prior Judicial Opinions Did Not Bind the PTAB”

files labeled as "patents"No just and coherent legal system would permit an administrative body to invalidate a property right that a court had previously upheld. Unfortunately, exactly that result was just endorsed by the Court of Appeals for the Federal Circuit in Novartis AG v Noven Pharm., Inc.  In its April 4 Novartis decision, the Federal Circuit affirmed a finding by the Patent Trial and Appeal Board (PTAB) that two of Novartis’ patents were obvious and therefore invalid. The patents cover a transdermal patch for treating Alzheimer’s Disease, an important medical advance in treating a scourge of the elderly.

The Federal Circuit handles all patent appeals, and this was not the first time they addressed the patents at issue in the case. Previously, the Federal Circuit had found the patents were not obvious on appeal from a district court.  However, when the PTAB—a unit of the Patent & Trademark Office—reached the opposite result and invalidated the patents, the Federal Circuit accepted the inconsistent results as part of Congress’ design.  The court explicitly stated that consistent results in different proceedings are merely “aspiration[al].”

None of the Federal Circuit’s purported justifications can justify such a discrepancy from the foundational requirement of the rule of law and the Constitution that people and their property are treated equally. First, the court did not contend that the record in the two cases differed in any substantive way.  To underscore this point, the court specifically held that it would have followed the PTAB’s decision even if the records were the same.

Second, the court justified the inconsistency by citing the different standards of review applied by district courts and the PTAB. This reasoning is exactly backwards. The court was wrong to rely on different standards to justify inconsistent results.  Instead, we should rely on the inconsistent results as evidence that having two separate adjudicatory systems with widely differing procedures and standards is a problem.

It is difficult to imagine a worse-functioning system of property rights. After lengthy litigation in courts ordained by the Constitution, the second highest court upholds a patent. This validation is still not sufficient for patent owners to be secure in their property rights once administrative review at the PTAB begins.  Procedures at the PTAB are stacked against patent owners, as Greg Dolin has shown in a CPIP policy brief.  Unfortunately, the harms of this bias against innovators have just been ratified again by the Federal Circuit.

This is exactly the type of legal uncertainty that kills economic development, not to mention the incentives to create and commercialize the innovation the patent system is supposed to spur. Given the high stakes for the innovation economy, it is becoming increasingly clear that the courts will not do their constitutional job reining in an overreaching administrative tribunal. If the Patent Office itself won’t constrain itself to respect basic due process protections for property rights, then Congress should fix this constitutional and innovation-threatening disaster. The Novartis decision is just one more addition to a fast-growing, long list that proves this point.