Posts Tagged: "innovation"

On May 12, Frederick Reinhart published an article titled “Knowledge Ecology International Letter Misleads on March-In Rights.” Reinhart is a past president of the Association of University Technology Managers (AUTM), and his views echo those expressed by many in the university technology transfer field, including a frustration that not everyone acknowledges and appreciates the considerable investments and risks undertaken by the for-profit companies that license patents to inventions funded by the federal government. Knowledge Ecology International (KEI) recognizes the importance of the private sector in bringing therapies to the market, even when federal funding of R&D has played a role, and also that robust returns on those investments have a positive impact on innovation.

Last week, the House Committee on the Judiciary’s Subcommittee on Courts, Intellectual Property, and the Internet convened a hearing to perform oversight of the U.S. Patent and Trademark Office. USPTO Andrei Iancu fielded questions on Section 101 patent eligibility issues and fraudulent trademark application filings and, while several Representatives on the subcommittee noted Director Iancu’s procedural changes at the Patent Trial and Appeal Board (PTAB), much of the previous backlash to those changes seemed to have dissipated. In his opening statement, Representative Hank Johnson (D-GA), Chairman of the House IP Subcommittee, discussed the impact that issued patents have on small businesses, noting that the first patent granted to a startup results in the business both hiring an average of 16 employees and earning an average of $10.6 million in additional sales within five years. However, Johnson added that recent case law from the U.S. Supreme Court have resulted in major issues with patent eligibility under 35 U.S.C. § 101, threatening innovation in critical technology areas like medical diagnostics. He was also concerned by a rise in fraudulent trademark filings coming from China that can hurt American businesses trying to register legitimate marks.

Yesterday, we discussed patenting trends in artificial intelligence (AI). Today, we turn to the cleantech and green tech industries, which are changing many established industries in different sectors of the economy, as well as providing entirely new areas to innovate. Cleantech innovation is relatively steady in recent years after a growth spurt that started nearly a decade ago. Those early growth trends were likely driven by government stimulus funds that have disappeared along with the growing innovation trend.  The promise of a green revolution powered by cleantech may still be happening, but it simply is not a patent growth area in general except for a few areas explored below. Developing new products in this space takes years and there are many factors that interrupt this cycle to make product introduction difficult.

Is Congress really going to do anything useful with respect to lowering drug prices? When the question is presented that way the answer almost seems painfully obvious. Of course not. The question is just how bad they will mess things up, and will they destroy the incentive to innovate as they attempt to seek a very worthwhile solution for the problem of growing costs for healthcare. Unfortunately, the political climate in the United States has increasingly become more circus and circumspect than bold and visionary. It is better to do something entertaining and memorable that plays to the crowd than to go about the business of governing the country, not just for the moment, but for the future. And the political structures in place create outright gerrymandering that practically ensure the overwhelming percentage of Representatives have more to fear from a primary challenge than from a contender in the general election. It is no wonder nothing truly useful can get accomplished in Washington, DC.

Artificial intelligence (AI) has become a hot topic in both the tech and political spheres. This technology holds huge widespread potential, and strategic use of AI may well be a source of commercial and/or political power. For example, potential uses of AI may range from facilitating targeted and efficient drug development to controlling traffic lights (and thus reducing pollution and commute times), to developing life-like online personas. With all of the media attention that AI is receiving and with its widespread potential uses, how is a company to decide how fervently to pursue patents in this area and to weight their patent portfolios across different types of AI innovations?

Senators and Representatives Coons, Tillis, Collins, Johnson, and Stivers recently announced in a press release a proposed framework to fix patent eligibility law in the United States. If written as proposed in the draft framework, section 101 may do harm to the patent system. The senators and representatives are now soliciting feedback on the draft framework. They are likely to take additional action on the framework as soon as early this week. Please send the following text with any of your edits to [email protected].

Our last article in this series discussed patenting trends in the Therapeutics and Diagnostic Molecules Industry. Today, we turn to the blockchain industry, which is a foundational technology that is expected to revolutionize many different industries and not just digital currency. Blockchain patent filings are exploding, but we are still very early in the innovation cycle of this technology. Important to note about the data here: it is limited and especially thin, as this industry was just invented a decade ago, when there were just a handful of filings, and less than a thousand filings today. This is the only area in the greater study that was not long established, but the importance of blockchain is something that cannot be ignored in many industries. Although the most well-known application of blockchain is cryptocurrency, blockchain provides authenticity to any electronic transaction or contract in an open and trusted way. Blockchain underpins algorithmically protected currency but is expected to disrupt many other industries where algorithms can be trusted more than conventional mechanisms.

There will be debate on Capitol Hill this week around tech and innovation, as hearings get underway on Tuesday in the U.S. Senate on 5G networking issues related to national security and intellectual property, commercial space challenges, and the development of advanced rare earth element extraction technologies. On Wednesday, things heat up at the U.S. House of Representatives with Federal Communications Commission oversight, as well as wind and solar innovation efforts. The week closes on Thursday with hearings in both houses of Congress on weather forecasting innovation and technology. Elsewhere in Washington, DC, the Information Technology and Innovation Foundation kicks the week off on Monday by looking at efforts to reduce greenhouse gas emissions through innovation. On Wednesday, the Brookings Institution holds its inaugural conference looking at the intersection between technology and terrorism.

In our first article examining the 2018 patent market, we provided an overview of the data and found that prices were stabilizing across listings, buying and selling programs were becoming more streamlined, and there were more transactions overall. This trend extends to “patent packages” as well. At 591 packages (502 last year), listings have increased by 17.7%. The only year in which we saw more listings was the 2016 market. If the assets from Provenance Asset Group were included in these numbers, the numbers would show an all-time high. The number of total assets and of U.S.-issued patents also increased (see Table 2). We have benchmarked our deal flow with that of other large corporations and defensive aggregators and have found that the number of brokered packages we received is generally similar, so we are confident that our numbers reflect the market. Compared to prior years, the total number of U.S.-issued assets listed in packages increased twice as fast as the number of packages listed. Notably though, the total number of assets listed increased even more than the U.S.-issued assets. This signifies the continued importance of international assets and an elevated level of focus on elements of a package other than U.S.-issued assets. But, U.S.-issued assets are still the focus in most listings (see Figure 4). While we limit the types of package included in this dataset to the more common types (e.g. quasi-public/brokered packages containing 200 or fewer assets), we also track larger bulk deals and private deals.

Recently, Knowledge Ecology International sent to Congress a letter objecting to the draft “Green Paper on Unleashing American Innovation” disseminated by the National Institute of Standards and Technology (NIST) in December, 2018. The KEI letter was signed by 10 other organizations* (the Organizations). The letter, unfortunately, is full of misstatements, distortions, falsehoods and disingenuous arguments. It would be easier to focus on the letter’s one accurate statement:  that high drug prices are a serious concern for people everywhere. It is very unfortunate that KEI, in my opinion, utilizes tactics which continually sacrifice fair and constructive dialog in favor of apparently achieving goals “by any means necessary.” The most disturbing element of the letter is KEI’s advocacy of inappropriate and unjustified use of government march-in rights under the Bayh-Dole Act as a purported means of controlling drug prices. In doing so KEI and the Organizations are threatening medical advances and thereby undermining their own missions.

The U.S. Court of Appeals for the Federal Circuit recently affirmed the Patent Trial and Appeal Board’s (PTAB’s) decision upholding the patentability of Eli Lilly & Co.’s patent claims directed to reducing toxicity of a chemotherapy agent. In so holding, the Federal Circuit cited the Food and Drug Administration’s (FDA’s) skepticism of the efficacy of the methods as evidence supporting non-obviousness. See Neptune Generics, LLC v. Eli Lilly & Co., Nos. 2018-1288, 2018-1290, 2019 U.S. App. LEXIS 12492 (Fed. Cir. Apr. 26, 2019) (Before Moore, Wallach, and Hughes, J.) (Opinion for the Court, Moore, J.) Neptune Generics, LLC, Fresenius Kabi USA, LLC, and Mylan Laboratories Ltd. (collectively, the Petitioners) filed three petitions for inter partes review (IPR) against claims 1-22 of U.S. Patent No. 7,772,209 (the ?209 patent) owned by Eli Lilly & Co. The ?209 patent generally relates to methods of administering folic acid and a methylmalonic acid (MMA) lowering agent, such as vitamin B12, before administering pemetrexed disodium, a chemotherapy agent, to reduce the toxic effects of pemetrexed. The Board found that the ?209 patent was not unpatentable as obvious because it was not known in the art to pretreat pemetrexed with vitamin B12 along with folic acid and the skepticism of others, specifically the FDA, supported a conclusion of non-obviousness. The Federal Circuit found that substantial evidence supported the PTAB’s findings and affirmed.

This week in Other Barks & Bites, IPWatchdog’s IP news roundup: the House of Representatives passes drug patent legislation, while antitrust legislation targeting patent-related activities is introduced into the Senate and the Trump administration mandates pricing information for pharmaceutical ads; the Patent Trial and Appeal Board (PTAB) issues a pair of precedential decisions on cases with multiple petitions; the USPTO issues marijuana-related trademark guidelines and a notice on modifying patent term adjustment practices; Gilead strikes a settlement with Teva to bring generic Truvada to the U.S. market in 2020; a new music licensing entity is created in Canada; Fourth Circuit rules that bankruptcy can eliminate damages for trade secret violations; and several amicus file briefs asking the U.S. Supreme Court to eliminate the Federal Circuit’s “blocking patent” doctrine.

In our last article exploring patent trends across 12 industries, we addressed the industrial design industry. Today’s article pertains to the therapeutic and diagnostic molecules industry. Few other industries have the potential to so dramatically affect individuals’ lives as does this industry. While on a day-to-day basis it can be easy to forget the intensive bench work and clinical trials that are being undertaken in attempts to better treat or cure disease, it is this steady pulse of investment and effort that has led to the cure of many ailments and diseases. Rather recently, biologics advancements have expanded the field to no longer merely rely on small-molecule compositions but to draw upon a large pool of sophisticated large-molecule options. However, research and development in the pharmaceutical space remains heavily regulated and extraordinarily expensive. Thus, investments must be chosen and protected wisely.

On Wednesday, the USPTO held the first of three scheduled hearings prompted by the Study of Underrepresented Classes Chasing Engineering and Science (SUCCESS) Act, which requires the USPTO Director to provide Congress with a report on publicly available patent data on women, minorities, and veterans, and to provide recommendations on how to promote their participation in the patent system. The hearing featured emotional testimony from five inventors, one of whom has recently joined Debtors Anonymous as a result of her patent being invalidated in the Southern District of New York. The SUCCESS Act was signed into law by President Trump on October 31, 2018 and gave the USPTO a one-year period to study representation of women, minorities, and veterans groups in patents. The Office released a report in February which showed that the number of women named as inventors had not been increasing at the same rate as the number of women who were now in STEM professions. Deputy USPTO Director Laura Peter said at the hearing on Wednesday that the Office is seeking input from industry, lawyers, and academics at the public forums, the next two of which are scheduled in Detroit on May 16 and San Jose on June 3. “We’re looking for concrete ideas and action plans to increase the numbers of these groups applying,” Peter said, before explaining that she would be unable to stay for the remainder of the hearing.

Yesterday, we looked at trends in the medical device industry. Today’s article pertains to Industrial Design, which was limited to design patent protection. The term of a design patent is 15 years from filing in contrast with 20 years from issuance for utility patents that are the subject of the 11 other industry areas of this study. Submarine patents are still possible in the design area. Unlike utility applications, nearly all design patents are allowed with a 99% success rate in recent years. This near perfect yield for filings coupled with costs that are about 10% of a utility patent with no maintenance fees contributes to the wild popularity of design patent protection. Our study not only identified a set of applications that pertained to this industry, but also—for each application in this set—we determined whether the application pertained to one or more of the categories shown in the topology below. If so, the application was appropriately tagged, such that it could be included in one or more category-specific data subsets for subsequent analysis.