Posts Tagged: "innovation"

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.

Jenna Close is a freelance commercial photographer and owner of a small business that licenses still images and videos to both domestic and international clients. She and her partner work 60-80 hours a week booking work, shooting, billing, accounting, marketing, and continuing to develop and maintain their skills. Jenna’s images are widely infringed online. She’s found exact reproductions of her work on competitors’ websites, on websites falsely advertising that the photographs are free to use, and she’s even come across instances where companies have photoshopped their own products into her images. Despite the brazen misuse of her images that she frequently encounters, Jenna does not generally pursue claims against her infringers because it is too expensive and time consuming to do so. It’s just not worth the cost—even though she registers at least some of her images for copyright protection, and so would be entitled to statutory damages and attorneys’ fees with respect to those images in case of a court victory. Unfortunately, Jenna’s story is not unique. For countless individual artists and small businesses, combating the unauthorized use of their creative works online is a source of enduring frustration. The frequency and ease with which photographs, sound recordings, videos, and other works of authorship are shared on the Internet leaves those without significant time and resources little recourse when they encounter infringement. But now, after years of advocacy by creators like Jenna, new legislation promises long-overdue support for these marginalized groups in the ongoing fight against overwhelming infringement in the digital age.

During a hearing of the Senate Committee on the Judiciary on Tuesday titled, “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition,” senators heard from five witnesses about proposals to lower drug prices for Americans and what role the patent system plays in the high cost of prescription drugs. The witnesses included two professors, a patient advocate, the Director of South Carolina’s Department of Health and Human Services, and the Executive Vice President and General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA). The hearing is one of several so far this term on the topic. Judiciary Committee Chair, Lindsey Graham (R-SC), opened the hearing by summing up the problem they faced in a question: essentially, how do we make sure that America continues to be the most innovative place on the planet and avoid killing the “goose that laid the golden egg,” without having a system that drives up cost for the consumer? Graham said he expects the committee will move on legislation related to patents and prescription drug pricing this year, and there seemed to be broad agreement on at least one bill currently under consideration—the CREATES Act of 2019, which has been floating around Congress since 2016.

In the sixth installment of our 13-part patent-trends study (performed in collaboration with GreyB) providing high-level data across industries, we will examine trends in the medical-device industry. The United States has been the largest target medical-device market, at nearly 50% of the global market. These devices are highly variable in purpose, design and complexity. Thus, developing an effective patent strategy can be highly valuable yet complicated. Our study not only identified a set of applications that pertained to this industry, but also—for each application in this set—it was 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.

Chairman of the Senate Judiciary Committeee’s Subcommittee on Intellectual Property, Senator Thom Tillis (R-NC), said last week that the subcommittee will  “explore increasing criminal penalties and opportunities for stepped up intellectual property enforcement to prevent counterfeiting and piracy during a hearing titled “World Intellectual Property Day 2019: The Role of Intellectual Property in Sports and Public Safety.” The hearing followed from the theme of this year’s World IP Day, “Reach for Gold: IP and Sports.” The sports industry witnesses and U.S. Senators in attendance emphasized that strong intellectual property frameworks, including enforcement, are critical to support successful global economies and provide health and safety protections for consumers of all ages, in addition to supporting wages for an effective work force.

On Monday, the International Intellectual Property Commercialization Council (IIPCC) gathered patent office and Federal Circuit experts, including current USPTO Director Andrei Iancu and former Federal Circuit Chief Judge Randall Rader, at the Capitol Building to discuss “The State of Innovation in the Union.” The panel was moderated armchair style and resulted in some poignant questions and answers from a few of the best-known players in the patent world. I attended the event, and at the end of the panel on which he participated I had the opportunity to ask Iancu what he thought about the current roundtables taking place in Congress and the efforts to reform Section 101. I reminded him that, at this time last year, he was giving speeches and testifying to Congress, saying to anyone who would listen that 101 should be something that we are all talking about and considering from a variety of angle. Then, as a newly minted Director, Iancu would tell Congress that if and when they were interested in engaging on 101 reform he and the Office would be ready to offer any assistance necessary. Congress seems to be working on the precursor to what will soon become legislative language. So, where does the Director stand on the issue today? His response was both correct, and something of a wake-up call. The final takeaway I think was that Iancu’s the only hope we’ve got, at least for the foreseeable future.“In the end, all three branches need to be rowing in the same direction on something like 101,” Iancu said. An obvious if seemingly cautious statement, but he did not stop there.

It has been a wild decade for the automotive industry, with U.S. auto brands almost dying in the Great Recession. Federal government intervention rescued brands and attempted to turn them toward efficiency instead of profitable large SUVs. Although there has been a steep increase in patent filings in the automotive space, U.S. companies have a smaller proportion of them, indicating global forces are a major threat. This is especially acute in the area of electric propulsion, where our early patent lead has plateaued. Many of the car brands and battery innovators have been sold to Chinese interests who are moving quickly with government support to dominate the car industry, at least for electric vehicles (EVs). 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.

On October 11, the Orrin G. Hatch-Bob Goodlatte Music Modernization Act (MMA) was enacted into law after passing both the U.S. Senate and House of Representatives. The bill was drafted in order to modernize U.S. copyright law as it relates to the licensing of copyright protected music for use in digital streaming services such as Spotify or Apple Music. Such digital service providers (DSPs) may obtain a new kind of license created by the law, known as a blanket license, which covers the distribution of all musical works available for compulsory licensing. DSPs may then make these works available to consumers through covered activities, such as delivering digital phonorecords of musical works available in the form of a permanent download, a limited download or as an interactive stream.In short, the blanket license under the MMA allows Spotify and others to offer streaming music services without having to negotiate licenses with copyright-owning entities, including recording studios and songwriters. Instead, these streaming services would obtain a blanket license from the Mechanical Licensing Collective (MLC), another new feature of the MMA. The MLC is a non-profit entity responsible for administering blanket licenses to DSPs, collecting and distributing royalties, enabling copyright owners to claim ownership of musical works and administering a process by which royalties for works with unidentified owners are equitably distributed to known copyright owners. The statutory language of the MMA directs the Register of Copyrights to designate the membership of the MLC within 270 days of enactment of the law. Given the date on which the MMA was enacted, this would indicate that July 8 of this year is the deadline for Register of Copyrights Karyn Temple to designate the MLC that would start administering blanket licenses at the beginning of 2021. There are two groups that have proposed their own membership of the MLC to the Copyright Office: a coalition of major publishers from the music industry, including the National Music Publishers Association (NMPA), Songwriters of North America (SONA) and Nashville Songwriters Association International (NSAI); and the American Music Licensing Collective (AMLC), a collection of songwriters, musicians, tech developers and executives from smaller rights organizations and publishers within the music industry.

This week on Capitol Hill, the heated drug pricing debate is back in the spotlight, with a Senate Judiciary Committee hearing on intellectual property and the price of prescription drugs on Tuesday. In the House of Representatives, oversight hearings will examine both the activities of the U.S. Patent and Trademark Office and data security efforts made by the Federal Trade Commission. Off the Hill, The Cato Institute looks at U.S. cyber defense capabilities, and the week closes with a Brookings Institution event on China’s actions towards global tech dominance.

In our fourth article studying patent trends data across industries, we turn to the computational biology and bioinformatics industry. Computers have transformed many aspects of our everyday lives. However, much of drug-discovery, treatment testing and biology research is performed using the same wet-lab techniques developed decades ago. Rather recently, biotech companies have begun to capitalize on the impressive computational power, sophisticated models and skilled workforce to integrate computers into their operation. This integration can facilitate generating more accurate hypotheses, conducting more efficient tests and more thoroughly evaluating results. For example, modeling can be used to identify a set of therapeutics that have a physical structure complementary to a target, to better define a screen. Given that this valuable technological area sits at the intersection of biology and computers—which traditionally are associated with very different types of applications, examination and applicants—it is important to be well informed about the patenting arena when identifying patenting strategies.Our study not only identified a set of applications that pertained to this industry, but also—for each application in this set—it was 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.

On June 19, it will be five years since the United States Supreme Court issued a decision in Alice Corp. v. CLS Bank, 134 S.Ct. 2347 (2014), which significantly changed the way courts and patent examiners evaluated patent eligibility of computer implemented innovation in the United States. While the Supreme Court ostensibly extended the patent eligibility analysis applied in the life sciences context that had previously been adopted in Mayo Collaborative v. Prometheus Labs., 132 S.Ct. 1289 (2012), even a cursory review of allowance rates from the USPTO and invalidity rates in federal courts shows that Alice changed the prevailing analysis in profound ways. We will be commemorating this anniversary on June 24-25 in Washington, DC with a dedicated event examining the damage, discussing real solutions, and offering strategies for innovators who need protection in these uncertain times (see below for more detail). Almost immediately after Alice, patent examiners started to issue new subject-matter eligibility rejections for computer implemented innovations using the abstract idea exception to the statutory categories of patent eligibility. “The ubiquity of subject-matter eligibility rejections in office actions exploded, leading many to wonder whether software implemented inventions remained patentable at all,” explained Kate Gaudry and Samuel Hayim, who have done a series of articles on IPWatchdog detailing their statistical analysis. “This effect was largely centered in business method art units of [USPTO technology center] (TC) 3600. For example, the number of allowances issued from business-method art units dropped from 24% in the months before Alice was decided to about 3% in months after.” For months there has been growing hope that a legislative fix spearheaded by a few dedicated Members of Congress would provide a solution. But in recent weeks, that hope is waning as the uncomfortable reality that big tech is dominating the discussions has started to set in.