Summer is always a busy time for me. Between crisscrossing the country teaching the PLI patent bar review course, I also fit in a week teaching a class at John Marshall Law School. Between keeping up with the Federal Circuit, the inevitable end of term patent decisions from the Supreme Court and whatever nonsense Congress is thinking up (this year relating to patent trolls) I manage to stay pretty busy. What that means is a number of items typically fly under my radar screen until sometime toward the end of July. With this in mind I thought I would do a rundown of some of the more interesting items that perhaps didn’t support an entire article worth of attention.
1. Reed Tech takes over USPTO Contract from Google
Many are probably familiar the fact that the USPTO has wholeheartedly embraced the President’s Open Government Initiative (OGI) to provide increased transparency of government operations and information by making bulk data available directly to the public for no charge. To that end, the USPTO entered into a no-cost contract with Google a number of years ago. Under this no-cost contract Google scraped information from the USPTO servers, transferring the many image files into searchable text documents, which were then released to the public. But all good things must come to an end.
Earlier this year the USPTO put out a Request for Proposal (RFP) again looking to again enter into a no-cost contract to continue the work already begun. In June 2013, the USPTO entered into a no-cost agreement with Reed Technology Information Services (RTIS) (a.k.a., Reed Tech) to make patent and trademark public bulk data more readily available to the public free of charge. Reed Tech is the company behind PatentAdvisor.
Reed Tech provides free online access to many data products that are otherwise available from USPTO only on a fee basis or only on physical media. This bulk data can be accessed at http://patents.reedtech.com or http://trademarks.reedtech.com.
Reed Tech is also continuing work on a special data product consisting of Public PAIR (Patent Application Information Retrieval) data, which is not currently available from the USPTO in bulk form. To facilitate distribution and benefit the entire community of data users, USPTO has authorized Reed Tech to “mine” the data from its Web site during hours of low usage. This arrangement serves as a bridge until such time that the USPTO is able to directly offer this data in bulk format. Public PAIR bulk data can be accessed at: http://patents.reedtech.com/Public-PAIR.php.
2. Pharma Patent Settlements Saved $25.5 Billion for US Health System
On the heals of the United States Supreme Court determining that so-called reverse payments (which settle patent litigation) may be an anti-competitive antitrust violation, see Supreme Say Reverse Payments may be Antitrust Violation, a new study suggests that the early entry of generic drugs into the market brought about by such settlements saves billions of dollars.
Generic pharmaceuticals launched prior to patent expiration due to a patent settlement helped the U.S. health system save $25.5 billion from 2005-2012 and brought generic medicines to market on average 81 months sooner than patent expiry, according to a new analysis conducted for the Generic Pharmaceutical Association (GPhA) by the IMS Institute for Healthcare Informatics. An additional $61.7 billion will be saved if the current level of savings continues through to patent expiry for each molecule analyzed, the study projects.
For years opponents of reverse payments that settle pharma related patent litigations have argued that settlements create a cost for consumers, but this new study suggests otherwise. As the Department of Justice and the FTC investigate bringing antitrust action against those engaging in patent settlements this study will undoubtedly loom large in defense of such claims.
“This new analysis provides the most current, complete and transparent estimate of the impact of patent settlements on health costs,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association. “The settlement involving Lipitor alone will save $22 billion over the next four years. This is critical for lawmakers to understand, because any further restrictions on settlements will put these savings at risk.”
3. Coffee Analysis Smart Phone App for that Perfect Brew
An inventor by the name of Greg Mayworm currently has a Kisckstarter campaign ongoing to raise funds to build his coffee analyzing smartphone app. Presently there are only a few days remaining and the funding goal has not been achieved. Still, what better story for a patent blog then one that deals with coffee (every attorney’s best friend in the morning), smartphones and patent pending technology?
The CoffeeNotes app gives you the unique power to evaluate your coffee so that you consistently brew that perfect cup of coffee. This innovative tool uses patent pending technology developed by Mayworm, which allows the user to analyze their coffee grind and achieve the perfect extraction using any brew method.
CoffeeNotes connects to a cloud-based platform and knowledge base which allows users to share their recipes with their friends and colleagues. All the brew parameters are stored from the type of brewer selected to the grind distribution, so that an accurate record is captured which then can be replicated at a later time. The open API allows sharing of data between different applications with the goal of advancing coffee knowledge and the brewing process.
After a year of self-funded development, the Kickstarter project was launched in hopes of getting grassroots support for completing the Android and iOS versions of the app as well as the backend server API used for sharing recipes throughout the world.
The science behind the app is based on the CoffeeNotes extraction model. Mayworm explains: “My lab testing has shown a strong linear correlation between grind particle size or surface area and coffee extraction. Once you know the grind distribution, you can accurately predict coffee strength based on the type of brewer used and its characteristics.”
4.FDA Approves Brain Wave Test to Assess ADHD in Children
Several weeks ago NEBA Health, LLC released study results regarding the FDA approval of NEBA®, the first brain wave test to help clinicians assess ADHD in children and adolescents. The FDA cleared NEBA for marketing on July 15, 2013.
The NEBA test integrates an ADHD biomarker together with a clinician’s ADHD evaluation. In other words, NEBA is not used as a stand-alone diagnostic tool, but rather in conjunction with the evaluation of a clinician. The clinician conducts the ADHD evaluation as in their regular practice using their usual assessment tools. Once the clinician determines that ADHD-like symptoms are present, NEBA helps the clinician to determine whether the symptoms are due to ADHD, or due to another condition.
Dr. Snyder, Vice President of Research and Development, said, “Our study supports that a clinician using NEBA as one part of a full ADHD evaluation would be more likely to converge upon diagnostic evaluation results of a multidisciplinary team.”
Although the press release and NEBA website are not particularly helpful with respect to ascertaining whether the test in question is patented, a patent search did uncover U.S. Patent No. 8,311,622, which is titled Systems and methods for analyzing and assessing depression and other mood disorders using electroencephalographic (EEG) measurements, which seems to relate to this newly approved NEBA test.
5. CAFC Copaxone® Patent Ruling Allows May 2014 Generic Launch
Mylan and Sandoz submitted Abbreviated New Drug Applications (ANDAs) to the Food and Drug Administration (FDA) seeking approval to market generic versions of Copaxone®, a drug used in treating multiple sclerosis. Teva, which markets Copaxone®, sued Mylan and Sandoz for patent infringement, which they are allowed to due upon the filing of an ANDA. The patents-in-suit were U.S. Patent Nos. 5,800,808 (’808 patent), 5,981,589 (’589 patent), 6,048,898 (’898 patent), 6,054,430 (’430 patent), 6,342,476 (’476 patent), 6,362,161 (’161 patent), 6,620,847 (’847 patent), 6,939,539 (’539 patent), and 7,199,098 (’098 patent). Each share a common specification and are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Copaxone®.
The Federal Circuit (Judge Moore writing for the panel) held that Group I claims were invalid for indefiniteness, but that Group II claims were not proven to be invalid for indefiniteness. The Group II claims are: claims 1 and 2 of the ’430 patent, claim 1 of the ’476 patent, claim 1 of the ’161 patent, and claims 1 and 8 of the ’098 patent. The remaining claims are collectively referred to as Group I claims.
The Federal Circuit also held that the district court did not err in its conclusions that the claims are infringed, and that the Appellants failed to prove that the claims would have been obvious and are not enabled. As a result, the Federal Circuit ultimately affirmed the district court’s judgments of infringement and no invalidity with respect to Group II claims, reversed its judgment of no invalidity with respect to Group I claims, and remanded.
According to Mylan CEO Heather Bresch the ruling means that Mylan can “launch its generic version of Copaxone® on May 25, 2014 upon expiration of Teva’s Orange Book patents.” The ultimate launch, however, is still subject to Mylan’s final regulatory approval being achieved.
6. A Permanent Injunction in a Patent Infringement Case!
Reaching back a bit, but still worth knowing, in May 2013 the United States Court of Appeals for the Federal Circuit issued a decision in Douglas Dynamics, LLC v. Buyers Products Co. that actually resulted in the issuance of a permanent injunction.
Douglas sued Buyers for infringement of several patents related to snowplow mounting assemblies. The United States District Court for the Western District of Wisconsin granted summary judgment of non-infringement of U.S. Patent No. Re. 35,700 (’700 Patent) in favor of Buyers. Following a jury verdict that found U.S. Patent No. 5,353,530 (’530 Patent) and U.S. Patent No. 6,944,978 (’978 Patent) valid and infringed, the district court denied Douglas a permanent injunction and assigned an ongoing royalty. While this case was on appeal, the ’530 patent expired, rendering an injunction on the technology covered by that patent moot. The ’978 patent, however, remained in force.
Because the district court applied an erroneous claim construction in granting summary judgment of non-infringement of claim 45 of the ’700 Patent, the Federal Circuit reversed, with Chief Judge Rader writing the opinion and with Judge Newman joining. This Federal Circuit majority also reversed the denial of a permanent injunction against continued infringement of the ’978 Patent, and remanded the case for entry of a permanent injunction consistent with this opinion. Judge Mayer dissented and filed a separate opinion.
For more on this decision see: CAFC Reverses Claim Construction, Orders Permanent Injunction.
7. Post-Grant Proceedings Treatise Publishes
Practising Law Institute (PLI) has announced the release of their newest title, Post-Grant Proceedings Before the Patent Trial and Appeal Board. Authored by Stephen G. Kunin, Scott McKeown, and Greg H. Gardella of Oblon Spivak Maier & Neustadt LLP, Post-Grant Proceedings is an in-depth guide to the new inter partes and post-grant review regulations under the AIA. McKeown is also know to many in the patent community as the primary author of the Patents Post Grant blog.
The 464-page comprehensive paperback discusses in detail the three new post-issuance patent procedures adopted by the AIA, with a major emphasis on the inter partes review and guides readers through the process of successfully prosecuting or defending a post-grant proceeding before the PTAB.