Bioinformatics is a growing interdisciplinary technological field in which computing and software resources are applied to biological data and solve biological problems. For example, bioinformatics can be used to predict protein sequences through analysis of large databases of biological data to enable the development of new drug therapies. Advances in computing and software, like artificial intelligence (AI), open increasing possibilities in bioinformatics. Bioinformatics is growing rapidly—the market is predicted to exceed $16 billion by 2022. As with most growing industries, mechanisms that protect and promote innovations are key to supporting that growth. Thus, it is no surprise that the number of patent applications filed and assigned to the designated bioinformatics art unit was 40% higher in 2017 than it was in 2010. Despite this significant increase in applications, for the last five years, the subject-matter-eligibility requirement (codified as 35 U.S.C. § 101) of the U.S. patent law has been particularly vexing to applicants of computer-related inventions like bioinformatics.
Federal Circuit Affirms Eastern District of Texas Holding that Medtronic Induced Infringement of Doctor’s Patents
On January 24, the Federal Circuit affirmed a jury’s finding that the defendant-appellant, Medtronic, induced surgeons to infringe two patents of plaintiff-appellee, Dr. Mark Barry, which were directed to methods of correcting spinal column anomalies, such as those due to scoliosis, by applying force to multiple vertebrae at the same time. Medtronic appealed on several grounds, “principally concerning the public-use and on-sale statutory bars, but also concerning prior invention, inequitable conduct, and induced infringement.” The majority of the panel rejected the appellant’s arguments, while Chief Judge Prost dissented and would have found that one of the patents was invalid due to either the public use or on sale bars of Section 102(b). Barry v. Medtronic, Inc., No. 2017-2463, 2019 U.S. App. LEXIS 2305 (Fed. Cir. Jan. 24, 2019) (Before Prost, Chief Judge, Moore and Taranto, Circuit Judges) (Opinion by Taranto) (Dissent by Prost).
Why Helsinn v. Teva Creates Inscrutable Uncertainty About the Scope of Prior Art Instead of Confirming Longstanding Law
To the casual observer, the Supreme Court’s January 23 decision in Helsinn v. Teva may seem like no big deal. In just a few pages of text, the Court informs us that Congress did not change the established meaning of “on sale” prior art when it rewrote Section 102 of the Patent Act in 2011. Move along, nothing to see here, right? More than a few commentators seem to assume that we’ll simply return to the pre-America Invents Act (AIA) status quo, and that sales of an invention, whether public or private, will just continue to trigger a familiar statutory one-year clock for filing a patent application. But nothing could be further from the truth. In fact, the impact of private sales (and of non-public commercial uses) on the patentability of later-filed patent applications will be significant, and very different from pre-AIA law. Patent applicants and owners of patents that were issued under the AIA have every reason to worry about traps for the unwary.
Intellectual property (IP) promotes innovation. The limited right to exclude others from copying patented inventions, copyrighted original works of authorship, and trademarked brands and logos encourages innovators to invest their time and money. IP appeals to our sense of fairness by discouraging or preventing counterfeiting, passing off, and other harmful takings of the fruits of investments in research, development, creativity and innovation, and is leveraged by entrepreneurs seeking start-up capital. Unfortunately, the general public lacks a true understanding of how IP fuels our innovation economy. Today, IP practitioners are bombarded with so many free newsletters about IP that we simply cannot read them all—it is no longer a function of getting access to information, but which sources of information are the best use of one’s time. The same is true for the general public, which is increasingly exposed to references about IP in social and news media, advertising, and other public channels. Unfortunately, those references to IP are not always accurate and often require explanation.
The success of a life science product, and thereby the company, rests heavily upon a combination of patent protection, regulatory exclusivity and product life cycle management. A company’s ability to formulate and articulate an integrated strategy is critical to obtaining investments, strategic partnerships and market success. In this two-part series, we will discuss recent judicial developments that affect life science companies’ IP strategies and also outline the four basic principles of an integrated IP strategy on which a company’s intellectual property audit and preparation for third-party diligence should focus. These are: (1) patent prosecution and strategy, (2) rights and ownership, (3) interplay of patent and regulatory exclusivity, and (4) freedom to operate and competitors. Part one will focus on patent prosecution and strategy, as well as rights and ownership.
Any patent attorney knows that each patent examiner can vary greatly in approach to examination. In this article, five different types of patent examiners and suggest prosecution strategies for each to help you get better outcomes for your clients.
Patentability of Blockchain is a hot topic primarily because of the tremendous expectations around this emerging, disruptive and promising technology. On December 5, 2018, the European Patent Office (EPO) held an International Conference on Patenting Blockchain at The Hague to explore this topic in detail.
Practitioners who work on patent applications or clearance advice in this field should be careful in the choice of keywords for prior art searches and should be aware of what kind of patent they are seeking: core technology (with possible risks of a pure algorithm objection), applied technology, and virtual currency claim (which is excluded in China).
When you see a docket report with a patent lawsuit filed by a non-practicing entity (NPE), do you think it’s just another ‘patent troll’ taking advantage of the system? Or would you be willing to consider that underlying every patent litigation is a human story of invention, which is the embodiment and manifestation of an innovator’s aspirations and sacrifices? These human stories are too often marginalized in the ‘patent troll’ debate. One such story is that of Wayne Evans. His life took him from the depths of poverty and loss to the struggles of being an entrepreneur raising a family and, ultimately, to late-in-life success as an inventor, innovator, and author.
Apple has increased its expenditures on research and development recently, spending $3.75 billion on R&D during Q4 2018 compared to just less than $3 billion during Q4 2017—a year-over-year increase of $750 million. One area of technology where this investment may pay off will likely be flexible screen technologies. This includes innovations in elastic substrate layers serving as the circuitry for future iPhones and the continuing development of organic light emitting diode (OLED) technologies with flexible characteristics.
It’s a challenge to resolve business disputes when emotions run high, which includes almost all trade secret cases. So, I was especially pleased when, in a hard-fought litigation where I had been appointed as a “referee” to resolve discovery disputes, both lawyers eventually reached out to tell me how much they appreciated my involvement in the case, which had settled. What was it about this variation on typical legal combat—where a private party is selected to rule on some important aspects—that they found so satisfying? First, they had saved their clients a lot of time, and probably money, compared to the cost of dealing with unpredictable court calendars. And second, they felt that the decisions they received were thoughtful, balanced and practical, reflecting an understanding of the relevant business environment.
For almost ten years, U.S. patent law has experienced extraordinary confusion and uncertainty about what types of inventions and discoveries are patent eligible. The U.S. system changed from offering strong protection for novel and nonobvious inventions to questioning whether groundbreaking technologies are even the type the Founders thought would promote the progress of the “Useful Arts.” But recent developments, including the USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (Section 101 Guidance), suggest that winds of change may clear the fog and bring back some clarity to U.S. patent law.
On behalf of nonprofit, U.S. Inventor, Inc., and over a dozen other amici, Flachsbart & Greenspoon, LLC has submitted a Brief of Amici Curiae urging the Supreme Court to grant certiorari from the Federal Circuit’s notoriously error-ridden decision in the waterskiing case: Zup, LLC v. Nash Manufacturing, Inc. Reviewing this decision will be an excellent way to get obviousness doctrine back on track.
In that 2-1 decision (with Judge Newman dissenting), the Federal Circuit held that even “considerable” or “strong” objective evidence of nonobviousness will sometimes not save a patent from an obviousness ruling. That ruling is wrong. It is also out of touch with Supreme Court doctrine.
Yesterday a unanimous Supreme Court ruled that the America Invents Act’s (AIA’s) language barring patent protection for inventions that were “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention” under 35 U.S.C. § 102(a)(1) extends to private sales to third parties. The decision upholds pre-AIA Federal Circuit precedent establishing that a “secret sale” could invalidate a patent. The question patent owners have been asking since 2011 was whether the AIA’s addition of the phrase “or otherwise available to the public” overruled the Federal Circuit’s judicial construction of the on-sale bar. “No,” said the High Court. As always, IPWatchdog reached out to experts across industries for their views on the decision. From “well-reasoned and correct” to “a disappointment” and “dismissive,” they had wide-ranging perspectives on the ruling’s broader implications.
Since its inception, the Patent Trial and Appeal Board (PTAB) has been a frequent venue for patent challenges in the pharmaceutical and biotechnology industries. By the end of the U.S. Patent and Trademark Office’s (USPTO’s) 2018 fiscal year, patents in those fields were targeted in nearly 10% of all petitions for inter partes review (IPR), totaling approximately 900 individual petitions. Of these 900 petitions, roughly 5% challenged patents listed in the FDA’s Orange Book for approved drug products. The remaining petitions challenged biologic drugs (1.3%) and other biologic-, biotechnology-, or pharmaceutical-related patents (3.5%). Many of these petitions have ultimately resulted in the cancellation of all challenged claims, including those of a significant number of Orange Book patents. Based on the PTAB’s initial high rate of claim cancellation in pharma and other areas, critics of the PTAB were quick to deem it a patent “death squad.” Does the PTAB still deserve the “death squad” label when it comes to Orange Book patents? In this article, we examine the rates of challenge, institution, and final written decision outcomes for patents listed in the Orange Book, from the PTAB’s inception through the end of its 2018 fiscal year.
In AC Techs., S.A. v. Amazon.com, Inc. the Federal Circuit found the PTAB did not exceed its statutory authority by addressing a non-instituted ground on reconsideration; in fact, it would have violated the statutory scheme for the PTAB not to consider the previously non-instituted ground… The claims at issue related to data access and management, namely, storing copies of data across a network to improve data integrity and reduce network lag. Amazon and Blizzard challenged the ’680 patent based on a single prior art reference. They presented three grounds in their petition, all centered on the construction of the term “computer unit.”