GlaxoSmithKline v. TEVA
Patent and U.S. Food and Drug Administration practices are complex. But these two fields were further complicated by meshing them together in a design intended to both (1) reward drug innovators but then (2) insure that cheaper, generic versions of drugs hit the market quickly after the innovator patents expired. One aspect of this tangled net of highly specialized legal fields was brought to light in the recent case GlaxoSmithKline v. Teva, 2018-1976, 2018-2023 (Fed. Cir., August 15, 2021). This post covers only a small, but still complicated ... Read More ›
Well trained inventors are essential to building a high-quality patent portfolio that won’t blow the budget. The questions below are based on an informal poll of questions frequently asked of patent attorneys by inventors within large organizations, but they also apply to smaller companies and startups. They can form a starting point or a supplement to your inventor training.
Before reviewing the questions, inside counsel should first ask “Who trains my inventors?” and “How often?” Hopefully, the answer is not “nobody” and “never,” but even if it is, this ... Read More ›
In patent law, the doctrine of “assignor estoppel” refers to barring a party who assigned a patent from later challenging the validity of the patent. Assignor estoppel is an equitable doctrine that has been relied upon in order to prevent someone who has assigned the rights to a patent (or patent application) from later contending that what was assigned was, in fact, worthless. The doctrine has been applied to not just inventors, but also parties in privity with the original inventor, such as a corporation founded by the inventor. Essentially, the doctrine of assignor estoppel is ... Read More ›
Beauty is in the eye of the beholder is a catch phrase well known and of ancient origin. Benjamin Franklin even had a wry turn at it in Poor Richard's Almanack, 1741: “Beauty, like supreme dominion is but supported by opinion.” As it turns out, however, in the opinion of the District Court of Delaware, “beauty,” or in this case, enhancement of the skin is not a term one ought to have in their patent claims, because that which relies on opinion is indefinite in the eyes of the court. Univ. of Mass. and Carmel Labs., LLC v. L’Oréal Inc., D.Del. (April 21, 2021).
University of ... Read More ›
A recent opinion issued by a federal court in the District of New Jersey provides a cautionary tale regarding patent infringement cases. In EagleView Techs., Inc. v. Xactware Solutions, Inc., plaintiff, EagleView filed a motion for enhanced damages and attorneys’ fees. The Court granted enhanced damages and attorneys’ fees, excluding those associated with the pretrial phase. The basis for this judgement follows.
Pursuant to 35 U.S.C. 284, the court may increase damages up to three times the amount found. Enhanced damages serve as a punitive sanction for ... Read More ›
The ongoing pandemic has wreaked uncertainty for many businesses. Forecasting expenses and costs, especially in the research and development areas, has become more difficult. In the intellectual property world, opinions of counsel on patentability, infringement, clearance, and validity are often overlooked as tools to control budgets and forecast spending. While each of these opinions will necessarily require upfront costs, the information they provide often yields tangible cost savings resulting from a more focused research and development effort. This article ... Read More ›
Functional claim language—which defines an invention by what it does rather than what it is—can be a powerful claim drafting tool when used carefully. For example, functional language may be advantageous for computer-implemented inventions that are characterized with reference to logical components instead of physical hardware. 35 U.S.C. § 112(f) (formerly § 112¶ 6) expressly permits the use of functional claiming and is traditionally invoked by the phrase “means for” followed by a functional modifier. But even when the term “means” is not used, other terms that ... Read More ›
Design patent protection is an under-utilized tool that can provide fifteen (15) or more years of protection at a fairly reasonable cost for the new and non-obvious ornamental appearance of different Articles, which can vary from consumer and industrial products to computer icons. Once a design patent is issued, one study has shown that design patents provide a higher probability for obtaining an infringement verdict and a substantially lower chance of being found invalid than utility patents. Accordingly, where appearance distinguishes a product from others in the ... Read More ›
GLAXO GROUP LIMITED and HUMAN GENOME SCIENCES, INC. v. DRIT LP (Delaware Supreme Court, March 3, 2021, N16C-07-218).
Sophisticated parties will be held to the agreements they negotiate, and the implied covenant of good faith will not negate an unrestricted contractual right.
Lupus, or systemic lupus erythematosus, is an autoimmune disease in which a person’s own immune system turns on it and destroys healthy tissue. Patients suffering from Lupus have “intense B-cell activation.” That is, their immune systems are overcharged, and one type of immune cell, the ... Read More ›
Intellectual property (IP), like other forms of property, is an asset that can be subject to contractual obligations and agreements between multiple parties. Due to the unique nature of IP as compared to physical assets, the provisions governing IP agreements also have unique characteristics. Parties to these agreements must take special care to ensure that the scope of the agreements are clearly defined, in addition to making each party’s obligations explicit. IP agreements can come in a variety of forms, such as license agreements, assignment agreements, and joint ... Read More ›
On October 17, 2020, the Chinese Legislature passed the Fourth Amendment to the China Patent Law, which will take effect on June 1, 2021. The Fourth Amendment marks the first major change in Chinese patent law since 2008. These changes will have a major impact on both prosecution and enforcement. Key amendments include those related to patent terms, damages, and licenses. Below is a summary of a few of these key amendments.
New Article 20 adds a “Good Faith” provision which reads, in part, “patent rights shall not be abused to harm public interests or the legitimate rights and ... Read More ›
The requirements for ownership of a patent and the right to bring suit for the enforcement of the patent would seem to be well settled in patent law. As demonstrated in the recently decided Federal Circuit Court of Appeals (Case 2019-2244), AntennaSys, Inc. v. AQYR Technologies, Inc., et al., overlooking the ownership or enforcement requirement can result in wasted time and cost for the litigants and frustration for the courts. This article raises awareness of the nuances of ownership and enforcement rights in the hope of avoiding the cost and frustrations for all involved.
The ... Read More ›
One of the main advantages of hiring outside patent counsel is the ability to pass invention materials to a drafting attorney to prepare a patent application. This work transfer reduces the in-house counsel’s burden, freeing them to devote more of their time to strategic portfolio management rather than the minutiae of preparing an individual application.
Too frequently, however, the invention materials provided to outside counsel are incomplete. The understanding is that the drafting attorney will be able to use their engineering acumen to sort through the pieces, determine ... Read More ›
In November 2019, the China National Intellectual Property Agency (“CNIPA”) issued new Patent Examination Guidelines for applying China’s “inventive step” requirement, the patentability standard roughly equivalent to the US patent requirement of “non-obviousness.” Chinese Patent Law defines “inventive step” such that the invention has a prominent substantive feature and represents notable progress. Under the new Guidelines, inventive step can be determined as a whole from a perspective of “invention concept.”
Regarding “inventive step,” ... Read More ›
Fiction and reality collide. The Netflix series Designated Survivor included a story line about a viral outbreak in Louisiana; a devastating pandemic was looming. Fictional president Tom Kirkman learns that the fictional cancer drug Extasis, being developed by fictional Pharm. Co. Benevax, showed promise to defeat the virus. Fictional CEO Carlton Mackie and the fictional President had a heated exchange in the oval office where Carlton Mackie ineptly tried to explain the economics of drug development. The fictional President chewed him out, and then used a political strategy to ... Read More ›
In Valeant Pharmaceuticals International, Inc. v. Mylan Pharmaceuticals, Inc., the Federal Circuit reversed the District Court of New Jersey’s grant of summary judgement in favor of Valeant that claim 8 of U.S. Patent 8,552,025 (the ‘025 patent) owned by Valeant.
The message is clear for pharmaceutical formulation patents. To establish a prima facie cases of obviousness, compounds having similar structure and function can be used as the basis for establishing similar properties.Read More ›
OSI Pharmaceuticals, LLC (OSI) discovered and patented a method of treating non-small cell lung cancer (NSCLC). See US Patent No. 6,900,221. The method comprises administering a therapeutically effective amount of erlotinib to an NSCLC patient. Apotex Inc. (Apotex) challenged OSI’s patent by filing a petition for Inter Partes Review (IPR) at the United States Patent and Trademark Office (USPTO). Three references were produced during the IPR, as follows:
(1) The reference “Schnur” disclosed erlotinib along with 104 other different compounds, as potent inhibitors of a ... Read More ›
Google® CEO Sundar Pichai demonstrated the capabilities of Google Assistant onstage at Google I/O.1 Triggered by a voice command, the Google Assistant software seamlessly and successfully communicated with a hair salon employee, via a phone call that the software initiated, to book the appointment. Pichai explained that Google Assistant actually “understand[s] the nuances of conversation” by combining natural language understanding, deep learning and text-to-speech technology. This represents a new and less blatantly artificial development in the scope of AI ... Read More ›
Under 35 U.S.C. § 171 of the Patent Act, patent protection is provided for a “new, original and ornamental design for an article of manufacture.” Design patents cover the appearance of an article of manufacture. Design patents have been used to obtain patent protection on the appearance of articles including hair scrunchies, sneakers, paintball goggles, and almost any other consumer product one can think of.
Design patents are essentially comprised of a title, drawings, and a description of the drawings. In design patents, unlike utility patents, the claimed scope is defined ... Read More ›
Kaiser, K. et al. recently reported their synthesis of a brand new carbon molecule, cyclocarbon. The structure and synthesis of cyclocarbon, an 18 ring carbon chain with no substituents, is detailed in Kaiser et al. “An sp-hybridized molecular carbon allotrope, cyclocarbon” (2019) Science Online.
Cyclocarbon is an exciting development, as this molecule has never existed before now and some researches doubted that the molecule could be stably made in the lab. It provides important insights into the organic synthesis of complex carbon-based molecules ... Read More ›
Every aspect of day-to-day life is increasingly influenced by artificial intelligence and automation. Mundane household tasks such as setting the temperature on thermostats, brewing a pot of coffee to coincide with our morning routines, and other simple chores can now be performed by automation. (Google’s U.S. Patent 9,513,642: “Flexible functionality partitioning within intelligent-thermostat-controlled HVAC systems” and General Electric’s U.S. Patent 4,330,702: “Electronic control system for coffeemaker”).
Recently, more complex and ... Read More ›
On January 22, 2019, the United States Supreme Court ruled that the sale of an invention to a third party who is obligated to keep the invention confidential may place the invention “on sale” for purposes of the Leahy-Smith America Invents Act (AIA). The case is Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. With this decision, the Supreme Court answered a question about the “on-sale bar” to patentability that has lingered since the enactment of the AIA in 2011.
Prior to the AIA, it was settled law that a sale embodying an invention, whether public or private ... Read More ›
In a step toward consistent interpretation of patent claims before federal courts and the Patent Trial and Appeal Board (PTAB) during post-grant proceedings, today the United States Patent and Trademark Office (“USPTO”) published a final rule revising the claim construction standard used during proceedings established by the Leahy-Smith American Invents Act (“AIA”).
Changes to the Claim Construction Standard for Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (to be codified at 37 C.F.R. pt. 42)Read More ›
The United States Supreme Court today (June 22, 2018) ruled that a plaintiff in a patent case can recover damages for foreign sales, under certain circumstances. The case is WesternGeco LLC v. ION Geophysical Corporation, 2013-1527, 2014-1121, 2014-1526, 2014-1528.
WesternGeco LLC originally sought to recover damages for patent infringement based on Ion Geophysical Corp.’s sales of product components shipped outside the United States. The plaintiff argued that the Patent Act provided for recovery against patent infringement related to the supply of components of the ... Read More ›
The U.S. Supreme Court's June 2014 landmark decision Alice v. CLS Bank International, 134 S.Ct. 2347 (2014), altered the course and viability of software patents in the United States and continues to cause uncertainty over the eligibility of software for patent protection. Alice announced a multi-step test for analyzing patent eligibility, under which the basic question for any software application is, "does the application satisfy the patent eligibility conductions of 35 U.S.C. Section 101 (Section 101)?" The United States Patent and Trademark Office (USPTO) has established ... Read More ›
Divided infringement, or infringement carried out by multiple actors, seemed like an easy escape from accusations of direct infringement for entities teaming up to perform different steps of a patented method. That is until the Federal Circuit ultimately expanded the scope of direct infringement in the recent Travel Sentry, Inc. v. Tropp1 case. The Federal Circuit’s decision expanded the scope of direct infringement by loosening the standard used to determine whether all steps of a claimed method are attributable to a single entity.
In the midst of evolving case ... Read More ›
The identification of the proper venue for commencing a patent infringement or declaratory judgement action was rather straight forward for a number of years. However, when the U.S. Court of Appeals for the Federal Circuit, which has exclusive appellate jurisdiction in patent matters, addressed the venue issue in VE Holding v. Johnson Gas Appliance, 917 F.2d 1574 (Fed. Cir. 1990), it liberalized the venue requirement to where the defendant is subject to the court's personal jurisdiction. This decision lead to lower courts applying a liberal view of personal jurisdiction when ... Read More ›
Patent Term Adjustment (PTA) is additional time added to the term of a patent based on delays by the United States Patent and Trademark Office (USPTO) during prosecution. The PTA is determined after an application has been granted a patent. An applicant or patent prosecutor should be cognizant of PTA during prosecution because any gain of PTA due to USPTO delay is reduced by applicant delay. In the lifetime of a patent that covers a successful product or technological standard, every day can be highly valuable. This is especially true for biotechnology and pharmaceutical patents for ... Read More ›
THE COLLABORATIVE SEARCH PILOT PROGRAM
In an attempt to expedite and promote the quality of patent application examination, the United States Patent and Trademark Office (USPTO) began a Collaborative Search Pilot (CSP) program in partnership with the Japan Patent Office (JPO) and the Korean Intellectual Property Office (KIPO). The program is designed to provide USPTO examiners with the best prior art by collaborating with examiners at the JPO and KIPO that are examining corresponding Japanese and Korean patent applications.
In the initial CSP program, examiners shared and ... Read More ›
Throughout time industries have developed techniques and processes that are believed to be essential elements that contributed to the company's success. For almost as long, companies have sought and devised ways to protect those techniques and processes that constituted the company's intellectual property. Many companies turned to federal patent protection, others chose to treat the information as trade secrets, and others chose to use contractual obligations to protect their intellectual property. These various forms of protection were especially meaningful in what ... Read More ›
Kids are so indulged these days! They get to play with a new toy known as a “fidget spinner,” in contrast to previous generations who grew up creating their own, low-quality “fidget spinners” by spinning a ruler around the tip of a pencil. The official fidget spinner, the hottest toy fad of 2017, is a two or three prong gadget with a bearing in the center which allows the contraption to simultaneously balance and spin utilizing one or both hands. Although, as the name suggests, the toy is ideal for those who cannot remain still, all ages and levels of fidgeters are buying the “fidget ... Read More ›
On Tuesday, May 30, 2017, the United States Supreme Court issued another unanimous decision in an intellectual property appeal. In Impression Products, Inc. v. Lexmark International, Inc., No. 15–1189, the Supreme Court ruled that (i) a patentee’s decision to sell a product exhausts all of its patent rights in that item, regardless of any restrictions the patentee purports to impose, and (ii) an authorized sale outside the United States, just as one within the United States, exhausts all rights under the Patent Act.
The case at issue involved toner cartridges. The patent owner ... Read More ›
The landscape for patent law has changed more quickly over the last five years than it had in preceding decades. The America Invents Act, which was enacted in September 2011, may be the most comprehensive and significant change to patent law in decades, and recent case law appears to be accelerating changes. For example, Mayo Collaborative Services. v. Prometheus Labs, 566 U.S. 66 (2012), changed how patent-eligible subject matter is determined and what currently is patentable eligible. Alice v. CLS Bank International, 134 S. Ct. 2347 (2014), dramatically changed the landscape for ... Read More ›
In 2017, the Supreme Court will issue opinions on a wide range of important issues in intellectual property law. Below are two pending cases to keep on your radar, as well as three cases that the Court has already decided earlier this year.
TC Heartland LLC v. Kraft Food Brands Group LLC
In TC Heartland, the Supreme Court will examine whether the Federal Circuit’s stance on patent venue is correct. The Federal Circuit has interpreted patent venue broadly, holding that venue is proper in any federal court that has personal jurisdiction over the accused infringer.
Proper venue for patent ... Read More ›
The Supreme Court issued a decision today removing the laches as a defense to patent infringement. The case is reported at SCA Hygiene Products Aktiebolag et al. v. First Quality Baby Products, LLC, et al., Slip. Op. No. 15–927 (March 21, 2017).
Historically, laches is an equitable defense to patent infringement, based upon an unreasonable and prejudicial passage of time in bringing a lawsuit. Thus, if a patent owner knew of an alleged infringer for a long period of time, an accused infringer could argue that the patent owner waited too long to sue for patent infringement and that the ... Read More ›
Patents have had unusual attention from the U.S. Supreme Court recently. In addition to high-profile cases like Alice v. CLS Bank International, 134 S. Ct. 2347 (2014), that dramatically changes the landscape for technology-based patents, Samsung v. Apple, 137 S. Ct. 429, 431 (2016), that has the potential to dramatically change the landscape for damages in design patent infringement, and Life Technologies v. Promega, 2017 U.S. LEXIS 1428 (U.S. Feb. 22, 2017), which tests the limits of liability under U.S. law for infringement abroad, the court is poised to consider whether the ... Read More ›
In my last post “Design Patents Face Another Million Dollar Question,” I noted that the U.S. Supreme Court declined to decide what the relevant ‘article of manufacture’ was for calculating damages in Apple’s design patent row with Samsung, and the Supreme Court remanded this to the Federal Circuit Court of Appeals.
Now the Federal Circuit has itself “passed the buck,” further remanding the case back to the District Court for the Northern District of California. This effectively gives the Judge at the District Court level a blank slate to craft a test for identifying ... Read More ›
This article reviews the television show “Shark Tank” on a weekly basis, with a focus on the intellectual property (IP) embodied by the products or business ideas each contestant pitches on that show. As always, keep in mind the following types of IP protection:
- A utility patent is used to protect the functional aspects of an idea, and this is what the Sharks (judges) are for the most part referring to when they inquire into how contestants have protected their idea.
- A design patent protects the ornamental appearance of an article.
- A trademark protects any word, symbol or design that ...
Many small business entities find that they occasionally have a new product or process for which they wish to seek patent protection. Some of those small businesses may have had some prior experience with the patent process. Unfortunately, many of the prior patent laws changed with the advent of the America Invents Act (AIA). The AIA made fundamental changes in the consequences associated with a business engaging in market activities prior to the filing of a patent application and many commercial entities that occasionally pursue patent protection have not made the necessary ... Read More ›
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