Patent Life Research Articles

Quantifying the TRIZ Levels of Invention A Tool to Estimate the Strength and Life of a Patent

TRIZ (Theory of Inventive Problem Solving) classifies inventions into five novelty levels. Altshuller, the father of TRIZ, has also conjectured through the s-curve correlation with the levels of inventions to map the level of invention at various stages of evolution of a technology. Our aim in this paper is to use the levels of invention and timing information as described in TRIZ and give heuristics to quantify the level of an invention and to give an informed 'guesstimate' on probable life of an invention in terms of number of years. These heuristics have been worked out by the author using TRIZ for more than a decade in analyzing patents and estimating the level of inventions using the heuristics. We also have made a spreadsheet based tool that uses these heuristics and quantifies the level of invention and also gives life of the patent/invention.

A longer patent life for formulated drugs in Australia?

A longer patent life for formulated drugs in Australia?

Market Outcomes and Dynamic Patent Buyouts

Patents are a useful but imperfect reward for innovation. In sectors like pharmaceuticals, where monopoly distortions seem particularly severe, there is growing international political pressure to identify alternatives to patents that could lower prices. Innovation prizes and other non-patent rewards are becoming more prevalent in government's innovation policy, and are also widely implemented by private philanthropists. In this paper we describe situations in which a patent buyout is effective, using information from market outcomes as a guide to the payment amount. We allow for the fact that sales may be manipulable by the innovator in search of the buyout payment, and show that in a wide variety of cases the optimal policy still involves some form of patent buyout. The buyout uses two key pieces of information: market outcomes observed during the patent's life, and the competitive outcome after the patent is bought out. We show that such dynamic market information can be effective at determining both marginal and total willingness to pay of consumers in many important cases, and therefore can generate the right innovation incentives.

Second Chances for Shelved Compounds

Pharmaceutical companies are increasingly looking to see if compounds they shelved might have other uses. However, rescuing these agents, and finding new uses for approved drugs, presents some challenges, such as dwindling patent life, that can make their development financially risky.

A Nonclinical Safety Assessment of MnTE-2-PyP, a Manganese Porphyrin

Manganese (III) meso-tetrakis(N-ethylpyridinium-2-yl)porphyrin (MnTE-2-PyP or BMX-010; CASRN 219818-60-7) is a manganese porphyrin compound developed as a potential drug substance for use as a radioprotective and for the ex vivo treatment of cells, tissues, and organs intended for transplantation. In preparation for an investigational new drug filing, a full good laboratory practice nonclinical safety assessment was conducted in order to evaluate the safety of MnTE-2-PyP and included the performance of in vitro genotoxicity studies, local tissue tolerance evaluation, safety pharmacology core battery studies, and single- and repeat-dose intravenous (iv) toxicity studies in mice and monkeys. The MnTE-2-PyP was determined not to be genotoxic or hemolytic, did not demonstrate flocculation or elicit adverse pharmacologic effects on respiration, the central nervous system (CNS), and had limited transitory effects on the cardiovascular system only at levels well above the therapeutic target dose. The intended iv clinical solution did not cause venous irritation in rabbits. The no observed adverse effect level (NOAEL) in mice was determined to be 10 mg/kg/day after 18 consecutive days of bolus iv dosing once daily in the morning. The NOAEL in monkeys after 14 days of bolus iv dosing in the morning was determined to be 5 mg/kg/day. At doses relevant to clinical use in humans, neither study revealed any indication of any specific target organ toxicity, including the classic heme porphyrin kidney, liver, CNS, or cardiac toxicities, or manganese toxicity. Mortality seen shortly after dosing in individual animals at higher doses was not accompanied by any organ or clinical pathology indications, suggesting a functional pharmacological-mediated effect. Based on the results of these studies, a conservative safe initial starting clinical dose of 5.0 mg (0.083 mg/kg in a 60 kg adult) was proposed for the initiation of human trials. Because of patent life issues, use of MnTE-2-PyP as a transplantation aid or radioprotective agent is not currently being pursued past the preclinical stages. It serves as a model for the clinical development of this class of drugs.

The troubled life of Patent No. 6,456,841

Tracing the tortured legal trail of a simple smartphone patent. Takeshi Tomimori, an engineer at Mitsubishi Electric Corp., in Tokyo, had an idea. What if you could alert a cellphone user of incoming messages by displaying an icon on the screen? He worked out the details for what Mitsubishi's lawyers called, in their 1999 filing, a "Mobile Communication Apparatus Notifying User of Reproduction Waiting Information Effectively." Three years and three months later, the U.S. Patent and Trademark Office awarded Tomimori and his employer Patent No. 6,456,841. Let's call it Icon, for short.

IMMEDIATE DRUG RELEASE DOSAGE FORM: A REVIEW

Among all dosage forms tablet is the most popular dosage form existing today because of its convenience of self administration, compactness and easy manufacturing; sometimes immediate onset of action is required than conventional therapy in many cases. So that to overcome these drawbacks, immediate release dosage form has emerged as alternative oral dosage forms. Immediate drug release dosage forms disintegrate rapidly after administration with enhanced rate of dissolution. The basic approach used in development tablets is the use of superdisintegrants like Cross linked Polyvinylpyrrolidone or crospovidone (Polyplasdone), Sodium starch glycolate (Primogel, Explotab), carboxymethylcellulose (Croscarmellose) etc. These superdisintegrants provide instantaneous disintegration of tablet after administration in stomach. In this field immediate release liquid dosage forms and parenteral dosage form have also been introduced for treating patients. In liquid dosage form can be suspensions with typical dispersion agents like hydroxypropyl methylcellulose, AOT (dioctylsulfosuccinate) etc. The development of immediate release therapy also provides an opportunity for a line extension in the marketplace, a wide range of drugs e.g., neuroleptics, cardiovascular drugs, analgesics, antihistamines and other drugs can be considered candidates for this dosage form. As a drug entity nears the end of its patent life, it is common for pharmaceutical manufacturers to develop a given drug entity in a new and improved dosage form. A new dosage form allows a manufacturer to extend market exclusivity, while offering its patient population a more convenient dosage form or dosing regimen. Keywords: - : Immediate release, polymers, superdisintegrant.

Mouth dissolving tablets- A unique dosage form curtailed for special purpose: a review

The concept of mouth dissolving tablets known as MDTs has emerged with an objective to improve patient’s compliance. Methods to improve patient’s compliance have always attracted scientists towards the development of fancy oral drug delivery systems. Among them, mouth dissolving drug delivery systems (MDDDS) have obtained an important position in the market by overcoming previously encountered administration problems and contributing to extension of patent life. These dosage forms rapidly disintegrate in contact with saliva even within <60 seconds, an attribute that makes them highly attractive for paediatric, geriatric, bedridden patients and for active patients who are busy and in travelling may not have access to water. This special dosage form has some prerequisite criteria for formulation and this also involves the use of special techniques for large scale industrial production. The aim of this article is to review the advantages and disadvantages of MDTs, common excipients used in the formulation especially highlighting the use of superdisintegrating agents and taste masking agents in formulation and finally the popular methods used to produce large scale tablets for commercial purpose. KeywordsDrug delivery, Mouth dissolving tablets, Mucosal membrane, Superdisintegrant, Taste masking

Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents

BackgroundWhile there has been much discussion by policymakers and stakeholders about the effects of “secondary patents” on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents.Methodology/Principal FindingsWe read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself) and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims (“independent” secondary patents).We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years), independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years), and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years). We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs.Conclusions/SignificancePolicies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of active “life cycle management” or “evergreening” of patent portfolios in the industry.

Additional Protection for Second Medical Uses of Known drugs?

Bristows, 100 Victoria Embankment, London, EC4Y 0DH, UK *Author for correspondence: E-mail: laura.reynolds@bristows.com Thursday 19 July 2012 may well come to be regarded as an important day for originators in the pharmaceutical industry. This was the day when the Court of Justice of European Union (CJEU) handed down its decision in Neurim [1] and opened the door to the possibility of supplementary protection certificates (SPCs) for second medical use patents. Neurim decided that the existence of an earlier marketing authorization (MA) for a medicinal product, whether for human or veterinary use, no longer precludes the grant of an SPC, provided that the earlier MA would not fall within the limits of the patent relied upon. This clearly demonstrates that Europe’s highest court recognizes the value of second medical uses for known drugs. The CJEU appears to have agreed with Lord Justice Jacob in the English Court of Appeal that it would be grossly unjust if Neurim were prevented from obtaining an SPC for the use of melatonin to treat human sleep disorders, due to the existence of an earlier MA for the use of melatonin in sheep breeding. The potential inequity is starkly illustrated when it is realized that it had taken 15 years for Neurim to obtain their MA and, without an SPC, Neurim would have had just 5 years of patent life remaining, in which to attempt to recoup its RD

Development of Innovative Orally Fast Disintegrating Film Dosage Forms: A Review

Over the past few decades, there has been an increased interest for innovative drug delivery systems to improve safety, efficacy and patient compliance, thereby increasing the product patent life cycle. The discovery and development of new chemical entities is not only an expensive but also time consuming affair. Hence the pharmaceutical industries are focusing on the design and development of innovative drug delivery systems for existing drugs. One such delivery system is the fast disintegrating oral film, which has gained popularity among pediatric and geriatric patients. This fast disintegrating film with many potential benefits of a fast disintegrating tablet but devoid of friability and risk of choking is more acceptable to pediatric and geriatric patients. Formulation of fast disintegrating film can be achieved by various techniques, but common methods of preparation include spraying and casting. These film forming techniques use hydrophilic film former in combination with suitable excipients, which allow the film to disintegrate or dissolve quickly in the mouth within a few seconds without the administration of water. In view of the advantages of the fast disintegrating films over the fast disintegrating tablets and other dosage forms, it has the potential for commercial exploitation. The oral film dosage form not only has certain advantages of other fast disintegrating systems but also satisfies the unmet needs of the market. The present review emphasizes on the potential benefits, design and development of robust, stable, and innovative orally fast- disintegrating films and their future scenarios on a global market as a pharmaceutical dosage form.&#x0D;

Modeling agricultural innovation in a rapidly developing country: the case of Chinese pesticide industry

AbstractTechnology and innovation play an increasingly important role in the economic development of both developed and developing countries. We investigate how policy and market factors influence firms’ (or other potential inventors’) decisions on innovation or imitation by developing a model that emphasizes expected market size, appropriability and technological opportunity. We empirically test the model using provincial pesticide innovation data from a rapidly developing country, China. We find that the government encouraged local innovation by opening regions to more international trade, by increasing investments in public research and education, and by strengthening intellectual property right (IPR) enforcement to meet its WTO TRIPS obligations. Moreover, while IPR enforcement and increases in market size are important in encouraging innovation, empirical evidence is mixed as inventors respond to these factors differently. Policies to increase expected market size could increase copying rather than inducing R&amp;D investments, and extended patent life may reinforce the original standing of infringers as well as inventors.

Bisphosphonates

Bisphosphonates are pharmacological compounds that have been used for the prevention and treatment of several pathological conditions including osteoporosis, primary hyperparathyroidism, osteogenesis imperfecta, and other conditions characterized by bone fragility. Many studies have been performed to date to analyze their effects on inflammation and bone remodelling and related pathologies. The aim of this review is, starting from a background on inflammatory processes and bone remodelling, to give an update on the use of bisphosphonates, outlining the possible side effects and proposing new trends for the future. Starting from a brief introduction on inflammation and bone remodelling, we collect and analyze studies involving the use of bisphosphonates for treatment of inflammatory conditions and pathologies characterized by bone loss. Selected articles, including reviews, published between 1976 and 2011, were chosen from Pubmed/Medline on the basis of their content. Bisphosphonates exert a selective activity on inflammation and bone remodelling and related pathologies, which are characterized by an excess in bone resorption. They improve not only skeletal defects, but also general symptoms. Bisphosphonates have found clinical application preventing and treating osteoporosis, osteitis deformans (Paget's disease of bone), bone metastasis (with or without hypercalcaemia), multiple myeloma, primary hyperparathyroidism, osteogenesis imperfecta, and other conditions that feature bone fragility. Further clinical studies involving larger cohorts are needed to optimize the dosage and length of therapy for each of these agents in each clinical field in order to be able to maximize their properties concerning modulation of inflammation and bone remodelling. In the near future, although "old" bisphosphonates will reach the end of their patent life, "new" bisphosphonates will be designed to specifically target a pathological condition.

The America Invents Act and Its Importance to Patent Prosecution in the Biotech Sector

Industrial BiotechnologyVol. 8, No. 2 PATENT UPDATESThe America Invents Act and Its Importance to Patent Prosecution in the Biotech SectorTiffany A. Reiter, Erin L. Baker, and J. Peter FasseTiffany A. ReiterSearch for more papers by this author, Erin L. BakerSearch for more papers by this author, and J. Peter FasseSearch for more papers by this authorPublished Online:13 Apr 2012https://doi.org/10.1089/ind.2012.1512AboutSectionsPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetailsCited byThriving in a new patent world: Mitigating the unintended consequences of the America Invents Act29 June 2019 | Cogent Business & Management, Vol. 6, No. 1Implications of the America Invents Act for R&D Managers: Connecting the Patent Life Cycle with the Technology Development Process28 December 2015 | Research-Technology Management, Vol. 57, No. 5Translational tidbitsScience-Business eXchange, Vol. 6, No. 31 Volume 8Issue 2Apr 2012 InformationCopyright 2012, Mary Ann Liebert, Inc.To cite this article:Tiffany A. Reiter, Erin L. Baker, and J. Peter Fasse.The America Invents Act and Its Importance to Patent Prosecution in the Biotech Sector.Industrial Biotechnology.Apr 2012.66-69.http://doi.org/10.1089/ind.2012.1512Published in Volume: 8 Issue 2: April 13, 2012Online Ahead of Print:March 28, 2012PDF download

Napsterizing Pharmaceuticals: Access, Innovation, and Welfare

We analyze the effects of a hypothetical change from the status quo with patent protection on pharmaceuticals to a world in which all patent rights on both existing and future branded drugs would be eliminated. Our analysis takes into account stylized facts concerning the nature of competition between branded and generic competition, the value of the flow of potential new drugs, the effective patent life under the existing Hatch-Waxman framework and, most critically, the essential features of prescription benefit coverage whereby consumers face relatively low marginal prices (copayments) for their prescriptions. Our calibration of a simple model indicates that the costs of Napsterizing pharmaceuticals exceed the benefits by a ratio of about 3 to 1.

Man-made Boards Technology Trends based on TRIZ Evolution Theory

Abstract China is one of the world's largest manufacturers and consumers of man-made board applications. A systematic and efficient method of foreseeing future technology trends and their evolutionary potentials is a key task that can help companies guide their planning and allocate their resources. Application of the law of evolution with a S-shaped curve could contribute essentially to the accuracy of the long-term forecast. This research seeks to determine the current stage and the position on the S-curve of man-made board technology in China on the TRIZ evolution theo ryand introduce a methodology which combines patent analysis and technology life cycle forecasting to find a niche space of man-made technology development in China.

The Health Related Quality of Life for Kidney Transplant Patients in Bulgaria—A Pilot Study

ABSTRACTThe aim of the present study was to analyze the pharmacotherapy cost and quality of life of patents after kidney transplantation compared to those with chronic kidney disease in Bulgaria. This retrospective pharmacotherapy cost study and prospective health related quality of life (QoL) study was performed during 2010–2011 at the biggest Sofia hospital serving all transplant patients. The cost of pharmacotherapy was analyzed after reviewing patients' records. The health related quality of life was evaluated with the multi-attributable questionnaire SF-36, which measures 9 health domains.Forty-two percent of the patients with chronic kidney disease, and 26% of those with kidney transplant were female. The average age of the transplanted patients was 39.7 for male patients and 42.2 for female ones, while in the group suffering from chronic kidney disease the average male age was 48.3 and that of female patients, 51.2. No statistically significant difference was observed among the mean monthly cost of therapy per patient during the two-year period. The QoL was with lower values in the role limitations domain for patients with chronic kidney diseases and this difference was statistically significant. We found a correlation among the mean cost of pharmacotherapy and mean QoL in both groups of patients. In the group of patients with kidney transplantation the place of living and general health state were positively correlated. The cost of pharmacotherapy and the health state in comparison with the previous year were also positively correlated.This is the first Bulgarian study of the quality of life of kidney transplant patients. It shows that the SF-36 could be successfully used in this group of patients as well as for comparison with the QoL of patients with chronic kidney disease.

Formulation technologies of orally fast disintegrating tablets

ABSTRACT: Methods to improve patient’s compliance have always attracted scientists towards the development of new drug delivery systems. Among them, orally fast disintegratings tablets (FDTs), have acquired an important place in the drug market by overcoming previously encountered administration problems and contributing to extension of patent life. FDTs have the unique property of rapidly disintegrating and/or dissolving and releasing the drug as soon as they come in contact with saliva. Therefore, these tablets are very practical for the patient population that include bed ridden, dysphagic, geriatric or pediatric and phychic patients. This article focuses on the technologies available and the advances made so far in the field of fabrication of FDTs along with their advantages and limitations. KEY WORDS: orally fast disintegrating tablets, formulation technologies of orally fast disintegrating tablets

Pharmacotherapeuetic Options for the Treatment of Multiple Sclerosis

Multiple sclerosis is the most common progressive and disabling neurological condition in young adults. Neuro-inflammation is an early and persistent change and forms the basis of most pharmacotherapy for this disease. Immunomodulatory drugs are mainly biologies (β-interferons, a four amino acid peptide, and a monoclonal antibody to a cell adhesion molecule on the blood-CNS barrier) that either attenuate the inflammatory response or block the movement of immune cells into the CNS. They reduce the rate of relapse, but have little or no effect on the progression of disability. The market landscape for MS drugs is in the midst of major change because the patent life of many of these medicines will soon expire, which will lead to the emergence of biosimilars. In addition, new small molecule immunomodulatory and palliative drugs have entered the market, with more in the pipeline; a number of monoclonal antibodies and other immunomodulatory drugs are also in clinical development.

Getting the most out of your IP – patent management along its life cycle

Effectively managing and optimizing the value of the patent portfolio is a major challenge for many firms, especially those in knowledge intensive industries, such as the pharmaceutical, biotechnological and chemical industry. However, insights on effective patent portfolio strategies are rare. Therefore, in this article we investigate in detail how firms successfully manage and optimize their patent portfolios to increase their overall competitiveness. We discover that successful patent portfolio management is rooted in managing the patents along their life cycles. Based on the findings of ten case studies, we develop a holistic patent life cycle management model reflecting five distinctive phases of patent management: explore, generate, protect, optimize and decline. We conclude with how our findings can be used in practice.