Formulation Patent Research Articles

Protection of Indonesia’s biodiversity against biopiracy through adoption of Traditional Knowledge Digital Library

Abstract This research is important to formulate a form of adoption of traditional knowledge digital libraries as implemented in India which is proven to be able to cancel formulation patent applications for traditional medicines in Europe as a form of protection for intellectual property over traditional knowledge. This research is normative legal research that is prescriptive. The research takes a legislative (statute) approach to relevant legal sources, including data obtained through documentation studies. The research results showthat The Indonesian government is starting to seriously implement communal intellectual property protection by providing defensive protection through inventory and documentation of intellectual property through the National Information System for Communal Intellectual Property as regulated in Government Regulation Number 56 of 2022 concerning Communal Intellectual Property. However, defensive measures are still insufficient to prevent biopiracy actions in Indonesia. Positive protection is also required, in the form of sui generis regulation of communal intellectual property. In terms of specifically defensive protection of traditional knowledge as part of communal intellectual property, you can adopt the Traditional Knowledge Digital Library as a tool to assist patent examiners so that patent offices around the world do not grant patent rights to the wealth of traditional knowledge of indigenous and tribal peoples in Indonesia. Optimizing the database system through the Indonesian Traditional Knowledge Digital Library is a form of implementing the precautionary principle which can prevent even greater biopiracy practices in Indonesia and also as a means to protect biodiversity in Indonesia.

Navigating Dry Eye Research: A Comprehensive Review of Etiology, Clinical Trials, Patents, and Recent Advancements.

Millions of people worldwide suffer from dry eye disease. Dry eye, a multifunctional condition of the ocular surface, typically occurs in conjunction with an unbalanced tear film. With increasing age, the dry eye problem becomes worse. Aqueous-deficit dry eye and evaporative dry eye are the two traditional classifications for dry eye. Various examination tools are used to diagnose dry eye. Clinical trials are conducted in four phases to check the safety and efficacy of drugs. The quick clearance from the precorneal space is ensured by the eye's advanced defense mechanism. It restricts the integrated medicine's entry into the eyes, resulting in a usually low bioavailability for topical eyedrops. In this study, we focus on recently developed formulations for curing dry eye. This review's goal was to outline the etiology, clinical discovery and development, patents, and recent advancements for dry eye disease. The current study has described the widespread incidence of dry eye, which was found to be more common as people aged and recently developed formulations are treating dry eyes. According to research, novel formulations are enhancing ocular drug delivery. In this review, etiology, clinical data, dry eye formulation patents, and recent advancements are all included.

USPTO's Lax Policy Leads to Humira Formulation Thicket.

Biosimilar drugs enter the United States market well after they enter the European market. That is likely because pharmaceutical companies have many more patents in the United States than in Europe. But why is patent coverage of biological drugs so much more extensive in United States? This case study seeks to answer this question for drug formulation patents.

A Comprehensive Review on Recent Advances and Patents of Niosomes

Abstract: Niosomes are novel, self-assembled vesicular carriers that deliver both lipophilic and hydrophilic drugs at the specific site in a targeted way, enhancing bioavailability and extending therapeutic effects. Niosomes are a versatile drug delivery system with a diverse range of applications from gene to brain-targeted delivery and they are more attractive choices than liposomes as they are efficient at biodegrading. Niosome offers several advantages over conventional drug delivery systems, including enhanced stability, and also have gained a lot of focus in natural product delivery in recent years. This review provides a comprehensive view of niosomal research and recent advancements, including classification and fabrication methods, and their role in drug delivery and targeting. The description of the rise in niosomal formulation patents around the world is also elaborated along with the natural product delivery of niosomes which has recently gained significance. Patents on novel preparation, loading, and modification techniques have enhanced the importance of niosome in the pharmaceutical industry.

Global Patent Landscape of Benign Prostatic Hyperplasia Drugs

ObjectiveTo characterize the changing landscape of BPH drugs by investigating patent documents derived from pipeline projects. Benign prostatic hyperplasia (BPH) drugs were first approved for the mainstream market about 20 years ago. The fixed patent term warns of possibly transforming the landscape of BPH drugs as technological and commercial substitution causes the displacement of established technologies and competitors by newer ones. However, very few studies focus on patents of BPH drugs, though many literature reviews have analyzed this topic from technological and clinical perspectives. MethodsAll available patent data relevant to BPH-related drugs were collected from the Cortellis database. Descriptive statistics, bibliometric analyses, and citation analyses were used to analyze the patent landscape. ResultsBy analyzing 1,936 patent families from 1967 to 2019, this study addresses the main results on the changing landscape of BPH drugs, involving associated indications, the shifting centers of innovation globally, notable formulation patents, and promising therapeutics. ConclusionThe results provide a significant reference for decision-making by researchers, clinicians, policymakers, and investors with an interest in BPH drugs.

An Analysis of Remdesivir Patenting

Pharmaceutical patents are categorized into primary patents and secondary patents. Primary patents refer to compound patents, while secondary patents mainly include crystalline form patents, process patent, formulation patent and method of use patent. In the recent outbreak of COVID-19, Wuhan Institute of Virology, has applied for a new method of use patent on Remdesivir for its efficacy and safety in the treatment of the pneumonia caused by 2019-nCoV. But Gilead Sciences, the inventor of Remdesivir, is the eligible holder of the compound patent of Remdesivir. In theory, the patent applied for by Wuhan Institute of Virology has utility and novelty rather than innovativeness, for which it may not be granted the method of use patent of Remdesivir. In this case, we suggest that the patent of Remdesivir be implemented through cross licensing and compulsory licensing between different patent holders.

The High Cost of Insulin in the United States: An Urgent Call to Action

The High Cost of Insulin in the United States: An Urgent Call to Action

Abstract 2165: Self-microemulsifying drug delivery systems (SMEDDS) containing novel compounds in combination with gemcitabine: Bioavailability enhancement and synergistic anticancer efficacy studies for pancreatic cancer management

Abstract Pancreatic cancer (PC) is the third leading cause of deaths in the United States claiming approximately 45,000 lives every year and is predicted to be the second cause of cancer related deaths by 2020. Late diagnosis, poor prognosis, limited success and significant side effects with existing anticancer drugs has resulted in such high mortality rates (5 year survival rate is less than 8%). These limitations have encouraged scientists to develop chemopreventive strategies and combination drug alternatives that can serve as better therapeutics. In our previous studies, we have reported the synergistic chemoprevention potential (formulation patent pending) of lipid nanocarriers (SMEDDS) of Loratadine (LOR), H1-receptor antagonist drug; with free Sulforaphane (SFN), a neutraceutical compound from broccoli when administered at low doses in human PC cell lines (MIA PaCa-2 and Panc-1). To confirm the hypothesis that enhanced efficacy using the SMEDDS formulation results from bioavailability enhancement, preclinical in vivo pharmacokinetic studies were performed in Sprague Dawley rats. The results confirmed that the bioavailability and Cmax of LOR increased 5-fold (2203.2 ± 293.7 ng.h/mL for plain LOR and 10266.1 ± 250.0 ng.h/mL for LOR SMEDDS) and 4-fold (120.9 ± 10.5ng/mL for plain LOR and 503.2 ± 5.8ng/mL for LOR SMEDDS) when administered as SMEDDS compared to plain drug. This corroborated the significant enhancement in bioavailbility with SMEDDS formulation. This promising results in bioenhancement and chemoprevention activity led to an hypothesis to assess the potential of LOR SMEDDS-SFN combination as an adjuvant therapy with classical anticancer drugs like Gemcitabine (GEM) to give synergistic efficacy enhancement in PC treatment. For this, IC50 concentrations were calculated for various treatment groups [GEM alone or in addition to the LOR free drug or as SMEDDS with or without SFN] using MTS viability assay on human PC cell lines in accordance with published protocol over an incubation time of 72 h. The LOR SMEDDS-SFN-GEM combination revealed 2-fold and 2.5-fold enhancement in anticancer activity compared to free drug combination and GEM alone respectively. This confirmed the synergistic anticancer potential of the free drug combination followed by further activity potentiation using SMEDDS formulation. In conclusion, a novel SMEDDS of LOR and free SFN was invented (provisional patent applied) to successfully elicit PC chemoprevention and adjuvant treatment in combination with GEM. We anticipate that, this adjuvant therapy will lead to relatively low doses of anticancer drugs and thereby can reduce the side effects with enhanced efficacy. Citation Format: Sunil Prabhu, Preshita Desai, Naga Jyothi Thumma, Jeffrey Wang. Self-microemulsifying drug delivery systems (SMEDDS) containing novel compounds in combination with gemcitabine: Bioavailability enhancement and synergistic anticancer efficacy studies for pancreatic cancer management [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 2165.

Abstract 2238: Self-microemulsifying drug delivery systems (SMEDDS) containing novel compounds for the chemoprevention of pancreatic cancer

Abstract Pancreatic cancer (PC) is the fourth leading cause of deaths in the United States, claiming approximately 43,000 lives every year. Existing trends suggest that it will be the second cause of death after lung cancer within the next 20 years. With mortality rates remaining high even after decades of research, scientists are now turning to develop chemopreventive strategies that may stop or delay the initiation and progression of the disease. Our study reports the chemoprevention potential of (1) a free drug combination of H1-receptor antagonist drug with Sulforaphane (SFN), a neutraceutical compound derived from broccoli and (2) lipid nanocarriers of H1-receptor antagonist drug (SP1 SMEDDS; formulation patent pending) with free SFN when administered at low doses in human pancreatic cancer cell lines (MIA PaCa-2 and Panc-1). IC50 concentrations were calculated for various treatment groups using MTS viability assay in accordance with published protocol, using 96-well microplates and incubation time of 72 h. The free drug combination revealed almost 70-fold and 20-fold enhancement in chemoprevention efficacy (based decrease in cancer cell viability) as compared to controls. Interestingly, the free drug combination (at 5µM) showed ~55 % (p<0.001) inhibition in cell lines whereas no measurable response was observed with individual free drug treatments at the same concentration. This confirmed the synergistic chemoprevention potential of the free drug combination. SP1 SMEDDS were optimized for particle size, encapsulation efficiency and chemoprevention efficacy. SP1 SMEDDS (10µM) by itself exhibited 54% (p<0.001) cell line inhibition whereas no measurable response was observed with free drug at that same concentration, confirming the potential of lipid nanocarriers in enhancing the chemoprevention activity. Moreover, the SP1 SMEDDS in combination with free SFN demonstrated synergistic activity with 500-fold, 140-fold and 7-fold enhancement in chemoprevention potential as compared to the free HI-receptor antagonist, SFN and the free drug combination, respectively. In conclusion, a novel lipid formulation of an H1-receptor antagonist in combination with free SFN was invented (provisional patent applied) to successfully elicit PC chemoprevention. Future studies will look into the efficacy of this novel formulation in in vivo PC models. Citation Format: Preshita Desai, Arvind Thakkar, Jeffrey Wang, Sunil Prabhu. Self-microemulsifying drug delivery systems (SMEDDS) containing novel compounds for the chemoprevention of pancreatic cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 2238.

Patents Court finds medac’s methotrexate formulation patent invalid

The Patents Court has found that medac’s formulation patent for a new dosage form of methotrexate is invalid for lack of inventive step.

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.

Formulation Patents and Dermatology and Obviousness

Most patents covering dermatologic products contain patent claims directed to the pharmaceutical formulation of the product. Such patents, known as formulation patents, are vulnerable to attacks based on the legal argument that the formulations covered are obvious over formulations already known prior to the filing of the patent application. Because obviousness is an important concept in patent law, recent court cases concerning obviousness and formulation patents were examined and discussed below. Courts have ruled that patent claims are obvious when features of the claimed formulation are found in the prior art, even if the features or characteristics of the formulation are not explicitly disclosed in the prior art. However, patentees have successfully overcome obviousness challenges where there were unexpected results or properties and/or the prior art taught away from the claimed invention.

Recent Patents on Oral Combination Drug Delivery and Formulations

Oral combination drug delivery systems have been proven to be highly beneficial and vital in the treatment of several dreadful diseases such as cancer, HIV (AIDS) and tuberculosis. Further, pharmaceutical companies have often explored the strategy of combination drug therapy for treating diseases such as diabetes (Type 2), cardiovascular diseases, central nervous system (CNS) disorders, and for treating several other microbial infections. Patenting combination drug delivery systems and formulations has been proven to be very beneficial for the sustainment and growth of pharmaceutical industry. Several pharmaceutical companies have explored this opportunity in extending the life cycle of their blockbuster molecules, and providing additional sources of revenues when the new chemical entity (NCE) discovery is scarce. The article reviews some recent combination formulation patents and patent publications, particularly the US patents and patent applications, relevant to oral delivery of pharmaceuticals. Examples of some oral combination products on the US and worldwide market are presented. Patents and patent applications on combination oral formulations relevant to analgesics (including anti-inflammatory and antipyretics), cardiovascular system (CVS) products, antibacterial and antiviral, and central nervous system (CNS) products are briefly discussed.

Strategies for Strengthening Patent Protection of Pharmaceutical Inventions in Light of Federal Court Decisions

In this article, a brief history of patent law is presented, along with recent changes in its interpretation that are relevant in securing patents in the current landscape. Specific patent examples are presented to illustrate key issues. For example, the case of KSR International Co. v. Teleflex, Inc. is an important recent decision by the United States Supreme Court, which developed a more flexible definition of the teaching-suggestion-motivation (TSM) test in determining obviousness, which negates patentability. Although KSR case involved a mechanical invention, the ruling in this case has had implications in other areas of patent law, particularly as it applied to pharmaceutical and chemical inventions. It has had a significant impact on the outcome of patent prosecution at the United States Patent and Trademark Office (USPTO), as well as in defending patents in federal courts. If an invention is obvious to try and there are a finite number of predictable solutions in the prior art, then the invention will be considered obvious by current standards. Bayer Schering Pharma AG v. Barr Laboratories, Inc is presented as a case in which the court of appeals has applied the KSR standard of obviousness in invalidating a formulation patent claim, in which a finite number of options were available to the formulator. Unlike the formulation patent example, patents covering new molecules have survived challenges more successfully. In The Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., the court of appeals for the Federal Circuit determined that the invention of risedronate was unobvious, although it was a mere positional isomer of a prior bisphosphonate. However in Altana Pharma AG v. Teva Pharmaceuticals USA, Inc., the court of appeals judged against the innovator company when there was a clearer case of predictable prior art. Finally, Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc. presents an example of a case at the Federal Circuit where topiramate was more easily defended, because the scientist had at his disposal a great number of unpredictable options and the results were clearly surprising. In light of these and other court decisions the USPTO has established new guidelines for patent examinations going forward that this article describes.

“Obviously” a challenge: Patent survival statistics & tips

Industrial BiotechnologyVol. 5, No. 3 FEATURE COMMENTARY“Obviously” a challenge: Patent survival statistics & tipsSteven C. Carlson and Willy ChangSteven C. CarlsonSearch for more papers by this author and Willy ChangSearch for more papers by this authorPublished Online:1 Oct 2009https://doi.org/10.1089/ind.2009.3.172AboutSectionsPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail "“Obviously” a challenge: Patent survival statistics & tips." , 5(3), pp. 172–173FiguresReferencesRelatedDetails Volume 5Issue 3Sep 2009 InformationCopyright 2009, Gen Publishing Inc., Mary Ann Liebert, Inc.To cite this article:Steven C. Carlson and Willy Chang.“Obviously” a challenge: Patent survival statistics & tips.Industrial Biotechnology.Sep 2009.172-173.http://doi.org/10.1089/ind.2009.3.172Published in Volume: 5 Issue 3: October 1, 2009PDF download

The battle over global drug markets: enforcement of pharmaceutical patents in the United States, Europe and Japan

The pharmaceutical industry is one of the most productive and competitive industries in the world. Many of the large pharmaceutical companies (often termed ‘Big Pharma’) base their primary operations in the USA and maintain extensive facilities in countries around the world. Pharmaceutical research is, therefore, an activity of global importance. The intensely competitive and global nature of Big Pharma, and the pharmaceutical industry in general, make pharmaceutical product innovation and development a crucial determinant of any company’s success. Innovator pharmaceutical companies are constantly challenged by the time and cost required to bring new, branded drug products, ie the so-called ‘pioneer’ drugs, successfully to market. Companies must continually seek new and improved ways to expedite the research, development, and regulatory approval phases of drug development and to manage competition from generic drug manufacturers. These companies seek to maintain an advantage in the marketplace both by introducing new drug products whenever possible and by finding new ways of protecting existing drug products, widening the breadth of patent protection for innovative products. Successful companies have maintained a competitive advantage in the global pharmaceutical industry by evaluating and strengthening the way existing drug products are protected, frequently changing the nature of protection under the patent laws by improving upon the product itself. In the pharmaceutical industry, there are several types of patents an innovator can obtain. The main type of patent is directed to brand-name pioneer drugs and their uses, eg for specific indications. Pioneer drug patents include (i) product patents that cover the active ingredient or compound in a drug; (ii) process patents that cover a process for manufacturing a drug; (iii) method-of-use patents that relate to a particular method of using a drug; and (iv) formulation patents that cover both the active and inactive ingredients in a drug (eg a final dosage form, tablet, or capsule). These types of patents are infringed by the sale and use

Broad claim scope invalidates formulation patent despite 'powerful arguments' to the contrary

Broad claim scope invalidates formulation patent despite 'powerful arguments' to the contrary

Protection and Challenge of Pharmaceutical Patents

Recent trends of patent enforcement in the pharmaceutical industry are discussed with particular reference to chemical process patents, formulation patents, patented salts and derivatives, polymorph patents, second indication inventions, metabolite patents and dosage regimen patents. The basic principles of patent rights are summarised and practical recommendations are disclosed on the patentability, enforceability and invalidation of the patent types discussed above. Some tactical advice is presented for generics companies on how to endeavour to avoid patent conflicts and what to do in case of an infringement suit. The importance of patenting the R&D results of generic companies, in terms of the creation of chemical and biological generic products, is emphasised.

BASF receives cleaning formulation patent

BASF receives cleaning formulation patent

{BLR 374} FDA - Formulation patents - Drug Price Competition Act

Biotechnology Law ReportVol. 4, No. 6 {BLR 374} FDA - Formulation patents - Drug Price Competition ActFDA CONCLUDES THAT COMPOSITION AND FORMULATION PATENTS ARE COVERED BY DRUG PRICE COMPETITION ACT OF 1984, TITLE IPublished Online:23 Mar 2009https://doi.org/10.1089/blr.1985.4.189aAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail "{BLR 374} FDA - Formulation patents - Drug Price Competition Act." , 4(6), pp. 189–215FiguresReferencesRelatedDetails Volume 4Issue 6Jun 1985 To cite this article:{BLR 374} FDA - Formulation patents - Drug Price Competition Act.Biotechnology Law Report.Jun 1985.189-215.http://doi.org/10.1089/blr.1985.4.189aPublished in Volume: 4 Issue 6: March 23, 2009PDF download