Patent protection strategies - NCBI - NIH
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Patenting dietary supplements & pharmaceutical compounds

India has a long tradition of medicine and has many things to offer to the world. Dietary supplements & pharmaceutical compounds can be patented if the formulation is novel in the market.

Most of us know that good nutrition and a balanced diet are important for good health. In the current scenario, the demand for dietary supplements for adults as well as children is constantly increasing. To meet the demands many new products are being researched and introduced to the consumer market. Various dietary supplements are sold in different combinations to provide specific effect in the human body. For example, a combination of dietary supplements includes ingredients to provide strength to the body, desired weight and some provide stress relief. So for an industry overflowing with new products, new formulations and new ideas, protecting the intellectual property is essential to business success.

Currently, over-the-counter (OTC) and prescription drugs play a vital role in health care system. 

Patent protection strategies - NCBI - NIH
Patenting of Pharmaceuticals: An Indian Perspective

While both are regulated by Food and Drug Administration, over-the-counter (OTC) drug products are available to consumers without a prescription. There are more than 80 therapeutic categories of over-the-counter (OTC) drugs, ranging from acne drug products to weight control products, and over 100,000 over-the-counter (OTC) drugs are currently being sold in India.

Thus, over-the-counter (OTCs) are critical to country’s health care system because they provide easy access to certain drugs that can be used safely without the help of a healthcare practitioner.

Why intake of dietary supplements & pharmaceutical compounds necessary for human body?

The medical and health management of certain anemias can be handled rather well by increasing the daily intake of iron in diets. In other cases, heavy physical exercise may require the intake of considerable quantities of minerals apart from those generally obtained through what otherwise would be considered a balanced diet.

Recent Patents of Dietary Supplements and Pharmaceutical Compounds:-

US 20170266225

Date of Publication- 21st Sept 2017

Title- NATURAL COMPOSITIONS CONTAINING EGGSHELL CALCIUM, ORGANIC HONEY AND LEMON

The present invention discloses compositions and edible orally delivered products, such as candies, beverages, nutritional bars and dietary supplements that increase bone growth and treat age-related bone loss in humans. The major component of the invention is biological calcium which is derived from natural eggshell powder. The compositions also include organic honey and lemon.

US 20170280749 A1

Date of Publication- 5th Oct 2017

Title- ANTIHISTAMINES COMBINED WITH DIETARY SUPPLEMENTS FOR IMPROVED HEALTH

The present invention provides combinations comprising a sedating antihistamine and selected indole-based natural products such as L-tryptophan, 5-hydroxytryptophan and melatonin, along with pharmaceutically acceptable calcium and magnesium salts and selected B vitamins. These combinations are useful in providing a medicament for improving sleep in mammals, especially humans.

US 20170151274 A1

Date of Publication- 1st June 2017

Title-  COMPOSITIONS AND METHODS FOR ENHANCING IMMUNITY

The present disclosure relates generally to immunostimulatory compositions, and more specifically to immunostimulatory compositions containing a β-glucan preparation, a ginseng extract, and a mushroom extract.

US 20170202806 A1

Date of Publication- 20th July 2017

Title- COMBINATION DRUG THERAPIES FOR CANCER AND METHODS OF MAKING AND USING THEM

In alternative embodiments, provided are therapeutic combinations, pharmaceutical compositions, formulations, kits and devices for treating, preventing or ameliorating a tumor or a cancer, and methods and uses for treating, preventing or ameliorating a tumor or a cancer. In alternative embodiments, provided are therapeutic combinations, pharmaceutical compositions, formulations, kits and devices comprising: a beta adrenergic receptor antagonist (a “beta blocker”) such as propranolol; a non-steroidal anti-inflammatory drug (a NSAID) such as etodolac; and, a sorafenib or NEXAVAR™ or equivalent thereof. In alternative embodiments, the therapeutic combinations further comprise an anti-cancer or anti-tumor antibody, a cytokine, and/or an additional chemotherapeutic agent. In alternative embodiments, the methods, uses, therapeutic combinations, pharmaceutical compositions, formulations, kits and devices are used for treating, preventing or ameliorating a hepatocarcinoma or hepatocellular carcinoma (HCC), an adenocarcinoma, a metastatic adenocarcinoma of the liver, or an advanced hepatocellular carcinoma.

US 20170056339 A1

Date of Publication- 2nd March 2017

Title- FORMULATION OF FAT-SOLUBLE VITAMIN

The invention relates to a composition comprising A) microcapsules comprising at least one fat-soluble active substance selected from a vitamin K compound or a provitamin or a prodrug of a vitamin K compound embedded in a matrix comprising a hydrocolloid and optionally one or more other matrix components, and B) at least one dietary mineral; as well as uses and products comprising such compositions.

US 20170068777 A1

Date of Publication- 9th March 2017

Title- METHODS OF IDENTIFYING AND FORMULATING FOOD COMPOUNDS THAT MODULATE PHENOTYPE-RELATED TARGETS

This invention relates generally to (but is not limited to) identifying food compounds that have an impact on a phenotype of interest in a subject, and more particularly to identifying a phenotype-related target, identifying a stimulus (e.g., a pharmaceutical agent) that modulates that target, and identifying food compounds exhibiting similarity to the agent (e.g., having a chemical structure that is similar to the agent’s structure). The similarity can be determined, for example, by a computer-interfaced comparison between a drug database and a food database.

US 20160213629 A1

Date of Publication- 28th July 2016

Title- METHOD FOR ENHANCING ENERGY PRODUCTION AND METABOLISM IN CELLS

The present invention relates to use of a composition comprising D-glyceric acid (DGA), DL-glyceric acid, L-glyceric acid, or hydroxypyruvatic acid and/or their salts or esters. Further, the invention relates to the use of said composition for enhancing direct and indirect mitochondrial metabolism, e.g. the ATP producing electron transport system (ETS), citric acid cycle or tricarboxylic acid cycle, (TCA), and beta oxidation, and also enhancing the shuttling of reducing equivalents from mitochondrial matrix into the cytosol and protein synthesis in the endoplasmic reticulum. Directly related to the above the use of DGA relates also to reducing the formation of reactive oxygen species (ROS). Alleviating, preventing and even healing effects towards extremely wide range of non-communicable diseases materializes.

United States Patent 9704096 B2

Date of Publication- 11th July 2017

Title- METHOD AND SYSTEM FOR MAKING CUSTOMIZED FORMULATIONS FOR INDIVIDUALS

The one or more embodiments disclosed herein provide a method for automatically assembling multiple components into a single edible custom composition, in which each compound is individually customized to proportions formulated from a profile of an individual or group. The single custom mixture can contain a plurality of compounds including foods or flavors, nutritional additives, herbals, biologics, or pharmacologically active substances. Using the method and a related algorithm, the formulation of a custom mixture is suggested.

Therefore, when protecting intellectual property by way of filing patents which is a part of a corporate strategy, the patent law can protect valuable research such as product formulations. The protected and patenting pending technologies will provide competitive advantage over any third party in the form of product formulation patents. Discuss your patenting legal issues with our team of experienced patent attorneys and patent agents.

Indian Patent Attorney, INTELLECTUAL PROPERTY STRATEGY, MARKET ENTRY strategy, medical device patents, Startup Lawyer India, venture capital financing

Overview of Pharmaceutical Patent Prosecution*Examination Guidelines IPO

  Pharmaceutical based Inventions Filed before the Indian Patent Office

The patent examination guidelines for pharmaceutical based inventions cover the following points: 

1. Patent Claims Of Pharmaceutical Inventions which includes Markush claims 

2. Comprehensive patent search strategy for conducting prior art search by the Patent Examiner 

3. Definition of “invention” under section 2(1)(j) of the Indian Patent Act 

4. Assessment of Novelty aspect of the invention 

5. Assessment of Inventive Step 

6. Industrial applicability of the technology 

7. Subject matter of Inventions which are not patentable 

8. Sufficiency of description, clarity and support of the patent claims in the specification 

9. Unity of invention

Patent Search Strategy for Pharmaceutical Inventions:

Comprehensive patent search strategy will be followed by the Indian Patent examiners. The patent search strings will include a combination of various search parameters.

The search parameters will be a combination of keywords, International Patent Classification (IPC), and compound searches. Thorough prior art search is expected to be carried out in patent as well as non-patent databases.

Pharmaceutical Compounds can be searched and identified from the various databases:

a) Molecular formula and structural formula searching; 

b) Name searching using IUPAC nomenclature; 

c) Compound searching using CAS Registry Numbers; 

d) Generic name searching (INN); and 

e) Search using International Patent Classification (IPC)

Many a times pharmaceutical compounds which are derivatives of known compounds having established pharmaceutical activities are claimed in the patent specification in the form of generic names (International Non-Proprietary Names, INN). In such cases, the patent examiner will search the prior art with INNs prior art search string. Moreover, in numerous pharmaceutical based inventions the patent applicant claims the second use or an indication in the form of a product claim of an already known pharmaceutical compound or a new form of a known pharmaceutical compound.

Even though, the patent examiner can seek information about the INN of the said pharmaceutical substance claimed in the patent application from the patent applicant there are chances that the conclusions drawn from the information provided may mislead the patent examiner. In my view, the Indian patent examiner can find out more information about the International Non-Proprietary Names by analysing data from the Electronic Orange Book.

Prior Art Search Strategy for Conducting Drug Patent Search in India

Search on Electronic Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Search String based on

Active Ingredient

Applicant Holder

Proprietary Name

Application Number

Patent

Therefore, prior art patentability search for patents covering (International Non proprietary Names – INN) as listed in the USFDA Electronic Orange Book should be taken into consideration. However, the Orange Book only provides US patent data. The patentability search can be extended and this information can be further used to conduct patent family searches on EPO website. Further, patentability search can be performed by analysing forward citation and backward citation of the identified patent specifications.

Biological Material and Micro-organism Deposit Details to be Disclosed in the Indian Patent Application

If the invention relates to a biological material which is not possible to be described in a sufficient manner and which is not available to the public, the application shall be completed by depositing the material to an International Depository Authority (IDA) under the Budapest Treaty. The deposit of the material shall be made not later than the date of filing of the application in India and a reference of the deposit shall be given in the specification within three months from the date of filing of the patent application in India. All the available characteristics of the material required for it to be correctly identified or indicated are to be included in the specification including the name, address of the depository institute and the date and number of the deposit.

 

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