Patent pharmaceutical

Intellectual Property Rights | Patent pharmaceutical

An Intellectual Property Rights patent pharmaceutical or drug can be given for novelty, inventive step and for industrial application. It can be claimed as

·        A drug or pharmaceutical product,

·        Modified drug or pharmaceutical of a known compound, if proved to be more efficeous than the known compound, and

·        A process of making the product and formulation containing the drug.  

Generic drug is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. Patent pharmaceutical drug includes all medicines for internal or external use of human beings or animals and all substance intended to be used or in the diagnostics, treatment, mitigation or prevention of diseases in human being and animals.

If genetically modified gene sequence or amino acid sequence is novel which involves an inventive step and has industrial application, for which;

1. Gene sequence /amino acid sequence,

2. A method of expressing above sequences,

3. An antibody against the protein / sequence and a kit made from the antibody/sequence can be claimed and applied for patent.

The human genome product resulted in the identification of large number of genes and gene fragments which resulted in a large number of patent applications on DNA sequences and part sequences.

In case of an herbal, chemical, pharmaceutical or a medicinal composition, the process can be claimed and applied for patent by the following processes:

(a) A novel product by itself,

 (b)A process of extraction and/or process of mixing the ingredients either pre-prepared or extracted.

(c) Apparatus, if novel, either for the process of extraction and/or for the process of preparation.

In case of non-drug or non-pharmaceutical chemical, the following can be claimed:

(a) product, if it is novel,

(b) Process of making the chemical

(c) Apparatus for the preparation of a chemical, if it is novel and applied for patent.

In case of national emergency or extreme emergency, then the compulsory license may be granted without any terms and conditions in respect to any patented invention. In that situation, the central government may take a declaration by notification in the official gazette. Then the controller may grant compulsory license to any interested person to work on the patented invention. It includes public health crisis like Acquired immuno deficiency syndrome, human immuno deficiency syndrome, tuberculosis, malaria and other epidemic diseases.

The pharmaceutical industry includes chemical industry which includes agricultural chemicals and biotechnology industry whose innovations are from engineered plant varieties to human pharmaceutical therapies. The patented products of pharmaceutical companies can be easily and cheaply replicated by copiers with little investment.  Patented pharmaceuticals will pass through rigorous testing and approval before they can be introduced in to the market.In many technology based industries, many inventions are kept secret until they marketed. This enables the inventors to delay in patent filing and to maximize the effect till twenty years. 

The patent pharmaceutical industry is heavily regulated by government agencies to assure the safety and efficacy products which will be sold to consumers. In 2001, the pharmaceutical industry develops 402 new cancer medicines, 123 new treatments for heart disease and stroke, 83 new AIDS treatment and 176 new medicines for neurological disease. If any country has no manufacturing capacity, then the license has been granted by such country to import the patented pharmaceutical products from India and the pharmaceutical business is based on formulations, bulk products etc.

PATENT PROTECTION

Intellectual Property Rights | PATENT PROTECTION

An Intellectual Property Rights Patent protection can be obtained by patent registration in the Intellectual Property Office. For patent protection, the invention should be novel, non obviousness, with inventive step and industrial capability. The procedure involves the following formalities to obtain the patent protection. It involves the submission of application with complete specification, examination of application, acceptance of complete specification, opposition to grant of patent, grant and sealing of patent. 

Application can be applied by any person claiming to be true and first inventor of the invention or assignee of the person claiming to be true and first inventor of the invention or legal representative of any deceased person. As well as application can be applied by jointly by above said person.

During patent protection, for each invention separate application has to be applied in the patent office by the applicant with the respective patent fee. Patent application shall be accompanied with provisional or a complete specification.The provisional specification contains only a general descriptive of the invention, field of the invention and prior art information without claims. The complete specification contains full description of the invention with all the claims which seeks the monopoly right. 

Patent protection seeks from the filing date and after applying the provisional application, the complete specification shall be applied within twelve months from the filing date of the provisional application. If the applicant desires extension, then three months extension can be given by paying the fee by the applicant. 

Applicant shall request for early publication, and then the patent application will be published in the patent office journal within one month. If the request is not made then patent application will be published after eighteen months. Once patent is published then, other parties can oppose with the help of any prior document related to the applicant's invention. It is said to be pre grant opposition where, patent is opposed before grant of patent. 

 The applicant must request for examination of application for patent within 48 months from the date of filing the application for patent protection. Once patent application has been published, and then the first examination report shall be sent to the applicant after six months from the published date by submitting the request for examination. 

When the applicant receives the first examination report, then he shall amend the attachments, whatever queries said by the examiner within twelve months from the examination report received date. After submission of the relevant amendments enclosed by the applicant in the patent office, the controller will start to evaluate the patent with respect to patent act 1970.

Then the patent is granted to the applicant, and then the applicant will become patent holder or patentee. If there is any opposition after patent grant then it is said to be post grant opposition. Then the patent protection becomes effective from the filing date of complete/ provisional specification. The date of every patent with applicant and inventors details will be entered in the register. Then the patentee shall pay patent renewal fee for every year.

 

INTELLECTUAL PROPERTY LITIGATION

INTELLECTUAL PROPERTY RIGHTS | INTELLECTUAL PROPERTY LITIGATION   Intellectual property Rights, Intellectual Property litigation is nothing but defending ones own work from the company or any other person who duplicated it. The inventor whose invention is infringed and sold in the market without his/her knowledge can raise a litigation case against the person who sells the product without the permission of the inventor.   Intellectual Property Litigation is a primary focus of Intellectual Property practice. Litigation includes legal actions to protect IP's against infringement and may result in monetary damages or an injunction against the infringement. Infringement occurs when another party makes, uses or sells a patented item without the permission of the patent holder.   Intellectual Property Litigation includes patent litigation and trademark litigation. Patent litigation is applicable only after the patent is granted or only to the patentee. The patent litigation may help the inventor in asking for the compensation of the product to which he/ she has patented. Trademark litigation involves a dispute over whether one party has encroached on the other trademark rights. Trade dress litigation involves disputes over whether the distinctive configuration or packaging of a product line has been infringed. Unfair competition claims, often asserted together with trademark claims, can be made when a defendant product is likely to confuse the public as to the affiliation between goods, services or companies. It can also include false advertising. Trademark litigation cost varies substantially based on the case and the opposing party. According to one trade organization survey for the year 2000, the average cost through trial, where more than $1 million was at risk, typically ranged from $350,000 to $900,000 (depending on location), with the median being about $500,000. Most trademark litigation matters, however, are settled at a much earlier stage and at far lower cost. Although, like any other lawsuit, can be disruptive of business, the disruption to technical personnel tends to be less than in patent or trade-secret cases. To protect business assets and well worth it in appropriate circumstances trademark litigation is worth it.   Intellectual Property Litigation cases are as follows: Case 1: ABTOX, in two cases against Johnson & Johnson involving plasma steriles. The trial court granted summary judgment of non-infringement in favor of ABTOX on the two patents asserted by Johnson & Johnson. The summary judgment was affirmed in part and reversed in part on appeal. Subsequently, summary judgment was again granted in favor of our client in ABTOX v. Johnson & Johnson. In MDT Corporation v. ABTOX, Inc., defended ABTOX against patent infringement charges on two patents relating to plasma sterile. After motions for summary judgment and a mini-trial, the Court held the patents not infringed and dismissed the case. The Federal Circuit affirmed this decision on appeal.

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INTELLECTUAL PROPERTY VIOLATION

INTELLECTUAL PROPERTY RIGHTS | INTELLECTUAL PROPERTY VIOLATION     Intellectual property violation is the single most significant threat to competitiveness of international firms. The intellectual property violation varies from region to region and from country to country.    Two factors that correlate to the Intellectual Property Violation are market factors and involvement factors.  The market factor will include the economic development, business environment and cultural traits dominant in particular country. Involvement factors describe a particular nation's level of activity in international trade as well as membership in organizations which monitor and advocate intellectual property protection.   Intellectual Property Violation is widely is a developing country problem. In some countries protection may not exist due to lack of appropriate legislation or as a matter of policy to ensure availability of products even if they are copies. It is common that enforcement of protection may be negligent in domestic firms. The unavailability of authentic products, or when available their high price provides justification for both the violators and the respective governments to allow or at least tolerate the practice. Developing nations also fear that strict enforcement of Intellectual Property Rights would harm their prospects. In rapidly industrializing countries which are dependent on world for technology flows, legislation and enforcement efforts have been stepped up. Industrialized nation have always seen the protection of intellectual property rights as a guarantee of continued investments and innovation.   Intellectual property violation may be a copyright infringement, a patent infringement or a trademark infringement.       Copyright violation or infringement is defined as the unauthorized use of material that is covered by copyright law, in a matter that violates one of the copyright owner's exclusive rights. In electronic and audio-visual media, unauthorized reproduction and distribution is occasionally referred to as piracy. The practice of labeling the act of infringement as "piracy" predates copyrights.   Patent violation or infringement is the act of utilizing a patented invention without permission from the patent holder. The permission is granted in the form of license. The scope of patented invention or the extent of protection is defined as claims of the granted patents. The term of claims inform people that they are not allowed to violate without the permission of patent holder. Patent are territorial and infringement is possible only in a country where are patent is in force. The scope of protection varies form country to country because the patent is examined by patent office in each country and may have difference of patentability. Patent is violated when any party manufactures, imports, uses, or offers a sale of patented technology during the term of patent and within the country that issued the patent is considered for violation.   Trademark violation or infringement is a violation of the exclusive rights attaching to a trademark without the authorization of the trademark owner or any licensees. Violation or infringement occurs when one party uses a trademark identical or confusingly similar to a trademark owned by another party. An owner of trademark may commence the legal proceedings against the party which infringes its registration.    These are the three different Intellectual Property violation or infringement process.

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