Autoclave Sterilization Principle & Working PDF PPT – Autoclave Validation – Autoclave Diagram

Autoclave Sterilization Principle & Working Diagram

Autoclave Sterilization: Autoclaves provide a physical method for disinfection and sterilization. They work with a combination of steam, pressure and time. Autoclaves operate at high temperature and pressure in order to kill microorganisms and spores.

Autoclave Sterilization

Autoclave Sterilizers are used to decontaminate certain biological waste and sterilize media, instruments and lab ware. Regulated medical waste that might contain bacteria, viruses and other biological material are recommended to be inactivated by autoclaving before disposal.

An autoclave is used to sterilize surgical equipment, laboratory instruments, pharmaceutical items, and other materials. It can sterilize solids, liquids, hollows, and instruments of various shapes and sizes. Autoclaves vary in size, shape and functionality. A very basic autoclave is similar to a pressure cooker; both use the power of steam to kill bacteria, spores and germs resistant to boiling water and powerful detergents.

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Autoclave Sterilizers:

To be effective against spore forming bacteria and viruses, autoclaves need to have steam in direct contact with the material being sterilized (i.e. loading of items is very important).

Create vacuum in order to displace all the air initially present in the autoclave and replacing it with steam.

Implement a well designed control scheme for steam evacuation and cooling so that the load does not perish.

The efficiency of the sterilization process depends on two major factors. One of them is the thermal death time, i.e. the time microbes must be exposed to at a particular temperature before they are all dead. The second factor is the thermal death point or temperature at which all microbes in a sample are killed.

The steam and pressure ensure sufficient heat is transferred into the organism to kill them. A series of negative pressure pulses are used to vacuum all possible air pockets, while steam penetration is maximized by application of a succession of positive pulses

Autoclave Sterilization Principle & Working PDF PPT - Autoclave Validation - Autoclave Diagram

Autoclave Uses & Advantages:

An autoclave chamber sterilizes medical or laboratory instruments by heating them above boiling point. Most clinics have tabletop autoclaves, similar in size to microwave ovens. Hospitals use large autoclaves, also called horizontal autoclaves. They’re usually located in the the Central Sterile Services Department CSSD) and can process numerous surgical instruments in a single sterilization cycle, meeting the ongoing demand for sterile equipment in operating rooms and emergency wards.

They are important in tattoo shops, beauty and barber shops, dentist offices, veterinarians and many other fields.

Autoclave disadvantages:

Autoclave is unsuitable for heat sensitive objects.

Autoclaves Working Principle:

Autoclaves use pressurized steam as their sterilization agent. The basic concept of an autoclave is to have each item sterilized -whether it is a liquid, plastic ware, or glassware- come in direct contact with steam at a specific temperature and pressure for a specific amount of time. Time, steam, temperature, and pressure are the four main parameters required for a successful sterilization using an autoclave.

The amount of time and temperature required for sterilization depends on the type of material being autoclaved. Using higher temperatures for sterilization requires shorter times. The most common temperatures used are 121 C and 132 C. In order for steam to reach these high temperatures, steam has to be pumped into the chamber at a pressure higher than normal atmospheric pressure.

Now that we have covered the basic principle of how autoclaves use pressurized steam to sterilize contaminated materials, we will now go over how autoclaves operate.

Autoclave Design Diagram & Parts

Autoclave Sterilization Principle & Working Diagram

Similar to pressure cookers, steam sterilizer autoclaves work quickly and effectively because of their high temperature. The machine’s temperature and unique shape make it easier to hold the heat inside much longer. The autoclave also does a great job of efficiently penetrating each piece of equipment. The autoclave’s chambers are usually in the shape of a cylinder because cylindrical shapes are more equipped to handle the high pressure that is needed for the sterilization process to work. For safety reasons, there is an outside lock and a safety valve that prevents the autoclave steam sterilizer’s pressure from getting too high.

Once you close the autoclave sterilizer chamber, a vacuum pump removes all the air from inside the device or it is forced out by pumping in steam. If done the first way, the sterilizer is pumped with high pressured steam to quickly raise the internal temperature. On every autoclave there is a thermometer that is waiting for the thermal sweet point, 268-273 degrees Fahrenheit, and then it starts its timer. During the sterilizing process, steam is continuously entering the autoclave to thoroughly kill all dangerous microorganisms. Once the required time of sterilization has the elapsed, the chamber will be exhausted of pressure and steam allowing the door to open for cooling and drying of the contents.

Mode of Action Autoclave Sterilizers:

Moist heat destroys microorganisms by the irreversible coagulation and denaturation of enzymes and structural proteins. In support of this fact, it has been found that the presence of moisture significantly affects the coagulation temperature of proteins and the temperature at which microorganisms are destroyed.

Autoclave Working – Operation:

Place containers in the autoclave.

Check the strainer to see if it is clogged. The strainer is located on the bottom of the chamber near the door. The autoclave will not come up to pressure if the strainer is clogged.

Close door.

               For the SMALL autoclave, rotate the handle clockwise until it is snugly closed.     

                For the LARGE autoclave, rotate the small, inner handle clockwise first until it locks. Then rotate the large outer handle clockwise until it is snug.

Open the glass-faced door in the upper right corner. Set STERILIZE time and, if needed, set DRY time.

Select the SETTING you want by pushing in the colored button that corresponds to:

ON-OFF                FAST EXHAUST  FLUIDS  DRY

GREEN= FAST EXHAUST:  Pressure will decrease rapidly at the end of sterilization. Fluids will bubble over if you use this setting.

YELLOW= Fluids: Pressure decreases more slowly at the end of sterilization.

BLUE=Dry:  Use this setting for paper goods, cotton swabs, etc.

Push in the RED button to turn the autoclave on.

Wait until the temperature reaches 121°C and the RED sterilization light in the glass-faced box turns on before recording the Chamber Pressure on the Log. The chamber pressure should be 16-20 psi once the sterilization cycle starts. Anything below 16 psi should be reported to your lab manager.

At the end of the run, insure the CHAMBER PRESSURE has returned to ZERO before attempting to open the door. The FLUIDS cycle takes much longer than FAST EXHAUST – be patient. If the door cannot be easily opened, WAIT 10 minutes before trying again. If you wrench on the door and  attempt to force it open, the internal metal rod that connects to the door handle will twist from the pressure.

To open the door:

SMALL autoclave: rotate the handle counterclockwise. Be careful, steam burns!  Step to the side and crack open the door. Allow the steam to escape from the chamber then open the door and remove your items.

LARGE autoclave: First rotate the LARGE OUTER handle counterclockwise until it is loose. Next, rotate the SMALL INNER handle counterclockwise until the door opens. Be careful, steam burns!  Step to the side and crack open the door. Allow the steam to escape from the chamber then open the door and remove your items.

As a courtesy to others needing to use the autoclave, promptly remove your items when the cycle is completed and you can easily open the door. Wear protective, heat resistant gloves when removing items.

Autoclaved waste materials are to be taken directly to the dumpster for disposal. Orange autoclave bags must be put into black trash bags before disposing in the dumpster.

Autoclave Cycles

To be effective, the autoclave must reach and maintain a temperature of 121° C for at least 30 minutes by using saturated steam under at least 15 psi of pressure. Increased cycle time may be necessary depending upon the make-up and volume of the load.

The rate of exhaust will depend upon the nature of the load. Dry material can be treated in a fast exhaust cycle, while liquids and biological waste require slow exhaust to prevent boiling over of super-heated liquids.

Liquids cycle

 Liquids rely on the Liquids Cycle to avoid a phenomenon known as “boil-over.” Boil-over is simply a liquid boiling so violently that it spills over the top of its container.  Boil-over will occur if the pressure in your autoclave chamber is released too quickly during the exhaust phase of the cycle.  Significant liquid volume can be lost to boil-over, and this can result in unwanted spills on the bottom of the autoclave chamber that must be cleaned up to avoid clogging the drain lines and the subsequent repair costs to the department.

To help prevent boil-over during the exhaust phase, the chamber pressure must be released slowly.  This process is controlled by the sterilizer’s control system. Controlling the exhaust rate allows the liquid load to cool off as the surrounding chamber pressure is decreased.

The exhaust rate for a Liquids Cycle is different from a standard Gravity or Vacuum Cycle, where the chamber pressure is released quickly. To prevent boil-over, the chamber pressure must decrease slowly to allow the temperature of the load to remain below the boiling point.  If the pressure is exhausted all at once, the temperature of the load will be above its boiling point, resulting in instant and violent boiling.

(Slow Exhaust)

Material Recommended for:

Use with glass containers with vented closures; 2/3 full only

  • Liquid media
  • Nonflammable liquids
  • Aqueous solutions
  • Liquid biological waste

Solids or Dry cycle

(Fast Exhaust)

Material Recommended for:

Glassware: empty and inverted

no tight or impermeable closures

Dry hard items, either unwrapped or in porous wrap

Metal items with porous parts

Other porous materials

Gravity Cycle: Wrapped Goods or Pre vacuum cycle

(Clean: Fast Exhaust

Dirty: Slow Exhaust)

The traditional “Gravity Cycle” is the most common and simplest steam sterilization cycle. During a Gravity Cycle, steam is pumped into a chamber containing ambient air. Because steam has a lower density than air, it rises to the top of the chamber and eventually displaces all the air. As steam fills the chamber, the air is forced out through a drain vent. By pushing the air out, the steam is able to directly contact the load and begin to sterilize it.

At the end of the cycle, the steam is discharged through the drain vent. However, the load can still be hot and possibly wet. To address this issue, gravity autoclaves can be equipped with a post-cycle vacuum feature to assist in drying the load. The sterilizer runs a normal Gravity Cycle and after the load is sterilized, a vacuum pulls steam and condensation through the drain vent. The longer the vacuum system runs during the dry phase, the cooler and dryer the goods will be when removed from the chamber.

Gravity Cycles are commonly used on loads like glassware, bio-hazardous waste (autoclave bag waste), and wrapped and unwrapped instruments.

Material Recommended for:

Glassware that must be sterilized upright and/or can trap air

Wrapped dry items that can trap air

Pipette tip boxes

Sharps decontamination

(in collection containers)

Biohazard waste decontamination, in autoclave bags; can be wet or dry

Autoclave Types & Market

  • Medical autoclaves
  • Dental autoclaves
  • Laboratory autoclaves

Medical autoclaves

Tabletop autoclaves
large horizontal autoclaves
Plasma Sterilizer
Washer Disinfectors
Autoclaves maintain a healthy, clean and sterile environment.
Fast and effective disinfection of surgical instruments in preparation for sterilization is ensured by Autoclaves.
Autoclaves that satisfy the needs of any hospital operating room, central sterile services department or medical clinic.

Dental autoclaves

– ideal sterilizer for dentists

Laboratory autoclaves 

vertical loading autoclaves and fast liquid cooling autoclaves

Life science labs and research institutes need sterilization techniques inevitably

Autoclave Validation

Chemical Indicators

Tape Indicators

Tape indicators are adhesive-backed paper tape with heat sensitive, chemical indicator markings.  Tape indicators change color or display diagonal stripes, the words “sterile” or “autoclaved” when exposed to temperatures of 121°C.  Tape indicators are typically placed on the exterior of the waste load.  If the temperature sensitive tape does not indicate that a temperature of at least 121°C was reached during the sterilization process, the load is not considered decontaminated.   If tape indicators fail on two consecutive loads, notify your Department Safety Manager.

Tape indicators are not designed nor intended to prove that organisms have actually been killed. They indicate that a temperature of 121°C has been achieved within the autoclave.  EHS recommends that you DO NOT use autoclave tape as the only indicator of decontamination or sterilization.

Integrated Chemical Indicator Strips

Integrated chemical indicator strips provide a limited validation of temperature and time by displaying a color change after exposure to  normal autoclave operating temperatures of 121ºC for several minutes.  Chemical color change indicators can be placed within the waste load.  If the chemical indicators fail on two consecutive loads, notify your Department Safety Manager.                            

Biological Indicators

Biological indicator vials contain spores from B. stearothermophilus, a microorganism that is inactivated when exposed to 121.1oC saturated steam for a minimum of 20 minutes. Autoclaves used to treat biological waste will be evaluated with a biological indicator by EHS on a quarterly basis.

Validation Procedure for Autoclave:

EHS will coordinate biological validation testing with laboratory staff.

The indicators will be incubated by EHS for 24 hours at 60°C with a control that has been maintained at room temperature.

Results

If the autoclaved indicator exhibits growth, the validation has failed and will be repeated.

If the second validation indicator fails, EHS will notify the Department Safety Manager and request service on the autoclave.  Autoclave should not be used until service has been conducted and the validation test passes.

Validation tests results are emailed by EHS staff to the appropriate labs and the Department Safety Manager.

EHS maintains documentation of all validation tests.

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Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT Papers

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT Papers

What is Homology Modelling?

Homology modelling allows users to safely use rapidly generated in silico protein models in all the contexts where today only experimental structures provide a solid basis: structure-based drug design, analysis of protein function, interactions, antigenic behavior, and rational design of proteins with increased stability or novel functions. In addition, protein modeling is the only way to obtain structural information if experimental techniques fail. Many proteins are simply too large for NMR analysis and cannot be crystallized for X-ray diffraction.

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT Papers

Among the major approaches to three-dimensional (3D) structure prediction, homology modeling is the easiest one.
In the Homology Modelling, structure of a protein is uniquely determined by its amino acid sequence (Epstain, Goldberger, and Anfinsen, 1963). Knowing the sequence should, at least in theory, suffice to obtain the structure.
2. During evolution, the structure is more stable and changes much slower than the associated sequence, so that similar sequences adopt practically identical structures, and distantly related sequences still fold into similar structures. This relationship was first identified by Chothia and Lesk (1986) and later quantified by Sander and Schneider (1991). Thanks to the exponential growth of the Protein Data Bank (PDB), Rost (1999) could recently derive a precise limit for this rule. As long as the length of two sequences and the percentage of identical residues fall in the region marked as “safe,” the two sequences are practically guaranteed to adopt a similar structure.

Homology Modelling or Protein Modelling Example

Imagine that we want to know the structure of sequence A (150 amino acids long,). We compare sequence A to all the sequences of known structures stored in the PDB (using, for example, BLAST), and luckily find a sequence B (300 amino acids long) containing a region of 150 amino acids that match sequence A with 50% identical residues. As this match (alignment) clearly falls in the safe zone (Fig. 25.1), we can simply take the known structure of sequence B
(the template), cut out the fragment corresponding to the aligned region, mutate those amino acids that differ between sequences A and B, and finally arrive at our model for structure A. Structure A is called the target and is of course not known at the time of modeling.

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT

Homology Modelling Steps

In practice, homology modeling is a multistep process that can be summarized in seven steps:
1. Template recognition and initial alignment
2. Alignment correction
3. Backbone generation
4. Loop modeling
5. Side-chain modeling
6. Model optimization
7. Model validation

At almost all the steps choices have to be made. The modeler can never be sure to make the best ones, and thus a large part of the modeling process consists of serious thought about how to gamble between multiple seemingly similar choices. A lot of research has been spent on teaching the computer how to make these decisions, so that homology models can be built fully automatically. Currently, this allows modelers to construct models for about 25% of the amino acids in a genome, thereby supplementing the efforts of structural genomics projects.

Homology_Modelling – Protein PPT

homology modeling

Protein Homology modelling steps ppt Structures

Homology Modelling Steps, Homology Modelling Software, Homology Modelling Ppt, Homology Modelling Pdf, Homology Modeling Server, Protein Modelling Bioinformatics, Homology Modeling Tutorial, Homology Modelling Slideshare

Explain how protection of geographical indications takes place at the national and international level

Explain how protection of geographical indications takes place at the national and international level

Explain how the protection of geographical indications takes place at the national and international level

A geographical indication (GI) is a name or sign used on certain products which corresponds to a specific geographical location or origin (e.g. a town, region, or country). The use of a GI may act as a certification that the product possesses certain qualities, is made according to traditional methods, or enjoys a certain reputation, due to its geographical origin.
Examples include Darjeeling tea, Basmati Rice, Bikaneri Bhujia Feni (liquor) from Goa, Paithani and Banaras saree, Kanchipuram silk saree, Nagpur oranges, Alphonso Mangoes (many other varieties), Kolhapuri chappals, Lonavala Chikki, Tirunelveli Halwa,foodstuffs like Mysore rasam and many others
At international level Champagne’, ‘Havana’, ‘Tequila’, ‘Scotch Whisky’, ‘Bordeaux’, ‘Burgogne’, ‘Irish Whisky’, ‘Porto’, ‘Cognac’, ‘Sherry’, ‘Camembert’, ‘Gouda’ and many others are some of the popular examples
Protection of GI in India
In India the Geographical Indications of Goods (Registration and Protection) Act, 1999 came in force with effect from September 2003.
The salient features of the Act are defines Geographical Indication, provides a mechanism for registration of GIs, establishes a GI Registry, elaborates the concept of authorised user and registered proprietor, higher level of protection for notified goods and remedies for infringements.
• Section 2(e) of the Act defines a GI as : “geographical indication”, in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.
• Explanation: – For the purposes of this clause, any name which is not the name of a country, region or locality of that country shall also be considered as the geographical indication if it relates to a specific geographical area and is used upon or in relation to particular goods originating from that country, region or locality, as the case may be;”

Explain how protection of geographical indications takes place at the national and international level

Registry

• GI Registry at Chennai is having all India jurisdiction.
• Registry maintains a Register of GI which is divided in to two parts, Part A and Part B. Part A contains details of distinguishing characteristics of the goods and of the registered proprietor which would be an association of persons or producers or a body representing interest of such producers like for instance the Tea Board, Coffee Board, Spices Board etc. To include all producers a collective reference may be made in the application.
• Part B contains particulars of ‘authorised users’ of GI such as those producers (traders and dealers) who have not been included in the original application for registration. (this provision included due to socio economic factors)
Prohibitions
S. 9 lays down the following prohibitions to registration of certain GI:-
a. the use of which would be likely to deceive or cause confusion; or
b. the use of which would be contrary to any law for the time being in force;or
c. which comprises or contains scandalous or obscene matter; or
d. which comprises or contains any matter likely to hurt the religious susceptibilities of any class or section of the citizens of India; or
e. which would otherwise be disentitled to protection in a court; or
f. which are determined to generic names or indications of goods and are, therefore, not or ceases to be protected in their country of origin, or which have fallen in to disuse in that country; or
g. which, although literally true as to the territory, region or locality in which the goods originate, but falsely represent to the persons that the goods originate in another territory, region or locality, as the case may be.

Application
• Section 11 of the Act deals with application for registration, its contents, making and filing, acceptance or refusal.
• Once filed the Registrar will have the Application examined and may consult a expert group to verify the technical details. Thereafter the Examination report is issued to which the Applicant files a reply and on satisfaction the Registrar accepts the Application which will then be published in the GI journal. Any person then can file a Notice of Opposition within a maximum period of four months of publication in the Journal. Thereafter the matter will for reply, evidence and then hearing. If the Registrar accepts the Application then a certificate of registration issued.
• Registration is valid for ten years but can be renewed from time to time on payment of renewal fee.
• Similar procedure followed for registration as an ‘authorised user’.
Effect
The Act provides that once the GI is registered, an infringement action can be initiated both by the registered proprietor and by authorised users whose names have been entered on the Register.
A registered GI is infringed by a person who not being an authorised user, uses such GI by any means in the designation or presentation that indicates or suggests that such goods originates in a geographical area other than the true place of origin of such goods in a misleading manner or uses a GI which constitutes an act of Unfair competition (Act explains it as dishonest practices).
• The Act provides for both civil and criminal remedies for infringement.
• The civil includes imposition of fines, forfeiture to government of all goods and things means of which the offence had been committed, damages, account of profit, together with or without any order for delivery of the infringing label and indications for destruction or erasure.
• The criminal remedies includes imposition of fine or imprisonment or both.
• In addition the statute vide section 25 prohibits registration of GI as a trade mark. The Registrar of Trade Marks shall suo motu or at the request of interested party refuse or invalidate the registration of a trade mark which consists of a GI with respect to goods not originating in the territory which such GI indicates, if use of such a GI as a trade mark would confuse or mislead the public as to the true origin of the goods. However, the Act protects use of trademarks that consists of a GI where it is registered in good faith under the Trade Marks Act or where the right to such trade mark was acquired prior to coming in to force of the Act.
• Higher level of protection for notified goods (TRIPS ). This will enable such higher level of protection not only in respect of wines and spirits but for other goods as may be decided by the Govt.
• The Act says that in respect of the such notified goods, infringement shall include, interalia, using of such expression as ‘Kind”, “style”, “imitation”, or like expressions by unauthorised users. Such additional protection requires no proof of likelihood of deception. Such prohibition also applies to translations and the use of such GI for notified goods would be forbidden whenever the goods do not come from the area in question.
• Also a trade mark shall not be granted, if it contains a GI for Notified goods and the products do not originate from the region in question.
• The Act makes no difference between an Indian GI or a foreign GI.
• The Act apart form according statutory protection to this form of Intellectual Property would ensure and orderly marketing of premium products. The civil and criminal legal remedies available under the statute would facilitate business confidence among the producers and manufacturers.
Agreement on Trade-Related Aspects of Intellectual Property Rights
The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) defines “geographical indications” as indications that identify a good as originating in the territory of a Member, or a region or locality in that territory, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographic origin. Examples of geographical indications from the United States include: “FLORIDA” for oranges; “IDAHO” for potatoes; “VIDALIA” for onions; and “WASHINGTON STATE” for apples. Geographical indications are valuable to producers for the same reason that trademarks are valuable. Geographical indications serve the same functions as trademarks, because like trademarks they are: source-identifiers; guarantees of quality; and valuable business interests. Although, as mentioned above “geographical indications” are often associated with Europe, the U.S. system for protection of geographical indications can be dated to at least the Trademark Act of 1946.
In 1994, when negotiations on the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) were concluded, governments of all WTO member countries (151 countries As of August 2007) had agreed to set certain basic standards for the protection of GIs in all member countries. There are, in effect, two basic obligations on WTO member governments relating to GIs in the TRIPS agreement:
1. Article 22 of the TRIPS Agreement says that all governments must provide legal opportunities in their own laws for the owner of a GI registered in that country to prevent the use of marks that mislead the public as to the geographical origin of the good. This includes prevention of use of a geographical name which although literally true “falsely represents” that the product comes from somewhere else.
2. Article 23 of the TRIPS Agreement says that all governments must provide the owners of GI the right, under their laws, to prevent the use of a geographical indication identifying wines not originating in the place indicated by the geographical indication. This applies even where the public is not being misled, where there is no unfair competition and where the true origin of the good is indicated or the geographical indication is accompanied by expressions such as “kind”, “type”, “style”, “imitation” or the like. Similar protection must be given to geographical indications identifying spirits.
Article 22 of TRIPS also says that governments may refuse to register a trademark or may invalidate an existing trademark (if their legislation permits or at the request of another government) if it misleads the public as to the true origin of a good. Article 23 says governments may refuse to register or may invalidate a trademark that conflicts with a wine or spirits GI whether the trademark misleads or not.
Article 24 of TRIPS provides a number of exceptions to the protection of geographical indications that are particularly relevant for geographical indications for wines and spirits (Article 23). For example, Members are not obliged to bring a geographical indication under protection where it has become a generic term for describing the product in question. Measures to implement these provisions should not prejudice prior trademark rights that have been acquired in good faith; and, under certain circumstances — including long-established use — continued use of a geographical indication for wines or spirits may be allowed on a scale and nature as before.

Discuss copyright protection. Explain the ownership and limitations on copyright protection. How do you take care of piracy and infringement?

Discuss copyright protection. Explain the ownership and limitations on copyright protection. How do you take care of piracy and infringement?

Discuss copyright protection. Explain the ownership and limitations on copyright protection. How do you take care of piracy and infringement?

Copyright protection is a tangible material that is protected by a copyright. Anything can be copyrighted that you can view, hear, if it can be saved on your computer, or anything else that is a way of saving. Copyright Protection begins when something is created in tangible form. Once you have your material written down or saved somewhere, it is copyrighted, but you can’t sue them unless you register your copyright with the U.S. Copyright Office. Even if your copyright isn’t registered, you can still assert a copyright claim as the author.

When you see a “© Copyright 2004, 2005 Chris Wilson”, it doesn’t mean that the copyright expires in 2005. What it means it that the material was created in 2004 and then edited in 2005. A copyright lasts until 50 years after the death of the original author.

Discuss copyright protection. Explain the ownership and limitations on copyright protection. How do you take care of piracy and infringement?

Taking anyone’s work from the internet is illegal! If you see a background that you like, or part of someone’s source that you’d like to use, that’s illegal! That material is copyrighted. There are three things that aren’t illegal when taking things: if it has been created by the federal government, if the copyright has been abondoned by the holder, and if the copyright has expired.

If you have downloaded a free item from a website, you still have to comply with the owner’s terms and or conditions. If it says that you must give them credit, you must give them credit, or else you’re commiting copyright infringment. If the owner says you cannot edit it, you can’t edit it legally.

You cannot take someone’s work and translate it into a different language and then call it your own either.The Bern Convention says:

Quote
Authors of literary and artistic works protected by this Convention shall enjoy the exclusive right of making and of authorizing the translation of their works throughout the term of protection of their rights in the original works.
You have to have the author’s permission to translate it into a different language.

Define trademarks. How are trademarks protected? Discuss trademark licensing. Trademark

Define trademarks. How are trademarks protected? Discuss trademark licensing. Trademark

Define trademarks. How are trademarks protected? Discuss trademark licensing.

Trademark

A trademark, trade mark, or trade-mark is a distinctive sign or indicator used by an individual, business organization, or other legal entity to identify that the products or services to consumers with which the trademark appears originate from a unique source, and to distinguish its products or services from those of other entities.
A trademark is typically a name, word, phrase, logo, symbol, design, image, or a combination of these elements.There is also a range of non-conventional trademarks comprising marks which do not fall into these standard categories, such as those based on color, smell, or sound.
Protection of trademarks
The law considers a trademark to be a form of property. Proprietary rights in relation to a trademark may be established through actual use in the marketplace, or through registration of the mark with the trademarks office (or “trademarks registry”) of a particular jurisdiction. In some jurisdictions, trademark rights can be established through either or both means. Certain jurisdictions generally do not recognize trademarks rights arising through use. If trademark owners do not hold registrations for their marks in such jurisdictions, the extent to which they will be able to enforce their rights through trademark infringement proceedings will therefore be limited. In cases of dispute, this disparity of rights is often referred to as “first to file” as opposed to “first to use.” Other countries such as Germany offer a limited amount of common law rights for unregistered marks where to gain protection, the goods or services must occupy a highly significant position in the marketplace — where this could be 40% or more market share for sales in the particular class of goods or services.

Trademark licensing

Most jurisdictions provide for the use of trademarks to be licensed to third parties. The licensor (usually the trademark owner) must monitor the quality of the goods being produced by the licensee to avoid the risk of trademark being deemed abandoned by the courts. A trademark license should therefore include appropriate provisions dealing with quality control, whereby the licensee provides warranties as to quality and the licensor has rights to inspection and monitoring

Define trademarks. How are trademarks protected? Discuss trademark licensing. Trademark
5. Layout designs of integrated circuits is another field in the protection of intellectual property . Discuss
‘Integrated circuit’ means a product, in its final form or an intermediate form, in which the elements, at least one of which is an active element, and some or all of the inter-connections are integrally formed in and/or on a piece of material and which is intended to perform an electronic function,
‘Layout-design (topography)’ means the three-dimensional disposition, however expressed, of the elements, at least one of which is an active element, and of some or all of the interconnections of an integrated circuit, or such a three-dimensional disposition prepared for an integrated circuit intended for manufacture …
Integrated Circuit layout designs are creations of the human mind Like most of the other forms of intellectual propertiy,. They are usually the result of an enormous investment, both in terms of the time of highly qualified experts, and financially. There is a continuing need for the creation of new layout-designs which reduce the dimensions of existing integrated circuits and simultaneously increase their functions. The smaller an integrated circuit, the less the material needed for its manufacture, and the smaller the space needed to accommodate it. Integrated circuits are utilized in a large range of products, including articles of everyday use, such as watches, television sets, washing machines, automobiles, etc., as well as sophisticated data processing equipment.
The possibility of copying by photographing each layer of an integrated circuit and preparing masks for its production on the basis of the photographs obtained is the main reason for the introduction of legislation for the protection of layout-designs.
In United States intellectual property law, a mask work is a two or three-dimensional layout or topography of an integrated circuit (IC or “chip”), i.e. the arrangement on a chip of semiconductor devices such as transistors and passive electronic components such as resistors and interconnections. By extension, it also refers to the copyright-like intellectual property right conferring time-limited exclusivity to reproduction of a particular layout. The layout is called a mask work because, in photolithographic processes, the multiple etched layers within actual ICs are each created using a mask, called the photomask, to permit or block the light at specific locations, sometimes for hundreds of chips on a wafer simultaneously.
Because of the functional nature of the mask geometry, the designs cannot be effectively protected under copyright law (except perhaps as decorative art). Similarly, because individual lithographic mask works are not clearly protectable subject matter, they also cannot be effectively protected under patent law, although their combined functions and structure certainly may be protected

What is unfair competition? Explain the Need & Legal basis for Protection Examples

What is unfair competition? Explain the Need & Legal basis for Protection Examples
  1. What is unfair competition?
  2. Explain the need and the legal basis for protection .
  3. Highlight some examples of unfair competition.

You will get these three answers from this article.  

Unfair competition

Unfair competition in a sense means that the competitors compete on unequal terms, because favourable or disadvantageous conditions are applied to some competitors but not to others; or that the actions of some competitors actively harm the position of others with respect to their ability to compete on equal and fair terms. It contrasts with fair competition, in which the same rules and conditions are applied to all participants, and the competitive action of some does not harm the ability of others to compete. Often, unfair competition means that the gains of some participants are conditional on the losses of others, when the gains are made in ways which are illegitimate or unjust.

What is unfair competition? Explain the Need & Legal basis for Protection Examples

To an important extent, the principles of fair competition in the business world are defined by law, and therefore unfair competition may well be unlawful or criminal. But because the forms of competition can change continually and new forms of competition may arise, competition may be unfair, but not illegal, at least not until a legal rule is explicitly made to prohibit it. The exact meaning of unfair advantage or harm caused in business competition may be vague or in dispute, in particular if different competitors promote different interpretations which suit their own interests. It may be difficult to define what it would mean to compete on equal terms, and the operative terms of competition that exist in reality may be challenged only when a participant is seriously disadvantaged by them. Often “equal terms” is defined as an “equal opportunity” or “equal chance” to compete.
Sometimes unfair competition is also interpreted to mean that the existence of competition as such is unfair or unjust. The argument is then that there should not be any competition. In this case, the alternative to unfair competition is not fair competition, but no competition or cooperation.

Need for protection

What is unfair competition? Explain the Need & Legal basis for Protection Examples
Unfair competition in commercial law refers to a number of areas of law involving acts by one competitor or group of competitors which harm another in the field, and which may give rise to criminal offenses and civil causes of action. The most common actions falling under the banner of unfair competition include:
• Matters pertaining to antitrust law, known in the European Union as competition law. Antitrust violations constituting unfair competition occur when one competitor attempts to force others out of the market (or prevent others from entering the market) through tactics such as predatory pricing or obtaining exclusive purchase rights to raw materials needed to make a competing product.
• Trademark infringement and passing off, which occur when the maker of a product uses a name, logo, or other identifying characteristics to deceive consumers into thinking that they are buying the product of a competitor. In the United States, this form of unfair competition is prohibited under the common law and by state statutes, and governed at the federal level by the Lanham Act.
• Misappropriation of trade secrets, which occurs when one competitor uses espionage, bribery, or outright theft to obtain economically advantageous information in the possession of another. In the United States, this type of activity is forbidden by the Uniform Trade Secrets Act and the Economic Espionage Act of 1996.
• Trade libel, the spreading of false information about the quality or characteristics of a competitor’s products, is prohibited at common law.
• Tortious interference, which occurs when one competitor convinces a party having a relationship with another competitor to breach a contract with, or duty to, the other competitor is also prohibited at common law.
Various unfair business practices such as fraud, misrepresentation, and unconscionable contracts may be considered unfair competition, if they give one competitor an advantage over others. In the European Union, each member state must regulate unfair business practices in accordance with the principles laid down in the Unfair Commercial Practices Directive, subject to transitional periods

Examples

• Trademark infringement – such as using the Coca-Cola® trademark on a soda container manufactured by a competing beverage maker.
• False advertising – such as making false claims about a drug’s abilities to promote weight loss.
• Unauthorized substitution of one brand of goods for another – such as substituting a low-cost handbag for a designer handbag.
• Misappropriation of trade secrets – such as stealing a competitor’s soft drink formula.
• False representation of products or services – such as exaggerating a software program’s spellcheck capabilities.

Popular Pharma News Blogs – Latest Pharmaceutical Industry News Websites

Popular Pharma News Blogs - Latest Pharmaceutical Industry News Websites

Pharmacy websites are real matter of concern for information and news. Pharmaceuticals play a vital role in our day-to-day living. And hence their rising costs are destined to be our major concern. If asked to name one thing that affects our life in most phases one would hardly say pharmaceuticals. But wait this is a fact that most of us since our birth depend on pharmaceuticals in one-way or other. Definitely by age our dependence on pharmacy products increases but even teenagers and young ones consume a big percentage of pharmaceutical derivatives.

pharmatimes.com

Blog belong to Covent Garden, London. This blog is all about In-depth news, features and insights for the pharmaceutical and healthcare sectors. Our wide editorial lens delivers sharp, informed and entertaining coverage from every side.

fiercepharma.com

Popular Pharma News Blogs - Latest Pharmaceutical Industry News Websites
Popular Pharma News Blogs – Latest Pharmaceutical Industry News Websites

FiercePharma blog is all about pharma industry news on big pharma, FDA decisions, patents, pharmaceutical marketing, generic drugs, and other pharma news.

rxrights.org

RxRights blog belongs to United States that is dedicated to promoting and protecting American consumer access to sources of safe, affordable prescription drugs.

pharmamkting.blogspot.com

Newtown, PA A blog about pharmaceutical marketing and advertising written by PharmaGuy, a constructive critic of the industry.

pharmaphorum.com

Pharmaphorum is United Kingdom based Pharma Blog with lots of information on Pharma news, views and analysis of healthcare in a rapidly changing world. Not only do we keep you connected with the latest trends in pharma, we can also help you develop and bring to life your own thoughts, ideas and inspirations to enable you and your business to become key pharma influencers.

medadnews-digital.com

You can get pulse of the pharma industry with help from the news posts on this site.

pharmacycheckerblog.com

PharmacyChecker.com publishes profiles, ratings and comparative drug prices of US, Canadian and other online pharmacies. Since 2003, we have provided the American consumer with useful information on how to save money on prescription drugs. In this blog, we endeavor to further support the American consumer by providing clarity to public policy issues affecting drug prices.

pharmalive.com

pharmalive.com is established in 2013, Outcomes LLC provides the $500 billion pharmaceutical industry with need-to-know business information.

[PDF+ PPT] WIPO – Functions Objectives Treaties Salient Features Role World Intellectual Property Organization (WIPO)

objectives of World Intellectual Property Organisation (WIPO)

In this article we are going to discuss World Intellectual Property Organisation (WIPO) What is WIPO?, Functions of WIPO, History of WIPO, How WIPO functions, Simple explanation with PDF of WIPO and its functions, World Intellectual Property Organization, Indian and WIPO relations, WIPO treaties objectives and functions of WIPO,importance of WIPO, salient features of WIPO, powers and functions of WIPO, organs of WIPO,
objectives of WIPO and mainly role of WIPO in protection of ipr.

The World Intellectual Property Organization (WIPO) is one of the 16 specialized agencies of the United Nations. WIPO was created in 1967 “to encourage creative activity, to promote the protection of intellectual property throughout the world.”

History of WIPO

WIPO currently has 184 member states, administers 24 international treaties, and is headquartered in Geneva, Switzerland. The current Director-General of WIPO is Francis Gurry, who took office on October 1, 2008.

183 of the UN Members as well as the Holy See are Members of WIPO. Non-members are the states of Cook Islands, Kiribati, Marshall Islands, Federated States of Micronesia, Nauru, Niue, Palau, Solomon Islands, Timor-Leste, Tuvalu, Vanuatu and the states with limited recognition. Palestine has observer status.

Amongst the many roles that WIPO carries out to support the worldwide promotion of intellectual property rights, is its role in the administration of specific treaties and conventions. The international protection for trademarks,industrial designs and appellations of origin is carried out through three registration systems: The Madrid System for trademarks, the Hague System for industrial designs, and the Lisbon Agreement for the protection of appellations of origin

objectives of World Intellectual Property Organisation (WIPO)

  1. a) The Hague System covers the deposit of industrial designs, the Madrid System the registration of trademarks and the Lisbon Agreement concerns the registration of appellations of origin.
  2. b) The two treaties in the Madrid System are the Madrid Agreement concerning the International Registration of Marks (1891) and the Madrid Protocol relating to the Madrid Agreement (1989).

Role of World Intellectual Property Organisation (WIPO)

Strategic partnership through carefully formulated national IP strategy commensurate with the country’s existing development policies and objectives
Providing technical expertise and advice Support and assistance in the implementation of national IP strategy.

Functions of WIPO -World Intellectual Property Organisation (WIPO)

Enable a country to use its IP system in an effective and optimal manner while ensuring that it contributes to overall national development policies and goals
Provides a clear picture of where a country wants to go and how it will get there by using the IP system Helps ensure the development of a balanced national IP system that fits with the specific needs and expectations of a country
Provides an effective framework of cooperation between the country concerned and WIPO (and other agencies providing technical assistance in the areas related IP)
Other advantages

World Intellectual Property Organisation WIPO Functions Objectives PDF PPT

More tangible/concrete results Better coordination and cohesion among all parties concerned (increasing synergies) Optimal use of available resources

Functions of WIPO
Functions of WIPO

What does WIPO do?

The activities of WIPO are basically of three kinds:

  • assistance to developing countries,
  • setting international norms and standards for the protection of intellectual property
  • registration activities.

All these activities serve the overall aim of WIPO, namely, to maintain and increase respect for intellectual property throughout the world, in order to promote industrial and cultural development by stimulating creative activities and facilitating the transfer of technology as well as the dissemination of literary and artistic works.

1. Assistance to developing countries constitutes the first pillar of WIPO’s activities, and takes the form of
training (groups and individuals, in general or specialized courses, seminars to provide for an exchange of information and experience),
promotion of creative activities and of technology transfer,
the provision of technological information contained in patent documents,
the provision of advice on laws and regulations as well as
the management of industrial property offices and copyright collective administration societies, as well as
the provision of equipment.

2, The second pillar relates to activities in the setting of international standards and norms for the protection and administration of intellectual property. They are concerned with revision of existing treaties or creation of new ones,
simplifying procedures at the national, regional or international levels for the granting of intellectual property rights,
the effective enforcement and protection of such rights,
the efficient management of collections of industrial property documents used for search and reference, and devising means for making access to the information they contain easier;
the maintenance and updating of international classification systems,
the compilation of statistics;
collection of laws on industrial property and copyright law administration.

Under this heading could be included the work of the WIPO Arbitration and Mediation Center. Promotion of the acceptance–or wider acceptance–of treaties, by countries is also an important activity of WIPO.

3.The registration activities are the third pillar of WIPO and involve direct services to applicants for, or owners of, industrial property rights. These activities concern the receiving and processing of international applications for the protection of inventions, or for the international registration of marks or deposit of industrial designs.

Such activities are financed normally from the fees paid by the applicants, which account for about 85% of the annual total income of WIPO for the 1996/97 budget. The rest of the budget is covered mainly by contributions from member States under various treaties administered by the Organization, as well as by the sale of publications and miscellaneous income.

Strategic Goals

WIPO’s revised and expanded strategic goals are part of a comprehensive process of strategic realignment taking place within the Organization. These new goals will enable WIPO to fulfill its mandate more effectively in response to a rapidly evolving external environment, and to the urgent challenges for intellectual property in the 21st Century.

The nine strategic goals were adopted by Member States in the Revised Program and Budget for the 2008/09 Biennium [PDF].  They are:

  • Balanced Evolution of the International Normative Framework for IP
  • Provision of Premier Global IP Services
  • Facilitating the Use of IP for Development
  • Coordination and Development of Global IP Infrastructure
  • World Reference Source for IP Information and Analysis
  • International Cooperation on Building Respect for IP
  • Addressing IP in Relation to Global Policy Issues
  • A Responsive Communications Interface between WIPO, its Member States and All Stakeholders
  • An Efficient Administrative and Financial Support Structure to Enable WIPO to Deliver its Programs

Objectives of WIPO World Intellectual Property Organization (WIPO)

The objectives of WIPO are, firstly, to promote the protection of and the respect for intellectual property throughout the world through cooperation among States; and, where appropriate, in collaboration with other international organizations; secondly, to ensure administrative cooperation among the intellectual property Unions established by the treaties that are administered by WIPO

  • To make IP speaks the language of the economic circumstances and social context that it serves.

  • To create better functional linkages between the national economic objectives, development priorities and resources, and the IP system of the country concerned.

Treaties and Unions of World Intellectual Property Organization (WIPO)

  • The constitution, the “basic instrument,” of WIPO is the Convention, mentioned above, signed at Stockholm in 1967.

The treaties administered by WIPO fall into three groups.

The first group consists of treaties which establish international protection, that is to say, they are treaties which are the source of legal protection agreed between countries at the international level. Four treaties on industrial property fall into this group.

They are
the Paris Convention for the Protection of Industrial Property,
the Madrid Agreement for the Repression of False and Deceptive Indications of Source on Goods,
the Lisbon Agreement for the Protection of Appellations of Origin and their International Registration, and
the Nairobi Treaty on the Protection of the Olympic Symbol.

Two treaties in the field of copyright and neighboring rights fall into this group, namely
the Berne Convention for the Protection of Literary and Artistic Works and
the Rome Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations.

  •  The second group consists of treaties which facilitate international protection. Seven treaties on industrial property fall into this group. They are
    the Patent Cooperation Treaty which provides for the filing of international applications for patents,
    the Madrid Agreement Concerning the International Registration of Marks,
    the Protocol Relating to the Madrid Agreement just mentioned (both of them provide for the filing of international applications for marks),
    the Lisbon Agreement which has already been mentioned because it belongs to both the first and the second groups,
    the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure,
    the Hague Agreement Concerning the International Deposit of Industrial Designs and
    the Trademark Law Treaty which entered into force on August 1, 1996.
  • Two treaties in the field of neighboring rights may also be considered as falling into this group, namely
    the Geneva Convention for the Protection of Producers of Phonograms Against Unauthorized Duplication of Their Phonograms and the Brussels Convention relating to the Distribution of Programme- Carrying Signals Transmitted by Satellite.
  • The third group consists of treaties which establish classification systems and procedures for improving them and keeping them up to date.
  • The following four treaties, all dealing with industrial property, fall into this group:
    the Strasbourg Agreement concerning International Patent Classification (IPC),
    the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks,
    the Vienna Agreement Establishing an International Classification of the Figurative Elements of Marks and
    the Locarno Agreement Establishing an International Classification for Industrial Designs.

Revising these treaties and establishing new ones are tasks which require a constant effort of intergovernmental cooperation and negotiation, supported by a specialized secretariat. WIPO provides the framework and the services for this work. Recent examples of such work include the above-mentioned Madrid Protocol and Trademark Law Treaty, which entered into force on December 1, 1995, and August 1, 1996, respectively. Currently, at least four possible treaties are being negotiated under the aegis of WIPO: The proposed Patent Law Treaty, a possible Protocol to the Berne Convention, a possible Treaty on Neighboring Rights and a proposed Treaty on the Settlement of Disputes between States in the Field of Intellectual Property.

Why is an intergovernmental intellectual property organization needed?

Intellectual property rights are limited territorially; they exist and can be exercised only within the jurisdiction of the country or countries under whose laws they are granted. But works of the mind, including inventive ideas, cross frontiers with ease and, in a world of interdependent nations, should be encouraged to do so. Therefore, governments have negotiated and adopted multilateral treaties in the various fields of intellectual property, each of which establishes a “Union” of countries which agree to grant to nationals of other countries of the Union the same protection as they grant to their own nationals.

Functions of WIPO, History of WIPO, Simple Explanation of WIPO

objectives and functions of WIPO,importance of WIPO,
salient features of WIPO,powers and functions of WIPO, organs of WIPO,
objectives of WIPO,
what is WIPO and its function,
role of WIPO in protection of ipr

What are the Unions?

The Unions administered by WIPO are founded on the treaties. A Union consists of all the States that are party to a particular treaty. The name of the Union is, in most cases, taken from the place where the text of the treaty was first adopted (thus the Paris Union, the Berne Union, etc.).

WIPO’s Unions are

the Paris Union, the Berne Union, the Madrid Union,
the Hague Union, the Nice Union, the Lisbon Union,
the Locarno Union, the PCT Union, the IPC Union,
the Vienna Union and the Budapest Union.

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Define TRIPS? Relationship b/w TRIPS & IPR #Regulatory Affairs M Pharmacy Notes PDF PPT

Define TRIPS? Relationship b/w TRIPS & IPR #Regulatory Affairs M Pharmacy Notes PDF PPT

Define trips? highlight the relationship between trips and ipr?

Trips TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS

The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members. [1] It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994.

 Specifically, TRIPS contains requirements that nations’ laws must meet for: copyright rights, including the rights of performers, producers of sound recordings and broadcasting organizations; geographical indications, including appellations of origin; industrial designs; integrated circuit layout-designs; patents; monopolies for the developers of new plant varieties; trademarks; trade dress; and undisclosed or confidential information. TRIPS also specifies enforcement procedures, remedies, and dispute resolution procedures.

Protection and enforcement of all intellectual property rights shall meet the objectives to contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. The

TRIPS agreement introduced intellectual property law into the international trading system for the first time and remains the most comprehensive international agreement on intellectual property to date. In 2001, developing countries, concerned that developed countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that resulted in the Doha Declaration. The Doha declaration is a WTO statement that clarifies the scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the goal “to promote access to medicines for all.”

TRIPS has been criticized by the alter-globalization movement. Members of the movement object, for example, to its consequences with regards to the AIDS pandemic in Africa.

TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994. Its inclusion was the culmination of a program of intense lobbying by the United States, supported by the European Union, Japan and other developed nations.

Campaigns of unilateral economic encouragement under the Generalized System of Preferences and coercion under Section 301 of the Trade Act played an important role in defeating competing policy positions that were favored by developing countries, most notably Korea and Brazil, but also including Thailand, India and Caribbean Basin states.

In turn, the United States strategy of linking trade policy to intellectual property standards can be traced back to the entrepreneurship of senior management at Pfizer in the early 1980s, who mobilized corporations in the United States and made maximizing intellectual property privileges the number one priority of trade policy in the United States.

 

After the Uruguay round, the GATT became the basis for the establishment of the World Trade Organization. Because ratification of TRIPS is a compulsory requirement of World Trade Organization membership, any country seeking to obtain easy access to the numerous international markets opened by the World Trade Organization must enact the strict intellectual property laws mandated by TRIPS. For this reason, TRIPS is the most important multilateral instrument for the globalization of intellectual property laws.

States like Russia and China that were very unlikely to join the Berne Convention have found the prospect of WTO membership a powerful enticement. Furthermore, unlike other agreements on intellectual property, TRIPS has a powerful enforcement mechanism. States can be disciplined through the WTO’s dispute settlement mechanism.

Objectives of TRIPS

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Principles:

1. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.

2. Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.

Discuss the provisions of TRIPS

Nature and Scope of Obligations  TRIPS:

1. Members shall give effect to the provisions of this Agreement. Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement. Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

2. For the purposes of this Agreement, the term “intellectual property” refers to all categories of intellectual property that are the subject of Sections 1 through 7 of Part II.

3. Members shall accord the treatment provided for in this Agreement to the nationals of other Members.

(1) In respect of the relevant intellectual property right, the nationals of other Members shall be understood as those natural or legal persons that would meet the criteria for eligibility for protection provided for in the Paris Convention (1967), the Berne Convention (1971), the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits, were all Members of the WTO members of those conventions.

(2) Any Member availing itself of the possibilities provided in paragraph 3 of Article 5 or paragraph 2 of Article 6 of the Rome Convention shall make a notification as foreseen in those provisions to the Council for Trade-Related Aspects of Intellectual Property Rights (the “Council for TRIPS”).

Define TRIPS? Relationship b/w TRIPS & IPR #Regulatory Affairs M Pharmacy Notes PDF PPT
Define TRIPS? Relationship b/w TRIPS & IPR #Regulatory Affairs M Pharmacy Notes PDF PPT

Define TRIPS? Relationship b/w TRIPS & IPR #Regulatory Affairs M Pharmacy Notes PDF PPT

Provision requirements of TRIPS:

TRIPS requires member states to provide strong protection for intellectual property rights. For example, under TRIPS:

• Copyright terms must extend to 50 years after the death of the author, although films and photographs are only required to have fixed 50 and to be at least 25 year terms, respectively.(Art. 7(2),(4))

• Copyright must be granted automatically, and not based upon any “formality”, such as registrations or systems of renewal.

• Computer programs must be regarded as “literary works” under copyright law and receive the same terms of protection.

• National exceptions to copyright (such as “fair use” in the United States) are constrained by the Berne three-step test

• Patents must be granted in all “fields of technology,” although exceptions for certain public interests are allowed (Art. 27.2 and 27.3)[2] and must be enforceable for at least 20 years (Art 33).

• Exceptions to the exclusive rights must be limited, provided that a normal exploitation of the work (Art. 13) and normal exploitation of the patent (Art 30) is not in conflict.
• No unreasonable prejudice to the legitimate interests of the right holders of computer programs and patents is allowed.

• Legitimate interests of third parties have to be taken into account by patent rights (Art 30).

• In each state, intellectual property laws may not offer any benefits to local citizens which are not available to citizens of other TRIPs signatories by the principles of national treatment (with certain limited exceptions, Art. 3 and 5)[3]. TRIPS also has a most favored nation clause.
Many of the TRIPS provisions on copyright were imported from the Berne Convention for the Protection of Literary and Artistic Works and many of its trademark and patent provisions were imported from the Paris Convention for the Protection of Industrial Property.

Access to essential medicines:

The most visible conflict has been over AIDS drugs in Africa. Despite the role which patents have played in maintaining higher drug costs for public health programs across Africa, this controversy has not led to a revision of TRIPs. Instead, an interpretive statement, the Doha Declaration, was issued in November 2001, which indicated that trips should not prevent states from dealing with public health crises.

A 2003 agreement loosened the domestic market requirement, and allows developing countries to export to other countries where there is a national health problem as long as drugs exported are not part of a commercial or industrial policy.[4] Drugs exported under such a regime may be packaged or colored differently to prevent them from prejudicing markets in the developed world.
In 2003, the Bush administration also changed its position, concluding that generic treatments might in fact be a component of an effective strategy to combat HIV. Bush created the PEPFAR program, which received $15 billion from 2003-2007, and was reauthorized in 2007 for $30 billion over the next five years. Despite wavering on the issue of compulsory licensing, PEPFAR began to distribute generic drugs in 2004-5.

Implementation in developing countries:

The obligations under TRIPS apply equally to all member states, however developing countries were allowed extra time to implement the applicable changes to their national laws, in two tiers of transition according to their level of development. The transition period for developing countries expired in 2005. The transition period for least developed countries was extended to 2016, and could be extended beyond that.

Developed countries are massive net-exporters of copyright-, patent- and trademark-related royalties. It has therefore been argued that the TRIPS standard of requiring all countries to create strict intellectual property systems will be detrimental to poorer countries’ development.[5] Many argue[who?] that it is, prima facie, in the strategic interest of most if not all underdeveloped nations to use any flexibility available in TRIPS to write the weakest IP laws possible. This has not happened in most cases. A 2005 report by the WHO found that many developing countries have not incorporated TRIPS flexibilities (compulsory licensing, parallel importation, limits on data protection, use of broad research and other exceptions to patentability, etc.) into their legislation to the extent authorized under Doha.

Trips TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS PDF PPT

This is likely caused by the lack of legal and technical expertise needed to draft legislation that implements flexibility, which has often led to developing countries directly copying developed country IP legislation,[7] or relying on technical assistance from the World Intellectual Property Organization (WIPO), which, according to critics such as Cory Doctorow, encourages them to implement stronger intellectual property monopolies.

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“Scientific discoveries are not the same as inventions” #M. Pharmacy Notes IPR Material

#M. Pharmacy Notes IPR Material

Scientific discoveries are not the same as inventions Do you agree? Substantiate your answer.

Invention makes or develops something that did not exist. Discovery finds real (non-abstract) things that are already exsistant Patentable inventions must — under conventional patent law — be new, useful and involve an ‘inventive step’. In contrast, it is generally accepted that utilizing something that already exists in nature is a ‘discovery’, and is therefore not patentable.

Drawing an appropriate boundary between un-patentable natural phenomena and patentable inventions is crucial in preventing the patent laws from unduly restricting access to fundamental scientific discoveries. Some would argue that, particularly in the U.S., patents are being issued that purport to claim a novel product or process but that, in effect, encompass any practical application of a fundamental biological principle.

#M. Pharmacy Notes IPR Material
Examples include gene patents, which Congress is considering banning, and patents relating to biological correlations and pathways, such as the patents at issue in the headlinegrabbing LabCorp v. Metabolite and Ariad v. Eli Lilly litigations. In view of the mounting concern, it seems likely that government and/or the courts will address the issue, and perhaps substantially shift the boundary.
The question of what should and should not be patentable subject matter has spawned a number of battlegrounds in recent years, setting against each other those in each area supporting patentability, claiming that patents would cause increased innovation and public good, against opponents with views that patentability was being sought only for private good but would do public harm.

Flashpoints have included the patenting of naturally occurring biological material; genetic sequences; stem cells; “traditional knowledge”; programs for computers; business methods.

In March 2010, a federal district court judge in the Southern District of New York ruled that purified DNA sequences and the inventions using them are unpatentable. As has been discussed Judge Sweet relied entirely upon Supreme Court precedent and ignored contrary case law of the Federal Circuit Court of Appeals to conclude that isolated DNA is of the same fundamental quality as natural DNA and is thus unpatentable under section 101 of the Patent Act; and that the method claims of the patents were abstract mental processes that were also unpatentable. His rationale is controversial and his ruling has been appealed to the Federal Circuit.
In the process, different jurisdictions have come to different views as to what should be allowed and what should not.

Types of Patents – All about Patents – Intellectual Property Rights & Regulatory Affairs notes

Patents on business methods have proven to be a particularly controversial type of statutory subject matter. They have been criticized because the patents granted are perceived as being too broad, perhaps due to the difficulty in searching for prior art and recruiting suitably qualified patent examiners who have historically had a science background rather than a business background. Patent applications for business methods are also subject to delays in prosecution at the United States Patent and Trademark Office and other patent office