Patents - How to apply for?

 

On the face of it, applying for a patent it is not an easy task! Due to the facts that there are so many options to intiate a patenting procedure, it is practically impossible to make any suggestion at this stage. From another point of view, as each new patent application must have in support a certain number of novel claims, different circumstances and conditions may be asked for particular consideration in each situation.

First of all, let's summarise which are these options, then what are the main requirements that shoud be met in each case.
To apply for a patent, you must lodge a patent application with a Patent Authority either for a national patent or a multi-national patent.
Primarly, a provisional patent application can be lodged, which regularly is followed by a standard/complete patent application, a special patent application but for a limited patent (e.g. petty patent for six years - Australia or "Abzweigung" for 10 years, divisional petty patent - Germany; design patent - US; innovation - some countries members of the European Community), a regional patent application (e.g. European Patent Application), or an international PCT patent application. Some of the applicants may decide or choose to bypass the provisional patent application stage and put straightforward a full patent application in both cases domestic and/or international.
A provisional application is a new type of patent application created by the GATT legislation, which is designed to be a simple and inexpensive application that will not be examined except for certain formal requirements. The provisional application provides a method by which applicants can quickly establish an early effective filing date in a patent application and gives an inventor up to twelve months to further develop an invention, determine marketability, acquire funding or capital, seek licensing, etc. before filing a full application. A provisional application cannot mature into a patent, so a full application must be filed within twelve months of the provisional filing date to preserve the original filing date.
During this one-year period, the invention has patent pending status. This is critical since most companies will not discuss an invention with an individual until the invention is at least patent pending.

Provisional Patent Application - Advantages and Disadvantages

Advantages

• relatively easy to prepare and file
• establishes the priority date for a standard/complete patent application if this is field in term (twelve months)
• permits further development of the invention before filing the standard/complete patent application
• it is never-ever published/open to the public inspection (OPI), which means that does not disclose the invention state of art if the inventor/applicant, for some reasons, fails to file the standard/complete patent application
• availability to an international-type novelty search which may be conducted by an International Searching Authority on request
• one or more than two provisional applications can be associated to the same standard/complete patent application but in term of twelve months from the filing date of the earliest associated provisional application
• initially it can be filed in any language but translation must be filed in due course
• inexpensive to file

Disadvantages

• it is not absolutely clear whether a provisional patent application may be used as the basis for making a priority claim for filing patent applications in other countries under the Paris Convention.
• the "twelve months" term it cannot be extended rather than very special conditions must be considered
• further inventive features developed after filing a provisional application are not disclosed until a standard/complete patent application describing those features is filed
• if the description is not adequate, the provisional specification will not serve its function of establishing a priority date for the standard/complete patent application must be filed

A standard/complete patent application establishes the filing date and consists of the following:

• An abstract (a brief summary of the contents of the specification)
• A complete/fulltext specification, which has two parts:

  • a clear and complete description of the invention and its usefulness
  • a list of the claims, which set out the essential features and define the boundaries of patent protection being sought

• Drawings - if applicable, showing all features of the invention, as defined by the claims. NOTE: A test of the specification's clarity is that it should enable anyone with average skill in the technology to make or use the invention
  

A divisional patent application is an application claiming priority from some previously filed patent application and known as parent application in which more than one invention was disclosed. The divisional application has claims directed to a different invention than that claimed in the parent application.
Petty Patent protection is more cheaper and easier to obtain than a standard patent, but the invention claimed is also be limited in scope and the patent life is shorter (6 years - Australia, 10 years - Germany). Technically, the petty patents are similar to standard patents in most respects, but they have a few important differences. A Petty Patent:

• lasts for shorter time
• is examined automatically, and is usually granted within 6 to 12 months
• can only have one single independent claim, and no more than two dependent claims
• the overall cost of a petty patent is usually much less than that of a standard patent application

International Patent Application
If foreign protection is sought, no matter which alternative is to be adopted, the application must be filed before the particulars are publicly disclosed and/or disclosed in a printed document or publication anywhere in the world.
There are two alternatives: to file a spearate application in each individual country or, to file one single application under the European Patent Convention and/or Patent Cooperation Treaty (PCT).
By lodging a European patent application under the European Patent Convention, it is possible to designate any country-member under this convention and the application will be examined as a single application. If patent application is found to be acceptable, each of the designated countries will grant a national patent on the application. However, an European patent application is normally cost-effective only if more than about three or four countries are designated.
By using the PCT procedure, the inventor/applicant bigins with filing of an international application (international phase) and ends the grant of a number of national and/or regional patents (national phase).
The international phase consists of four main steps:

1. filing the international application
2. establishment of the International Search Report
3. publication of the international application with the International Search Report (as soon as possible after 18 months from the priority date)
4. establishment of an International Preliminary Examination Report (optional)

Advantages

• more time for evaluation
• saves effort, time, and money when protection has been sought in a number of countries
• helps the inventor/applicant to make decisions following the international search report results before entrered into national phase with each national office of the designated countries
• facilitates the inventor/applicant to file one application, in one place, in one language and pay one set of fees in one currency
• reduces the formal requirements differing from one country to another to one single international standard form
• refrains the inventor/applicant from appointing attorneny or agents in each country in which protection may be sought
• delays considerably paying the national fees up to 20 months from the priority date or even longer (30 months) where international preliminary examination may be requested
• covers both its member-countries and various regional patent treaties or systems
• allows to name the European Patent Office (EPO) as one-single designated country

Disadvantages

• slow to issue if prior art is a problem
• permits only 8 months deferrment of examinations and payments
• application is rejected, can no longer file in any country, although total rejection is unlikely
• the search and examination conducted under the PCT is not binding on any national Patent Office

NOTE: The PCT provides a common application procedure which in certain circumstances may be advantageous to the inventor/applicant, but the cost of using the PCT international patent application should be carefully balanced against advantages to be obtained. Patent Application - Forms & Fees
Australia

• IP Australia - Application Forms & Fees

Patent Cooperation Treaty (PCT)

• Comprehensive Index to the PCT Applicant's Guide Tables
• PCT - Patent Forms - Index

  • PCT Request(Form PCT/RO/101) - available in Adobe PDF format

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EPO - European Patent Office

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United States Patent and Trademark Office (USPTO)

• Fees - Index; 1 or 2

PCT & EPO - Fees (Information available on USPTO Server)

• PCT
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Japan

• Schedule of Fees

Other Hot-links

• Directory of Intellectual Property Offices
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• European Patent Office - Member States

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TRAMADOL, EP1077923

TRAMADOL

http://www.google.com/patents/EP1077923B1?cl=en

Neile A. Grayson, Robert E. Halvachs, Esa T. Jarvi
Applicant	Mallinckrodt Inc.

Example 2

Synthesis of Tramadol in the Presence of the Additive 1-methylimidazole

• 
  
  The Mannich reaction was run to give Mannich hydrochloride in water. This was adjusted to pH 10.8 and extracted with toluene and then dried with magnesium sulfate. A 200 mL solution containing 98 g of the Mannich base B in toluene was thus obtained.
• 
  
  To 24 g of magnesium turnings under 425 mL of dry THF was added 177 g of meta-bromoanisole at such a rate as to keep the reaction at reflux. After the addition, reflux was continued for one hour. At a temperature of 60°C, 77 g of 1-methylimidazole was added. A precipitate formed. The mixture was stirred until all of the precipitate dissolved.
  
  The temperature was allowed to fall to 28°C, and then the solution of Mannich base B in toluene (above) was added over 15 min, while a temperature rise to 60°C was observed. During 2 hours, the reaction mixture was stirred and allowed to cool to room temperature. The mixture was cooled to 15°C and 420 mL of 4 M ammonium chloride in water was slowly added, keeping the temperature under 30°C. To the mixture was added 350 mL of water.
  
  The mixture was cooled while 215 mL of concentrated hydrochloric acid was added, giving a pH of 1.0. The top, organic layer was separated and discarded. The aqueous layer was washed with 150 mL toluene and the toluene discarded. The aqueous mixture was cooled in an ice bath and taken to pH 9.5 with 355 mL of concentrated ammonium hydroxide. The mixture was extracted with 140 mL of toluene.
  
  The two phase mixture was filtered before separation to remove insolubles. The aqueous layer was extracted with a second 140 mL of toluene, and the toluene extracts were combined. Small amounts of toluene were added for transfer. Approximately 90 mL of toluene was distilled out to remove water. The toluene solution was assayed to show there is 106 g of a mixture of trans/cis isomers of C there, in a 90.3/9.7 ratio (HPLC).
  
  A simple assay of the solution is to remove solvent from a few milliliters of sample by rotary evaporation followed by drying in high vacuum. The solution can be used as such in Example 8 type experiments, or concentrated further. An additional extraction of the original aqueous layer with toluene gave 5.4 g more of the desired product.

Process for the preparation of ramelteon WO 2010103553 A1

RAMELTEON


Industriale Chimica S.R.L.

http://www.google.im/patents/WO2010103553A1?cl=en

Ramelteon, having the structural formula (I) illustrated below,

⁽U is a product known in literature and was described for the first time, with relative synthesis, in the patent EP 885210 B1 to Takeda Chem. Ind.

The starting products for the preparation of ramelteon can be 2,3- dihydrobenzofuran or 6-hydroxy-indanone. The cyclisation for formation of the third ring can therefore follow two paths:

(D (2)

The amine function is introduced by Wittig reaction on an intermediate of type (3) followed by reduction of the -C=N group to give an intermediate of type (4):

(3) (4)

Reduction of the double bond resulting in position 8 in the intermediate (4) must provide the end product with stereochemistry S. For this purpose chiral catalysts can be used, or achiral catalysts with subsequent separation of the mixture obtained.

(4)

The transformation from amine to amide occurs in the usual way, with the use of chloride of the acid in the presence of an organic base, and is schematised by the following reaction:

One of the critical points of the synthesis pathways of optically active products like ramelteon is control of the process stereochemistry in order to obtain the desired product with correct spatial arrangement of all the atoms.

In EP 885210 B1 , as described in the experimental part, two pathways are followed to obtain the above.

According to the first pathway, illustrated in paragraph [380], example 11 , the ramelteon is optically resolved by preparative HPLC with chiral column working on a small amount of product. The example gives data of [αjo²⁰, melting point and NMR without, however, providing the most indicative datum, i.e. the enantiomeric excess, of the product obtained. The indication "optically resolved", in the absence of a numerical datum, does not clarify to what extent the ramelteon has been resolved, and therefore the text in this regard does not give exhaustive indications on the possibility of resolving the racemic mixture via this pathway. Furthermore, the option of resolution on a chiral column is clearly of analytical interest only and has no application for production on an industrial scale.

The second possibility described in EP 885210 B1 , in the reference examples 2O₃ 21 and 22, tackles the problem in a different way, intervening on the synthesis. In this case hydrogenations are performed with chiral catalysts, obtaining reduction products with enantiomeric excess (e.e.) up to 90%. The reference example 20, paragraph [302], obtains an e.e. of 100%, but only after repeated crystallisations starting from an e.e. of 88.8%. From the experimental procedures of the examples cited it can be observed that the hydrogenation pressure varies between 50 and 100 bar. Such high pressure values, which already at laboratory level require specific equipment, cannot be easily applied to ordinary plant reactors; rather, they require specific dedicated and constantly controlled reactors.

A similar observation can be made with regard to the reference example 29, paragraphs [310] and [311], in which the intermediate (E)-N-[2-(6-methoxyindan-1- ylidene)ethyl]propionamide is hydrogenated at 70 ⁰C and at a pressure of 90 bar; in this example an e.e. of 99% is reached after chromatographic purification and crystallisation. From the stereochemical point of view the result is more than satisfactory except that it is obtained on one of the first intermediates of the synthesis. This means that the short column chromatography described in paragraph [311] is such and can be performed with ordinary equipment only at laboratory level; it certainly does not apply in the case of industrial production.

The article "Approach to the stereoselective synthesis of melatonin receptor agonist ramelteon via asymmetric hydrogenation", Tom Yamano et al., Tetrahedron: Asymmetry, vol. 17 (2006), 184-190, which was published roughly ten years after the patent EP 885210 B1 , describes purification of the asymmetric hydrogenation products of some substrates (indicated as 3, 4a and 4b) and shows how the technique illustrated always requires a final chromatographic purification (see in particular hydrogenation of substrate 3, performed on a few mg, and substrate 4a). In the conclusions of the article the results obtained are defined as encouraging for the development of more efficient processes.

Lastly, the recent patent application EP 1792899 A1 describes a synthesis of (S)-2-(1 ,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethylamine with a high degree of purity, applicable industrially and characterised by high process yields. This application touches on another crucial aspect of synthesis of pharmaceutical products, i.e. the impurities generated by the synthesis itself. The description of said (numerous) impurities is detailed, the structures are given in full and their final content in the ramelteon is good, each being below 0.15%, but the method of obtaining the results appears complicated and costly. As described in example 2, the process comprises a double hydrogenation on (E)-2-(1 ,6,7,8-tetrahydro-2H- indeno[5,4-b]furan-8-ylidene)ethylamine with two different catalysts followed by a crystallisation, then transformation, in a separate operation, of the amine thus obtained to propionamide (i.e. ramelteon) and further purification.

It is therefore evident that there is still the need to develop production processes for ramelteon which are alternative to the known processes and are simpler to apply on an industrial scale.

Summary of the invention

One object of the present invention is therefore to provide a process for the synthesis of ramelteon which is industrially applicable without the need for special plants and which, at the same time, allows the compound to be obtained in a pharmaceutical quality and with high yields in a simple manner, limiting reprocessing and chromatography.

A further object of the invention is to provide a process for the synthesis of ramelteon which comprises more practical stereoselective reductions than those previously known.

These and further objects are obtained according to the present invention with a process for the preparation of N-[2-(8S)-1 ,6,7,8-tetrahydro-2H-indeno[5,4- b]furan-8-il]ethyl]propionamide (ramelteon) of formula (I)

(I) comprising the following reactions: a) alkylation of the hydroxyl of 6-hydroxy-indanone, (II), to obtain 6-allyIoxy- indan-1 -one, (III):

(II) (III) b) thermal Claisen rearrangement on (III) to obtain 7-allyl-6-hydroxy-indan-1- one, (IV):

(III) (IV) c) protection of the free hydroxyl of (IV) to obtain an intermediate of formula

(V):

(IV) (V) in which (PG-OH) indicates the hydroxyl group protected with a protective group stable in a basic environment; d) reaction of the intermediate of formula (V) with a dialkyl cyano methylphosphonate to obtain an intermediate of formula (Vl)

(V) (Vl)

Having obtained an intermediate of type (Vl) two synthesis pathways can be followed: a sequence (indicated below as e → f_→ 3_. → h ^→ i) in which the reaction e is enantioselective; or a sequence (indicated below as E → F → G → H → 1) in which the reaction ] is enantioselective.

Sequence e -→i → g → h → i e) enantioselective reduction on the intermediate of formula (Vl)₁ to obtain an intermediate of formula (VII)

(Vl) (VII) f_) oxidative demolition of the double bond of the intermediate of formula (VII), to obtain an intermediate of formula (VIII):

(VII) (VIII)

§) reduction of the carbonylic function present in the intermediate of formula (VIII), to obtain an intermediate of formula (IX):

(VIII) (IX) h) transformation of the free hydroxylic group present in the intermediate of formula (IX) in order to make it a good leaving group, to obtain an intermediate with general formula (X)₁ in which (LG) indicates a leaving group:

(IX) (X) i) intramolecular cyclisation of the intermediate of formula (X) to obtain (1 ,6_>7_J8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)acetonitrile_l (Xl):

(X) (Xl)

Sequence E_→ F_→ G_→ H_→ I

E) selective oxidative demolition of the terminal double bond on the intermediate of formula (Vl), to obtain an intermediate of formula (7):

(Vl) (7) F) reduction of the carbonylic function present in the intermediate of formula (7), to obtain an intermediate of formula (8):

(7) (8)

G) transformation of the free hydroxylic group present in the intermediate of formula (8) in order to make it a good leaving group, to obtain the intermediate of formula (9), in which (LG) indicates the leaving group:

(8) (9)

H) intramolecular cyclisation of the intermediate of formula (9) to obtain (I ^J.δ-tetrahydro-EH-indenofδ^-bjfuran-δ-ylideneJacetonitrile of formula (10):

(9) (10)

I) enantioselective reduction on the intermediate of formula (10) to obtain (1 ,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)acetonitrile of formula (Xl):

(10) (Xl) The intermediate (Xl)₁ a common product of the two synthesis pathways, can be made to react to obtain ramelteon according to one of the following two pathways: g) hydrogenating the triple bond -C=N in the presence of propionic anhydride to obtain ramelteon (I):

(XI) (I) or βl) reducing the triple bond of the group -C=N to -CH₂NH₂ to obtain the intermediate (XII); and βf) reacting the intermediate (XII) with propionic anhydride or propionyl chloride, to obtain ramelteon (I):

......................................(Xl)......................... (XII)................................. (I)

EXAMPLE 9

This example refers to reaction g of the process of the invention (preparation of ramelteon).

470 g of product of formula (Xl), obtained as described in Example 8, are dissolved in 84 kg of THF. 615 g of propionic anhydride and 150 g of Pt/C Escat 22 (Pt at 5% on carbon) are added to the solution. The suspension is brought to T = 65 ± 5 ⁰C and hydrogenated at P = 8/9 bar. After 4 h the progress of the reaction is checked (TLC), it is filtered and a further 50 g of Pt/C Escat 22 are loaded. The suspension is brought to T = 65 ± 5 ⁰C and hydrogenated at P = 8/9 bar, checking the progress of the reaction (TLC). At the end of the reaction, the catalyst is filtered and the solvent is eliminated at reduced pressure. The residue is recovered with 11 kg of isopropyl acetate. The organic phase is washed with a basic aqueous solution (900 g of NaHCO₃ in 10 I of water), with an aqueous solution of NaC! (500 g of NaCI in 10 I of water) and then with water until neutral pH is reached. The solvent is distilled at reduced pressure and T = 55 ± 5 ⁰C. The residue obtained, which tends to crystallise spontaneously, is crystallised with heptane and ethyl acetate. 380 g of ramelteon are obtained, the analytical characteristics of which match the data reported in literature.

This product, analysed with chiral HPLC (Ceramospher Chiral RU-1 ) shows an e.e. of 100%.

EXAMPLE 10

This example refers to reaction g of the process of the invention (preparation of ramelteon).

20 g of product of formula (Xl) are dissolved in 1.8 kg of THF. 26 g of propionic anhydride and 5 g of Pt/C Escat 22 are added to the solution. The suspension is brought to T = 65 ± 5 ⁰C and hydrogenated at P = 10/12 bar. After 4 h the progress of the reaction is checked (TLC)₁ it is filtered and a further 2.5 g of Pt/C Escat 22 are loaded. The suspension is brought to T = 65 ± 5 ⁰C and hydrogenated at P = 10/12 bar, checking the progress of the reaction (TLC). At the end of the reaction, the catalyst is filtered and the solvent is eliminated at reduced pressure. The residue is recovered with 1 I of isopropyl acetate. The organic phase is washed with a basic aqueous solution (10 g of NaHCO₃ in 1 I of water), with aqueous solution of NaCI (10 g of NaCI in 1 I of water) and lastly with water until neutral pH is reached. The solvent is distilled at reduced pressure and T = 55 ± 5 °C. The residue obtained, which tends to crystallise spontaneously, is crystallised with heptane and ethyl acetate. 16.7 g of ramelteon are obtained, the characteristics of which match the data reported in literature.

http://www.google.im/patents/WO2010103553A1?cl=en

Via Grieg, 13

21047 Saronno (VA)

Saronno, Italy.

Phone:+ 39-02-964.26.411

Fax:+ 39-02-962.19.97

ichimica@chemogroup.com

Founded in 1984, Industriale Chimica is a subsidiary of the CHEMO Group and is devoted to the manufacture of APIs for the pharmaceutical industry.

Industriale Chimica makes a big investment in its research and development departments. The activity is conducted by a highly-qualified team of researchers and staff. Industriale Chimica laboratories, are totally equipped with the most advanced instruments of analysis.

The development and production comprises: development of small sizes batches, methods of analysis, identification and isolation of impurities, and a stability program in order to supply customers with the data needed to prepare the DMF.

SARANNO ITALY

PATENT BASICS

What is a patent?

A patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application.

The patent owner may give permission to, or license, other parties to use the invention on mutually agreed terms. The owner may also sell the right to the invention to someone else, who will then become the new owner of the patent. Once a patent expires, the protection ends, and an invention enters the public domain; that is, anyone can commercially exploit the invention without infringing the patent.

What kind of protection does a patent offer? 

In principle, the patent owner has the exclusive right to prevent or stop others from commercially exploiting the patented invention. In other words, patent protection means that the invention cannot be commercially made, used, distributed, imported or sold by others without the patent owner's consent.

Is a patent valid in every country? 

Patents are territorial rights. In general, the exclusive rights are only applicable in the country or region in which a patent has been filed and granted, in accordance with the law of that country or region.

How long does a patent last? 

The protection is granted for a limited period, generally 20 years from the filing date of the application.

What kinds of inventions can be protected? ↓

Patents may be granted for inventions in any field of technology, from an everyday kitchen utensil to a nanotechnology chip. An invention can be a product – such as a chemical compound, or a process, for example – or a process for producing a specific chemical compound. Many products in fact contain a number of inventions. For example, a laptop computer can involve hundreds of inventions, working together.

Is a patent valid in every country? ↓

Patents are territorial rights. In general, the exclusive rights are only applicable in the country or region in which a patent has been filed and granted, in accordance with the law of that country or region.

How are patent rights enforced? ↓

Patent rights are usually enforced in a court on the initiative of the right owner. In most systems a court of law has the authority to stop patent infringement. However the main responsibility for monitoring, identifying, and taking action against infringers of a patent lies with the patent owner.

What does it mean to “license a patent” and why is it done? ↓

Licensing a patent simply means that the patent owner grants permission to another individual/organization to make, use, sell etc. his/her patented invention. This takes place according to agreed terms and conditions (for example, defining the amount and type of payment to be made by the licensee to the licensor), for a defined purpose, in a defined territory, and for an agreed period of time.

A patent owner may grant a license to a third party for many reasons. The patent owner may not have the necessary manufacturing facilities, for example, and therefore opts to allow others to make and sell his/her patented invention in return for “royalty” payments. Alternatively, a patent owner may have manufacturing facilities, but they may not be large enough to cover market demand. In this case, he/she may be interested in licensing the patent to another manufacturer in order to benefit from another income stream. Another possible situation is one in which the patent owner wishes to concentrate on one geographic market; therefore the patent owner may choose to grant a license to another individual/organization, with interests in other geographical markets. Entering into a licensing agreement can help to build a mutually-beneficial business relationship.

Unlike selling or transferring a patent to another party, the licensor continue to have property rights over the patented invention.

Why are patents useful (to society, business, individuals etc.)? ↓

Patented inventions have, in fact, pervaded every aspect of human life, from electric lighting (patents held by Edison and Swan) and plastic (patents held by Baekeland), to ballpoint pens (patents held by Biro), and microprocessors (patents held by Intel, for example).

Patents provide incentives to and protection for individuals by offering them recognition for their creativity and the possibility of material reward for their inventions. At the same time, the obligatory publication of patents and patent applications facilitates the mutually-beneficial spread of new knowledge and accelerates innovation activities by, for example, avoiding the necessity to “re-invent the wheel”.

Once knowledge is publicly available, by its nature, it can be used simultaneously by an unlimited number of persons. While this is, without doubt, perfectly acceptable for public information, it causes a dilemma for the commercialization of technical knowledge. In the absence of protection of such knowledge, “free-riders” could easily use technical knowledge embedded in inventions without any recognition of the creativity of the inventor or contribution to the investments made by the inventor. As a consequence, inventors would naturally be discouraged to bring new inventions to the market, and tend to keep their commercially valuable inventions secret. A patent system intends to correct such under-provision of innovative activities by providing innovators with limited exclusive rights, thereby giving the innovators the possibility to receive appropriate returns on their innovative activities.

In a wider sense, the public disclosure of the technical knowledge in the patent, and the exclusive right granted by the patent, provide incentives for competitors to search for alternative solutions and to “invent around” the first invention. These incentives and the dissemination of knowledge about new inventions encourage further innovation, which assures that the quality of human life and the well-being of society is continuously enhanced.

Applying for patent protection

What conditions must be met to obtain patent protection? ↓

There are numerous conditions that must be met in order to obtain a patent and it is not possible to compile an exhaustive, universally applicable list. However, some of the key conditions include the following:

• The invention must show an element of novelty; that is, some new characteristic which is not known in the body of existing knowledge in its technical field. This body of existing knowledge is called “prior art”.
• The invention must involve an “inventive step” or “non-obvious”, which means that it could not be obviously deduced by a person having ordinary skill in the relevant technical field.
• The invention must be capable of industrial application, meaning that it must be capable of being used for an industrial or business purpose beyond a mere theoretical phenomenon, or be useful.
• Its subject matter must be accepted as “patentable” under law. In many countries, scientific theories, aesthetic creations, mathematical methods, plant or animal varieties, discoveries of natural substances, commercial methods, methods for medical treatment (as opposed to medical products) or computer programs are generally not patentable.
• The invention must be disclosed in an application in a manner sufficiently clear and complete to enable it to be replicated by a person with an ordinary level of skill in the relevant technical field.

Who grants patents? ↓

A patent is granted by a national patent office or by a regional office that carries out the task for a number of countries. Currently, the following regional patent offices are in operation:

• African Intellectual Property Organization (OAPI)
• African Regional Intellectual Property Organization (ARIPO)
• Eurasian Patent Organization (EAPO)
• European Patent Office (EPO)
• Patent Office of the Cooperation Council for the Arab States of the Gulf (GCC Patent Office)

Under such regional systems, an applicant requests protection for an invention in one or more member states of the regional organization in question. The regional office accepts these patent applications, which have the same effect as national applications, or grants patents, if all the criteria for the grant of such a regional patent are met.

There is currently, no universal, international system for the grant of patents.

Do I need a patent attorney/agent to prepare and file a patent application? ↓

In general, applicants can prepare their patent applications and file them without assistance from a patent attorney. However, given the complexity of patent documents and the legal skills required, such as claim drafting, it is highly advisable to seek legal assistance from a patent attorney/agent when drafting a patent application.

Furthermore, the legislation of many countries requires that an applicant, whose ordinary residence or principal place of business is outside the country, be represented by an attorney or agent qualified in the country (which usually means an agent or attorney who resides and practices in that country). Information on the qualified attorneys and agents can be obtained directly from national and regional IP offices.

How much does it cost to patent an invention? ↓

The costs vary considerably from country to country (and even within a country). As the official fees vary widely from country to country, please contact the relevant national or regional patent office which will be able to give you details on the fee structure. Consult our list of national and regional intellectual property offices.

The cost of patenting an invention depends on factors such as the nature of the invention, its complexity, patent attorney’s fees, the length of the application, and possible objections raised during the examination by the patent office. Some countries offer discounts to small- and medium-sized enterprises and applicants filing the application online. In addition, some countries allow expedited examination upon payment of additional fees.

In addition to the national official filing fees, once a patent is granted by the patent office, you must pay maintenance or renewal fees, generally on an annual basis, to maintain the validity of the patent.

In case you decide to patent your invention abroad, you should also consider the relevant official filing fees for each country in question, the translation costs, and the costs of using local patent agents, which is a requirement in many countries for foreign applicants.

How can patents be obtained worldwide? ↓

At present, you cannot obtain a universal “world patent” or “international patent”. Patents are territorial rights. In general, an application for a patent must be filed, and the patent granted and enforced, in each country in which you seek patent protection for your invention, in accordance with the law of that country. Therefore, one way of obtaining patents in a number of countries is to file a national patent application with each relevant national patent office.

In some regions, a regional patent office, for example, the European Patent Office (EPO) and the African Regional Intellectual Property Organization (ARIPO), accepts regional patent applications, or grants patents. These have the same effect as applications filed, or patents granted, in the member states of that region. This means that, in certain regions, you can obtain a regional patent from a regional patent office, which is valid in some or all of its member states.

If you are seeking patent protection in a number of countries worldwide, a good option is to file an international application under the Patent Cooperation Treaty (PCT), administered by WIPO. Any resident or national of a state party to the PCT (contracting state) can file a single international application which has the effect of a national patent application (and certain regional patent applications) in some or all PCT contracting states. In some cases, this can be a more straightforward choice than choosing to try to submit individual applications in each and every country in which you require protection. Find out more about the PCT System.

What practical steps do I have to take to obtain patent protection? ↓

The first step in securing a patent is the filing of a patent application. Many patent offices provide a specific form to fill in. In some patent offices, you can file a patent application on line.

In the patent application, in general, you must describe the title of the invention, as well as provide an indication of its technical field. You must also include the background to and a description of the invention, in clear language and enough detail that a person with an average understanding of the field could use or reproduce the invention. Such descriptions are usually accompanied by visual materials such as drawings, plans, or diagrams to better describe the invention and an abstract, which contains a brief summary of the invention. You must also clearly and concisely define the matter for which patent protection is sought in the “claims” part of the patent application.

In addition, depending on the applicable patent law, you may need to submit various kinds of statements, declarations or supporting documents to a patent office. In view of the complexity it is recommended that you consult a patent attorney or a patent agent to prepare a patent application.

What happens after I’ve submitted my application? ↓

The procedures vary significantly from one country to another, so it is impossible to provide an exhaustive step-by-step overview. If you wish to research a country’s legislation in the field of patents independently, you can browse the WIPO Lex database of intellectual property (IP) legislation from around the world.

However it is recommended that you consult either a practicing lawyer specializing in IP or the relevant IP office. Consult our directory of national and regional IP offices.

Can the decision to grant a patent be challenged? ↓

The grant of a patent can be challenged either via a patent office or in a court of law. A court may invalidate or revoke a patent upon a successful challenge by a third party. In addition, many patent offices provide administrative procedures that allow third parties to oppose to the grant of a patent (including so-called "opposition systems"), for example, on the basis that the claimed invention is not new or does not involve an inventive step.

Procedures for challenging patents differ from country to country. Find out more about opposition systems.

Is it possible to extend the term of patent protection? ↓

In some countries, patent protection may be extended beyond 20 years or a Supplementary Protection Certificate (SPC) may be issued in very specific cases. The extension aims to compensate for the time expended on the administrative approval procedure before products can be put on the market. The time taken for this procedure means that the patent owner may sometimes not be able to benefit from his right for a considerable period of time after the grant of the patent.

Can I obtain a patent for a software-related invention? ↓

Possibly, but laws and practices in this regard can differ from one country or region to another. For example, in some countries, “inventions” within the meaning of patent law must have a “technical character”. In other countries, such requirements do not exist, meaning that in these countries software is generally patentable subject matter.

However this does not mean that all software will be able to be patent protected. In order to obtain a patent, a software invention must not fall under other non-patentable subject matter (for example, abstract ideas or mathematical theories) and has to fulfill the other substantive patentability criteria (for example, novelty, inventive step [non-obviousness] and industrial applicability [usefulness]).

It is therefore recommended that you consult a practicing lawyer specializing in intellectual property or the intellectual property offices of those countries in which you are interested in obtaining protection. Consult our directory of national and regional intellectual property offices to get in contact with a local IP professional, or browse the WIPO Lex database of intellectual property legislation from around the world.

Find out more about using patents to protect software and business methods.

Should a patent turn out not to be a viable option for your software-related invention, then using copyright as a means of protection may be an alternative. In general, computer programs are protected under copyright as literary works. The protection starts with the creation or fixation of the work, such as software or a webpage. Moreover, in general, you are not required to register or deposit copies of a work in order to obtain copyright protection.

However, according to a well-established principle, copyright protection extends only to expressions, not to ideas, procedures, methods of operation, or mathematical concepts as such. Thus many companies protect the object code of computer programs by copyright, while the source code is kept as a trade secret. Find out more about copyright.

Can I patent my app? ↓

How can I search for inventions that have already been patented? ↓

How can I find the patent laws of various countries? ↓

WIPO Lex provides easy access to intellectual property legislation from a wide range of countries and regions as well as to treaties on intellectual property.

Many national or regional patent offices also provide information concerning national or regional legislation on their websites. Consult our list of national and regional intellectual property offices.

Confidentiality

Can I obtain a patent and keep my invention secret? ↓

Can I discuss details of my invention with a potential investor before filing a patent application? ↓

Patents and business

How are patents relevant to my business? ↓

Why should I consider patenting my inventions? ↓

What happens if I don’t patent my inventions? ↓

How do I go about licensing my patent to a 3rd party? ↓

Are utility models and trade secrets alternatives to patent protection? ↓

My employee has invented a new product or process: Who will own the rights to the patent? ↓

Patent information

What is patent information? ↓

Why should I care about patent information? ↓

Where can I find patent information? 

Patent documents are published by national and regional patent offices, usually 18 months after the date on which a patent application was first filed or once a patent has been granted for the invention claimed by the patent applicant. Some patent offices publish patent documents through free-of-charge online databases, making it easier than ever to access patent information.

WIPO’s PATENTSCOPE database provides free-of-charge online access to millions of international patent applications filed under the Patent Cooperation Treaty (PCT) System as well as patent documents filed at national and regional patent offices such as the European Patent Office and the United States Patent and Trademark Office.

Though accessibility of patent information has grown as more and more patent offices make their patent documents available through online databases, certain skills are still required in order to make effective use of this information, including carrying out targeted patent searches and providing meaningful analysis of patent search results. As a result, it may be advisable to contact a patent information professional for assistance where business-critical decisions are at stake.

WIPO Patent Information Services (WPIS) provide free-of-charge patent search services for individuals and institutions in developing countries.

WIPO also supports the establishment and development of Technology and Innovation Support Centers (TISCs), which provide patent information and related services in many countries around the world.

Where can I find out more about patent information? WIPO has issued a series of free-of-charge publications related to the subject, including Finding Technology Using Patents  and the WIPO Guide to Using Patent Information .

WIPO and patents

What role does WIPO play with regards to patents? WIPO works to develop a balanced and effective international intellectual property (IP) system, a key part of which is dedicated to patents. WIPO’s member states collaborate in various areas, including on agreeing the treaties and conventions that underpin the international IP system and that make the global exchange of creativity and innovation possible. The IP services that WIPO offers, such as the facilitation of international patent protection under the PCT System, complement services available at the national and/or regional level. It’s important to remember that WIPO does not actually grant patents per se; the grant or refusal of a patent still rests with the relevant national or regional patent office.