In the pharmaceutical industry, a lot of research, time, manpower and money goes into R&D for the development of novel drugs and bringing them into market. If the innovations are not protected with a proper fence of integrated technologies then generic companies would exploit the invention without giving much benefit to the innovator company. Hence, it is mandatory for the innovator company to apply for patent protection at least in those geographical areas where the innovator company wishes to market their product, retain monopoly and refrain their competitors entering into the market till the patent term for the innovation expires. This article discusses various strategies employed by the innovator companies in US to extend the life of the patent and gaining market exclusivity for the pharmaceutical product.

It is estimated that around 7 to 12 years of extensive research is involved to bring the innovation into a shape, which can be marketed. Apart from product development there are hassles regarding approval of the pharmaceutical product by respective drug authorities. Considering the patent term or the protection offered by the patent to be 20 years from the filing date of the patent, effectively a period of 8 to 10 years would be available with the innovator company to get benefits of their developed product. Innovator companies execute various strategies to extend the life of the patent as well as the product.

On grant of patent for the invented drug and regular payment of maintenance fees gives the patent holder monopoly over the drug and rights to exclude other from manufacturing, using and selling the patented invention for a stipulated time. On expiration of the patent, generic competitors would exploit the market, which would lead to reduction of market share and revenue loss for the innovator company. Hence, additional patents are filed in order to fence the invented drug or product. These additional patents for the extension of invention / product protection could comprise of method of preparation, new formulation, method of preparation of formulation, drug derivatives and its metabolites, polymorphs, stereo-selective enantiomers etc. Additional patents filed could also cover improvements to the invention or new uses, which are not mentioned in the initial granted patent.

We will discuss in brief various strategies employed by the innovator companies in US to extend the life of the patent and reap maximum fruits for an extended period of time.

The Hatch-Waxman Act provides a system wherein the New Drug Applicant (NDA) holder could apply to have extension of its patent. The extension was meant to compensate the applicant for a portion of any time lost after the issuance of a patent during which the testing and approval phases of the FDA's regulatory review process commenced.

Following are the paths by which patent term can be extended:

1) Patent term adjustments - delay during patent prosecution

The patent term adjustment is provided in case of United States Patent and Trademark Office (USPTO) fails to act to patent application from patent filing or fail to reply to applicant's appeal in a stipulated time.
The purpose of the patent term adjustment provision was to guarantee that patent applicants would still have a patent term of at least seventeen years from grant under the twenty-year patent term system.

2) Patent extensions - delays due to regulatory approval

USPTO can restore the term of a patent that is lost due to delays during regulatory approval by Federal Food and Drug Administration (FDA). Patents relating to drug products, medical devices, food additives, and color additives are eligible for patent extension. The maximum of patent term that may be restored is five years.

3) Interim term extensions

If the term of the patent expires before the certificate of extension is given to the application, then the Director extends the term of the patent up to one year under Interim term extension. This extension is only possible if the director feels that the patent should be considered for extension.

Apart from patent term extensions, market exclusivities can be gained separately. Exclusivity gives FDA approved drugs market exclusivity which does not allow the generic competitors to enter into the market till the exclusivity is valid.

Following are the market exclusivities offered by FDA:

1) New Chemical Entity (NCE) exclusivity

NCE exclusivity is awarded for 5 years to NDA applicant who receives the first approval for a drug product. No salt or ester of the novel chemical entity should have ever received FDA approval. During this 5-year period, the FDA is stopped from accepting an Abbreviated New Drug Application (ANDA) for review. The only exception is that if a patent is also listed on the NDA product subject to NCE exclusivity, the FDA may accept an ANDA after 4 of the 5-year period has expired, if the ANDA contains a Paragraph IV certification challenging the patent. NCE exclusivity can be considered as a total exclusivity as generic competitors cannot submit or approve their product while the exclusivity is valid.

2) New Use / New Clinical Studies exclusivity

This kind of exclusivity is granted for a period of three years to NDA holder who applies for new use of approved drug. New clinical studies are to be carried out to get approval from FDA for use of the approved drug for its use for new indication. Exclusivity can be granted for new dosage form (Sustained release dosage form, Controlled release dosage form), a new use or indication, a new salt or ester of a drug product, change in concentration, novel drug delivery etc. The 3-year exclusivity may block FDA approval of a generic version until after the exclusivity expires. It is also possible that the FDA approves generic version if approval does not infringe on the protected change.

3) Orphan Drug exclusivity

Seven-year orphan drug exclusivity is granted to promote research and marketing for the development of drugs to treat rare diseases. US FDA had defined Orphan drug / rare diseases as those diseases affecting 200,000 or fewer patients in the US. This exclusivity period can block the FDA from approving competing generics of a drug product for the orphan use. Applicant may request orphan drug designation for a previously unapproved drug or for an already marketed drug. One or more applicants may receive orphan drug status for the same drug for the same orphan disease.

4) Pediatric exclusivity

Pediatric exclusivity gives an incremental 6 months exclusivity to an existing marketing exclusivity that has been earlier granted or to a patent protection. This type of exclusivity is granted to clinical studies of drugs for pediatric population. This type of exclusivity ensures an incentive for an NDA applicant for the clinical studies carried out specifically for pediatric patients. Products with no patent life or exclusivity remaining cannot qualify for pediatric exclusivity.

Hence, it is seen that various methods are adopted by the innovator companies to extend the term of their patent to extend their monopoly in the filed of pharmaceuticals.

Reference:
•    Patent term adjustment under 35 U.S.C. s. 154 - Simplification of Patent Term Adjustment
•    Reference: http://www.uspto.gov/web/offices/com/strat21/action/lr1ap11_12.htm
•    Interim Extension of Patent Term During the Processing of the Application [R-2] - 2700 Patent Terms and Extensions
•    Reference: http://www.uspto.gov/web/offices/pac/mpep/documents/2700_2755_01.htm

By Kuldeep D Karnik

After working with web design companies, agencies and firms, I have found the following 7 steps will lead you to a much happier and fruitful relationship with your next web designer:

Never shop on price.
You almost never get what you expect if you aren't willing to pay properly for it. Pay careful attention to the portfolio of the website designer. Avoid web design companies that still use flash introductions on their own website.

Give a small project first. If you plan to spend a lot of money with the company, try giving them a small project first. If their service and quality of product is what you expect, they will deliver on their promises and you can move onto bigger things with that company. If they don't deliver, then you haven't wasted huge sums of money.

ALWAYS define exactly what you need before the project begins. Like it or not, a project plan with specifications is going to save a lot of trouble later on, both for you and the design company. A good project manager should be able to convey your requirements to the team properly, but good project managers are uncommon.

Due diligence. If you are getting them to do a $250 online greeting card, getting 10 references, having 4 prior meetings and asking for a 100 page specification is likely going to cause you to be tossed aside in favour of a client that is worth the trouble. On the other hand, if you are having them build the next major shopping portal for you group of 185 country-wide chain of stores and plan to have it intergrate with the services of several large companies, be absolutely sure the web design company knows what they are doing and has experience doing it. You don't want a company that is learning the ropes by using you as a guinea pig.

I hope that armed with this information you will be able to make an informed choice on which web design company, agency or firm you will use on your next project.

A. Web Design that is Screen Resolution Friendly
Surfing the web always brings up a swath of different problems all based on the different settings implemented by the web designers in their signature web designs. Among these problems is a major one that has to do with the screen resolution settings of all the different visitors who may visit any given web design. When it comes to screen resolution, it doesn’t matter how perfect and beautiful the web design may be, it is very frustrating when a viewer either cannot see the images or text properly, or the viewers have to scroll to the side to see the rest of what the site has to offer. It is truly annoying when the width of the site doesn’t fit within the width of a visitor’s monitor’s screen size.

The reason for this is that many older monitors – frequently VGA monitors – have a maximum of 640x480 pixels that they will support. There area also many visitors to your website who have older video cards. This means that no matter how good their monitor and your website, they simply will not be able to handle higher resolutions. You will need to keep this in mind when you are creating a web design for a large target audience. Actually, there are quite a few reasons to explain this web design pattern. For one, there are likely quite a number of web designers who don’t even realize the issue that they are creating. Similarly, there are those web designers who don’t care that some people will not be able to enjoy their websites. Also, we must consider that some web masters have recognized that their target audience are typically equipped with high screen resolution capabilities, and therefore are simply catering to their desired market.

It is indeed hard to believe that there are some web designers out there who can call themselves professionals and not understand the way that the different technologies used by their viewers will be impacted by the web designs that they create. Of course, web designers can’t always be blamed, since they often have the latest technologies to make their work more pleasant and professional. When it comes to those web designers who know that not everyone will be able to see their website properly, but they just don’t care are the most likely to lose the highest number of visitors. Any graphic larger than 600 by 620 pixels will definitely create a horizontal scroll bar for several website visitors. This is frustrating to visitors who have to scroll in order to read each line of text. If the webmaster simply doesn’t care, they’re turning away an awfully large number of people who could be potential clients, part of a potential network, or even contributors.

When the webmaster has recognized that the primary audience of the site has higher screen resolutions, it is quite natural to create a website design that caters to that resolution.

B. A Beginners Guide to Web Design Courses
Fancy training courses may sound interesting and attention grabbing but could be a waste of time and money. If you are considering web designing as a serious career option, a comprehensive course is what you need. The course should enhance your chances of job opportunities. Typically, a good course should include essential programming languages like HTML, XHTML, PHP, SQL, CSS coding, Flash, Java, ASP, C, and C++ and so on. Apart from that a thorough training in Adobe Dream weaver is also required if you intend to take up this career professionally.

Recognized certification courses are another important aspect of choosing a web design course. There are training companies that offer an attractive program with their internal certificates. Employers prefer hiring candidates with certification from reputed companies like Cisco, Adobe, Microsoft and the likes. Moreover, these certifications are recognized globally, so you stand to gain better employment opportunities.

Technical courses such as web design courses can be complex at times. Some training courses offer online support, which means you can get help from any part of the world.
Before taking up web design course, research well about the training material. The study material should be interesting, complete and comprehensive. Some of the latest techniques of teaching include interactive tutorials. There are online courses that offer study from home option; they appoint personal tutors for each student. It is advisable to attend classes, since programming languages are best learned in a classroom. Once you complete a beginner's course in web designing, you can think of upgrading your knowledge through online training courses. However, initially it is good to invest some time and efforts in learning web designing through classroom training.

Proficiency of the faculty also plays an important role. Incompetent trainers will only lead to dissatisfaction. Though you cannot test the teaching skills of a faculty, you can certainly ask for an introduction session or a free classroom session before joining. As a beginner, you should consider the above-mentioned factors before you join any web design courses.

Two of your major art design course objectives should first be an emphasis on your professional skills development and to gain the techniques, skills, methodology, and vocabulary that will be required for your success as a productive artist, designer, or scholar.

With art and design history mixed in with studies in the liberal arts and sciences, gives you the context for stimulating intellectual and creative thinking.

Find courses that start with the exploration of art design fundamentals, ones that provide the experience suitable for beginning as well as advanced artists. Once you gain a basic understanding of how to see and describe something in visual terms, you can investigate expressive and experimental directions in your art designs.

Working with the dynamics of color has significant implications in the work of artists, illustrators, craftspeople and designers. The course you choose should explore the issue of color by developing creative exercises, look at studies from nature, the human environment using collage, paint and other art media. Look for or request projects that will facilitate in-depth exploration of the role of light, the psychological impact of color on the brain, and how such factors as hue, value and intensity affect artistic design. Historical background should be provided via lectures and power point presentations. The artist's visual language is how the sculptor conceives of the figure and interprets anatomy. You must learn to think of the human body as an interconnected system full of layered forms. You really should include in your art design course studies critical thinking about what it means to represent the human body in your art.

A. Summer Art, Fashion and Design Courses in Milan
Are you a fashion or design lover? Art Courses in Italy in fact presents Summer Courses 2009, on its 6th edition, which in the last years made great success among students from every corner of the world.

Naba (Nuova Accademia di Belle Arti) organizes Introduction, Intermediate (Studio Level) and Advanced Level courses, according to your skills in design and also Italian language; the courses are open to all students with a high school diploma and from first and second year of university.

You will have at your disposal a wide choice of art courses you can choose among, of a duration of 2 weeks: Fashion Design, Styling and Accessories, Fashion Marketing and Merchandising, Fashion Photography and Journalism, Fashion Textiles and Fibres, Interior and Product Design, Landscape Architecture, Lighting Design Studio, Graphic Design, Graphic Art Design for Fashion, Photography and the Moving Image, Theatre Design.

During Interior and Product Design Course for example, students will analyze contemporary interior spaces and will design an interior layout for a special location in the city, whereas in Theatre Design Course students will become aware of costume designers’ tools and methodologies, and afterward, through an intensive workshop experience, they will produce handicrafts using artistic techniques and materials.

Moreover, Fashion Merchandising Studio will provide international students the necessary tools to understand the dynamic context of the fashion business in Italy and internationally, and the key activities in fashion buying, retailing and merchandising.

If you want to learn Italian language, the School Leonardo da Vinci for foreigners in cooperation with NABA, organizes many useful and qualified Italian language courses for complete beginners and intermediate level students.

B. Interior Design Course
Interior Designers use intrinsic artistic flair and specialized skills to improve the physical appearance as well as the practicality of any given space. Interior design courses are perfect for anyone who wishes to gain the knowledge and skills necessary to become an interior designer.

Online Degrees
Online Degrees are rapidly gaining popularity in this highly competitive age. The biggest advantage of enrolling in online courses is that students do not have to attend any predetermined number of classes unlike conventional degree courses. Students looking to gain additional qualifications are thus increasingly turning towards online degrees where enrolment can be done anytime and the courses are mainly self-paced.

Interior design courses give individuals the opportunity to enroll in a course and further their careers while they are already working and allow students to enroll in more than one course at a time, which increases their employability.

Interior Design Course Content
Interior design courses encompass many different areas. Many interior designers use specialized Interior design courses to branch out from general interior designing to work in a particular area of their choice.

Most online interior design degrees cover these important areas:

Definition as well as responsibilities of Interior Designing
Principles of Interior Designing
Elements of Interior Designing
Goals of Interior Designing
Process of Interior Designing
Scope of Interior Designing
Basics of all other creative designing fields
Relation between Interior Designing and other Designing

Professionals

Online Interior Design Degrees
Earning a degree in Interior Designing has never been easier. Online Interior design courses can be done by anybody who has the flair and aptitude for it. Online Interior Design courses can be done from the convenience and comfort of your home. Online Interior design courses are excellent for experienced interior designers as well as newcomers to this career.