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Patent are the most valuable form of information available for competivie analysis. Different indicator are being used to predict the value of a patent or any company's strength. Tech-Line® uses three standard patent indicators and six advanced citation indicators invented by CHI to analyze corporate technological strength.

All indicators are calculated for p

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

articular companies, in specific technologies over a time period. Because patent citation rates differ by technology, comparisons should be made only within similar technology groups.

Basic Indicators

* Number of patents

* Patent growth percent in area

* Percent of company patents in area

Patent Citation Indicators

* Cites per patent

* C

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

rrent impact index (CII)

* Technology strength (TS)

* Technology cycle time (TCT)

Science Linkage Indicators

* Science Linkage (SL)

* Science Strength (SS)

Basic Indicators

Tech-Line uses three indicators based on patent counts:

Number of Patents - A count of a company's patents issued in the U.S. patent system. Because the U.S. is

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

such a large market, even non-US companies seek the protection of a U.S. patent for their most important innovations. By tracking number of patents, growth in patenting and distribution across technology areas, you can monitor and compare the evolution of companies' R&D activity by technology area. Number of patents tracks R&D spending but can be disaggregated

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

across technologies whereas R&D spending usually cannot.

Patent Growth Percent in Area - The change in the number of patents from one time period to another, expressed as a percentage. This identifies technologies receiving increasing emphasis and those in which innovation is slackening off. It also identifies companies increasing their technological developm

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

nt, and those whose R&D is played out.

Percent of Company Patents in Area - The number of patents in a technology area divided by the total number of patents for that company, expressed as a percentage. This tells you which technologies form the core of a company's intellectual property portfolio.

Patent Citation Indicators

Four Tech-Line indicators are der

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ived by analyzing the references on the front pages of patents, or "patent citations." References are placed on patents to help establish the novelty of the invention. Inventions must be novel to be awarded a patent. To enable the patent office examiner to assess the novelty of the invention, a patent document lists "prior art" in the form of references to pre

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ious patents in the same area. Patent citations also play an important role in patent infringement litigation by delineating the domain of the patent.

In counting citations, we reverse the perspective and count how many citations a patent receives from subsequent patents. This is a way of counting how many times a patent becomes prior art in future technologi

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

cal advances. Research has established that highly cited patents represent economically and technically important inventions. Details on the history and validity of patent citation analysis are in the Tech-Line background paper.

Cites Per Patent- A count of the citations received by a company's patents from subsequent patents. This allows you to assess the te

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

hnological impact of patents. High citation counts are often associated with important inventions, ones that are fundamental to future inventions. Companies with highly cited patents may be more advanced than their competitors, and have more valuable patent portfolios.

Current Impact Index (CII) - The number of times a company's previous five years of patents

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

are cited in the current year, relative to all patents in the U.S. patent system. Indicates patent portfolio quality. A value of 1.0 represents average citation frequency; a value of 2.0 represents twice average citation frequency; and 0.25 represents 25% of average citation frequency. In a Tech-Line company report, you can identify the technologies in which c

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ompanies produce their best work. In a Tech-Line technology report you can benchmark a company's technological quality against other companies and against the average for the technology. (CII's vary by technology. For example, they are high in semiconductors, biotechnology, and pharmaceuticals, and low in glass, clay & cement, and textiles.) CII has been found

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

to be predictive of a company's stock market performance.

Technology Strength (TS) - Quality-weighted portfolio size, defined as the number of patents multiplied by current impact index. Using Technology Strength you may find that although one company has more patents, a second may be technologically more powerful because its patents are of better quality.

T

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

echnology Cycle Time (TCT) - Indicates speed of innovation or how fast the technology is turning over, defined as the median age in years of the U.S. patent references cited on the front page of the company's patents. Companies with shorter cycle times than their competitors are advancing more quickly from prior technology to current technology. In semiconduct

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

rs, cycle times are short (3-4 years); in shipbuilding they are long (more than 10 years). The average is 8 years. In fast moving technologies, TCT allows you to identify companies that may gain the advantage by innovating more quickly.

Science Linkage Indicators

Two Tech-Line indicators are derived by analyzing the front page of patents. Patent documents mu

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

t cite relevant prior art (see patent citation). Increasingly, patents are citing non-patent documents as prior art, and many of these are papers in scientific journals. Tech-Line's Science Linkage and Science Strength indicators are based on counts of patent references to scientific papers. Patents that reference many scientific journal articles are different

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

from patents that reference none. For example, a patent on a genetically engineered seed, or on a neural network based process control may reference 10 or more scientific articles. In contrast, an improved design for a part of a motor may reference none. Tech-Line's indicators build on this difference, differentiating companies and technologies that are high-

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ech from those that are not. This is particularly useful in areas like agriculture, where patents for plows are mixed in with advanced agrobiotechnology. Science Linkage can differentiate between the two.

Science Linkage (SL) - The average number of science references cited on the front page of the company's patents. High science linkage indicates that a comp

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

any is building its technology based on advances in science. High-tech companies tend to have higher science linkage than their competitors. Science Linkage enables you to pick out the high-tech players in even traditional areas such as agriculture or textiles. Science Linkage has been found to be predictive of a company's stock market performance.

Science St

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ength (SS) - The number of patents multiplied by science linkage. Indicates the total amount of a company's science linkage activity. Science strength reminds us that although a small biotech firm may use science very intensively, a big pharmaceutical firm in fact has a greater reliance on science because it makes use of research across a much larger R&D effor

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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