September 28, 2012

IP Protection Tested in International Markets

An article in the September 17, 2012 issue of Chemical & Engineering News discusses how Landmark drug patent protection cases involving Bayer, Roche, and Novartis are advancing in India this month. Together, they will help determine how friendly the country is to Western pharmaceutical makers.”
“Although each case involves its own complex scientific and legal circumstances, drug makers and patient activists are watching the disputes for the tone they collectively will set about intellectual property protection in India. Some observers see India as a model for the developing world.” (Click here to read full article).

As emerging countries seek to expand into new technologies to spur economic development, there are an increasing number of lawsuits involving patent infringement and trade secret protection. Large pharma companies not only want to protect their potential for revenue generation, they also seek to ensure a level of patent profitability to maintain eligibility for grants from health agencies to fund research for new medicines. The counter argument is that public health considerations are addressed when new medicines are allowed to either enter or be manufactured in developing countries.

What side of the argument do you favor?


September 21, 2012

Why Should You Engage the Services of a Consultant?

You may not need a consultant. Yes, indeed. That’s possible. If you are certain that you have no problems at all – in Personnel, Manufacturing, R & D, Marketing, Sales, Finance, and so on – and that you have “maximized profits” such that it is impossible to earn more profit for your company, then you don’t need a consultant. Why spend the money when you are perfect already?

If that situation exists, then you are in an elite group of executives. It is so elite that you are the first member.

However, if you have any problems, like the ten, or fifty or one hundred problems that your competitors have, then you may think about engaging the services of a consultant. I didn’t say hiring; I said engaging the services.

A long time ago a very good boss of mine, while reflecting in a leisure moment, said, “You know, if you never get sick, and you never have a legal problem, and you happen to find an oil well in your back yard, you can live an easy and comfortable life. If that situation does not exist, then you have to adapt.” That can be extended to business. Just as a person may occasionally need the services of a doctor or a lawyer, a business may need the services of a consultant.

There are many executives who have consultants on a regular basis for checkups, just as persons go to their doctors for regular checkups.

Let’s look at the advantages of hiring a consultant:

1-      The consultant provides a fresh and unbiased look at the situation. Sometimes the executive is “too close to the forest to see the trees”. The executive doesn’t have to admit that publicly. He or she simply has to be aware of it.

2-      The consultant provides a service and can be utilized as defined in the contract. Such contracts usually have a clause that states that “…either party can cease this contract before completion of the objectives with X days notice.”

3-      The executive does not withhold employment taxes as in the case of an employee.

4-      The executive usually does not pay insurance for the consultant.

5-      The executive does not contribute to the pension plan of the consultant.

6-      The consultant concentrates all of his or her time on the project assignment. There is no dilution of effort or distraction from the project as happens by design with regular employees who have various other responsibilities and priorities. A primary advantage of a consultant is concentrated effort.

7-      The consultant usually brings some specialized knowledge to a project - for example, FDA regulations as they apply to a particular drug type for a pharmaceutical firm, or some analogous knowledge in engineering, banking, etc.
When a typical ROI (Return on Investment) calculation is performed, comparing the potential profits gained from the consulting project to the cost involved, that number – expressed either as a ratio or as a percent figure – is a pleasant surprise to the executive.

When the cost figures are computed and realized to be favorable, the executive can then concentrate on the consultant bringing an unbiased look, undiluted effort, and specialized knowledge to solve a problem.

Consider the following example:

The Mayor of a city hired a consultant to determine how the life of the bridge into the city could be extended. The bridge was 50 years old and thousands of cars traveled over it every day. A new bridge would cost millions of dollars.

The consultant examined the engineering drawings and observed the traffic over the bridge for several days. At the end of that time, the consultant submitted a report that contained a picture of one of the support beams of the bridge. A bolt was drawn on the picture as was an arrow pointing to the bolt. Nothing had to be torn down and new structures built. Only one bolt was needed in an existing structure. Submitted at the same time was the consultant’s invoice for $50,000.

The mayor, although pleased with the report, exclaimed, “$50,000 for one bolt!” I need a more detailed invoice than this. Please check your figures and resubmit the invoice.

The consultant did just that and submitted the following invoice.

City Bridge Project
Bolt ……………………………………....$10.00
Knowing where to place the bolt  …… .$49,990.00

Enough said.

 The author has 35 years experience in the Pharmaceutical, Pharma Consulting, and Pharmaceutical Packaging industries with extensive experience in the areas of Laboratory Management and Food and Drug Administration Regulations.

He likes to explore and instruct "the business end of science" as detailed in his books, Effective Financial Tools for Scientific Managers and most recently The Executive MBA for Engineers and Scientists, both published by CRC press. Details on both books can be found here.


September 13, 2012

Patent Infringement and Trade Secret Violations: When Does Application of an Insider’s Industrial Knowledge Cross the Line?

In the wake of a US court injunction on Kevlar rival Hepacron (read summary of issues here), some may have questions about what activities constitute patent infringement or trade secret violation.

We interviewed Dr. Stanley Tocker, CECON Project Manager about this topic.

What is the difference between a patent and a trade secret?
A patent is a registered invention, protected by the US Patent and Trademark office for 17 years from the issue date or 20 years from the filing date, depending on the application date.  A trade secret is a company’s proprietary process or technology, which is not disclosed to others and often protected by a confidentiality agreement with employees.

What constitutes a violation of each?
A patent is considered infringed upon if technology that is detailed in the patent claims is used without the patent holder’s permission.  A trade secret violation occurs when an ex-employee of a company reveals details about a company’s systems and processes that are considered to be proprietary.

How can companies and consultants check to see if a technology is under patent protection?
By doing a patent search through the US Patent and Trademark office. This can be difficult, time consuming, and expensive, but it is vitally important that it is done before incurring major expenses.  This search should be done by someone with a technical background related to the technology in question. A new technology may be anticipated in an old existing patent and knowledge of technical terms and processes may be needed to recognize this. Intellectual property or patent analysis experts can help with this process.

What if a technology is considered “common practice” in a field and a company or consultant is unaware of a patent protection? Before proceeding with a new product or technology, one has to be completely certain that the process designs and compositions  are not patented as well as do thorough technical due diligence. Ignorance of a patent is not a defense against patent infringement.

In the Kevlar case, the scientist accused of revealing trade secrets was sentenced to prison. Does this happen often?
Rarely – often cases don’t make it to trial.

You knew the inventor of Kevlar, Stephanie Kwolek, personally when you both worked at DuPont. Can you share a little bit about her?
I remember her as a remarkable person who was always willing to help her fellow researchers. She was one of very few female researchers working at the Experimental Station in the 1950s and 1960s and was a trailblazer for other female chemists.  Think of how many lives she has saved through her invention!

Read more about the DuPont v. Kolon Industries Inc case here.

The CECON Group, Inc, specializes in placing experts with many years of industry experience in science and engineering fields in consulting and expert witness jobs. Discerning whether technical information is protected by a current patent is a frequent consulting request.

September 6, 2012

Concussions: New Research, Awareness, and State Laws

There have been several studies conducted recently on the long and short term effects of concussions (see “Why Concussions Affect People Differently”) and breakthroughs found in treatments of concussions (see “Progesterone Seems to Protect Neurons After Injury”). This week, the National Football League (NFL) announced it is partnering with the National Institutes of Health (NIH) and the US military to raise awareness of the effects of brain injuries and channel funds for further research. The NFL has pledged $30 million for medical research to the Foundation for the National Institutes of Health for research on brain injuries and their long term impact. (Read the article in the Huffington Post)

Increased public awareness about the effects of concussions may help athletes, parents, coaches, injured soldiers, and car accident victims recognize the warning signs of a concussion and seek medical attention.

Several states have passed concussion laws in the past two years. Click here for a round-up by state.

The CECON Group provides science, engineering, and technology consultants to law firms and businesses on a short and long term basis.