Monthly Archives: June 2012

Top 10 Reasons For Filing A Biotech Patent Application

This list is based on my experience of working with biotech clients who were either research companies or in tech transfer. It includes incidental advantages (such as showcasing the invention) which can’t really be thought of as ‘objectives’ when filing, but which are important to bear in mind.

1. Providing A Monopoly That Can Be Commercially Exploited

A patent provides a space in the market which can be exploited now or in the future.

2. Attracting Investors

Patent applications are very important in attracting money for commercialising academic research.

3. For Defensive Purposes

Patents and application are bargaining chips in negotiations, can be used in cross-licensing and by the threat of countersuing they can deter infringement actions.

4. For Providing Additional Layers Of Protection

It is advantageous to have several patent cases covering your products, deterring competitors from challenging them or infringing.

5. To Increase The Value Of The Portfolio/Company

Each patent case will increase the overall value of the portfolio and in certain situations that can mean a substantial increase in the value of the company.

6. For External Image

Biotech companies are expected to have patents and applications.  These can be seen as evidence of a successful research program.

7. For Internal Motivation

The filing of patent applications represents a tangible goal that can act as encouragement for departments and individual scientists.

8. To Showcase The Invention

In a tech transfer situation the patent application itself can act as a document that showcases the invention to interested collaborators or commercial parties.

9. To Fill A Gap In A Previous Case

Sometimes patent applications need to be filed to fill gaps in areas not covered by previous cases.  That can happen as the technology develops or if it realised that broad claims are unlikely to be granted on previous cases.

10. To Open Up New Revenue Streams

Patent applications can be filed by a company on technology which it cannot exploit itself, but which can be licensed out to others.

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Top 10 Debateable Biotech and Patent Topics In The UK

1. How Do We Better Commercialise UK University Research?

UK universities produce high quality biotech research.  However so little of it seems to get successfully commercialised.  One reason for this might be that nature of the research cannot form the basis of high quality broad patents.  How do we make UK research more ground-breaking so that it results in more patenting opportunities?

2. What Is Wrong With The Structure Of UK Biotech?

Perhaps lots of small one product biotechs with the founder scientist as CEO need to be replaced with much larger companies having 10-plus projects that are reviewed, developed and axed (where necessary) by teams which are dispassionate and which include business expertise.

3. Why Can’t Big Pharma Do Innovative Research?

Small biotechs seem capable of innovation which big pharma cannot do. Being risk-averse and having committees rather than individuals make decisions could be part of the answer. There is clearly no easy solution.

4. Can IP Exchanges Work For Biotech?

A lot of revenue is being lost due to failure to sell or licence patented technology.  There does not seem to be an easy way for buyers and sellers to find each other in biotech. Perhaps IP exchanges will evolve to fill this gap.

5. Is The Patenting Process Too Uncertain?

Whilst biotech financing and research seem perilously risky, does the patenting process also have to be so uncertain?  ‘What claim scope will be granted?’ seems to be a difficult question to answer most of the time.  Are applicants or patent offices to blame?

6. How Does One Make It Easier For Investors To Do Due Diligence In The Biotech Sector?

Even big pharma finds it difficult to know which biotech companies to buy, and so there seems little hope for others to know where to invest in biotech.  Unfortunately that probably means biotech is losing out on a lot of potential sources of funding, such as the Middle East.

7. Should One Be Able To Negotiate Patent Term With Examiners?

Should patent term be negotiable depending on the value of the contribution made? This would make the patent system more flexible and perhaps fairer.  However given the increase in complexity and uncertainty for third parties it will probably never happen.

8. Does Academic Research Suffer When It Is Forced To Commercialise?

As the pressure on scientists to think more commercially intensifies, is academic research being harmed?  Will a culture of secrecy and competitiveness develop?  Will certain areas of research be neglected?

9. Do We Need A System To Protect Research Which Is Not Patentable?

A lot of biotech research is not novel and inventive, for example confirming in vitro predictions in clinical settings. Is there a way of protecting all research which results in something useful, irrespective of whether the outcomes are patentable?

10. Is Patent Quality In Decline? Does It Matter?

There is a feeling that patent quality is in decline.  Too many applications are being filed based on poor quality research where the contribution over the prior art is not clear.  For the many years these remain unexamined they cause third parties uncertainty.  However perhaps this is a valid strategy for small biotechs which are short of resources.

Top 10 Tips For Evaluating Biotech Inventions

These tips are probably more applicable to a university tech transfer situation rather than a research company.

  1. Internet searches using search engines (e.g. Google) and PubMed and can be effective for identifying relevant prior art for many areas of biotech. Such searches will cost little and can quickly give a good picture of the prior art.
  2. As a preliminary point it may be worth assessing whether the invention is ground-breaking or whether it a development of earlier work.  Inventions which represent ‘follow-on’ work can of course be valuable, but may be more likely to be objected to as being obvious.  Patent application based on follow-on work might have narrow claims.
  3. Some analysis of commercial worth is usually essential.  This will be an important factor in choosing whether or not to file.  Commercial worth can of course be complex to assess.  It can be based on the value of sales of the product or factors such as whether the patent application will be an important part of a collaboration agreement.
  4. Make sure you are aware of all possible inventors and all parties that may have rights in the application.  All contributions from external people should be looked at carefully as well as confidential information and materials they might have provided.
  5. Inventive step (obviousness) is often the most important issue for patentability.  All surprising advantages and unexpected effects should be identified and assessed.
  6. At many patent offices biotech Examiners are very good at spotting what is obvious.  Inventions that arise from routine experimentation will be challenged.  Thus one must take into account variations of the invention that would be obvious in the relevant field, such as combining the drug with other agents for the same conditions or delivering in the same way.
  7. The initial view of what the invention is may change once a patent attorney provides comments on patentability.  This can help focus the scientists’ minds on what the actual contribution is.  Scientists can be too optimistic or too negative about their own work, and will often find it difficult to assess patentability.
  8. It can be useful to probe the scientists for their reasons for doing the work that they did.  This can provide insights which might not be easy to see when simply comparing the invention to the prior art, and might help in the way the invention is presented in the patent application.
  9. Ascertain the relationship between the invention and all relevant work being done by the group.  That will assist the understanding of how the invention fits into the research as a whole, as well as providing information about work to be done in the priority year and work which may lead to future filings.
  10. Bear in mind that obscure publications or publications with unsubstantiated disclosure can still be problematic prior art, though such papers might be dismissed by the scientists.

Top 10 Controversial Issues In Biotech Patenting

1. Patents Inhibit Innovation

Do the monopolies provided by patents hinder research? The answer may vary in different technology areas, but in biotech they seem to be important to attract investment money. Whilst patents may deter research in particular areas, they are clearly an important part of the capitalist economic system without any real alternative.

2. Patenting Life, Nature And Parts Of Human Beings

Should nature or human genes be patentable?  Don’t these belong to everyone? Why should someone else have a monopoly that covers my DNA, just because it is converted to an ‘isolated’ form?

3. Broad Claims On Biotech Cases

Having worked on many biotech cases I would agree with the fact that broad claims are often pursued and granted.  However that is simply due to the nature of the subject matter and difficult to avoid.

4. Health Care Costs

Patents on medicines increases healthcare costs which are presently increasing to unsustainable levels.  Whilst government authorities are probably becoming wiser in decision on what drugs to purchase, compulsory licensing is never mentioned in the developed world.

5. Research Stifled In The Developing World

Foreign investment and technology needs to be protected in the developing world, but not at the expense of growing their own research capability.

6. Biopiracy

The natural resources of the developing world belong to the relevant country.

7. Patent Office Backlogs

Performing a freedom to operate search for a biotech invention often makes one realise how many unexamined patent applications there are out there.  How given the length of time it takes to develop biotech products patent office backlogs are probably an advantage for the biotech sector.

8. Evergreening

Evergreening refers to obtaining further patent term for an invention by filing new patents which protect the original invention.  For example protection for cancer drugs can sometimes be extended by filing on the specific formulation which is used in administration.

9. Patents Are Expensive To Obtain And Enforce

This is undoubtedly true and thus the big players are at an advantage.

10. Patents Are Anticompetitive

Companies have portfolios providing multiple layers of patent protection for key products (patent thickets).  This is a commercial strategy which contributes little to innovation.  Also weak patent applications are filed for commercial reasons, and again these contribute little to innovation.