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Posted: Sep 15th, 2008
Key patent strategies for nanotechnology inventors
(Nanowerk Spotlight) At its simplest, a country's patent system provides for the disclosure of information about inventions. To obtain a patent, an inventor must 'teach' the public how to make and use the invention in the best way the inventor knows. Thus, the patent system rewards only those inventors who are willing to share with the whole world by granting them exclusive ownership of their innovation.
But complex technical and scientific issues means complex intellectual property (IP) issues. This especially is the case with nanotechnologies, which are not easy to classify (see: Nanotechnology and intellectual property issues). Taking the example of bionanotechnology and nanomedicine, the chapter "Patenting Inventions in Bionanotechnology: A Guide for Scientists and Lawyers" in the recent book Bionanotechnology: Global Prospects discusses the importance of securing valid and defensible patent protection for any player interested in bionanotechnology commercialization.
In the various fields of nanotechnology, early efforts to secure patents on key discoveries has led to a nanotechnology patent land rush which, instead of clarifying the legal issues, has contributed to a considerable confusion about legal rights. This has been further complicated by the issuance of overlapping and overly broad patents, especially by the U.S. Patent and Trademark Office (USPTO).
"Emerging thickets of patent claims – an overlapping set of patent rights requiring those seeking to commercialize new technology obtain licensees from multiple patentees – and an inadequate patent classification scheme are creating a chaotic, tangled patent landscape in various sectors of bionanotechnology where the competing players are unsure as to the validity and enforceability of numerous issued patents" Dr. Raj Bawa tells Nanowerk. "If this trend continues, it could stifle competition, limit access to some inventions, or simply cause commercialization efforts in certain sectors of bionanotechnology to grind to a halt."
Bawa argues that patents are critical to the bio-nanotechnology 'revolution'. When investors in nanomedicine or drug companies consider the merits of their investment, patent issues are one of the most important items they review. There is also ample evidence that companies, start-ups, and universities are ascribing ever-greater value and importance to patents. Increasingly, they are willing to risk a larger part of their budgets to acquire and defend patents.
Patents are especially important for start-ups and smaller companies because they may help in negotiations over infringement of their patents during competitive posturing with larger corporations. Bawa makes an interesting observation: Often, larger competitors employ frivolous lawsuits to pressure smaller companies or start-ups whose patents stand in their way, or which they wish to acquire. Frequently, the cost in executive time and corporate money for the smaller company or start-up becomes so onerous that it caves in to a licensing agreement. One viable strategy to avoid being taken over is to license the patent to the large competitor, in whose interest it then becomes to protect its position by protecting and defending the patent.
The article lists nine key considerations and strategies that bionanotechnology inventors must follow in order to adequately protect an invention even before a patent application is drafted or filed.
1) Avoid an early publication or any public disclosure
The inventor should refrain from publishing a description of, publicly presenting, submitting grant proposals for, or offering the invention for sale prior to filing a patent application. Often a company releases information on a new product, or discusses details during negotiations prior to filing a patent application. All of these activities create prior art against the inventor.
2) Consider obtaining a foreign patent
Filing a bionanotechnology patent in a foreign country should be carefully considered and should largely depend upon commercial considerations. If there is an interest in expanding into foreign markets, then obtaining patents abroad should be seriously considered. Furthermore, even if the inventor does not plan to establish a market for the particular bionanotechnology invention in a foreign country, obtaining a patent there could be critical in securing licensing deals (and discouraging unlicensed copying or use by foreign competitors).
3) Beware of pre-grant publication of U.S. patent applications
Today, as part of the application process, all U.S. patent applications are published 18 months from the earliest filing date. In effect, this implies that almost always a patent application, as filed, will eventually appear in the public domain (whether or not it is patented) and will be available to competitors.
4) Maintain proper laboratory notebooks
Laboratory notebooks often contain valuable and critical information that may not be readily apparent to a company or its R&D facility. Laboratory notebooks are also useful to patent practitioners to establish the date of an invention, especially in light of a competitor’s challenge in court as to who invented first in what is known as 'interference proceeding'.
5) Conduct a 'prior art' search and a 'freedom-to-operate' search
It is highly recommended that a proper prior art search be conducted prior to filing a patent application. The purpose of this is to gauge the competition. This may also assist the inventor to design around potential prior art. Moreover, because the patent owner does not automatically have the right to practice his/her invention, it may be wise to conduct a 'freedom-to-operate search' of the issued bionanotechnology patent prior to investing in and commercializing it.
6) Educate employees and researchers
It is important that business and IP professionals within a company educate scientists to spot potential inventions during the R&D phase, as this may not always be apparent to them. In fact, a company should implement policies involving incentives where scientists are rewarded for reporting or submitting invention disclosures. This may be especially critical in a university setting where generating invention disclosures may be less of an incentive to researchers who are promoted or tenured based on their research grants. Scientists often overlook the fact that their inventions can be patented. Further, “patent awareness” may enable a researcher to pursue a particular research path that has a greater likelihood of leading to a patentable invention.
7) Require strong employment agreements and safeguard IP
Companies must require all employees to sign agreements that clearly specify that all company inventions, intellectual property, and proprietary information is company property and cannot be disclosed or exploited by any employee at any time. This could become critical if a former employee joins a competitor company or research laboratory.
8) Employ standard terminology while drafting patent applications
The fact remains that bionanotechnology is an inherently difficult topic for discussion, in part due to the confusion surrounding its definition. Although it is well recognized in patent law that a patent applicant can be his or her own lexicographer, it is recommended that an applicant should employ standard language in bionanotechnology patent applications whose meaning is well recognized in the pharmaceutical, medical, or biotechnology fields. Furthermore, the language should be precise and the use of terms consistent throughout the claims and specification (avoid synonyms and be repetitive in the use of phrases when appropriate). This will prevent confusion at the patent office as well as prevent possible prosecution delay.
9) Relative ease of obtaining 'broad' patents in bio-nanotechnology
Broad patents continue to be issued by the PTO in bionanotechnology. The overburdened PTO faces new challenges and problems as it attempts to handle the enormous backlog in bio-nanotechnology applications filed and the torrent of improperly reviewed patents granted. At present, all these factors favor obtaining broad patents in bio-nanotechnology.
Especially with regard to the last point, Bawa cautions that It is almost certain that the enforceability of numerous – broad – U.S. bionanotechnology patents (like e-commerce patents previously) will be a major problem in the future. He also points out that obtaining undeserving patents and profiting from the threat of litigation rather than providing beneficial bionanotechnology products runs counter to the foundations of our patent system.
"Ownership of technology in the form of patents is one thing, deriving sufficient economic value therefrom is a different issue" says Bawa. "If the current dense patent landscape becomes more entangled and the patent thicket problem worsens, it may prove to be the major bottleneck to viable commercialization, negatively impacting the entire bionanotechnology revolution. For investors, competing in this high stakes patent game may prove too costly."