Patents and Licensing

Intellectual Property Protection

Intellectual property (IP) is legal property rights over creations of the mind—both artistic and commercial. Under intellectual property law, owners are granted exclusive rights to a variety of intangible assets, such as ideas, discoveries and inventions. Common types of IP include copyrights, trademarks, patents, and trade secrets.

IP protection provides the owners the right to prevent competitors from profiting from their invention as defined by the patent claims, for the duration of the term.

Owners of IP have the right to license the use of their property to other parties. IP protection is often necessary to bring Boston Children's Hospital inventions and discoveries to the public. Venture capitalists, investors and medical device, pharmaceutical and biotechnology companies' desire protection before investing significant resources into the Research and Developing (R &D) required to translate discoveries into products and to keep competitors from creating the same products.

TIDO primarily protects Boston Children's inventions and technologies through patent filings.

Below are some frequently asked questions regarding patents and the process of patenting a technology or innovation.

1. What is a patent?

A patent grants the inventor a right to prohibit another from making, using, selling, or offering for sale the subject matter claimed in the patent in the country where the patent was issued.

2. Are there different kinds of patents?

Yes. In the US patent system, there are (i) utility patents (ii) design patents and (iii) plant patents.

Typically, the inventions created here at Boston Children's Hospital fall under the utility patent category. For utility patent protection, an invention must be (i) a method or process, (ii) a machine, (iii) an article of manufacture (e.g. hammer or saw) or (iv) a composition of matter (e.g. a drug for treating cancer) or an improvement of (i)-(iv) thereof.

3. How long does a patent last?

A utility patent typically lasts 20 years from the first filed application. A design patent lasts 14 years from the date it was issued. A plant patent lasts 20 years from the filing date of the application.

4. What are the criteria for a patent?

There are many criteria a patent examiner uses and which the invention needs to fulfill, before a patent may be granted. An invention is required to be new, useful and non-obvious. To fulfill the "new" requirement, the invention must be novel, i.e. never been described before. To be "useful", the invention must work and serve some useful function. To be "non-obvious," the invention cannot be an obvious extension of what has come before. Obviousness is a subjective criteria that a patent examiner may use to reject an invention. Also, an invention has to be "enabled" in the patent application. To be "enabled", the patent application must instruct a person of ordinary skill in the art to practice the invention, so he or she can build the invention easily.

5. I was a co-author on a manuscript, why am I not included as an inventor on the patent filing from that work?

These are two distinct issues. Although authors or co-authors may be inventors, authorship is determined by contribution according to academic customs whereas inventorship is a legal determination based on patent law. There are many factors for determining inventorship. Contribution to the conception of at least one claim is a factor for determining inventorship. The test combines the principles of the existence of and completion of conception. Conception exists if the inventor(s) had a specific settled idea, a particular solution to the problem at hand and not a general goal or research plan, which was definite and permanent enough that one skilled in the art could understand the invention.

6. What is the difference between being an owner of a patent and an inventor on a patent?

An inventor is considered the owner of the patent unless the inventor has assigned his or her rights to another party. As part of the employment terms at Boston Children's Hospital and pursuant to Boston Children's Hospital policies, inventors are required to assign all of their rights of the invention to Boston Children's Hospital. The Bayh-Dole Act allows universities, research hospitals and academic institutions to retain title to and ownership of inventions made as a result of federally funded research. To encourage economic development and facilitate the development of these inventions, these institutions may license inventions and receive royalties, provided that a portion of the royalties is paid directly to the inventors. The policy governing the inventor's share of the royalties is found in the Boston Children's Hospital Intellectual Property Policy (.pdf).

7. Can my own publicly disclosed abstract or manuscript prohibit me from a patent?

Yes. Since the patent rules and laws are very specific, particularly around the novelty of your invention, a public disclosure of your work prior to a patent filing could prohibit you from obtaining a patent. Always contact TIDO if you believe you have a patentable invention before publicly disclosing your data or the invention.

8. How do you define public disclosure?

A public disclosure can be (i) a published draft of an abstract prior to a conference, (ii) an abstract or a presentation shown at a meeting, (iii) a published manuscript (including a pre-published electronic draft on the internet), (iv) a seminar presentation that is open to individuals outside the hospital, (v) a presentation given at a company, (vi) an NIH grant application upon award (abstracts are published on NIH website).

9. How long does it take to file a patent application? How long does it take to have a patent granted?

A patent application is similar to a grant application in some ways. TIDO and patent attorneys recommend at least four weeks to draft, review, finalize and file a patent application. During the process, attorneys apply legal standards to identify the actual inventors. Once filed, it takes three to five years for the U.S. Patent & Trademark Office (USPTO) to evaluate and examine the patent application in light of the scientific literature, other patents and any other related materials. If patent rights are sought worldwide, the process could take 10 years before a patent may issue.

10. How does TIDO decide on which invention disclosures to file patents?

The patenting process is a long, difficult and expensive undertaking. A patent application will not be filed on every technology that is disclosed to the TIDO. However, TIDO does an in depth and comprehensive assessment of inventions disclosed, and many factors are analyzed in arriving at a decision to file or not to file. Also, if a patent application is pursued, there is no guarantee that it will issue in any jurisdictions--or a patent may issue in some countries but not in others.

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