our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in foreign
intellectual property laws. Additionally, laws of some countries outside of the United States and Europe do not afford intellectual
property protection to the same extent as the laws of the United States and Europe. Many companies have encountered significant
problems in protecting and defending intellectual property rights in certain foreign jurisdictions. The legal systems of some
countries, including India, China and certain developing countries, do not favor the enforcement of patents and other intellectual
property rights. This could make it difficult for us to stop the infringement of our patents or the misappropriation of our other
intellectual property rights. For example, many foreign countries have compulsory licensing laws under which a patent owner must
grant licenses to third parties. Consequently, we may not be able to prevent third parties from practicing our inventions in certain
countries outside the United States and Europe. Competitors may use our technologies in jurisdictions where we have not obtained
patent protection to develop their own products and, further, may export otherwise infringing products to territories where we
have patent protection, if our ability to enforce our patents to stop infringing activities is inadequate. These products may
compete with our diagnostic test, and our patents, if issued, or other intellectual property rights may not be effective or sufficient
to prevent them from competing.
to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert
our efforts and resources from other aspects of our business. Furthermore, while we intend to protect our intellectual property
rights in major markets for our diagnostic test, we cannot ensure that we will be able to initiate or maintain similar efforts
in all jurisdictions in which we may wish to market our diagnostic test. Accordingly, our efforts to protect our intellectual
property rights in such countries may be inadequate.
we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and
could prevent or delay us from developing or commercializing our diagnostic test.
is a substantial amount of intellectual property litigation in the biotechnology and pharmaceutical industries, and we may become
party to, or threatened with, litigation or other adversarial proceedings regarding intellectual property rights with respect
to our current or future diagnostic test, including interference proceedings before the USPTO, misappropriation claims, or other
allegations. The outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified
in advance. For example, the biotechnology and pharmaceutical industries have produced a significant number of patents, and it
may not always be clear to industry participants, including us, which patents cover various types of products or methods of use.
The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform. If we were sued
for patent infringement, we would need to demonstrate that our diagnostic test or methods either do not infringe the patent claims
of the relevant patent or that the patent claims are invalid or unenforceable, and we may not be able to do this. Proving invalidity
is difficult. For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome
the presumption of validity enjoyed by issued patents.
addition, several of our employees have executed proprietary rights, non-disclosure and non-competition agreements, or similar
agreements with their previous employers, who may allege these employees have used or disclosed intellectual property, including
trade secrets or other proprietary information. Even if we are successful in these proceedings, we may incur substantial costs,
and the time and attention of our management and scientific personnel could be diverted in pursuing these proceedings, which could
significantly harm our business and operating results. We may also not have sufficient resources to bring these actions to a successful
we are found to infringe a third party’s intellectual property rights, we may have to pay monetary damages, lose valuable
intellectual property rights or personnel, or be forced to cease developing, manufacturing or commercializing the infringing diagnostic
test. Alternatively, we may be required to obtain a license from such third party in order to use the infringing technology and
continue developing, manufacturing or marketing the infringing diagnostic test. However, we may not be able to obtain any required
license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby
giving our competitors access to the same technologies licensed to us. In addition, we could be found liable for monetary damages,
including treble damages and attorneys’ fees if we are found to have willfully infringed a patent. A finding of infringement
could prevent us from commercializing our diagnostic test or force us to cease some of our business operations, which could materially
harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have
a similar negative impact on our business.
terms may be inadequate to protect our competitive position on our diagnostic test for an adequate amount of time.
the amount of time required for the development, testing and regulatory review of new diagnostic tests, patents protecting such
candidates might expire before or shortly after such candidates are commercialized. We expect to seek extensions of patent terms
in the United States and, if available, in other countries where we are prosecuting patents. In the United States, the Drug Price
Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the normal expiration
of the patent, which is limited to the approved indication or any additional indications approved during the period of extension.
However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authorities
in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions
to our patents, or may grant more limited extensions than we request. If this occurs, our competitors may be able to take advantage
of our investment in development and clinical trials by referencing our clinical and preclinical data and launch their product
earlier than might otherwise be the case.