In addition, patents have a limited lifespan.
In most countries, the statutory term of a patent is 20 years from the earliest domestic priority date claimed. In the United States,
for applications filed after June 7, 1995, the statutory term of a patent is 20 years from earliest non-provisional priority date
claimed. Various extensions of patent protection may be available in particular countries; however, in all circumstances, the life
of a patent, and the protection it affords, has a limited term. If we encounter delays in obtaining regulatory approvals, the period
of time during which we could market a product under patent protection could be reduced. We expect to seek extensions of patent
protection where these are available in any countries where we are prosecuting patents. Such possible extensions include those
permitted under the Drug Price Competition and Patent Term Restoration Act of 1984 in the United States, which permits up to five
years’ extension of patent protection and no more than fourteen years following product approval for a single patent that
covers an FDA-approved drug or biologic that contains an active ingredient or salt or ester of the active ingredient that has not
previously been marketed. The scope of protection available during an extension of a patent claiming a product is limited to the
approved product itself for approved uses, and the scope of protection available during an extension of a patent claiming a method
of using a product is limited to the uses claimed in the patent and approved for the product. The actual length of the extension
is calculated by adding one half of the time between the IND effective date and a company's initial submission of a marketing application,
plus the entire time between the submission of the marketing application and the FDA's approval of the application. However, the
applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority 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 then may be able to launch
their product earlier than might otherwise be the case.
Any loss of, or failure to obtain, patent protection
could have a material adverse impact on our business. We may be unable to prevent competitors from entering the market with a product
that is similar to or the same as our products.
Confidentiality agreements with employees and third parties
may not prevent unauthorized disclosure of proprietary information.
We seek to protect our proprietary technology
and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors.
We also seek to preserve the integrity and confidentiality of our data and know-how by maintaining physical security of our premises
and physical and electronic security of our information technology systems. Nonetheless, despite these precautions, agreements
or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our know-how may otherwise
become known or be independently discovered by competitors. To the extent that our consultants, contractors or collaborators use
intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how
Enforcing a claim that a third party illegally
obtained and is using any of our know-how is expensive and time consuming, and the outcome is unpredictable. In addition, courts
outside the United States sometimes are less willing than United States courts to protect know-how. Misappropriation or unauthorized
disclosure of our know-how could impair our competitive position and may have a material adverse effect on our business.
We may become involved in lawsuits to protect or enforce our
intellectual property, which could be expensive, time consuming and unsuccessful, and which may lead to a finding that our patents
are invalid and/or unenforceable.
Competitors may infringe our patents or misappropriate
or otherwise violate our intellectual property rights. To counter infringement or unauthorized use, litigation may be necessary
to enforce or defend our intellectual property rights, to protect our know-how and/or to determine the validity and scope of our
own intellectual property rights. Intellectual property litigation can be expensive and time consuming. Many of our current and
potential competitors have the ability to dedicate substantially greater resources to litigate intellectual property rights than
we can. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing or misappropriating our intellectual
property. Litigation could result in substantial costs and diversion of management resources, which could harm our business and
financial results. In addition, in an infringement proceeding, a court may decide that our patents are invalid or unenforceable,
and may refuse to stop the other party from using the technology at issue, including on the grounds that our patents are invalid
or unenforceable or do not cover the technology in question. An adverse result in any litigation proceeding could put one or more
of our patents at risk of being invalidated, held unenforceable or interpreted narrowly. Furthermore, because of the substantial
amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential
information could be compromised by disclosure during this type of litigation.