48 Patents

Gabriel Lopez

The realities of modern international corporations
and the international marketplace for pharmaceu-
ticals demand a global view of patents and other
forms of intellectual property. Because patents are
territorial, that is, they only protect an invention
within the borders of the issuing country, the inven-
tor must think of protecting an invention in coun-
triesotherthaninthehomecountry.Nationalpatent
applications are very frequently extended to other
countries,aswewillseebelow.Therefore,although
the discussion to follow concentrates on the United
States, which is the largest and most profitable
market for pharmaceutical products, this chapter
will also reference international patent concepts.
Even if it was limited to US law, this chapter
would not be intended to be a learned treatise on
patent law, given the enormity of the subject.
Rather, it is designed to expose those in the phar-
maceutical industry only to some general princi-
ples. It is biased toward pharmaceutical patent
practice; meaning that issues totally different
from those discussed herein might arise if the
invention was a computer program, an electric
switch, or a device for milking yaks. Also to be
remembered is that, as in most fields of law, both
the substantive and procedural aspects of the sub-
ject are always changing, either by legislative act,
judicial ruling or international treaty. This constant

change will make today’s statements on substance

and procedure, not necessarily obsolete, but cer-

tainly dated in the not too distant future.

As a simple example, the life span of a US patent

used to be easy to calculate: US patents used to last

17 years, calculated from the date of issue. But US

patents filed after 7 June 1995 now last 20 years,

calculatedfrom the date of filing(which has been

typical outside the United States for many years).

Also, a form of tax, known as a maintenance fee, is

now imposed on US patents. If the patentee does

not pay each fee as it becomes due, the patent

lapses. Lastly, patents can be extendedviatwo

different mechanisms. Under the rules of Patent

Term Restoration, certain patents, mostly pharma-

ceutical patents, can be extended for up to five

years. The theory is that the patentee has suffered

an injustice because he or she was essentially

denied a portion of the patent’s life and not allowed

to earn potential profit from the patented invention

because of the need to first obtain regulatory (e.g.

FDA) approval before bringing the product to mar-

ket. Under the rules of Patent Term Adjustment,

extensions can also be obtained for certain proce-

dural delays during the prosecution of a patent

application. The actual term extension for each

patent is determined by its specific facts. These

two calculations are independent of one another.

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9