First to file

By the turn of the century the U.S. PTO may be operating under a system that includes (/) pubHcation of patent appHcations (2) opposition of allowed appHcations for purposes of testing vaHdity (J) the dawn of first-to-file priority examination and (4) the end of the antiquated test of inventorship called "interference practice." Legislation implementing many of these changes is pending before the U.S. Congress. 

Another important item for a patent is the priority date. The priority date is established when a patent application is filed for the first time. If the invention is known before this date, then the patent is not granted. Most countries are first-to-file countries, which means that the patent is awarded to the person with the earliest filing date. In the United States, patents are awarded to the first person to invent. The inventor can attempt to show the invention was made before another person s filing date to claim priority. 

For 1 of the 29 drug products, 2 different generic applicants were the first to file for each of the 3 different strengths of this drug product. In each strength, the brand-name company did not sue the generic applicant. As noted above, this brand-name drug product is only coimted once in the total of 29. 

The USA, unlike many other world regions, also adopts the first to invent principle. Put simply (although patent disputes are rarely simple), if two inventors file similar patents, the patent will be granted to the one who proves that he/she was the first to invent the product , even if he/she was not the first to file for a patent. Proving you were the first to invent can be complex and usually hinges around the availability of full and detailed laboratory notebooks or other records as to how and when the invention was made. 

USA operate a first to invent system rather than the first to file system operated in other countries. 

In the first to file system, the first person who makes a patent application at the Patent Office wins the race for patent rights regardless of whether or not he was the first to make the invention covered by the application. 

The general adoption of a first to file system including a grace period for filing patent applications following disclosure by an inventor, with small entity fee reductions would assist smaller companies and may prevent them from losing patent rights to their irmovative products and processes. 

From time to time, different persons invent the same subject matter and intend to protect it by patent rights. In these cases, two or more patent applications are filed by the inventors claiming substantially the same invention. Most countries in the world apply the first-to-file principle to determine who is entitled to the patent. In contrast, the United States do not give priority in case of conflict to the first applicant, but to the first to invent. Interference proceedings are instituted to determine who is the first inventor and consequently entitled to the patent (see 35 U.S.C. 102 g (1)). The parties involved in such a proceeding may provide evidence of facts to prove their date of invention. 

Only one party can be awarded a patent to an invention (die same invention cannot be patented twice), and die prize usually goes to the party that can establish that it was die first party to invent the contested subject matter. This is a consequence of die United States being a first-to-invent country (more will be explained regarding this facet of U.S. law in Chapter 3). The first-to-invent system makes a provisional patent application less critical than if die United States were a first-to-file country like the rest of the world. However, filing a provisional patent application in the United States is still advantageous because any... 

The first-to-file a successful paragraph IV abbreviated new drug application is awarded 180 days exclusivity, during which it will be the sole generic entrant to the market. 

Competing Applications. For the EPO patent rights belong to the first to file. In the US it is the first to invent, decided by assessment in interference proceedings. Hence the importance of keeping accurate dated records of work leading to the invention, e.g. laboratory notebooks. 

In the United States priority of invention is important because the first inventor rather than the inventor first to file a patent application is entitled to award of a patent. An interference is a proceeding initiated hv the Patent Office to determine which of two or more parties claiming the same or overlapping subject matter was first inventor and therefore entitled to an award of priority and issuance of a patent on the common matter. 

The question is who receives the patent grant. In all countries except the United States, the first to file a patent application is granted the patent. In the United States, the patent is granted to the first to make the invention. 

Unlike the rest of the world, US patent practice is a first-to-invent rather than first-to-file system, the argument being that the Constitutional basis for the patent system was to secure rights for inventors not for hasty filers. This occasionally leads to a quasi-judicial proceeding known as an interference. 

U.S. patent law, for example, is notable for its difference from the patent laws of certain other countries in the patentability of pharmaceutical compositions and medical procedures (both patentable in the United States), and in cases where competing inventors apply for conflicting patents on the same invention (the United States awards the patent to the first to invent, while most other countries award the patent to the first to file, although, as of the date of publication of this chapter, legislation is pending in the United States to change the standard to flrst-to-flle). 

Throughout most of the world outside the United States, patents are granted to the first to file rather than the first to invent. In such countries, the failure to file quickly can result in loss of valuable patent rights. Moreover, if others independently make the same invention and obtain a patent, the inventor who files late may be prevented from using the very technology upon which vast sums and significant human resources were spent. 

U.S. patent law establishing entitlement to a patent in the case of essentially simultaneous invention is different from the law of substantially all other countries throughout the world. Nearly all countries award the patent to the first party who files a patent application (i.e., the first-to-file rule) (12). The United States, however, follows the first-to-invent rule whereby, at least in theory, the first to invent is generally entitled to the patent, even though he or she was not the first to file a patent application. Thus, it is possible that one party (i.e., the first to invent) who loses the race to the PTO may be entitled to patent protection in the United States, whereas another party (i.e., the first to file) may be entitled to patent protection for the... 

Currently there is considerable interest in the world community for the United States to harmonize its laws with those of the rest of the industrialized world and adopt the first-to-file system. Although efforts have been made in the United States to adopt the first-to-file rule, there has been considerable resistance to such a change. Adoption of a first-to-file rule does not appear likely in the near future. Should... 

Generally, most countries provide an exception to the first-to-file rule in cases of derivation i.e., where the first to file, who is not actually an inventor, learns of the invention from the actual inventor who files second). 

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