United States patent law

Patents, trademarks, service marks, and copyri ts are examples of means by which intellectual property is protected by United States laws. 

Patents and trade secrets are protected by securing rights to ideas and the appHcation of ideas that have commercial worth. The grant of rights in patents and trade secrets is based on an appreciation of development, advancement, and invention that will stimulate innovation by advancing technology. Patents and trade secrets are two distinct mechanisms for protecting invention vis-a-vis the appHcation of ideas. Both are supported by the poHcies and laws of the United States. 

Once the patent appHcation is complete and the inventor has made a formal declaration of inventorship, the appHcation is filed with the U.S. PTO. In the U.S. PTO, the appHcation is the subject of a thorough, formal, and substantive examination by a patent examiner. Once the patent examiner is convinced that the patent appHcation satisfies the statutory requirements provided for under the laws of the United States, the patent appHcation will be allowed to issue as a patent. Issuance takes the form of a pubHcation provided by the U.S. Government. The pubHcation of patents occurs only on Tuesdays that ate not federal hoHdays. At the time of issuance, the patent is assigned a number and made pubHc in a form which allows all interested patties to obtain access to it. 

A fundamental requirement for obtaining a patent is defining an advance, development, or invention which is within those classes of "subject matter" which the law of the United States regards as patentable. Two classes of patentable subject matter, ie, computer software and biotechnology, are the subject of relatively new and evolving law. However, other types of subject matter rest on fairly certain ground as to patentabiUty. Examples of patents directed to various types of subject matter are described in the following. 

However, even if there is some disclosure of the invention in the prior activity, the law of patents in the United States requires a high level of detail concerning the invention. A summary of factors to consider in establishing that an invention is not obvious is as foUows ... 

In drafting a patent appHcation, proceeding methodically through the several steps necessary to produce the type of disclosure legally and technically sufficient to satisfy the requirements of the laws of the United States is absolutely essential to a successful granting of the patent. A first step is to outHne those elements of the invention which are absolutely essential to its practice. A body of disclosure should be outlined for each of the essential elements of the claim. This disclosure should describe each element in terms of its function, as weU as the parameters that are relevant to the essential nature of the individual element. For example, if a chemical mixture has a component which acts so as to thicken the mixture, it is appropriate to outHne the family of constituents that can serve this function. At the same time, a full outHne of the disclosure of this individual element will include mention of those chemicals that are preferred for use within the mixture so as to perform the desired thickening function. 

Patent laws provide for several stages in the life of an application for a patent on an invention. The pattern followed by patent laws in effect in most industrialized countries during the nineteenth and early twentieth centuries, and still in effect in the United States in 1995, calls for the examination of all patent appHcations to certify that the claimed invention meets the national standards for novelty, usehilness, and inventiveness. The owner of the technology to be patented files appHcation papers that include a specification containing a description of the invention to be patented (called the disclosure) and claims defining the limits of the invention to be protected by the patent, a formal request for the issuance of a patent, and fees. Drawings of devices and apparatuses, electrical circuits, flow charts, etc, are an important part of the disclosures of most nonchemical and many chemical patents. 

Under U.S. law, the inventor is defined as the owner of the patent unless the patent rights have been assigned to his or her employer, or some other individual or organization. Designations of assignment are typically filed with the U.S. Patent and Trademark Office (U.S. PTO) prior to the issuance of patents, and the name of the assignee is printed on the patent. In most countries outside of the United States, the patentee is the employer, rather than the employed inventor. 

Because each country has its own patent laws, the precise meaning of the bibhographic data and the legal significance of the pubUshed patent document vary from country to country. The Patent Cooperation Treaty (PCT) provides a recommended code to distinguish the various types of documents and to simplify storage and retrieval of patent data (2), but the code is implemented differentiy by different countries. For example, in the United States an A-document in 1995 was a patent in the Nethedands, an A-document was a pubUshed unexamined appHcation. It is essential to understand each country s system to interpret the status of its patent documents. 

U.S. Laws and Regulations Related to Drug Product Development and Manufacture. Until early in the twentieth century, dmg products were made and sold in the United States having virtually no imposed control. QuaUty was generally poor. Many products were patent medicines of dubious value. Some were harmful and addicting. 

Trade secrets (or undisclosed information ) are also protected under the TRIPS Agreement [34]. Despite this international agreement, there is a wide range of difference in the manner in which countries implement these provisions. Few countries, apart from the United States, have explicit provisions in their laws on the protection of trade secrets. In some countries, protection is only granted when a former employee takes confidential information to a new employer, whereas in other countries, protection is granted more widely. Unfortunately, once a trade secret is no longer a trade secret it can be freely used by anybody else who obtained the information fairly. The value of the trade secret is thus much more limited than, for example, patents or copyrights. 

Drugs Under Patent. This book [77] is a cross-referenced listing of over 2500 drugs covered in the United States under patent law and marketing exclusivity provisions of the Waxman-Hatch Act. Eight indexes provide market and patent status information by company, trade name, generic name, expiration date, dosage form, exclusivity code, patent number, and NDA number. Updated annually, this book is available commercially. 

While the tripartite countries of the more developed regions of the world have their own patent laws, and while they honor each other s property protection rights, some countries do not. Patent pirates in these countries freely copy (pirate) innovator drugs and drug products that are under patent protection in the United States and elsewhere without compensating patent holders. India is perhaps the worst pirate offender,... 

Rillieux, for example, had trouble filing for U.S. patents. An official who returned one of his forms wrote, It is required that the applicant shall make oath or affirmation of citizenship and as the laws of the United States do not recognize slaves as citizens, it is impossible for the negro slave to bring his application before the office. Rillieux exploded furiously, Now, I was the applicant for the patents and not the slave. I am a citizen of the United States and made oath of the facts in my affidavit.. . . How could the Commissioner arrive at such a monstrous conclusion against the express declaration to the contrary ... 

Allison, J. and Lemley, M. 2002. The growing complexity of the United States patenting system. Boston University Law Review 82(1), 77-144. 

The Supreme Court reversed the decision of the Court of Appeals, holding that Ohio s law of trade secrets is not preempted by the patent laws of the United States, and further held (footnotes omitted) ... 

Perhaps its author is trying to tell us something about the rate of change in trade secret law by publishing this treatise in loose-leaf form with yearly supplements. A U.S. patent has a fixed term of 17 years and extends protection to the United States only—although its disclosures are worldwide. Foreign patents can be obtained separately in each country and may be quite costly. The scope of protection and subject matter which is patentable varies tremendously. There is action towards patents common to several countries, but the cost is apt to remain high, and many years will be required to determine their effectiveness. 

The citation of trade names and/or names of manufacturers in this publication is not to be construed as an endorsement or as approval by ACS of the commercial products or services referenced herein nor should the mere reference herein to any drawing, specification, chemical process, or other data be regarded as a license or as a conveyance Ol any right or permission to the holder, reader, or any other person or corporation, to manuTacture, reproduce, use, or sell any patented invention or copyrighted work that may in any way be related thereto. Registered names, trademarks, etc., used in this publication, even without specific indication thereof, are not to be considered unprotected ty law. PRINTED IN THE UNITED STATES OF AMERICA... 

Novelty is essential to patentability and is well-defined in the respective patent laws of at least the United States of America, the European Patent Convention (EPC) [1], Japan, and other jurisdictions. Nothing can be patentable that is not new. Although novelty is basic to patentability, different concepts of novelty exist throughout the different patent systems in the world. The most straightforward is that of absolute novelty , which is applied by the European Patent Convention in Art. 54 ... 

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