International Legal and Ethical Issues in Business IP Week 4 - Essay Example

Competition law and the antitrust laws are examples of such regulations. The laws are set of rules and regulations designed to enhance competitive environment in the business environment. This paper evaluates an example of a merger between two major telecommunication companies. Some issues arise due to generic competition. Generic competition stems from producers who do not incur costs in research before they launch a product to market. It results in the original manufacture imposing some restrictions to protect their brands.

This paper will address legal barriers in introducing a new product to market and possible dilemmas. Key words: competition, legal, mergers, antitrust and law. International Legal and Ethical Issues in Business Introduction The antitrust laws were put in place by the federal and state governments in United States to regulate businesses. The laws ensure that companies do not become too big and they do not fix their prices. The law also ensures that there is perfect competition in market so that the consumer welfare is maintained.

The federal governments are also mandated in reviewing potential mergers to attempt to prevent market concentration. The antitrust laws apply to businesses and individuals. The laws were enacted to stop businesses that go too large from blocking competition and abusing their power (Baker, 2004). The antitrust law is aimed at ensuring perfect competition. . It is estimated that pharmaceutical companies spend an average of $800-1 billion and between eight and sixteen years to research a new drug (Crandal & Clifford, 2003).

Research need to be conducted to ensure that the drug introduced to the market can compete perfectly. The drug should also meet the target population needs; it should be in a position to solve their problems. As a result, an extensive research should be conducted to make sure that the brand conforms to set standard and market needs. Due to this, high cost is incurred. Legal Barriers to Market Entry Legal requirements have to be followed by the drug manufacturers to ensure that they enter the market with legal approval.

There are legal barriers that control the entry of drugs to the market in the United States. In 2003, President Bush signed into law the Medicare Prescription Drug, Improvement and Modernization Act of Approval. The act has had major impact on the entry of generic pharmaceutical drugs to the market. The 2003 act contains three rules that control the entry of the drugs to the market. The act allows a minimum of one 30- month stay per generic application, clarifies the types of patents that must not be submitted to Food and Drug administration for listing in the orange book, revises the information required to be submitted on patents, and consolidates all patent information on declaring forms to ensure that the submissions are more informative and precise.

In addition to the 30 month stay per application, the FDA tightened control on the types of patent claims submitted by the innovator company. The law ensures that the innovator drug companies would no longer be able to submit patents claiming packaging, metabolites and