Patent expired new drug research and development difficult

The "patent expiration" is now almost the sword of Damocles hanging on top of every multinational pharmaceutical company. Faced with this situation, some pharmaceutical companies have tried to use existing market positions or some way to limit generic drugs in order to extend the time for patented drugs to make huge profits. However, this practice is causing huge troubles and “penalties” for pharmaceutical companies.

GlaxoSmithKline, the UK's largest pharmaceutical company, has been accused of having exchanged money for other pharmaceutical companies to delay the listing of Paroxetine (aka celite), GlaxoSmithKline's best-selling antidepressant drug. If the case is confirmed, GlaxoSmithKline will be fined a sum equal to 30% of the company's average annual turnover in the United Kingdom from 2001-2004. In fact, Sanofi had previously been fined more than 40 million euros by the French government for trying to restrict the sale of Plavix's generic drugs.

Each surprisingly restricts generic drugs

Patented medicines that once used to bring huge revenues to pharmaceutical companies, once the patent protection period ends, sales revenue will fall as steeply as the price of generic drugs with much lower prices. Nowadays, the development of medicines is generally in a bottleneck. In this case, some pharmaceutical companies “pay for peace”.

The Fair Trade Office of the United Kingdom has announced that it has launched an investigation into GlaxoSmithKline, focusing on the company’s “delayed trading” with pharmaceutical companies such as Yalai Pharmaceuticals and Norton Medical Center from 2001 to 2004, which caused the delay of these pharmaceutical companies. The company's anti-depressant drug selex (paroxetine) imitation plan, and then maintain the market price of the drug is high, in order to keep the drug can bring high profits to GlaxoSmithKline during this period. According to OFT’s estimates, this will add at least a few million pounds in British health insurance annually.

However, the official of GSK has publicly stated that the company “supports fair competition. As the parrotitin’s legal patent owner, we firmly believe that this behavior of the company is legal”. GlaxoSmithKline believes that the signing of agreements with generic manufacturers actually promoted the listing of Paroxetine generics before the expiration of GlaxoSmithKline's patents.

Faced with the same situation, Sanofi took another approach. The company had previously tried to limit the sales of the generic version of Plavix by doing work on doctors. The move was considered by the French authorities as unfair competition and was finally punished. More than 4000 million euros fine. According to the French Competition Commission’s statement, Sanofi, on the grounds of safety, smashed the copy of the imitation version of Polivi produced by Teva and other pharmaceutical companies in the crowd of doctors and pharmacists. Sanofi also publicly stated that the company has always taken drug safety as its primary principle. They do not agree with the French Competition Commission’s allegations and will appeal it.

Southern Metropolis Journalist learned that Selett and Plavie had closed the patent protection period in 2004 and 2004 respectively. According to the financial statements of the two companies, the two patented drugs were brought to their respective companies at least once a year during the patent period. More than 2 billion euros in sales revenue. In recent years, 18 of the world’s top-selling top 20 prescription drugs are facing patent expirations, and the 18 prescription drugs have annual global sales of US$142 billion. In the face of this unfavorable situation, major pharmaceutical companies, in addition to increasing their R&D efforts, have attempted to move to the generic market and have even acquired generic pharmaceutical factories.

R & D mode is attacked

However, at present, various multinational pharmaceutical companies are facing bottlenecks in chemical drug research and development. According to the statistics of the American Pharmaceutical Manufacturers Association, from 1980 to 2012, the investment in drug research and development of its member companies increased from 2 billion U.S. dollars to 49.4 billion U.S. dollars, an increase of 25 times in 30 years. However, due to the increasing FDA approval of new drugs and the increased complexity of the disease, the success rate of R&D of new drugs is declining. In 2000-2012, the number of new molecular entities approved by the FDA fell from 7.4 to 3.1 in every 1,000 clinical trials.

The attempts of multinational drug companies that are accustomed to the high-risk, high-input, and high-return patent medicine model have not gone smoothly. Prior to this, Pfizer’s Lipitor had helped Responsible imitation of the Huasheng pharmaceutical OEM after the patent expired. Edition to share the sales revenue of the imitation Lipitor. The product manager of a foreign company disclosed to the Southern Reporter that the poor performance of the plan since the first year of implementation was mainly due to price diving and fierce competition, making Pfizer’s revenue from the fake version of Lipitor much lower than expected. .

In the face of bottlenecks in the development of new drugs, and gaining little in the battle for generic drugs, GlaxoSmithKline and Sanofi switched to limiting generic drug competition in some way. However, this practice is easy to wipe off the gun and is considered by the relevant European and American regulatory agencies as unfair competition. The aforementioned product manager pointed out that “in Europe, the limits of unfair competition are much broader than those of the United States, so behaviors like “delayed transactions” are unlikely to have an opportunity to come back once they are deemed as unfair competition.”