Another patent dispute! Bijian compensation Forward Pharma $1.25 billion

On January 18, Baijian announced that it would pay Forward Pharma (FWP) $1.25 billion to settle the patent dispute between the two companies over dimethyl fumarate (trade name Tecfidera) out of court. In addition, there is a patent lawsuit between the two that will have a final judgment in March this year. According to the result of this judgment, Baijian may still have to pay FWP 1% ~ 20% of future sales commission. FWP rose 53% on this huge sum of money.

The patent dispute will start in 2008. Dimethyl fumarate (DMF) has occasionally been used to treat psoriasis (psoriasis) in some areas before, but DMF has not been developed into a drug for a long time until Biogen Idec (Baijian) applied for a patent on a new indication for the treatment of multiple sclerosis in 2008. Subsequently, dimethyl fumarate (trade name Tecfidera) developed by Biogen Idec was approved by the US FDA on March 27, 2013 and received a European patent in May of that year. Since then, Tecfidera has become the third oral multiple sclerosis drug after Novartis's fingolimod and Sanofi's teriflunomide. In its first six months on the market, this drug has achieved sales of US $0.5 billion. Bijian has also been promoting regulatory data protection and NAS qualifications to address patent challenges.

But when things progressed to 2014, Baijian reported a case of death after taking Tecfidera, a patient died of progressive multifocal leukoencephalopathy, a rare brain infection. Subsequently, the FDA added this information to the official description of the Tecfidera drug, and immediately after the Tecfidera's sales began to decline. More unfortunately, in 2016, the European Patent Office announced the withdrawal of one of the Tecfidera four patents, which is undoubtedly another major blow to Baijian.

Up to now, the patent dispute with FWP, in which Baijian needs compensation, has been predicted by many experts, and this settlement has preserved Tecfidera's market monopoly for several years to come, so the stock has only fallen by less than 1%.

Looking at the overall situation, there have been many recent patent disputes, bringing the importance of patents in the new drug industry into the public eye. First Gilead was awarded $2.5 billion in damages to Mercadon, and then Amjin wanted to drive the Praulent of Regeneron/Sanofi's similar PCSK9 drug out of the market. But the two disputes are still pending, and Baijian is ready to pay a one-time cash payment of $1.25 billion.

If nothing else, the FWP Board will accept the agreement. Even excluding sales commissions, this is the largest patent dispute in recent years.

Previously, Baijian was praised for its accurate judgment and timely acquisition of Tecfidera original manufacturer's Fumapharm when the threshold of success was likely to be reached, but obviously the patent investigation was not in place at the time of acquisition. This is supposed to be a dose/dosage form protection (480 mg orally), so you should be more cautious about patents. However, Baijian only spent 0.22 billion US dollars on the acquisition Fumapharm in 2006, so it might not have been thought that this product would become such a big Mac at that time, otherwise it should have paid a little money to fix the patent at that time.

There is no doubt about the importance of patents in drugs, because the production cost of drugs is very low, and the market is occupied by patent monopoly. Patent is a more intuitive competition in the competition for new drugs, patent law, although complex but still relatively clear. The two sides in patent disputes are generally of equal strength, and it is basically predictable how much they will lose. New drug research and development is more of a knife that does not see blood. The opponent is the unfathomable human physiological structure and life process of martial arts, and the epitome often loses all don't know how to lose. Tredaptive this almost certain drug can fail, let alone the first drug that rushed to the front line.

Forward Pharma went public in 2014 with dimethyl fumarate as its core asset to raise $0.2 billion, making it one of the largest IPOs of the year. A chemical raw material has created the largest IPO of the year, become the protagonist of the largest patent compensation in recent years, and supported 1/3 of the sales of a large company like Baijian. It is also a wonderful event in biopharmaceuticals in recent years. However, solanezumab such elaborate and highly complex drugs have been defeated, and there is still a long way to go to conquer the disease.

News source:http://news.bioon.com/article/6697475.html

This news was re-edited and reorganized by the Huaxun team and added analytical comments.