Novartis most challenged for its patents, followed by Pfizer

Novartis received 121 patent challenges in 5 and a half years… followed by Pfizer with 106 cases

33 generic companies file patient suits on 8 Novartis products including Entresto

Novartis was most targeted, followed by Takeda>Pfizer>Astellas>Bayer

United, Alvogen, Boryung, Dong-A, Chong Kun Dang also targeted for its patent

Among pharmaceutical companies, Novartis was found to have received the most amount of patent challenges since 2016.

 

Over the past five and a half years, 33 generic companies had filed a total of 121 patent suits against Novartis' 15 patents on 8 products.

 

In addition to Novartis, generic companies also targeted Pfizer, Boehringer Ingeheim, Astellas, and AstraZeneca.

 

The same went for domestic companies.

 

United Pharma, Alvogen Korea, Boryung Pharmaceutical, and Chong Kun Dang were also challenged on their patents by generic companies.

 

◆Generic companies challenge patents of 8 Novartis products On the 13th, Dailypharm’s tally of patent challenges in the biopharmaceutical sector since 2016 showed that Novartis has received the most challenges from generic companies.

 

Generic companies had challenged 15 patents of 8 drugs owned by Novartis.

 

A total of 121 requests for appeal and trial were filed by the companies against Novartis.

 

In the same period, the total number of appeals and trials claimed (scope of right + invalidation suits) amounted to 1,042.

 

In other words, 1.2 cases in every 10 patent suits filed had targeted Novartis.

 

The 8 products that received patent challenges were;▲heart failure treatment ‘Entresto’; ▲DPP-4 inhibitor antidiabetic ‘Galvus’; ▲Breast cancer treatment ’Afinitor’; ▲ glaucoma treatment ‘Simbrinza eye drops’; ▲ conjunctivitis treatment ‘Pazeo eye drops’; ▲ COPD treatment ‘Xoterna’; ▲ chronic iron overload treatment ‘Exjade FCT’; and ▲ immunosuppressant ‘Certican’ The interesting point is that only 2 of the drugs among those in legal dispute are blockbuster drugs that bring over ₩10 billion in annual sales.

 

According to the pharmaceutical market research institution IQVIA, only Entresto (₩21.7 billion) and Afinitor (₩14.9 billion) recorded over ₩10 billion in sales among the 8 Novartis products.

 

The other products, Exjade (₩8.5 billion), Galvus (₩7.3 billion), Certican (₩6.9 billion), Xoterna (₩6.2 billion), Pazeo (₩4.1 billion), and Simbrinza (₩2 billion) all recorded less than ₩10 billion in annual sales.

 

The analysis is that generic companies are now actively seeking patents not only for the well-sold large items but also for small and medium-sized sales items.

 

Five or fewer generic companies have requested a judgment for each of the products that sold less than ₩10 billion.

 

Also, Novartis targeted the most is because the company has that many patents.

 

As of the 12th, Novartis has 151 patents (on 69 drugs) listed on Korea’s patent list.

 

This is the most amount of patents registered among domestic and multinational pharmaceutical companies combined.

 

In other words, despite the aggressive patent challenges filed by generic companies over the past 5 and a half years, Novartis has kept over 80% of its patents safe and sound.

 

◆Followed by Pfizer with 106 patent cases > Boehringer Ingelheim with 95 cases > Astellas with 89 cases The runner-up was Pfizer.

 

Pfizer received the second-most amount of patent challenges after Novartis since 2016.

 

A total of 106 patent trials were filed on 8 patents of 6 drugs.

 

Pfizer's sedative ‘Precedex,’ the pneumococcal vaccine ‘Prevenar 13,’ smoking-cessation treatment ‘Champix,’ antidepressant ‘Prestiq,’ JAK inhibitor immunology drug ‘Xeljanz,’ and neuropathic pain treatment ‘Lyrica’ were the targets.

 

The 4 products other than Precedex and Pristiq were blockbusters that raised over ₩20 billion in sales last year.

 

Also, Boehringer Ingelheim (95 cases), Astellas (89 cases), and AstraZeneca (80 cases) received patent challenges from generic companies.

 

Boehringer Ingelheim received patent challenge for its SGLT-2 inhibitor diabetes treatment ‘Jardiance,’ NOAC ‘Pradaxa,’ and Parkinson’s disease treatment ‘Mirapex.’ Astellas was challenged for its patents on its OAB treatment ‘Betmiga' and immunosuppressant ‘Advagraf.’ AstraZenca’s SGLT-2 inhibitor ‘Forxiga’ also was a target of focus for patent challenges.

 

Among domestic companies, United Pharma, Alvogen Korea, Boryung Pharmaceuticals, Dong-A ST, and Chong Kun Dang were also actively targeted for their patents.

 

In the case of United Pharma, 4 patents on its gastrointestinal symptom treatment ‘Gastiin CR,’ antiplatelet drug ‘Cilostan CR,’ and expectorant ‘Levotics CR,’ were targeted by generic companies.

 

A total of 28 pharmaceutical companies had filed 80 patent trials.

 

Alvogen Korea was challenged by 50 pharmaceutical companies for one single drug - its antithrombotic drug ‘Sarpodipil SR.’ Also, 44 generic companies challenged Boryung Pharmaceuticals 'patent on its antihypertensive combination drug ‘Dukarb.’ Dong-A ST also was challenged by 31 generic companies on its gastritis drug ‘Stillen 2X.’ Chong Kun Dang was challenged for the patent of two of its drugs – its GERD treatment ‘Eso Duo’ and its antihypertensive combination ‘Telminuvo.’ The patents held by domestic companies that the by generic companies targeted are all Incrementally Modified Drugs (IMDs).

 

In other words, the drugs do not separately hold a substance patent and are therefore relatively easy to target.

 

The analysis is that the patent challenges focused on IMDs as most were well-sold products that brought over ₩10 billion a year.