[Column] On patent strategies post Amgen v. Sanofi dispute

Patent Attorney Min Son (U.S. lawyer, Vice President of the International Association for the Protection of Intellectual Property (AIPPI) Korea

One of the most significant events that occurred in the bio-pharmaceutical sector in recent years was the ruling made on the Amgen vs.

 

Sanofi patent dispute in the United States.

 

In May last year, the U.S.

 

Supreme Court issued its final ruling on the patent dispute between the two biotech giants.

 

The case received special attention, as the dispute over the validity or invalidity of patents lasted for nearly a decade in the KRW 1 trillion drug market and the first in a long time the U.S.

 

Supreme Court ruled on the 'enablement requirement' of a patent.

 

In 2011, Amgen and Sanofi each patented an antibody for the treatment of hyperlipidemia that binds to the PCSK9 protein, and developed Repatha and Praluent, respectively.

 

Three years later, in 2014, Amgen registered two additional patents for antibodies that bind to the PCSK9 protein and immediately filed a patent infringement lawsuit against Sanofi.

 

In response, Sanofi sought to invalidate both of Amgen's patents, and the dispute came to a head.

 

Amgen was able to file its patent infringement lawsuit in 2014 instead of 2011 for a reason.

 

Amgen's 2011 patent limited antibodies to an amino acid sequence, whereas the 2014 patent claimed antibodies more broadly.

 

Amgen’s patent consists of an antibody that ▲binds to a specific amino acid or epitope of PCSK9; and ▲ prevents PCSK9 from binding to the LDL receptor.

 

Claiming an entire group of antibodies that exhibit this specific function is called a “genus type” claim, which can include millions of individual species antibodies.

 

As a result, genus-type claims have a very broad scope.

 

Despite making such a broad claim, Amgen’s patent specification only disclosed: i) 26 amino acid sequences for antibodies that would block or inhibit PCSK9, and ii) two alternative methods (the roadmap, conservative substitution) for arriving at the remainder of the genus.

 

The court found that the 26 exemplified antibodies were not sufficient to readily produce the entire genus of antibodies and that Amgen's 2 methods constituted separate research projects.

 

The experts ruled Amgen's patents invalid and that they did not meet the enablement requirement because it would require extensive experimentation and trial and error to reproduce the invention.

 

The Supreme Court’s ruling does not overturn the existing view of the enablement requirement, but it does set a clear precedent for the strict application of the requirement, which will have a significant impact on the industry going forward.

 

The Amgen case has several implications.

 

First, it highlights the need for new patent portfolio management.

 

The U.S.

 

Supreme Court's decision has a significant impact on the global patent industry in general.

 

In the biotech sector, especially for antibodies, it will become more difficult to patent an entire genus of antibodies by function.

 

The number of patent applications will naturally increase, and divisional patent application is expected to increase.

 

Furthermore, the treatment of a double patent varies by country, requiring closer attention.

 

A company that discovers a new target should attempt various different types of patent claims.

 

In the bio field, discovering a new target is like finding a gold mine.

 

Therefore, the company should protect the mine by pursuing the broadest claims possible.

 

"Functional claims," like in Amgen’s case, have the advantage of capturing the best features of the target, but they are more likely to be rejected or invalidated.

 

Therefore, rather than pursuing purely functional claims, claims should be drafted in a way that blends functional and structural elements.

 

It's also a good idea to experiment with multi-step claim construction, such as going from broad to narrow.

 

Deciding when to file is a key point in the bio patent application strategy.

 

Historically, patent strategies had been focused on patent maps during the R&D phase, freedom to operate (FTO), or litigation strategies before the product launch, but companies should now pay more attention to the patent application strategy.

 

In the bio sector, it takes a long time to generate experimental data, so it is especially important to decide when to file the patent, after securing how much data.

 

More data can lead to a broader scope of rights but at the cost of a later patent application date.

 

The patent application date should take into account whether the patent is for a platform technology or a follow-on technology, whether it is in the early research or clinical stage, how large the market is for the product, and how much data can be produced.

 

It is recommended that universities, research institutes, and companies plan their patent application strategies according to their data production capacity.

 

The stricter the patent system interprets the enablement requirement, the more favorable it is for global companies.

 

For example, if a global company and a university discover a disease target "at the same time," the global company will have a better chance of obtaining a broad patent because it can produce a lot of data in a relatively short period of time.

 

If a university, research institute, or startup makes an important early stage discovery, one way to reduce the risk is to find a collaborative research partner or license out the technology to increase data production capacity.