Regeneron Pharmaceuticals Inc. is an American biotechnology company headquartered in New York. In 2001, it filed patents for a new kind of genetically modified mouse. This was a breakthrough. A combination of a section of the mouse’s genetic material with that of a human’s genetic material. The resultant hybrid mouse can also produce antibodies. The idea of blending a ‘human variable region’ with a ‘mouse constant region’ was a huge contribution to science. Therefore, it was even claimed that this invention was suitable for a range of medical uses. The efforts to develop antibody therapies against Coronavirus was also included.
The First Suit
In 2013, Regeneron sued a British Company, Kymab Ltd. for patent infringement. The latter was engendering its own genetically modified mice. Kymice was its brand name. It had a similar genetic structure to Regeneron’s.
The company had filed its patents in 2001. They were invalid as they controverted a patent law rule called Sufficiency. It was said that the documents accompanying the patent must be explanatory enough. Scientifically skilled readers must also be able to rely on the documents. This is to recreate the invention. As provided in the rule of sufficiency.
The matter went into appeal. Regeneron’s patents had enough information for an expert, to fuse ‘some’ but ‘not full’ of the human material with a mouse’s genes. This was as per the Court. It meant that a reader reading the patents in 2001 would not be able to make many types of hybrid mice. This was as claimed by Regeneron.
However, the Court of Appeal upheld the patents. It opined that the patents need not explain how to make the full range of mice. “Principle of general application” was the idea behind Regeneron’s invention. Kymab then, challenged the decision in the Supreme Court of the UK.
The Supreme Court’s Opinion
Definition of Patent
A patent is nothing but a bargain between the inventor and the public. Patents allow inventors to monopolize over a product’s development and use in a time-bound manner. After the monopoly has expired, the public gets the right to remake the product. The bargain requires the inventor to publish enough information. This is to help a product’s recreation. Right of patent allows the holder to enjoy a legal monopoly proportionate to their technical contribution. It encourages both the inventor and the public (later) to conduct research for the society.
The Principle behind the Impugned Judgement
The Court of Appeal’s based its decision on the principle of General Application. This was also used by Regeneron. The Court thought it unfair to limit Regeneron’s monopoly only to the types of mice that could be made using the 2001 patents. The company’s contribution extended to hybrid mice. This made infusing larger amount of human genetic material. This was using later scientific developments.
The Applicable Principles
Many principles define this area, as per the authorities, that the Patentees cannot make expansive claims. The disclosed patent information must be proportional to the full range of claim. This will enable the expert to remake the product, as per the rule of sufficiency. The claims made must evoke the utilisation factor of the product. Varying colours or tails of varying length cannot change a mouse’s ability to produce antibodies.
Supreme Court’s Decision
The Supreme Court allowed Kymab’s appeal by a majority of four to one. It held that Regeneron’s patents are invalid. The majority judgement was given by Lord Briggs.
An expert cannot make mice containing more than a very small section of the human gene. This was on applying the above cited principles. The amount of genetic human material is an important dictator. It decides the usefulness of the antibodies the mice is capable of producing. Thus, Regeneron’s patents could not produce mice at the more valuable end of the spectrum. This was in contravention to their claims and their actual technical contribution.
The Court of Appeal upheld Regeneron’s patents over a range of mice. But in reality, the company could only make mice covering a small sphere of the compass. This was the least beneficial sphere involving the smallest amount of human genes. The analysis by the Court of Appeal diluted the rule of sufficiency. The scale shifted in favour of the patentees but against the public interest. Thus, the appeal was allowed and Regeneron’s patents were invalidated for insufficiency.
The Dissenting Judgement
Lady Black dissented, agreeing with the Court of Appeal. The application of the sufficiency is idiosyncratic and also dependent upon the specific invention. The facts of the case too are a factor, she said. The principle of general application applied by the Court of Appeal met the sufficiency need.
The judgement was delivered on June 24, 2020.
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