Health Boards
The U.S. Supreme Court rejected Johnson & Johnson's request to reinstate the largest patent- infringement verdict in American history, a $1.67 billion award it won against Abbott Laboratories over arthritis treatments.
The high court today declined to review a lower court ruling that a patent on a method to make antibodies was invalid because it inadequately described what J&J’s Janssen Biotech said it invented. J&J and patent co-owner New York University want to collect on the verdict they received over the drug Humira, which accounts for about 20 percent of Abbott’s annual revenue.
A U.S. appeals court said inventors must describe clearly their work to show they conceived the invention, and that failure to do so may lead to the patent being tossed out. J&J contends that requirement is too onerous when it comes to patents on basic research or discoveries that have broad applications.
“The directive has become unhinged from statutory text, is judicially unadministrable, and is erratic and unpredictable in outcome,” J&J said in its petition.
The dispute centers on a method to create antibodies that block the action of tumor necrosis factor, or TNF. When the body produces too much TNF, it can cause the immune system to attack healthy tissue and leads to inflammation.
J&J’s original research focused on mouse antibodies, and moved to chimeric antibodies that combine mouse and human. The company, whose own Remicade arthritis drug is based on chimeric technology, said its patent also covered a method of making fully human antibodies.
Dispute Over Claims
In ruling the patent invalid, the U.S. Court of Appeals for the Federal Circuit said the claims made in the invention, as written, “constitute a wish list of properties” that a human antibody should have.
Abbott said its researchers discovered ways to create human antibodies and J&J tried to “expand its patent rights to cover a class of antibodies that it did not invent or describe.”
A March 2010 Federal Circuit decision laying out the written description requirement got U.S. support, Abbott said, and J&J “seeks to disrupt the settled expectations of innovators like Abbott by upending decades of precedent.”
Novo Nordisk, the world’s largest insulin maker, and vaccine maker Bavarian Nordic urged the high court to take the case, saying they need broadly written patents to protect their research.
Drug Sales
Sales of Humira were $7.93 billion last year, including $3.43 billion in the U.S., Abbott reported Jan. 25. The drug accounts for about 20 percent of the Abbott Park, Illinois-based company’s revenue.
Abbott has filed its own lawsuit, claiming J&J’s arthritis drug Simponi, made with human antibodies, is infringing an Abbott patent. It also claims a J&J psoriasis medicine, Stelara, violates two other patents. Those cases are pending in federal court in Worcester, Massachusetts.
Arthritis involves the breakdown of the cartilage protecting joints and affects one in seven Americans, or 37 million people, according to the National Institutes of Health. Three of the largest drugs used to treat arthritis are Humira, Remicade and Thousand Oaks, California-based Amgen’s Enbrel.
Source: nj.com
The high court today declined to review a lower court ruling that a patent on a method to make antibodies was invalid because it inadequately described what J&J’s Janssen Biotech said it invented. J&J and patent co-owner New York University want to collect on the verdict they received over the drug Humira, which accounts for about 20 percent of Abbott’s annual revenue.
A U.S. appeals court said inventors must describe clearly their work to show they conceived the invention, and that failure to do so may lead to the patent being tossed out. J&J contends that requirement is too onerous when it comes to patents on basic research or discoveries that have broad applications.
“The directive has become unhinged from statutory text, is judicially unadministrable, and is erratic and unpredictable in outcome,” J&J said in its petition.
The dispute centers on a method to create antibodies that block the action of tumor necrosis factor, or TNF. When the body produces too much TNF, it can cause the immune system to attack healthy tissue and leads to inflammation.
J&J’s original research focused on mouse antibodies, and moved to chimeric antibodies that combine mouse and human. The company, whose own Remicade arthritis drug is based on chimeric technology, said its patent also covered a method of making fully human antibodies.
Dispute Over Claims
In ruling the patent invalid, the U.S. Court of Appeals for the Federal Circuit said the claims made in the invention, as written, “constitute a wish list of properties” that a human antibody should have.
Abbott said its researchers discovered ways to create human antibodies and J&J tried to “expand its patent rights to cover a class of antibodies that it did not invent or describe.”
A March 2010 Federal Circuit decision laying out the written description requirement got U.S. support, Abbott said, and J&J “seeks to disrupt the settled expectations of innovators like Abbott by upending decades of precedent.”
Novo Nordisk, the world’s largest insulin maker, and vaccine maker Bavarian Nordic urged the high court to take the case, saying they need broadly written patents to protect their research.
Drug Sales
Sales of Humira were $7.93 billion last year, including $3.43 billion in the U.S., Abbott reported Jan. 25. The drug accounts for about 20 percent of the Abbott Park, Illinois-based company’s revenue.
Abbott has filed its own lawsuit, claiming J&J’s arthritis drug Simponi, made with human antibodies, is infringing an Abbott patent. It also claims a J&J psoriasis medicine, Stelara, violates two other patents. Those cases are pending in federal court in Worcester, Massachusetts.
Arthritis involves the breakdown of the cartilage protecting joints and affects one in seven Americans, or 37 million people, according to the National Institutes of Health. Three of the largest drugs used to treat arthritis are Humira, Remicade and Thousand Oaks, California-based Amgen’s Enbrel.
Source: nj.com