Shire PLC rejected the claims of Hayman Capital Management regarding its patents on its bowel medications Gattex and Lialda.
Last week, the hedge fund submitted a patent petition with U.S. Patent and Trade Mark Office (USPTO) indicating that Shire lacks grounds to maintain its patents on the two medications.
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Hayman Capital claimed that Share is abusing the patent system by keeping generic alternatives off the market and increase the prices of its medicines.
In an interview with the Wall Street Journal last week, Kyle Bass, founder and principal at Hayman Capital said, “A small minority of drug companies are abusing the patent system to sustain invalid patents that contain no meaningful innovations but serve to maintain their anti-competitive, high-price monopoly to the detriment of Americans suffering from illness.”
Shire vows to defend its patents vigorously
In a statement, Shire emphasized that the FDA Orange Book for Gattex and Lialda protects the innovation and value the company brings to patients who benefit from the medicines.
According to Shire, it “will continue to defend vigorously its patents and pursue all legal options available to protect its products.” Lialda and Gattex account 12% of the Shire’s revenue last year.
Shire is a specialty biopharmaceutical company focused on developing and marketing medicines for rare diseases.
Shire explained that Lialda was still the only once-daily mesalamine product indicated for both induction and remission of mild to moderate ulcerative colitis. It is also for the maintenance of remission of ulcerative colitis. Its patent for the medicine is set to expire on 2010.
Lialda’s patent already” withstood a challenge of its validity” in the Federal District Court for the Southern District of Florida. The company added “there have not been any approvals of generic versions of Lialda.”
Furthermore, Shire said the United States approved Gattex to treat adults with short bowel syndrome (SBS) who are dependent on parenteral support. The medicine received an Orphan Drug Designation by the FDA in 2012. Its orphan drug exclusivity lasts until 2019.
Shire emphasized that its patents for the medicines were set to expire in 2015, 2022 and 2015. “The recently filed petition only challenges a subset of claims of the Gattex patent expiring in 2022. The remaining claims of that patent and the claims on the other patents were not challenged in the petition,” said Shire.
Hayman Capital’s first patent challenge
Hayman Capital’s filed its first patent challenge against Acorda Therapeutics in February. The hedge fund two of the five patents of the company covering Ampyra, a medicine for multiple sclerosis.
The patent challenges are part of Kyle Bass’ campaign to serve as the Robin Hood of Drug Prices. Bass aims to release monopolistic drug patents from greedy pharmaceutical companies, lower the prices of medicines, and make profits by betting that the stock price of those companies will decline.