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Away from whistle-blower allegations in India, drugmaker Sun Pharmaceutical Industries Ltd is faced with another problem involving an opthalmology drug and the sourcing of its research in the US. A transaction that Sun Pharma, however, says was done with “satisfactory” due diligence.
About three weeks ago, the University of Missouri had filed a suit against its former pharmaceutical professor, Ashim Mitra, for allegedly “stealing” a student’s research and selling it to a drug company, who then sold it to Sun Pharma, according to foreign media reports.
Clarifying its position in public for the first time, a Sun Pharma spokesperson told BusinessLine , "We purchased Ocular Technologies from Auven Therapeutics in 2016, thereby, acquiring a patented novel formulation of cyclosporine A 0.09 % in clinical development. The deal was completed with a satisfactory level of due diligence, including review of the publicly available patent, and appropriate seller assurances.”
US-based Auven Therapeutics and Sun Pharma have been named in the lawsuit, reports said, as the University’s Kansas City campus claimed ownership on the student’s breakthrough research done while at the University. “All of this occurred without any disclosure to — let alone approval from — the university,” a media report said, citing the lawsuit. Mitra has been quoted as having denied the allegations. Auven has reportedly said the University’s allegations had “no merit”, though it has indicated its willingness to engage with the University.
Last August, Sun Pharma had said it received approval for CEQUA (cyclosporine ophthalmic solution 0.09 %) from the US Food and Drug Administration. “CEQUA is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye)”,a note from the company had said. The product provides the highest FDA-approved concentration of cyclosporine A (CsA) and “is the first and only approved CsA product that incorporates nanomicellar technology,” the note added.
Universities & drugmakers
US attorney Mark Pohl doubts the development could be damaging for a large company with a reputation like Sun. But on learnings from the incident for other drugmakers, he says, “ For lessons, it's a reminder that business in the USA is perhaps more formal than in many other countries (eg, India, Poland, Finland, China). The USA has more laws covering more arcane areas, such as professor ownership of patents. By comparison, Finland is an advanced economy, yet until recently there was no Finnish law on professor IP (intellectual property) ownership, so professors simply did whatever they wanted with their inventions.”
Industry-watchers explain that such situations are not uncommon with universities, though the US law is clear that the University owns “everything” a researcher invents while being with them, unless there is a contract to the contrary. And sometimes foreign companies in the US do not understand the importance of this.
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