Could Amgen’s Patent Victory Be Bad For Medicine?

Forbes, 6 January 2017
Author: Matthew Herper
“Last night, in a nearly unprecedented move, a federal judge ordered a cholesterol medicine that is on the market and used by patients to be withdrawn because it infringes on the patents of a competitor. Some patent attorneys reacted with shock.”
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Scientists Battle In Court Over Lucrative Patents For Gene-Editing Tool

NPR, 5 December 2016
Author: Richard Harris
“A gene-editing technology called CRISPR-cas9 could be worth billions of dollars. But it’s not clear who owns the idea. U.S. patent judges will hear oral arguments to help untangle this issue, which has far more at stake than your garden-variety patent dispute. “This is arguably the biggest biotechnology breakthrough in the past 30 or 40 years, and controlling who owns the foundational intellectual property behind that is consequentially pretty important,” says Jacob Sherkow, a professor at the New York Law College.”
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When is a point of view a conflict of interest?

BMJ 2016; 355: i6194
Author: Jeanne Lenzer
“The US Food and Drug Administration has a longstanding policy on financial conflicts of interest for members of advisory committees involved in authorizing new drugs or medical products. But this year, for the first time, the agency is establishing guidelines regarding “appearance issues,” which include identification of intellectual conflicts. In a draft guidance issued in June, the FDA describes the characteristics of advisory committee members and situations that could create the appearance of a conflict or the perception that a committee member “lacks impartiality.”
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Questions hang over European patent for hepatitis C drug after ruling

BMJ 2016; 355: i5493
Author: Ned Stafford
“The medical activist group Doctors of the World (Médecins du Monde) is calling for European governments to campaign for the US biotechnology firm Gilead Sciences to lower the price off its effective but very expensive treatment for hepatitis C after the European Patent Office ruled that the current patent must be amended.”
Find article here.

Psychiatrist struck off for repeated plagiarism

BMJ 2016; 354 doi:
Author: Clare Dyer
“A psychiatrist who assured a 2014 fitness to practise tribunal that she had “learned her lesson” after suspension for plagiarising written assignments has been struck off after cutting and pasting other clinicians’ patient notes into her NHS trust’s computer system.”
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Supreme Court refuses to review prenatal test patent dispute

Reuters, 27 June 2016
Author: Andrew Chung
“The U.S. Supreme Court on Monday rejected a bid to review a legal fight over the cancellation of a patent on a less-risky form of prenatal testing, in a case that has left many companies and trade groups worried that important discoveries may no longer qualify for patents.”
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Canadian clinical genetics marks a milestone

CMAJ Early release, published at on April 11, 2016.
Author: Tim Lougheed
“Like early explorers who claimed an uninhabited land mass by planting a flag, many pioneering  biotechnology  firms  acquired  patents  on  genes  simply  by  “discovering”  these naturally occurring sequences. This legal control mattered little when the bio-molecular tools for extracting information from these genes were cumbersome and  expensive. But  those days  are  fading  fast.  Clinicians  conducting  genetic tests can  now  analyze  all  or  most  of  a  human  being’s  23 000 genes with a single in-house procedure  that  can  reveal  if  a  patient’s  condition  is  linked  to one gene.”
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India defends right to issue drug ‘compulsory licenses’

Reuters, 23 March 2016
Author: Zeba Siddiqui
“India has defended its right to grant licenses allowing local firms to override patents and make cheaper copies of drugs discovered by big Western drugmakers, and said reports to the contrary were “factually incorrect”.
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Multigate Medical Devices Pty Ltd v B Braun Melsungen AG [2016] FCAFC 21

Decision 3 March 2016
“Catchwords: PATENTS – intravenous catheters – safety needle protecting devices – construction of integers of claims – infringement – infringement claim upheld by primary judge – leave to appeal granted – appeal allowed in part PATENTS – cross-claim for invalidity dismissed by primary judge – chain of ancestor patents – entitlement of patents to priority dates of ancestor patents – external fair basis – whether claims of patents fairly based upon matter disclosed in ancestor patents – whether ancestor patents provided real and reasonably clear disclosure of subsequent claims – whether disclosures in ancestor patents incorporated by reference in subsequent patents – internal fair basis – novelty – appeal dismissed”
Find decision here. See also Multigate Medical Devices Pty Ltd v B Braun Melsungen AG (No 2) [2016] FCAFC 41 (16 March 2016).