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Brief History of Viagra and Pfizer's InvolvementPfizer, a global pharmaceutical corporation, played a pivotal role in the development and distribution of Viagra. Sildenafil, the active ingredient in Viagra, was patented in 1996. The patent application filed by Pfizer was a quick process in comparison to other drugs. In only two years, by 1998, it received FDA approval for use in treating erectile dysfunction, a clinical term for impotence. The Original Patent: Pfizer's 1994 Patent Application for Sildenafil as ViagraThe groundwork for Pfizer's patent began with the invention of sildenafil, believed to be the work of Peter Dunn and Albert Wood. Pfizer filed a patent for the use of sildenafil, under the brand name Viagra, to treat erectile dysfunction. This groundbreaking development was a significant stride in Pfizer's history, marking their venture into a novel medical solution for a globally prevalent condition. Viagra's Market Presence: Publication of the Patent and its Duration (2002-2019)After its patent was approved, Pfizer held exclusive rights to sell Viagra, creating a monopoly in the market for erectile dysfunction treatment. The patented Viagra proved to be a lucrative venture for Pfizer, generating substantial revenues annually. However, as per US patent law, Pfizer's exclusive rights to sell Viagra were valid until 2019. The Patent Beyond the US: Expiry of Pfizer's Patents on Viagra Outside the US in 2012While the US market remained under Pfizer's control, the scenario was different outside the US. Pfizer's patents on Viagra expired in Europe, Japan, and Australia in 2012. This expiration hinted at what Pfizer would later face in the United States.The end of Pfizer's patent protection led to a decrease in annual revenues from Viagra sales in these regions, from US$472 million to US$146 million between 2012 and 2015. Generic Drugs Enter the US Market: Pfizer's Settlements with Mylan and Teva in 2017As the end of the patent's term approached, Pfizer faced litigation from other pharmaceutical companies, eager to introduce their generic versions of sildenafil. Notably, Pfizer settled litigation with Mylan and Teva, allowing them to introduce their generics in the US market on 11 December 2017. Under the settlement, Teva was obligated to pay royalties to Pfizer until 2020. Patent Battles: Pfizer's 2011 Infringement Case Against Teva Pharmaceutical Industries Ltd in the USLegal battles were a significant part of Pfizer's journey with Viagra. In 2011, Pfizer won a patent infringement case against the US unit of Teva Pharmaceutical Industries Ltd, preventing Teva from selling a generic version of Viagra in the US. This ruling ensured that Pfizer could maintain its exclusivity in the US market for a few more years. Legal Challenges in Canada: The 2012 Supreme Court of Canada Ruling and Teva's AppealMeanwhile, Pfizer faced challenges in Canada. In 2012, the Supreme Court of Canada upheld an appeal by Israel's Teva Pharmaceutical, ruling that Pfizer's original patent application was incomplete. This ruling allowed Teva to sell a generic version of Viagra in Canada, breaching Pfizer's erstwhile monopoly. Ongoing Litigations: Pfizer's 2013 Litigation Against Teva Pharmaceuticals, USA Inc.
Patent Expiration in the UK: End of Pfizer's Patent Protection in 2013 and Emergence of Generic VersionsThe UK saw a similar progression with Pfizer's patent for Viagra. By 21 June 2013, Pfizer's patent protection in the UK had expired, permitting rival companies to sell generic versions of the drug under its chemical name, sildenafil. This development marked another region where Pfizer's exclusive control over Viagra had ended. Final Rulings on the Patent: The 2020 US Court Decision Upholding Pfizer's Patent Until 2019Despite various legal battles, Pfizer was able to maintain its patent in the US until 2019. A US court ruling in 2020 confirmed that Pfizer's patent for Viagra was valid until 2019, effectively halting any other companies from manufacturing unbranded versions of the drug until after this date. The Current Status of Viagra's Patent and its Impact on the Pharmaceutical MarketThe journey of Viagra's patent was characterized by significant market control by Pfizer, followed by a wave of generic versions after patent expirations. While Pfizer managed to extend its exclusive rights until 2020 through various settlements and legal battles, the market for erectile dysfunction treatment has since become more diverse. The patent journey of Viagra has had profound implications for the pharmaceutical market and the treatment of erectile dysfunction worldwide.
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How does it work?Although we had in TURP a very good and tested operation, there are side effects and costs associated with it. This led to many minimally invasive approaches over the last decade. Sadly most of these were abandoned due to or a high risk of pain or other side effects compared to TURP, or because they simply did not work! Previous Attempts with LasersMany laser energies have been used in the prostate before now, but limitations on laser power have meant removal of significant amounts of prostate tissue (the real test) has been impossible or unfeasibly slow. The only two contenders for the TURP crown up until now have been prostate electrovaporisation (easy to learn but higher risk of infection, impotence and incontinence) and holmium laser prostate enucleation (as effective as TURP but extremely difficult to learn and associated with severe operative complications in all but the most expert hands). The Greenlight HPS system from AMS addresses this problem by means of delivering a very powerful modulated laser beam which is absorbed by the haemoglobin pigment in tissue. This means that when the laser is applied to prostate tissue massive localised heating of the tissue occurs resulting in instantaneous vaporisation: due to the laser - characteristically bleeding is close to zero. Our results show that prostates of any size can be treated, with most men seeing their symptoms improve by two or three fold in the first six weeks. Many men have continuing benefits developing up to nine months after surgery The technique allowsrapid creation of a generous prostate cavity with almost no bleeding. More than 50% of men can leave hospital on the day of surgery without a catheter, with most others having a soft small catheter for around 18 hours at home (many men remove this themselves)Althoughwe placed catheters post operatively in our initial evaluation period, only a few men have had to have a catheter for more than 12 hours (these have usually been in urinary retention patients, and nearly all have voided extremely well on final catheter removal. Strikingly, very few patients report pain after the procedure: pain and burning on urinating have limited both laser techniques and TURP in the past. About one man in ten will get some burning which may need a fe weeks of simple painkillers to ease the discomfort. Sexual side effects are reduced compared to the standard technique. While very long term results are awaited, the figures after five years of follow up show improvements in symptoms and urological measurements comparable to historical TURP data (about one man in fifty requiring reintervention each year). In particular it appears the prostate tissue removal seen at the time of surgery is genuine when assessed by post-operative prostate ultrasound (between 40-60% of tissue reduction is seen). Post operative bleeding and discomfort can occur, but aremuch less than with standard TURP, and many men have gone back to work or normal activities within a couple of days, with sport and other activities being possible within a week or two. Of course, some men do take longer to recover and those men with very overactive bladders or catheters pre-operatlively may take some time to settle afterwards. Anticoagulation, large prostate size (>100g) and poor cardiac status are not contraindications to the procedure, even as a day case. Our results have been presented at a number of international meetings including the European Association of Urology and the American Urological Association Meeting. In particular our data on large prostates and the absence of absorption of irrigating fluid has attracted much interest. Mr Muir isa founder member of the International GreenLIght Users' Group, which seeks to fine tune and improve further the results from this therapy. IPSS Symptom scores changes following PVP to one year
The initial score of 23 on the IPSS system shows that most men were suffering severe symptoms which reduced by almost threefold within sixweeks. Urine flow rates at the same stage and out to five years in our series showimprovements of more than 100%.
GreenLight Training Courses at King's College Hospital (for urological surgeons wishing to learn the technique)
Course director: Gordon Muir, Consultant Urologist The course will be in the format of small group teaching with a mixture of didactic presentations linked to live 2 way videoconferencing observing a number of prostate vaporisations in the operating theatre downstairs from our conference room.. There will be an opportunity to visit our state of the art integrated operating theatres during procedures to observe the set-up and logistical issues relating to prostate laser surgery. The objectives of the course will be that at the end of the course participants will be able to:
Topics covered in the course include: GreenLight PVP results Previous lasers: problems and successes Why green light? Laser physics and safety Live cases Theatre and nursing issues Discussion: how to startup, avoiding complications
Certificates of GreenLight laser training and CME credits will be awarded to those who have successfully completed the training course. CME accreditation has been applied for. Refreshments and lunch are included in the course fee Course dates at King's College Hospital 6th April 2009 11th May 2009 8th June 2009 6th July 2009
Training video (NB this is NOT a substitute for attending a properly run course and having mentoring for the surgical technique) for further information on courses contact [email protected]
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GreenLight Training Courses
We are able to offer formal training courses for doctors interested in knowing about the GreenLight procedure. Formal half day courses are run in the Day Surgery Teaching UNit at KIng's College Hospital.
Course director: Gordon Muir, Consultant Urologist
The course will be in the format of small group (max 10) teaching with a mixture of didactic presentations linked to live 2 way videoconferencing observing a number of prostate vaporisations in the operating theatre downstairs from our conference room.. There will be an opportunity to visit the operating theatres during procedures to observe the set-up and logistical issues relating to prostate laser surgery.
The objectives of the course will be that at the end of the course participants will be able to:
Topics covered in the course include:
Certificates of GreenLight laser training and CME credits will be awarded to those who have successfully completed the training course
CME accreditation has been applied for.
Refreshments and lunch are included in the course fee