Posts Tagged: "pharmaceutical patents"

On Thursday, May 9, the Affordable Prescriptions for Patients (APP) Act was introduced into the U.S. Senate by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT). If passed by Congress and signed into law, the bill would modify the Federal Trade Commission (FTC) Act to give the FTC additional antitrust authority to challenge the anticompetitive nature of certain actions by pharmaceutical patent owners in the service of providing more consumer access to generic and biosimilar drugs.

On the morning of Thursday, March 7, the House Ways & Means Committee’s Subcommittee on Health held a hearing titled Promoting Competition to Lower Medicare Drug Prices. The hearing focused a great deal on the effect of patents in the pharmaceutical industry as they relate to pricing. Although some of the Republican membership of the subcommittee pointed out issues with various proposals to limit patent protections for drugmakers, the panel acted largely as a firing squad for patents. In his closing statement, Rep. Doggett expressed his dissatisfaction with the tenor of the day’s debate. “I view it as encouraging that there is bipartisan recognition of the serious problems so many Americans are facing with, really, prescription price gouging,” he said. “The question is whether we’ll have any bipartisan agreement on doing anything about it.”

While the claims-in-suit had previously survived validity challenges in an inter partes review (IPR) proceeding at the Patent Trial and Appeal Board (PTAB) and in a District of Delaware case, Aly credited additional testimony and evidence in this case with leading Judge Pallmeyer towards finding that the claimed advance was inherent to the invention in the prior art. “In IPR, there’s a limited record so there’s not a lot of testing to examine, and two tests were submitted in the Delaware case,” Aly said. While that could have been enough, he noted that, in the Fresenius Kabi case, multiple companies had done more than 20 tests, all of which showed that the claimed advances were inherent to the stable product.

Among members of the news media, patents have been a popular whipping boy when contemplating why Americans pay higher drug prices relative to the rest of the world. Meanwhile, the Chinese national government extended the period of exclusivity on pharmaceutical patents from 20 years up to 25 years. While China makes moves to embrace further innovation in the pharmaceutical sector by extending exclusivity for drug developers, the United States has evidenced an incredible amount of skepticism regarding the activities of pharmaceutical patent owners trying to protect their property.

In 2017, U.S. district courts saw a total of 417 patent infringement suits related to ANDA filings made by drugmakers with the U.S. Food and Drug Administration (FDA) seeking to bring generic versions of brand-name pharmaceuticals to the U.S. market. This total number of ANDA cases was below recent highs set in 2014 (437 cases) and 2015 (475 cases) but it was also a significant increase over the 324 ANDA cases filed in 2016. Going back to 2009, 2017 saw the third-highest number of ANDA cases in a single year. The fact that ANDA litigation is rising is pretty consistent with the number of ANDA applications being received by the FDA. In 2017, the FDA approved a record number of ANDAs with 763 such approvals that year; the agency attributed this uptick to an increased number of agency hires.

Thanks to a number of new Hepatitis C drugs (Sofosbuvir Ledipasvir, Ladispavir) the disease is curable for many patients. While this is an undeniable victory for patients and payers, the innovators who made this possible have been villainized and undermined. At a time when the public health community should celebrate the tremendous health benefits these breakthrough drugs have brought to patients around the world, they are instead organizing to ensure the destruction of the incentives that made these drugs a reality. A recent study from the Centers for Disease Control and Prevention estimates that 2% – 3% of the world’s population is living with hepatitis C. The World Health Organization states that globally an estimated 71 million people have chronic hepatitis C infection and approximately 399,000 people die each year from the disease.

A group of six patent law professors filed an amicus brief with the Court of Appeals for the Federal Circuit in Cleveland Clinic v. True Health Diagnostics. The professors’ brief urges the Federal Circuit to reverse a finding by the lower court invalidating patents asserted by Cleveland Clinic covering diagnostic methods for atherosclerotic cardiovascular disease. According to the brief, the district court’s invalidation of Cleveland Clinic’s patents represents an improper application of 35 U.S.C. § 101, the basic threshold statute governing the patentability of inventions.

Respiratory syncytial virus, commonly referred to simply as RSV, is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. Up to 2.5 million infections occur in the U.S. each year. It is also the leading cause of childhood hospitalization globally. Nearly all children are infected with the virus at least once by the age of two to three years, and many develop pulmonary disease and/or asthma that persists throughout adult life, making them susceptible to re-infection. RSV particularly dangerous for premature babies, children with preexisting health conditions and the elderly, and is responsible for 16,000 deaths each year in adults over 65.

On Thursday, December 15th, a subsidiary of Kenilworth, NJ-based pharmaceutical developer Merck & Co. (NYSE:MRK) was awarded $2.54 in royalty damages in a case involving one of the most popular available treatments for combating the hepatitis C virus (HCV). A federal jury decided that Gilead Sciences Inc. (NASDAQ:GILD), an American biotech firm headquartered in Foster City, CA, owed these royalties as a result of its infringement of patents for HCV treatments held by Merck’s Cambridge, MA-based subsidiary Idenix Pharmaceuticals. According to coverage of the verdict by Bloomberg, this $2.54 billion royalties award is the largest verdict for patent infringement in the history of the United States. The case was decided by jury in the U.S. District Court for the District of Delaware (D. Del.).

Last week the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) instituted six separate inter partes reviews (IPRs) against patents owned by Allergan plc, which cover RESTASIS®. Each of the patents is listed in FDA’s Orange Book and are set to expire on August 27, 2024. Each of these patents, with the exception of the ‘191 patent, were previously challenged by Apotex Corporation in IPRs filed on June 4, 2015. The Apotex IPRs were settled on December 16, 2015, prior to any decision on institution.

Pharmaceuticals is the industry sector where a strong patent system, promising substantial returns to successful innovation, is of paramount importance. Regrettably, the weakening of pharmaceutical patent rights through legislative means and antitrust lawsuits is symptomatic of a broader and more general policy attack that antitrust enforcers have directed against patents in recent years. Antitrust enforcers and legislators clearly need a few remedial lessons in the economics of innovation before their myopic meddling cripples the (up-to-now) highly successful American pharmaceutical sector and other key U.S. industries, which have stood as a testament to the value of strong patent rights.

The stark reality of how government operates leaves us with a patent system that will be perpetually on the brink. Giant corporations have become effectively insulated from any consequences associated with stealing patented innovations, yet they continually want more and more help from Congress, which they dress up and roll out as “reform.” Even if they fail this time these companies will return, with more lobbyists and special interest groups demagoguing innovators as inherently evil, Satan practically. Rather than recognize the critical role patents play in the innovation ecosystem and in the U.S. economy, Congress is poised to flush the patent system down the drain because there are a handful of giant tech corporations that believe they would benefit.