Posts Tagged: "FDA"

The Supreme Court of Canada issued a ruling in AstraZeneca Canada Inc. v. Apotex Inc., which gives patent owners a far greater ability to protect their intellectual property in the face of Canada’s Promise Doctrine, a part of Canadian patent law that requires an invention to be “useful” in order to be patent-eligible subject matter. The ruling is being heralded by patent owners, especially those in the pharmaceutical space, and it provides an interesting juxtaposition in contrast to recent United States policy, which has been tipping the scales in the favor of generic drugmakers over branded pharmaceuticals.

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(l) has two notification requirements that are important to this case… The second question addressed by the Court was whether the applicant must provide notice after the FDA licenses its biosimilar, or if it may provide notice before the FDA licenses its biosimilar. The Court concluded that an applicant might, but does not have to, provide notice to the manufacturer of the biologic before obtaining a license from the FDA.

The Eastern District of Texas granted a preliminary injunction against Aurobindo in favor of Mylan in the case of Mylan Institutional LLC v. Aurobindo Pharma Ltd. On appeal at the Federal Ciruit, Aurobindo challenged three district court findings: 1) it was likely that Aurobindo infringed; 2) Aurobindo failed to raise a substantial question of validity; and 3) there was irreparable harm to Mylan. The Federal Circuit found that, while the district court made some errors, it correctly analyzed one of the three Mylan patents, and the preliminary injunction was affirmed.

In Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., the Federal Circuit reversed the district court and held that Helsinn’s pre-AIA patent claims, “were subject to an invalidating contract for sale prior to the critical date,” and furthermore, “the AIA did not change the statutory meaning of ‘on sale’ in the circumstances involved here.” The asserted claims of the post-AIA patent were also ready for patenting prior to the critical date… The on-sale bar, before and after the AIA, does not require a finding that the offer or sale disclosed the details or claimed features of the invention, so long as the product embodies those features when sold. An invention is reduced to practice, and ready for patenting, when it is reasonably shown to work for its intended purpose, which for a pharmaceutical product is not contingent upon FDA approval.

The old arguments that patents inhibit innovation, and non-exclusivity with compulsory licensing leads to a brave new world are now in vogue. We’ve stood at this fork in the road before. It requires courage to reject the easy path downward and restore the system which created our prosperity. If we lack the will, we have no one else to blame as we plunge deeper into the mire. That’s the last place anyone wanting to drain the swamp while growing the economy should go.

Each year, millions of men rely on pharmaceuticals like Viagra and Cialis for their erectile dysfunction (ED), but they may not be the only ones facing dysfunctionalities. As the patents on these lucrative lifestyle drugs come to an end, price tags and bottom lines are expected to plummet… The lifestyle drug market is extremely lucrative. These medications can be used by all age groups worldwide and increased individual awareness of health and beauty has created a demand for physical fitness and improved performance of all our body parts. People are living longer, have higher disposable income, and the demand only grows more when a drug touts the high quality and safety of their formulations after it passes the stringent requirements for FDA approval… The real question, however, is whether U.S. patent law and policy will continue to give pharmaceutical companies the incentives necessary to innovate lifesaving medicines, or whether we will continue to see more and more blockbuster lifestyle drugs moving into the future.

On April 6, 2017, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in The Medicines Company v. Mylan, Inc. (2015-1113, 2015-1151, and 2015-1181) that imports certain subject matter from the specification into the claims… This case provides some key takeaways for patent practitioners, some more obvious than others. First, as has been known for some time, referring to the “invention” in a patent’s specification can hurt, as can indicating that a particular process “includes all” of the embodiments the specification describes. This is why patents for inventions in the U.S. now curiously, if understandably, usually avoid using the word “invention”. Also, setting forth definitions in a specification can have unintended consequences not just for the term being defined but also for terms that are not explicitly defined even if unequivocally characterized in some other way. Prosecution history also matters too, particularly where an applicant distinguishes its invention during prosecution by explicitly characterizing “the invention” in terms divorced from the language of the claims themselves.

A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and “exclusivity” separately. “Exclusivity” refers to exclusive marketing rights granted by the FDA upon approval and was designed to promote a balance between new drug innovation and generic drug competition. Some differences are that patents can be issued or expire at any time – before, during or after FDA approval– while exclusivity attaches upon approval of a drug product. Further, some drugs have both patent and exclusivity protection while others have just one or neither… Make no mistake, it would be tremendously unwise to proceed sans patents. No patent means the generic can enter the market as soon as the FDA exclusivity period expires, and having a patent can extend the exclusivity period to the end of the patent term, often years later.

Mylan had to show by clear and convincing evidence that the idea for the ’445 patent claim was conceived by someone at the FDA and communicated to Mr. Pavliv, the named inventor. The Court agreed with the district court that Mylan did not carry the burden of showing that someone other than Mr. Pavliv had conceived a “definite and permanent idea” of an EDTA-free Acetadote formulation. Mylan argued that Mr. Pavliv’s prior communications with the FDA, including the FDA’s request for justification of the inclusion of EDTA, required Cumberland to undertake research that would have inevitably led to the invention. However, this was not the same as a suggestion to remove EDTA. Derivation is not proved by showing conception and communication of an idea different from the claimed invention, even if that idea would make the claimed idea obvious.

On January 5, 2017, the District of Delaware issued its long-awaited decision in the patent dispute pending between Amgen and Regeneron wherein the Court granted Amgen’s request for a permanent injunction against Regeneron’s new PCSK9-inhibitor cholesterol drug. Both Amgen and Regeneron each independently spent billions of dollars over the past decade-plus developing a new class of cholesterol drug. The drug itself comprises an antibody that binds to PCSK9 proteins… Whereas Regeneron managed to be the first to market, Amgen succeeded in getting to the Patent Office first. Amgen originally sued Regeneron, along with Sanofi, its European partner, in October 2014. Amgen asserted three patents directed to antibodies that bind to PCSK9. Over the next month, Amgen commenced additional lawsuits as new patents issued from the Patent Office. The cases were eventually consolidated, but Amgen eventually went to trial against Regeneron on only two of the originally asserted patents.

With the Cures Act now signed into law, the incoming Trump administration has an opportunity to advance the broad-spectrum medical countermeasure goal set forth by the U.S. Department of Health and Human Services (HHS) 2015 Public Health Emergency Medical Countermeasure Enterprise, otherwise known as PHEMCE. If achieved, the PHEMCE broad-spectrum goal would spur the advancement of innovative therapeutics to defend against the many pathogens that are not addressed with traditional disease-specific drugs or vaccines approved by the FDA.

Earlier today, by a vote of 94 to 5, the United States Senate overwhelmingly passed the 21st Century Cures Act. Having passed in the House, the Cures Act now goes off to the White House for the President’s signature, where it will receive a warm reception. “I’ll sign it as soon as it reaches my desk, because like a lot of you I’ve lost people I’ve loved deeply to cancer,” President Obama said in his weekly address on December 3, 2016, as he called upon Congress to act swiftly to pass the legislation and send it to the White House.

The 21st Century Cures Act has broad bipartisan support having been passed in the U.S. House by an overwhelming 344-77 roll call vote. It also has the backing of the White House; a statement release from the White House’s Office of the Press Secretary on November 30th calls the 21st Century Cures Act “critically important legislation” which increases funding to combat the American heroin epidemic, supports the “Cancer Moonshot” led by Vice President Joe Biden and takes meaningful steps towards improving mental health and Alzheimer’s disease outcomes.

Modeled after the Hatch-Waxman Act, the BPCIA seeks not only to encourage competition in the field of biologics but also to promote innovation by, among other things, providing twelve years of market exclusivity to pioneer biologics… Like the Hatch-Waxman Act, the BPCIA also sets out a process for identifying disputes over patent infringement and managing any ensuing litigation once an applicant seeks a biosimilar license… To streamline the first wave of litigation, the BPCIA mandates that following the biosimilar applicant’s receipt of the RPS’s detailed statement on infringement, the parties negotiate in good faith to select patents for litigation from the lists initially provided by the RPS and the biosimilar applicant. [§ 262(l)(4)].

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug Applications (ANDAs) and 505(b)(2) new drug applications. Many provisions of the new rules affect information that must be submitted by applicants regarding patents which could affect the outcome of applications for new generic versions of drug treatments.