Posts Tagged: "biosimilars"

Courts Answer Key Questions Over the Reach of the BPCIA

Two recent Federal Circuit opinions provide some answers to the issues presented by complaints alleging non-compliance with the BPCIA. In Amgen Inc. v. Sandoz Inc., the Federal Circuit concluded that an aBLA filer’s participation in the patent dance is not mandatory under the BPCIA. 794 F.3d 1347 (Fed. Cir. 2015). Where an aBLA filer elects to forego the patent dance by failing to provide the aBLA and the biosimilar manufacturing information to the RPS, the only remedy available to the RPS lies in a declaratory judgment action for patent infringement, as expressly contemplated by § 262(1)(9)(C). In addition, the court concluded that an aBLA filer who did not engage in the patent dance was required to provide a notice of commercial marketing and that such notice could be effectively given only after the FDA had approved the aBLA. The court’s ruling left open the question whether an aBLA filer who participated in the patent dance was required to provide a notice of commercial manufacturing. This decision is on appeal to the Supreme Court, which has yet to decide whether it will hear the issue.

Biologics Applicant Must Give Post-Approval Notice to Reference Product Sponsor

The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would extend the 12-year exclusivity period given to a sponsor by 180 days (six additional months). Even when market entry is delayed under (8)(A) by 12 years plus 180 days, the result is the same, because the 12-year date is established as the earliest date, not the latest date, on which a biosimilar license can take effect. The Court affirmed that section (8)(A) covers applicants that filed (2)(A) notices as well as those that did not. This is to ensure that the necessary decision-making regarding further patent litigation starts from when the applicant’s product, uses, and processes are fixed by the FDA license. The 180-day period gives the sponsor essential time to assess its infringement position for the final FDA approved product and the as to yet-to-be-litigated patents. This is confirmed by the legislative history of the Biologics Act. Thus, an applicant must provide a reference product sponsor with the 180-day notice under 8(A), after approval and before commercial marketing begins, whether or not the applicant previously provided a (2)(A) notice of the FDA review.

The Amgen Quagmire: Federal Circuit Rules Patent Dance Does Not Excuse Biosimilar Applicants from Providing Notice of Intent to Market

The Supreme Court is currently considering whether to review Amgen Inc. v. Sandoz Inc., the Federal Circuit’s first decision regarding the Biologics Price Competition and Innovation Act (BPCIA). Although the Federal Circuit does not technically have any input into the Supreme Court’s grant or denial of certiorari, it nonetheless took the opportunity last week to bolster one of the challenged holdings: that a biosimilar applicant cannot provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product until that product is licensed. Specifically, in the course of ruling in Amgen Inc. v. Apotex Inc. that a biosimilar applicant must provide such notice even if it participated in the BPCIA’s so-called “patent dance,” the Federal Circuit addressed a primary criticism of its earlier decision, namely, that permitting only post-licensure notice effectively extends by 180 days the twelve-year exclusivity term of the biologic product. The solution suggested by the panel, however, is far from a legal certainty.

Clinical Trials and Tribulations: Why IP Protection is Critical to the Future of Biologic Medicine

Given the importance of intellectual property rights to economic growth and technological development, as well as the wider benefits of biopharmaceutical research, the provisions found in the recently negotiated Trans-Pacific Partnership (TPP) Agreement to protect biologic medicines are disappointing… As clinical trials become increasingly costly, these costs are increasingly born by the biopharmaceutical industry. A recent study from the Johns Hopkins Bloomberg School of Public Health calculates that the biopharmaceutical drug and medical device industry now funds six times more clinical trials than the federal government.

IP Protection for Biologics in the TPP: Trading Away Future Treatments and Cures

Globally there are approximately 7,000 medicines in development to treat and cure a wide variety of diseases. Of these, more than 5,000 are in development in the United States. It’s difficult to argue that the strength and success of the U.S. biopharmaceutical industry is uncorrelated with the IP protection available here. It is, therefore, disappointing that the recently negotiated Trans-Pacific Partnership (TPP) Trade Agreement fails to deliver sufficient IP protection for biologics. Much of the continuing controversy plaguing the TPP Agreement surrounds data exclusivity protection for biologic medicines and the future of the agreement may hinge on precisely this issue.

Trans-Pacific Partnership – What do IP practitioners need to know?

Trade partners negotiating the Tans-Pacific Partnership trade deal have reached an agreement. The agreement details have not been released, and likely will not be submitted to Congress for a mandatory review for at least a month, perhaps longer… Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement reportedly knocks that term of protection down to 5 years. While the term of data exclusivity is not one in the same with reducing the term of market exclusivity, there is little doubt that more limited data exclusivity would likely lead to significant negative consequences for the bio-pharma industry.

Obama Administration Caves on Data Exclusivity in Historic TPP Trade Deal

In order to reach an agreement the United States granted a key concession relating to biologics, which are advanced medicines made from living organisms. Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement knocks that term down to 5 years. Sources have confirmed to me that a TPP deal that so substantially reduced biologic data exclusivity will face an uphill battle in Congress.

The Need for Regulatory Data Protection in the TPP: Why Australia’s Got it All Wrong

While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe and effective. Regulatory data protection safeguards this data for a limited period of time, preventing competing firms from free-riding on the data that was generated at great expense. Specifically, biosimilar firms seeking regulatory approval are required to produce their own preclinical and clinical trial data to establish safety and efficacy, or wait the set period of time after which they are able to utilize the innovator’s prior approval in an abbreviated regulatory approval, eliminating the need for independently generated data.

The Sticking Point that Shouldn’t Be: The Role of Pharmaceutical Patents in the TPP Negotiations

The controversy swirling around the Trans-Pacific Partnership (TPP) Trade Agreement sheds light on two critically important but divisive issues: international trade and intellectual property protection for pharmaceuticals. One of the most significant sticking points in the negotiations is the issue of intellectual property protection for pharmaceuticals, specifically data exclusivity. Data exclusivity is a means of correcting a free-riding market failure, providing the innovative firms with a limited period of time in which data from clinical trials and other required testing cannot be used by competing firms to secure market access.

Biosimilars at the Federal Circuit – Will this be the Last Dance?

This statute tried to mirror the Hatch-Waxman statute for small molecules, including both an abbreviated drug approval process and a mechanism to address any patent claims during drug approval. However, because of the differences between these two types of drugs, stemming from the increased complexity in manufacturing and patent protection, unique provisions were included in the BPCIA. Unfortunately, as Judge Lourie of the Federal Circuit put it, the BPCIA could win a “Pulitzer prize for complexity or uncertainty.” And, it is these new provisions that could prove the downfall of the BPCIA, at least as it currently exists.

When Patents Aren’t Enough: The Case for Data Exclusivity for Biologic Medicines

Although complementary, patents and data exclusivity protection incentivize innovation in different ways and serve distinct purposes. Patents provide protection for innovations that meet the standards of patentability and are novel, nonobvious, and useful. In the context of biopharmaceuticals, patents protect both breakthrough discoveries as well as incremental improvements. Due to the length of the drug-development and patent-approval processes, effective patent terms rarely correspond to FDA approval. Accordingly, in some cases innovative therapies may experience patent expiry shortly after making it to market. In contrast, data exclusivity protects the tremendous investments of time, talent, and financial resources required to establish a new therapy as safe and effective. This is accomplished by requiring competing firms seeking regulatory approval of the same or a similar product to independently generate the comprehensive preclinical and clinical trial data rather than rely on or use the innovator’s data to establish safety and efficacy of their competing product.

Protecting Data Exclusivity, Protecting the Future of Medicine

Traditionally, “small molecule” drugs are patent protected for a twenty-year term. Biologic medicines, however, are more difficult to comprehensively protect with patents due to their size, complexity, and numerous similar effective variants. This comprehensive protection is critical given the investment and risk associated with biologics. Estimates are that the pre-approval cost of developing a biologic approaches $1.2 billion and that the time needed to recover the pre-approval R&D costs be between 12.9 and 16.2 years. In the United States, the Biologics Price Competition and Innovation Act of 2009 (“Biologics Act”) provides for 12 years of exclusivity for the drugs. Through this, Congress endeavored to fill the void left by patents and trade secrets in the protection of biologics.

Bio-Pharma at the U.S. Supreme Court

Since my last article here on IPWatchdog.com, the pharmaceutical industry has been simply overflowing with interesting developments, including the US Supreme Court hearing arguments concerning three significant cases. The first case argued at the Supreme Court will determine whether generic drugmakers can be sued for alleged flaws in the design of their medications. Another argument before the Supreme Court was about pay-to-delay deals in which a brand-name drugmaker agrees to pay a settlement to a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date. The Court also heard arguments about a case that raises crucial questions about whether human genes can be patented. And the outcome may well reset the boundaries and direction of medical research in the US, which of course has tremendous implications for investments made by the biopharmaceutical industry and the battle against many diseases, notably cancer.

Exclusive Interview: Jim Greenwood, President & CEO of BIO

On Wednesday, April 21, 2010, I had the pleasure of conducting an exclusive, on the record interview with Jim Greenwood, former Congressman and current President & CEO of BIO. It was a treat to chat with Jim Greenwood. Our conversation lasted about 35 minutes, and we talked about his decision to leave Congress to take over at BIO, exciting new technologies BIO companies are working on, healthcare reform, the importance of patents to start-up companies and capital investment requirements. We also learn that he is an avid bird watcher and has started to become a bit of a gym rat.

Health Care Bill Good for BIO According to Greenwood

Notwithstanding the above, I am conflicted in my feelings. It seems that one of the deals included in the Health Care Bill, provisions aimed at biotechnology, are unquestionably good. This is not the type of deal where residents of Nebraska get the rest of us to pay for them, or where seniors in Florida get to keep prescription coverage courtesy of the federal government while seniors everywhere else lose. The provisions favorable to the biotech community will spur innovation, lead to new cures and undoubtedly prolong life. If only Congress could have passed these provisions and scrapped the rest.