FDA Designates Orphan Drug Status for Rare Diseases

The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. At the time of the enactment of the Orphan Drug Act, the United States Congress made several factual findings.  For example, the Congress observed that there are many diseases and conditions, such as Huntington’s disease, ALS (Lou Gehrig’s disease), Tourette syndrome, and muscular dystrophy, for example, which affect such small numbers of individuals that the diseases and conditions are considered rare in the United States.  As a result, adequate drugs have not been developed and realistically cannot be expected to be developed because companies would likely incur a financial loss in the pursuit of such drugs, given the high cost of developing drugs.

Back in the early 1980s when the Orphan Drug Act passed, Congress made the determination that a seven (7) year period of exclusivity was appropriate if a company produced a drug to treat a rare disease that affects less than 200,000 people in the United States.  Orphan designation is also possible if a disease affects more than 200,000 people if it can also be shown that there is no reasonable expectation that the cost of developing the drug could be recouped absent this period of exclusivity. This “patent-like” exclusivity is available even if the drug is not novel and non-obvious.


Forest Labs sues over Generic Version of SAVELLA®

savellaForest Laboratories, Inc. (NYSE:FRX) and Forest Laboratories Holdings, Ltd. (collectively, “Forest”) announced the filing of patent infringement lawsuits in the U.S. District Court for the District of Delaware against Apotex Corp.; Hetero USA Inc.; Lupin Ltd.; Mylan Pharmaceuticals, Inc.; Par Pharmaceuticals, Inc.; Ranbaxy Laboratories Ltd.; and related companies and subsidiaries. The complaint alleges the aforementioned companies are infringing U.S. Patent No. 6,602,911 (“the ‘911 patent”), U.S. Patent No. 7,888,342 (“the ‘342 patent”), and U.S. Patent No. 7,994,220 (“the ‘220 patent”), which relate to Forest’s SAVELLA® product. Forest licenses the ‘911 patent, the ‘342 patent, and the ‘220 patent from Royalty Pharma.

Forest and Royalty Pharma received notification from these companies that they had filed Abbreviated New Drug Applications with Paragraph IV certifications seeking approval to market generic versions of SAVELLA before the expiration of the ‘911 patent, the ‘342 patent, and the ‘220 patent. The lawsuits were commenced before the expiration of 45 days from the date of receipt of each notification letter.


Patent Docs: Top Biotech/Pharma Patent Stories of 2011

We are pleased to share the latest from our friends at PatentDocs.org, the Biotech and Pharma Patent Law and News Blog. The authors, Donald Zuhn and Kevin Noonan, are partners at McDonnell Boehnen Hulbert & Berghoff, LLP, and contribute to Patent Docs on a daily basis. Today’s post comes from Patent Docs’ fifth annual list of the top biotech/pharma patent stories covered by Patent Docs in 2011. These stories were selected based on their potential to have the greatest impact on biotech/pharma patent practitioners and applicants.

Below is the post that covers the stories ranked numbers 12- 10. For access to the entire list of the top biotech/pharma stories of the past year, click here. (more…)

Implementing the Biologics Price Competition and Innovation Act?

Alexandra McTague, of DLA Piper, sent in this article discussing whether the final rules the FDA implements for follow-on biologics will actually end the debate surrounding the Biologics Price Competition and Innovation ACT (BPCIA).

The vigorous debate over the Biologics Price Competition and Innovation Act (BPCIA), which aims to provide an expedited approval framework for follow-on biologics, will likely inform the final rules the FDA implements, and those rules will determine the business strategies of innovator companies and the extent to which generic companies use the BPCIA.

Biosimilars vs. interchangeable biologics

Under the BPCIA, generic biologics can be characterized as “biosimilar” to or “interchangeable” with innovator products. Both require clinical studies for approval, with interchangeability requiring a higher showing. Only those follow-on biologics designated as “interchangeable” can be automatically substituted by a pharmacy for the innovator’s product. As a result, generic companies will have to market biosimilars to boost prescriptions and sales. Thus, when seeking approval, generic companies will weigh the cost of marketing biosimilars against the cost of the yet-to-be-determined clinical testing requirements for interchangeables. If those requirements are too onerous, the generic company may instead choose to pursue a Biologic License Application (BLA), which has the benefit of circumventing the innovator company’s marketing exclusivity. (more…)