Hatch files Amendment to Fix IPRs for Pharma

Senator Orrin Hatch (R-UT), co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee to address what many characterize as abusive inter partes review (IPR) filings relating to brand name pharmaceuticals. According to Senator Hatch, his amendment is intended to fix IPRs and restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development. The Hatch-Waxman Act encourages generic drug manufacturers to challenge patents of brand name drugs by filing Abbreviated New Drug Applications with the Food and Drug Administration, which can and typically does result in patent infringement litigation in federal district court.

“As the coauthor and namesake of Hatch-Waxman, I have a keen interest in ensuring we have a well-functioning generic drug industry,” said Senator Hatch in a press release published last night. “My amendment will ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop low-cost drugs while at the same time ensuring brand-name companies have sufficient protections in place to recoup their investments.”

In recent years inter partes review (IPR) at the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) has created an alternative path to challenge the patents of brand name drugs; a path alternative to the path envisioned in Hatch-Waxman. Those who support the Hatch-Waxman regime view IPRs as upending the careful Hatch-Waxman balance.

Senator Hatch’s amendment, the Hatch-Waxman Integrity Act of 2018, would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation, which affords certain advantages such as being able to rely on the drug innovator’s safety and efficacy studies for FDA approval, and IPR, which is cheaper and faster than Hatch-Waxman litigation but does not provide the advantages of a streamlined generic approval process. Parties would not be able to use both. In this way, the amendment aims to fix the misuse of IPRs by generics as parallel and duplicate proceedings to disputes already in place under Hatch-Waxman.

Politically, this Hatch “pick a path amendment is going to be paired with S. 974, The CREATES Act of 2017 (H.R. 2212).  This legislation aims to enable the sharing of samples so that generics can compete more effectively.  You can learn more about the substance of the CREATES Act by reading Senator Leahy’s summary here. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act enjoys broad, bipartisan support from Senators Leahy, Grassley, Feinstein, Graham, Durbin, Lee, Whitehouse, Cruz, Klobuchar, Kennedy, and Blumenthal.  Generics want the CREATES Act, and there are 28 co-sponsors.  The bill was voted out of the Judiciary Committee favorably, but Hatch voted against it.

Raising and connecting the Hatch-Waxman IPR fix to the CREATES Act balances two major interests of both the brand and generic industries.  Brand needs this Hatch-Waxman IPR fix and generics want CREATES.  Like Hatch’s original objective with Hatch-Waxman, each side gains something…resolving a major problem for them…and neither loses anything that they had any reasonable expectation that they would, or should, be able to maintain.

Tentative FDA Approval for Oral Pediatric HIV Treatment

Mylan Inc. recently announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients. The FDA’s tentative approval through the President’s Emergency Plan for AIDS Relief (PEPFAR), which is a U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world, means the formulations meet all of the agency’s quality, safety and efficacy standards. Mylan’s products are expected to be eligible for purchase in early 2015.

The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative (CHAI) and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation, at low cost, to a total of 115 resource-limited countries including all low-middle  income, least-developed countries and sub-Saharan Africa.


Cancer Research: New Hope for Pancreatic, Prostate Cancers

As many who are familiar with me may recall, my mother lost her battle with lung cancer approximately 19 months ago. Since that time, whenever I am trolling for news and items that I might be able to write about, I am continually drawn to news items discussing cancer research.

As anyone who is familiar with clinical trials know, there is no guarantee that even exciting therapies will ever make it to market, much less have a positive impact on patients. Still, the research has to start somewhere and science moves at a deliberate pace. As Thomas Edison even famously quipped, even a failure is successful at teaching what is now not possible.

Positive news stories about cancer research and development also provide hope. Cancer has taken far too many lives. With continued, concerted effort, eventually it will be eradicated. Whether that will be in our lifetime…who knows. It certainly won’t be if patent rights continue to erode. Without strong patent rights, there just isn’t going to be the incentive to pursue speculative therapies, drugs and treatments that cost hundreds of millions of dollars to develop and take to market…particularly when so many fail.

In any event, as I was looking for interesting things to write about, I stumbled across a pair of potentially interesting items…one dealing with pancreatic cancer and the other dealing with prostate cancer. For more information on FDA, pharma and biotech law, please also check these PLI resources:


Hatch-Waxman: Eli Lilly Sues Actavis after ANDA Filed on Axiron®

Actavis PLC (NYSE: ACT) recently filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Topical Solution, 30mg/1.5mL.  Actavis’ ANDA product is a generic version of Eli Lilly and Company’s Axiron®, which is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Eli Lilly and Company and Acrux DDS Pty Ltd. filed suit against Actavis on November 12, 2013, in the U.S. District Court for the Southern District of Indiana seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain of its U.S. patents.  The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.


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.