Archive for June, 2011

Report From Bio – Everyone Into The Pool!

Thursday, June 30th, 2011

I have been hearing about “patent pools” for biotech patents for years, but Kristen Neuman made it much more real at a Break-Out Session on Diagnostics and Personalized Medicine at the BIO International Convention in DC today (6/29/11). The session was chaired by Jennifer Gordon of BaketBotts but the star was Ms. Neuman of Proskauer who appeared on the panel representing Libreasse, a program sponsored by MPEG-LA, the group that settled the MPEG-2 patent disputes by setting up a patent pool where electronics’ manufacturers could license the patent rights they needed to develop say, iPods, by paying a single royalty.

Ms. Neuman proposed a similar model for patents directed to biomarkers and their use in diagnostic/predictive assays that are the foundation of personalized medicine – such as the Myraid patents. She said that the group had studied patents relating to diagnosing Lynch Syndrome, a condition involving colorectal cancer and endometrial cancer and had found at least 12 patents relating to gene mutations associated with this disorder owned by 12 institutions and private companies. As a model, she proposed that these rights owners would form a patent pool.  Any entity wishing to develop a clinical assay for this syndrome would be able to cut through this patent thicket by pulling their cart through the resultant patent “supermarket” online and obtaining non-exclusive, field-of-use limited licentiates to the patents they needed to proceed. She identified other patent thickets as associated with hereditary hearing loss, CV disease, and schizophrenia.

The audience was not totally receptive to the concept, and pointed out the exclusionary value of such “companion diagnostic” patents in innovator labeling (read Caraco for background) and in business models that depend on developing marketable assays from just a small group of the patents. Both admissions criteria and enforcement issues were also raised as concerns. Still, this was an inspiring proposal for those who believe that patent thickets pose a real danger to innovation. I am not quite ready to shop at this patent boutique but, given that draconian remedies such as exempting certain diagnostic assays from liability for infringement have been proposed in Congress, this proposal deserves our attention.

Supreme Court Grants Cert. In Caraco

Monday, June 27th, 2011

Today (June 27, 2010), the Supreme Court granted cert. in yet another patent appeal, Caraco Pharm. Labs., Ltd., v. Novo Nordisk, (Supreme Ct. 10-844). Earlier this month, I did an extensive post on the decision below, in which the Fed. Cir. denied Caraco’s counterclaim seeking to strike the broad “use code” that Novo had put on its drug, Prandin (U-968). Even though Caraco would market the generic for a narrower use, the broad use code effectively prevented Caraco from “carving out” the still-patented use(s) from its labeling, thus effectively keeping it off the market.

I took a chance by posting on this one because the Solicitor General’s office recommended review and there was a strong dissent below. However, when the appeal started getting some attention in the press – though the issues were often mischaracterized – it began to look more likely that cert. would be granted. I am not so sure that the Fed. Cir.’s recent streak of affirmances will be left intact.

Supreme Court Grants Cert. In Mayo v. Prometheus

Monday, June 20th, 2011

Today, in what may be an ominous turn for biotech IP law, the Supreme Court granted cert. for the second time in Mayo Collaborative Services v. Prometheus Labs., Inc, Supreme Court No. 10-1150. Post-Bilski, the Supreme Court granted cert., vacated and remanded the Fed.  Cir.’s decision, rendered December 17, 2010, (related posts are archived under “patentable subject matter”) that reaffirmed that claims involving methods of medical treatment coupled with determining the levels of metabolites of the administered drugs were directed to patentable subject matter, and were not directed to abstract ideas or phenomena of nature. 628 F.3d 1347 (Fed. Cir. 2010).

Is it pay-back time? In the decision below, the Fed. Cir. pointedly in fn. 2, declined to give weight to the “Metabolite Labs. dissent,” 548 U.S. 124) in which Justices Breyer, Souter and Stevens would have found claims to an assay for cobalamin deficiency patent-ineligible as involving “natural correlations and data-gathering steps.” The Prometheus claims are not without vulnerable points. The Fed. Cir. agreed that the steps recited comparing the determined level of the metabolite to a benchmark level and concluding that a need exists to increase or decrease the amount of the drug administered were mental steps and not per se patentable. The Fed. Cir. also held that the first steps of the claims – the administering and determining steps – were not merely data gathering steps, but were central to the claimed method of optimizing therapeutic efficacy of the treatment.

While two of the three Justices who wrote the Metabolite dissent have retired, the Court clearly feels that there are issues here that need resolution. However, it is difficult to see how “methods of medical treatment” could remain patentable subject matter if these claims are held not to be. While processes are s. 101 patentable subject matter, John L. White’s Chemical Patent Practice (1993) felt it necessary to include a section “Process of Treating Humans.” Paragraph three begins:

“Claims to the treatment of humans medicinally are now allowed. Ex parte Timmis (POBA 1959) 123 USPQ 581 (treatment of chronic myeloid leukemia). The fact the claimed process for modifying a function of the human body (combating the clotting of blood) involves a mental determination of the amount administered is not a bar to patentability where that portion is an incidental feature of the process. Ex parte Campbell et al., (POBA 1952) 99 USPA 51.”

These decisions are from the nineteen fifties not the eighteen fifties! In Prometheus, the Fed. Cir. explicitly noted that claims to methods of medical treatment are patentable subject matter. Are modern medicine and IP law about to part ways?

628 F3d 12_17_10

Caraco – The Little Counterclaim That Could?

Thursday, June 16th, 2011

I normally try to steer clear of issues raised in Hatch-Waxman litigation between the “innovators” and the “generics,” unless it raises specific points of patent law of general interest – there is just so much of it, and other blogs that are dedicated to following its often double-jointed trail. However, the Supreme Court may well grant cert. within the next few weeks in  Caraco Pharm. Labs, Ltd. V. Novo Nordisk, Supreme Ct. 10-844, opinion below, Novo Nordisk A/S v. Caraco Pharm. Labs. Ltd, 601 F.3d 1359 (Fed. Cir. 2010), reh’g den. 615 F.3d. 1374 (2010), evidenced both by the fact that the Solicitor General filed an amicus brief requested by the Court that supported cert., and the Fed. Cir. decision below drew a strong dissent.

There is almost no way to do a short course on the laws, regulations, and strategies employed by holders of NDA-approved drugs (the innovators’ or branded’s drugs) to keep generic competitors out of the market, but I will try to summarize the relevant facts. An innovator will list an FDA approved drug in the “Orange Book” along with a list of patents certified to cover the drug or its method of use in treatment. The innovator also provides a use code for each patent (e.g., U-83 is treatment of seizures, but some use descriptions are very narrow, e.g., Use of drug x with drug y and drug z to  improve glycemic control in patients with condition w.) These “use codes” are important because they are supposed to be reflected in the labeling.

(more…)